17beta-estradiol 3-benzoate : A benzoate ester resulting from the formal condensation of benzoic acid with the phenolic hydroxy group of 17beta-estradiol. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]
| ID Source | ID |
|---|---|
| PubMed CID | 222757 |
| CHEMBL ID | 282575 |
| CHEBI ID | 77006 |
| SCHEMBL ID | 174896 |
| MeSH ID | M0200617 |
| Synonym |
|---|
| BIDD:ER0126 |
| MLS002207215 |
| (17beta)-17-hydroxyestra-1(10),2,4-trien-3-yl benzoate |
| benzoato de estradiol [inn-spanish] |
| reglovar |
| estra-1,3,5(10)-triene-3,17-diol (17-beta)-3-benzoate |
| oestradioli benzoas |
| estradioli benzoas [inn-latin] |
| estradiol benzoate (van) |
| estradiol-17beta 3-benzoate |
| oestraform (bdh) |
| nsc 9566 |
| benzo-ginestryl |
| benztrone |
| oestradiolum benzoylatum |
| gynecormone gouttes |
| estradiolo benzoato [dcit] |
| oestradiolum benzoicum |
| estradiol-17-beta-3-benzoate |
| benzoic acid estradiol |
| ccris 281 |
| benzo-gineostril |
| benzoate d'oestradiol [french] |
| ostrin |
| estra-1,3,5(10)-triene-3,17-diol, (17beta)-, 3-benzoate |
| benzoate d'estradiol [inn-french] |
| einecs 200-043-7 |
| agofollin depot |
| estradiol benzoate [inn] |
| primogyn b oleosum |
| ai3-52465 |
| estra-1,3,5(10)-triene-3,17-beta-diol, 3-benzoate |
| brn 3107526 |
| metroval |
| 17beta-estradiol monobenzoate |
| 17-beta-estradiol benzoate |
| 17-beta-oestradiol 3-benzoate |
| oestradiol 3-benzoate |
| estradiolo amsa |
| dihydrofolliculine benzoate |
| estra-1,3,5(10)-triene-3,17beta-diol, 3-benzoate |
| progynon b |
| benzofoline |
| benzogynoestryl |
| ovocyclin benzoate |
| primogyn b |
| ebz , |
| eston-b |
| oestradiol monobenzoate |
| estradiol-17.beta. 3-benzoate |
| 50-50-0 |
| follicormon |
| follidrin |
| gynformone |
| hormogynon |
| 1,5(10)-estratriene-3,17.beta.-diol 3-benzoate |
| progynon-b |
| estradiol 3-benzoate |
| unistradiol |
| benovocylin |
| de graafina |
| .beta.-estradiol 3-benzoate |
| diogyn b |
| 17.beta.-estradiol 3-benzoate |
| estradiol benzoate |
| estra-1,5(10)-triene-3,17-diol (17.beta.)-, 3-benzoate |
| estradiol monobenzoate |
| ovahormon benzoate |
| 17.beta.-estradiol monobenzoate |
| nsc-9566 |
| estra-1,5(10)-triene-3,17.beta.-diol, 3-benzoate |
| 17.beta.-estradiol benzoate |
| gynecormone |
| graafina |
| oestradiol benzoate |
| dihydrofolliculin benzoate |
| progynon benzoate |
| dihydroestrin benzoate |
| diffollisterol |
| dimenformon benzoate |
| nsc9566 |
| ovocyclin-mb |
| hydroxyestrin benzoate |
| estradiol-17.beta. benzoate |
| estradiol, 3-benzoate |
| primogyn i |
| benzhormovarine |
| ovasterol-b |
| .beta.-estradiol benzoate |
| hidroestron |
| benzo-gynoestryl |
| oestroform [bdh] |
| solestro |
| femestrone |
| dimenformone |
| difolliculine |
| benzoestrofol difolliculin |
| wln: l e5 b666ttt&j e1 fq oovr |
| ovocyclin m |
| benzoestrofol |
| 17-beta-estradiol 3-benzoate |
| beta-estradiol 3-benzoate, >=97% |
| NCGC00021274-03 |
| D01953 |
| estradiol benzoate (jp17/usp) |
| MLS000028477 , |
| smr000058343 |
| beta-estradiol 3-benzoate |
| difolliculin |
| chebi:77006 , |
| benzestrofol |
| beta-estradiol benzoate |
| CHEMBL282575 |
| benzogynestryl |
| [(13s,17s)-17-hydroxy-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-3-yl] benzoate |
| E0329 |
| [(8r,9s,13s,14s,17s)-17-hydroxy-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-3-yl] benzoate |
| ST075190 |
| (8r,9s,13s,14s,17s)-17-hydroxy-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6h-cyclopenta[a]phenanthren-3-yl benzoate;17beta-estradiol benzoate; 1,3,5(10)-estratriene-3,17b-diol 3-benzoate; 3,17b-dihydroxy-1,3,5(10)-estratriene 3-benzoate |
| A828140 |
| dtxsid9022998 , |
| dtxcid902998 |
| cas-50-50-0 |
| tox21_110868 |
| AKOS015955542 |
| HMS2232P14 |
| S4110 |
| benzoato de estradiol |
| 1s4cjb5zgn , |
| 17beta-estradiol 3-benzoate |
| benzoate d'oestradiol |
| estradiol benzoate [usp:inn:ban:jan] |
| benzoate d'estradiol |
| 4-09-00-00406 (beilstein handbook reference) |
| estradiolo benzoato |
| unii-1s4cjb5zgn |
| estradioli benzoas |
| estra-1,3,5(10)-triene-3,17beta-diol 3-benzoate |
| folone |
| mesalin |
| estrogin |
| estradiol benzoate [mart.] |
| estradiol benzoate [ep monograph] |
| estradiol 3-benzoate [mi] |
| estradiol benzoate [who-dd] |
| estradiol benzoate [usp impurity] |
| estradiol benzoate [usp-rs] |
| estradiol benzoate [jan] |
| estradiol benzoate [green book] |
| estradiol benzoate [usp monograph] |
| SCHEMBL174896 |
| CS-4780 |
| .beta.-oestradiol 3-benzoate |
| primogyn boleosum |
| (17.beta.)-estra-1,3,5(10)-triene-3,17-diol 3-benzoate |
| estra-1,3,5(10)-triene-3,17.beta.-diol, 3-benzoate |
| 1,3,5(10)-oestratriene-3,17-.beta.-diol 3-benzoate |
| 3-benzoyloxy-17.beta.-hydroxyestra-1,3,5(10)-triene |
| 1,3,5(10)-estratriene-3,17.beta.-diol 3-benzoate |
| .beta.-oestradiol benzoate |
| 17-.beta.-oestradiol 3-benzoate |
| 17-hydroxyestra-1(10),2,4-trien-3-yl benzoate, (17.beta.)- |
| oestraform |
| pelanin benzoate |
| Q-201505 |
| (17?)-17-hydroxyestra-1(10),2,4-trien-3-yl benzoate |
| benzoic acid [(8r,9s,13s,14s,17s)-17-hydroxy-13-methyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-3-yl] ester |
| cid_222757 |
| bdbm56905 |
| [(8r,9s,13s,14s,17s)-13-methyl-17-oxidanyl-6,7,8,9,11,12,14,15,16,17-decahydrocyclopenta[a]phenanthren-3-yl] benzoate |
| HY-B1192 |
| (17beta)-estra-1,3,5(10)-triene-3,17-diol 3-benzoate |
| estradiol (benzoate) , |
| SR-01000003080-3 |
| sr-01000003080 |
| i(2)-estradiol 3-benzoate |
| beta-estradiol 3-benzoate, vetranal(tm), analytical standard |
| estradiol benzoate, united states pharmacopeia (usp) reference standard |
| estradiol benzoate, european pharmacopoeia (ep) reference standard |
| ss-estradiol 3-benzoate |
| 3,17ss-dihydroxy-1,3,5(10)-estratriene 3-benzoate |
| 3-benzoyloxy-17ss-estrol |
| estradiol benzoate for system suitability, european pharmacopoeia (ep) reference standard |
| (8r,9s,13s,14s,17s)-17-hydroxy-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6h-cyclopenta[a]phenanthren-3-yl benzoate |
| NCGC00021274-05 |
| DB13953 |
| diffolisterol,(s) |
| AS-13030 |
| BCP09252 |
| Q11450699 |
| AMY22166 |
| estra-1,3,5(10)-triene-3,17-diol (17b)-, 3-benzoate |
| estradiol-benzoate |
| CCG-268370 |
| NCGC00021274-04 |
| D97619 |
| estradiol benzoate for system suitability |
| (1s,3as,3br,9bs,11as)-1-hydroxy-11a-methyl-1h,2h,3h,3ah,3bh,4h,5h,9bh,10h,11h,11ah-cyclopenta[a]phenanthren-7-yl benzoate |
| EN300-19631609 |
| (17beta)estra-1,3,5(10)triene-3,17-diol-3-benzoate |
| estradiol benzoate (ep monograph) |
| estradiol benzoate (usp impurity) |
| estradiol benzoate coarse grade |
| benzoate d'estradiol (inn-french) |
| estradiol benzoate (usp:inn:ban:jan) |
| estradiol benzoate (usp-rs) |
| estradiol benzoate (usp monograph) |
| estradioli benzoas (inn-latin) |
| benzoato de estradiol (inn-spanish) |
| estradiol benzoate (mart.) |
| Excerpt | Reference | Relevance |
|---|---|---|
| "Estrous synchronization using a Controlled Internal Drug Releasing device (CIDR) in combination with GnRH or estradiol benzoate (EB) treatment was investigated in Japanese black cows characterized with initial ovarian conditions." | ( Estrous synchronization using an intravaginal progesterone device in combination with gnrh or estradiol benzoate characterized by the initial ovarian conditions in Japanese black cows. Ando, T; Hamana, K; Kamimura, S, 2004) | 0.32 |
| "With the aim of establishing a sensitive model for the detection of weak effects of endocrine disrupting chemicals on thyroid carcinogenesis, thyrotrophic and tumor-promoting influences of beta-estradiol-3-benzoate (EB) in combination with representative antithyroidal agents (goitrogens), sulfadimethoxine (SDM), propylthiouracil (PTU), potassium perchlorate (PPC), iopanoic acid (IOP) or an iodine-deficient diet were evaluated in a short-term (7-day) experiment without N-bis(2-hydroxypropyl)nitrosamine (DHPN) initiation and a long-term (30-week) experiment with DHPN initiation in ovariectomized F344 rats." | ( Comparison of enhancing effects of different goitrogen treatments in combination with beta-estradiol-3-benzoate for establishing a rat two-stage thyroid carcinogenesis model to detect modifying effects of estrogenic compounds. Hirose, M; Imai, T; Onodera, H; Takizawa, T; Ueda, M, 2006) | 0.33 |
| "Yougui pill combined with Buzhong Yiqi decoction (YPBYD) is used to relieve sexual dysfunction in clinical practice." | ( Efficacy of Yougui pill combined with Buzhong Yiqi decoction in alleviating the sexual dysfunction in female rats through modulation of the gut microbiota. Jiao, W; Shi, C; Shi, G; Wang, Y; Yu, W, 2022) | 0.72 |
| Excerpt | Reference | Relevance |
|---|---|---|
| "The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs." | ( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein. Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019) | 0.51 |
| Role | Description |
|---|---|
| xenoestrogen | A synthetic or semi-synthetic compound that has oestrogenic activity. |
| estrogen receptor agonist | An agonist at the estrogen receptor. |
| [role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res] | |
| Class | Description |
|---|---|
| benzoate ester | Esters of benzoic acid or substituted benzoic acids. |
| 17beta-hydroxy steroid | A 17-hydroxy steroid in which the hydroxy group at position 17 has a beta-configuration. |
| [compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res] | |
| Protein | Taxonomy | Measurement | Average (µ) | Min (ref.) | Avg (ref.) | Max (ref.) | Bioassay(s) |
|---|---|---|---|---|---|---|---|
| Chain A, Beta-lactamase | Escherichia coli K-12 | Potency | 112.2020 | 0.0447 | 17.8581 | 100.0000 | AID485294 |
| Chain A, Cruzipain | Trypanosoma cruzi | Potency | 19.9526 | 0.0020 | 14.6779 | 39.8107 | AID1476 |
| Luciferase | Photinus pyralis (common eastern firefly) | Potency | 16.9441 | 0.0072 | 15.7588 | 89.3584 | AID588342 |
| glp-1 receptor, partial | Homo sapiens (human) | Potency | 6.3096 | 0.0184 | 6.8060 | 14.1254 | AID624172 |
| ATAD5 protein, partial | Homo sapiens (human) | Potency | 25.9290 | 0.0041 | 10.8903 | 31.5287 | AID504466 |
| USP1 protein, partial | Homo sapiens (human) | Potency | 56.2341 | 0.0316 | 37.5844 | 354.8130 | AID504865 |
| TDP1 protein | Homo sapiens (human) | Potency | 13.7882 | 0.0008 | 11.3822 | 44.6684 | AID686978; AID686979 |
| AR protein | Homo sapiens (human) | Potency | 2.0069 | 0.0002 | 21.2231 | 8,912.5098 | AID743035; AID743036; AID743040; AID743053; AID743063 |
| glucocorticoid receptor [Homo sapiens] | Homo sapiens (human) | Potency | 6.0070 | 0.0002 | 14.3764 | 60.0339 | AID720692 |
| estrogen nuclear receptor alpha | Homo sapiens (human) | Potency | 11.1644 | 0.0002 | 29.3054 | 16,493.5996 | AID743075; AID743077; AID743091 |
| G | Vesicular stomatitis virus | Potency | 33.7858 | 0.0123 | 8.9648 | 39.8107 | AID1645842 |
| heat shock 70kDa protein 5 (glucose-regulated protein, 78kDa) | Homo sapiens (human) | Potency | 44.6684 | 0.0165 | 25.3078 | 41.3999 | AID602332 |
| serine-protein kinase ATM isoform a | Homo sapiens (human) | Potency | 17.7828 | 0.7079 | 25.1119 | 41.2351 | AID485349 |
| chromobox protein homolog 1 | Homo sapiens (human) | Potency | 89.1251 | 0.0060 | 26.1688 | 89.1251 | AID540317 |
| nuclear factor erythroid 2-related factor 2 isoform 2 | Homo sapiens (human) | Potency | 20.5962 | 0.0041 | 9.9848 | 25.9290 | AID504444 |
| potassium voltage-gated channel subfamily H member 2 isoform d | Homo sapiens (human) | Potency | 3.1623 | 0.0178 | 9.6374 | 44.6684 | AID588834 |
| huntingtin isoform 2 | Homo sapiens (human) | Potency | 11.2202 | 0.0006 | 18.4198 | 1,122.0200 | AID2673 |
| histone-lysine N-methyltransferase 2A isoform 2 precursor | Homo sapiens (human) | Potency | 10.0000 | 0.0103 | 23.8567 | 63.0957 | AID2662 |
| geminin | Homo sapiens (human) | Potency | 14.9856 | 0.0046 | 11.3741 | 33.4983 | AID624296; AID624297 |
| peripheral myelin protein 22 | Rattus norvegicus (Norway rat) | Potency | 3.6125 | 0.0056 | 12.3677 | 36.1254 | AID624032 |
| survival motor neuron protein isoform d | Homo sapiens (human) | Potency | 35.4813 | 0.1259 | 12.2344 | 35.4813 | AID1458 |
| muscleblind-like protein 1 isoform 1 | Homo sapiens (human) | Potency | 79.4328 | 0.0041 | 9.9625 | 28.1838 | AID2675 |
| lamin isoform A-delta10 | Homo sapiens (human) | Potency | 3.5717 | 0.8913 | 12.0676 | 28.1838 | AID1487 |
| Interferon beta | Homo sapiens (human) | Potency | 33.7858 | 0.0033 | 9.1582 | 39.8107 | AID1645842 |
| HLA class I histocompatibility antigen, B alpha chain | Homo sapiens (human) | Potency | 33.7858 | 0.0123 | 8.9648 | 39.8107 | AID1645842 |
| Cellular tumor antigen p53 | Homo sapiens (human) | Potency | 33.4915 | 0.0023 | 19.5956 | 74.0614 | AID651631 |
| Inositol hexakisphosphate kinase 1 | Homo sapiens (human) | Potency | 33.7858 | 0.0123 | 8.9648 | 39.8107 | AID1645842 |
| cytochrome P450 2C9, partial | Homo sapiens (human) | Potency | 33.7858 | 0.0123 | 8.9648 | 39.8107 | AID1645842 |
| [prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023] | |||||||
| Protein | Taxonomy | Measurement | Average | Min (ref.) | Avg (ref.) | Max (ref.) | Bioassay(s) |
|---|---|---|---|---|---|---|---|
| Estrogen receptor | Homo sapiens (human) | IC50 (µMol) | 0.0650 | 0.0000 | 0.7237 | 32.7000 | AID625258 |
| Estrogen receptor | Homo sapiens (human) | Ki | 0.0180 | 0.0000 | 0.4229 | 7.9070 | AID625258 |
| Glucocorticoid receptor | Homo sapiens (human) | IC50 (µMol) | 5.0740 | 0.0000 | 0.4953 | 10.0000 | AID625263 |
| Glucocorticoid receptor | Homo sapiens (human) | Ki | 2.3060 | 0.0001 | 0.3863 | 7.0010 | AID625263 |
| Tyrosine-protein kinase Fyn | Homo sapiens (human) | IC50 (µMol) | 22.9940 | 0.0002 | 1.6789 | 8.6800 | AID625185 |
| Glycine receptor subunit alpha-1 | Rattus norvegicus (Norway rat) | IC50 (µMol) | 5.0740 | 0.0015 | 0.7600 | 5.0740 | AID625263 |
| Glycine receptor subunit alpha-1 | Rattus norvegicus (Norway rat) | Ki | 2.3060 | 0.0007 | 0.7653 | 7.0010 | AID625263 |
| Aldo-keto reductase family 1 member B1 | Rattus norvegicus (Norway rat) | IC50 (µMol) | 17.2290 | 0.0004 | 1.8773 | 10.0000 | AID625207 |
| Aldo-keto reductase family 1 member B1 | Rattus norvegicus (Norway rat) | Ki | 17.0870 | 0.0032 | 2.2887 | 9.3160 | AID625207 |
| Adenosine receptor A3 | Homo sapiens (human) | IC50 (µMol) | 21.7800 | 0.0000 | 1.8940 | 8.5470 | AID625196 |
| Adenosine receptor A3 | Homo sapiens (human) | Ki | 12.3120 | 0.0000 | 0.9306 | 10.0000 | AID625196 |
| Androgen receptor | Rattus norvegicus (Norway rat) | IC50 (µMol) | 0.0100 | 0.0010 | 1.9794 | 14.1600 | AID625228 |
| Androgen receptor | Rattus norvegicus (Norway rat) | Ki | 0.0070 | 0.0003 | 1.2185 | 8.9270 | AID625228 |
| Alpha-1B adrenergic receptor | Rattus norvegicus (Norway rat) | IC50 (µMol) | 21.7800 | 0.0002 | 1.8742 | 10.0000 | AID625196 |
| Alpha-1B adrenergic receptor | Rattus norvegicus (Norway rat) | Ki | 12.3120 | 0.0001 | 0.9490 | 10.0000 | AID625196 |
| Alpha-2C adrenergic receptor | Homo sapiens (human) | IC50 (µMol) | 24.6500 | 0.0000 | 1.4725 | 7.8980 | AID625203 |
| Alpha-2C adrenergic receptor | Homo sapiens (human) | Ki | 3.5820 | 0.0003 | 0.4834 | 10.0000 | AID625203 |
| Glycine receptor subunit beta | Rattus norvegicus (Norway rat) | IC50 (µMol) | 5.0740 | 0.0015 | 0.7600 | 5.0740 | AID625263 |
| Glycine receptor subunit beta | Rattus norvegicus (Norway rat) | Ki | 2.3060 | 0.0007 | 0.7846 | 7.0010 | AID625263 |
| Glycine receptor subunit alpha-2 | Rattus norvegicus (Norway rat) | IC50 (µMol) | 5.0740 | 0.0015 | 0.8044 | 5.0740 | AID625263 |
| Glycine receptor subunit alpha-2 | Rattus norvegicus (Norway rat) | Ki | 2.3060 | 0.0007 | 0.7846 | 7.0010 | AID625263 |
| Sodium-dependent noradrenaline transporter | Homo sapiens (human) | IC50 (µMol) | 17.2290 | 0.0008 | 1.5416 | 20.0000 | AID625207 |
| Sodium-dependent noradrenaline transporter | Homo sapiens (human) | Ki | 17.0870 | 0.0003 | 1.4656 | 10.0000 | AID625207 |
| Glycine receptor subunit alpha-3 | Rattus norvegicus (Norway rat) | IC50 (µMol) | 5.0740 | 0.0015 | 0.7600 | 5.0740 | AID625263 |
| Glycine receptor subunit alpha-3 | Rattus norvegicus (Norway rat) | Ki | 2.3060 | 0.0007 | 0.7846 | 7.0010 | AID625263 |
| Sodium-dependent serotonin transporter | Homo sapiens (human) | IC50 (µMol) | 3.6720 | 0.0001 | 0.8645 | 8.7096 | AID625222 |
| Sodium-dependent serotonin transporter | Homo sapiens (human) | Ki | 1.9510 | 0.0000 | 0.7048 | 8.1930 | AID625222 |
| 5-hydroxytryptamine receptor 2B | Homo sapiens (human) | IC50 (µMol) | 11.5650 | 0.0001 | 1.1873 | 8.9125 | AID625217 |
| 5-hydroxytryptamine receptor 2B | Homo sapiens (human) | Ki | 7.3590 | 0.0003 | 0.7693 | 10.0000 | AID625217 |
| Alpha-1A adrenergic receptor | Rattus norvegicus (Norway rat) | IC50 (µMol) | 21.7800 | 0.0000 | 1.8194 | 10.0000 | AID625196 |
| Alpha-1A adrenergic receptor | Rattus norvegicus (Norway rat) | Ki | 12.3120 | 0.0000 | 0.9650 | 10.0000 | AID625196 |
| [prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023] | |||||||
| Protein | Taxonomy | Measurement | Average | Min (ref.) | Avg (ref.) | Max (ref.) | Bioassay(s) |
|---|---|---|---|---|---|---|---|
| streptokinase A precursor | Streptococcus pyogenes M1 GAS | EC50 (µMol) | 2.1775 | 0.0600 | 8.9128 | 130.5170 | AID1902; AID1914 |
| Sex hormone-binding globulin | Homo sapiens (human) | Kd | 1.1481 | 0.0002 | 0.3496 | 4.7863 | AID318680 |
| Estrogen receptor | Rattus norvegicus (Norway rat) | EC50 (µMol) | 2.4310 | 0.0060 | 22.3670 | 130.5170 | AID1914 |
| Estrogen receptor beta | Rattus norvegicus (Norway rat) | EC50 (µMol) | 2.4310 | 0.0060 | 22.3670 | 130.5170 | AID1914 |
| [prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023] | |||||||
| Assay ID | Title | Year | Journal | Article |
|---|---|---|---|---|
| AID1296008 | Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening | 2020 | SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1 | Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening. |
| AID1346987 | P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen | 2019 | Molecular pharmacology, 11, Volume: 96, Issue:5 | A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein. |
| AID1346986 | P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen | 2019 | Molecular pharmacology, 11, Volume: 96, Issue:5 | A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein. |
| AID504749 | qHTS profiling for inhibitors of Plasmodium falciparum proliferation | 2011 | Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043 | Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets. |
| AID504810 | Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign | 2010 | Endocrinology, Jul, Volume: 151, Issue:7 | A small molecule inverse agonist for the human thyroid-stimulating hormone receptor. |
| AID588497 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set | 2010 | Current protocols in cytometry, Oct, Volume: Chapter 13 | Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening. |
| AID588497 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set | 2006 | Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5 | Microsphere-based protease assays and screening application for lethal factor and factor Xa. |
| AID588497 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set | 2010 | Assay and drug development technologies, Feb, Volume: 8, Issue:1 | High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors. |
| AID588499 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set | 2010 | Current protocols in cytometry, Oct, Volume: Chapter 13 | Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening. |
| AID588499 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set | 2006 | Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5 | Microsphere-based protease assays and screening application for lethal factor and factor Xa. |
| AID588499 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set | 2010 | Assay and drug development technologies, Feb, Volume: 8, Issue:1 | High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors. |
| AID588501 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set | 2010 | Current protocols in cytometry, Oct, Volume: Chapter 13 | Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening. |
| AID588501 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set | 2006 | Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5 | Microsphere-based protease assays and screening application for lethal factor and factor Xa. |
| AID588501 | High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set | 2010 | Assay and drug development technologies, Feb, Volume: 8, Issue:1 | High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors. |
| AID1745845 | Primary qHTS for Inhibitors of ATXN expression | |||
| AID651635 | Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression | |||
| AID504812 | Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign | 2010 | Endocrinology, Jul, Volume: 151, Issue:7 | A small molecule inverse agonist for the human thyroid-stimulating hormone receptor. |
| AID588216 | FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase | 2004 | Current drug discovery technologies, Dec, Volume: 1, Issue:4 | Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. |
| AID588214 | FDA HLAED, liver enzyme composite activity | 2004 | Current drug discovery technologies, Dec, Volume: 1, Issue:4 | Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. |
| AID588219 | FDA HLAED, gamma-glutamyl transferase (GGT) increase | 2004 | Current drug discovery technologies, Dec, Volume: 1, Issue:4 | Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. |
| AID191532 | In vivo uterotrophic effect in estradiol stimulated immature rats | 1988 | Journal of medicinal chemistry, Jul, Volume: 31, Issue:7 | Nonisomerizable analogues of (Z)- and (E)-4-hydroxytamoxifen. Synthesis and endocrinological properties of substituted diphenylbenzocycloheptenes. |
| AID588217 | FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase | 2004 | Current drug discovery technologies, Dec, Volume: 1, Issue:4 | Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. |
| AID588218 | FDA HLAED, lactate dehydrogenase (LDH) increase | 2004 | Current drug discovery technologies, Dec, Volume: 1, Issue:4 | Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. |
| AID191709 | Uterotrophic effect in rats at 50 ug/animal/day hydroxytamoxifen | 1982 | Journal of medicinal chemistry, Sep, Volume: 25, Issue:9 | Estrogenic and antiestrogenic activity of monophenolic analogues of tamoxifen, (Z)-2-[p-(1,2-diphenyl-1-butenyl)phenoxy]-N, N-dimethylethylamine. |
| AID588215 | FDA HLAED, alkaline phosphatase increase | 2004 | Current drug discovery technologies, Dec, Volume: 1, Issue:4 | Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. |
| AID318680 | Displacement of [3H]5alpha dihydrotestosterone from human sex hormone binding globulin | 2008 | Journal of medicinal chemistry, Apr-10, Volume: 51, Issue:7 | An updated steroid benchmark set and its application in the discovery of novel nanomolar ligands of sex hormone-binding globulin. |
| AID170810 | Anti-uterotrophic effect in rats at 50 ug/animal/day in the presence of 0.5 ug estradiol benzoate | 1982 | Journal of medicinal chemistry, Sep, Volume: 25, Issue:9 | Estrogenic and antiestrogenic activity of monophenolic analogues of tamoxifen, (Z)-2-[p-(1,2-diphenyl-1-butenyl)phenoxy]-N, N-dimethylethylamine. |
| AID1347159 | Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay | 2020 | Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49 | Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors. |
| AID1347160 | Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors | 2020 | Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49 | Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors. |
| [information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||||
| Timeframe | Studies, This Drug (%) | All Drugs % |
|---|---|---|
| pre-1990 | 98 (9.71) | 18.7374 |
| 1990's | 107 (10.60) | 18.2507 |
| 2000's | 420 (41.63) | 29.6817 |
| 2010's | 337 (33.40) | 24.3611 |
| 2020's | 47 (4.66) | 2.80 |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be moderate demand-to-supply ratio for research on this compound.
| This Compound (15.45) All Compounds (24.57) |
| Publication Type | This drug (%) | All Drugs (%) |
|---|---|---|
| Trials | 79 (7.52%) | 5.53% |
| Reviews | 6 (0.57%) | 6.00% |
| Case Studies | 4 (0.38%) | 4.05% |
| Observational | 0 (0.00%) | 0.25% |
| Other | 962 (91.53%) | 84.16% |
| [information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023] | ||
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| Programmation of GnRH Antagonist Cycles With Estradiol Valerate: Impact on the Stimulation in IVF/ICSI. [NCT01218386] | Phase 4 | 80 participants (Actual) | Interventional | 2010-05-31 | Completed | ||
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Study to Evaluate the Therapeutic Equivalence of Estradiol Vaginal Cream USP, 0.01% (Teva Pharmaceuticals, USA) to Estrace® Estradiol Vaginal Cream, USP, 0.01% (Warner Chilcott [NCT03294538] | Phase 3 | 663 participants (Actual) | Interventional | 2016-05-18 | Completed | ||
| The Prognostic Accuracy of Within Cycle, Pre-embryo Transfer, Ultrasound Endometrial Patterns, to Predict Implantation During Assisted Reproduction [NCT03860636] | 200 participants (Anticipated) | Observational | 2018-11-26 | Recruiting | |||
| Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme [NCT01174524] | Phase 4 | 100 participants (Actual) | Interventional | 2008-01-31 | Completed | ||
| The Impact of Different Hormone Therapy Regimens on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness [NCT05280028] | 100 participants (Anticipated) | Observational | 2022-02-07 | Recruiting | |||
| An Open Randomized Two-Way Cross-Over Comparative Bioavailability Study to Compare the Extent of Systemic Absorption of Estradiol After a Single Dose Treatment With Two 25 mcg Estradiol Vaginal Tablet Formulations Administered in Postmenopausal Women With [NCT01085877] | Phase 1 | 70 participants (Actual) | Interventional | 2010-03-31 | Completed | ||
| Isolated and Associated Effects of Physical Exercise and Estrogen Therapy on Climactercs Women [NCT01120665] | 62 participants (Actual) | Interventional | 2002-02-28 | Completed | |||
| A Randomised Open-label Multi-centre Comparative Study to Evaluate Cycle Control of 2 Dosages of Estetrol Combined With Either P1 or P2, Compared to a Combined Oral Contraceptive Containing E2V and DNG [NCT01221831] | Phase 2 | 396 participants (Actual) | Interventional | 2010-09-30 | Completed | ||
| Effect of Vaginal Sildenafil Citrate on Endometrial Preparation and Outcome in Frozen Thawed Embryo Transfer Cycles [NCT03854175] | 80 participants (Anticipated) | Interventional | 2019-02-28 | Not yet recruiting | |||
| Multiple-dose Pharmacokinetic Study of Two Aqueous Suspensions of Estradiol and Progesterone Microspheres (1 mg/20 mg & 0.5 mg/15 mg) for Intramuscular Administration, in Postmenopausal Volunteers. [NCT01293747] | Phase 1 | 30 participants (Anticipated) | Interventional | 2011-02-28 | Completed | ||
| A Phase 3, Randomized, Active-Comparator Controlled Clinical Trial to Study the Contraceptive Efficacy and Safety of the MK-8342B (Etonogestrel + 17β-Estradiol) Vaginal Ring and the Levonorgestrel-Ethinyl Estradiol (LNG-EE) 150/30 μg Combined Oral Contrac [NCT02616146] | Phase 3 | 2,016 participants (Actual) | Interventional | 2015-12-01 | Terminated(stopped due to Study terminated by Sponsor as a result of a business decision to discontinue the development program for MK-8342B for reasons unrelated to safety or efficacy.) | ||
| The Effect of Estrogen in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis [NCT03620929] | Phase 4 | 186 participants (Anticipated) | Interventional | 2018-08-13 | Enrolling by invitation | ||
| In Vivo Imaging of the Effect of Fulvestrant on the Availability of Estrogen Receptor Binding Sites in Metastatic Breast Tumor Lesions Using FES-PET [NCT01377324] | Phase 2 | 16 participants (Actual) | Interventional | 2011-05-31 | Completed | ||
| Studying The Effect of Estradiol Pretreatment on Follicular Synchronization and Intracytoplasmic Sperm Injection (ICSI) Outcome in Antagonist Cycles [NCT05197374] | Phase 4 | 114 participants (Actual) | Interventional | 2020-06-01 | Completed | ||
| Effects of Dienogest and Dienogest Plus Estradiol Valerate on Ovarian Reserve and Endometrioma Size [NCT03789123] | Phase 4 | 710 participants (Anticipated) | Interventional | 2019-01-01 | Recruiting | ||
| Single Site, Open-label, Randomized, Two Treatments, Two Periods, Two Sequences, Crossover Single-dose Trial to Investigate the Bioequivalence of Two Oral Formulations of a Fixed-dose Combination Tablet Containing 1.5 mg Estradiol and 2.5 mg Nomegestrol A [NCT03749733] | Phase 1 | 0 participants (Actual) | Interventional | 2019-10-31 | Withdrawn(stopped due to Sponsor decision) | ||
| Influences of Long Term Hormone Therapy on Physical Fitness and Vascular Function in Transgender Women [NCT06116201] | 60 participants (Actual) | Interventional | 2020-08-15 | Completed | |||
| A Prospective Randomized Study of the Impact of Hormonal Monitoring and Progesterone Supplementation Adjustment on Outcome of Programmed Thawed Embryo Transfer Cycles [NCT05189145] | 600 participants (Actual) | Interventional | 2019-10-01 | Completed | |||
| A Multi-Center,Randomized,Non-Inferiority and Positively Controlled Clinical Trial to Evaluate the Safety and Efficacy of Dural Repair Patch in Neurosurgical Repairs [NCT02129114] | 132 participants (Anticipated) | Interventional | 2014-04-30 | Recruiting | |||
| LIBERTY 2: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associate [NCT03103087] | Phase 3 | 382 participants (Actual) | Interventional | 2017-06-14 | Completed | ||
| Contraceptive Hormones and Women With Cystic Fibrosis: Satisfaction and Effects on Disease [NCT02144246] | Phase 1 | 5 participants (Actual) | Interventional | 2014-05-31 | Terminated | ||
| A Prospective Multicenter Non-interventional Study to Evaluate User Satisfaction With Estradiol Valerate/ Dienogest in Real Clinical Practice to be Conducted in Russia [NCT04901377] | 255 participants (Actual) | Observational | 2021-06-24 | Completed | |||
| Hormonal Replacement Therapy Does Not Affect Self-estimated Pain or Experimental Pain Responses in Postmenopausal Women Suffering From Fibromyalgia: A Double-blind, Randomized, Placebo-controlled Trial [NCT01087593] | 29 participants (Actual) | Interventional | 2001-08-31 | Terminated(stopped due to Due to ethical concerns regard to the results from the WHI study) | |||
| Treating Where it Hurts: A Randomized Blinded Clinical Trial of Local Estrogen to the Vulvar Vestibule for Dyspareunia in Postmenopausal Women [NCT03240081] | Phase 4 | 50 participants (Actual) | Interventional | 2017-06-20 | Completed | ||
| A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women [NCT02691494] | Phase 3 | 378 participants (Actual) | Interventional | 2016-02-03 | Completed | ||
| Frozen-thawed Embryo Transfer in a Natural Versus Artificial Cycle: a Randomized Clinical Trial [NCT03642665] | Phase 4 | 554 participants (Anticipated) | Interventional | 2018-09-25 | Recruiting | ||
| Serum Estradiol Levels In Postmenopausal Women With Breast Cancer Receiving Adjuvant Aromatase Inhibitors and Vaginal Estrogen [NCT00984399] | 30 participants (Actual) | Interventional | 2009-09-30 | Active, not recruiting | |||
| The Effect of Different Types of Progestin on Sleeping of Menopausal Women [NCT02086032] | 100 participants (Actual) | Interventional | 2014-01-31 | Completed | |||
| LIBERTY 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Co-Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associate [NCT03049735] | Phase 3 | 388 participants (Actual) | Interventional | 2017-04-26 | Completed | ||
| Endometrial Estrogen Preparation Before Frozen-thawed Embryo Transfer : Comparison of Vaginal and Transdermal Administration [NCT03518528] | 100 participants (Anticipated) | Observational [Patient Registry] | 2018-08-30 | Recruiting | |||
| A Study of Prevention and Treatment of Postmenopausal Osteoporosis in Chinese Women [NCT00860964] | Phase 4 | 221 participants (Actual) | Interventional | 1998-02-28 | Completed | ||
| A Study to Evaluate the Relative Bioavailability of Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets (Teva Pharmaceuticals, USA) Compared to FEMCON® Fe (Norethindrone/Ethinyl Estradiol) 0.4 mg/0.035 mg Chewable Tablets (Warner Chilcott) in [NCT01344369] | Phase 1 | 36 participants (Actual) | Interventional | 2008-08-31 | Completed | ||
| Optimal Timing of Euploid Day 6 Blastocyst (Blastocyst Which Was Biopsied on Day 6 After Fertilization) Transfer in Frozen Hormonal Replacement Therapy Cycles: Day 6 or Day 7 of Progesterone Administration? [NCT05980091] | Phase 1 | 316 participants (Anticipated) | Interventional | 2023-09-22 | Recruiting | ||
| Flow-mediated Evaluation of the Brachial Artery of Climacteric Women Using Estradiol Valerate and Placebo. Randomized, Double Blinded, Placebo Controlled Study. [NCT02161614] | 60 participants (Actual) | Interventional | 2014-02-28 | Completed | |||
| A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial to Study the Efficacy and Safety of MK-8342B (ENG-E2 Vaginal Ring) in Women With Moderate to Severe Primary Dysmenorrhea (With Optional Extension) [NCT02668783] | Phase 3 | 25 participants (Actual) | Interventional | 2016-02-11 | Terminated(stopped due to Study terminated by Sponsor as a result of a business decision to discontinue the development program for MK-8342B for reasons unrelated to safety or efficacy.) | ||
| A Multicenter, Open-Label Study to Evaluate Ovarian Follicular Activity and Hormone Levels With the Oral Contraceptive Regimen DR-102 Compared to Two 28-day Oral Contraceptive Regimens Containing Different Synthetic Progestins [NCT01291004] | Phase 1 | 206 participants (Actual) | Interventional | 2011-01-31 | Completed | ||
| The Effect of Low-dose Rhythmic 17-β-estradiol Administration on Bone Turnover in Postmenopausal Women [NCT05903820] | Phase 4 | 48 participants (Anticipated) | Interventional | 2023-07-19 | Recruiting | ||
| The Effect of Tamoxifen on Endometrial Thickness and Pregnancy Outcome in Women With Thin Endometrium Undergoing Frozen Thawed Cycle. [NCT03060304] | Phase 4 | 100 participants (Anticipated) | Interventional | 2017-03-31 | Not yet recruiting | ||
| Characterisation of Relative Bioavailability and Assessment of Bioequivalence of a Newly Developed Ethinylestradiol/Dienogest IR Formulation in Comparison With a Marketed Reference Product (Valette®) [NCT01600274] | 20 participants (Actual) | Interventional | 2010-01-31 | Completed | |||
| Clinical Pregnancy Rate for Frozen Embryo Transfer With Hormonal Replacement Therapy (HRT): a Pilot Study Comparing 1 Versus 2 Weeks of Treatment [NCT03930706] | 150 participants (Actual) | Interventional | 2018-10-01 | Completed | |||
| Concomitant Clomiphene Citrate and Estradiol Versus Clomiphene Citrate Alone in Ovulation Induction: a Randomized Controlled Trial [NCT02186782] | Phase 4 | 600 participants (Anticipated) | Interventional | 2014-06-30 | Recruiting | ||
| Imaging of ER Density to Guide and Improve Tailored Therapy for Acquired Anti-hormonal Resistant Breast Cancer [NCT01088477] | 21 participants (Actual) | Observational | 2010-02-28 | Completed | |||
| Effect of Menopause Hormone Therapy In Postmenopausal Women With CeRebral Small Vessel DiseAse And Mild Cognitive DecLinE [NCT05982470] | Phase 2 | 328 participants (Anticipated) | Interventional | 2023-08-18 | Not yet recruiting | ||
| Evaluating Quality Performance of Extemporaneously Compounded Estrogen Hormone Products [NCT05645406] | Early Phase 1 | 12 participants (Anticipated) | Interventional | 2024-01-10 | Not yet recruiting | ||
| A Randomized Study to Analysis the Effectiveness of Estradiol Valerate Pretreatment in Antagonist Protocol for Poor Ovarian Response Patient [NCT03300518] | 552 participants (Actual) | Interventional | 2017-11-15 | Completed | |||
| Trial of Vaginal Estrogen for Urogenital Symptom Relief in Women on Aromatase Inhibitors: Systemic Impact Versus Local Objective Benefits and Quality of Life [NCT02528383] | 3 participants (Actual) | Interventional | 2015-08-31 | Completed | |||
| Timing of Estrogen Support During the Luteal Phase of IVF / Intracytoplasmic Sperm Injection Cycle: a Randomized Controlled Trial [NCT01367912] | 301 participants (Actual) | Interventional | 2008-02-29 | Completed | |||
| Single-center, Double-masked, Placebo-controlled Parallel-group Study of Pregnancy-related Hormones Estradiol and Medroxyprogesterone, in Conjunction With Hydrocortisone and Growth Hormone to Stimulate C-peptide Secretion in Women With T1DM [NCT01265017] | Phase 1 | 0 participants (Actual) | Interventional | 2012-07-31 | Withdrawn(stopped due to Insufficient funding) | ||
| Hormone Replacement Therapy Versus Minimal Ovarian Stimulation for Endometrial Preparation Prior to Frozen-thawed Embryo Transfer in Non Polycystic Ovarian Syndrome Patients [NCT02330757] | Phase 4 | 150 participants (Anticipated) | Interventional | 2016-10-10 | Recruiting | ||
| Prevention of Menstrual Migraines: Effects of Estrogen Add-back During the HFI in Patients Using Continuous Oral Contraceptives. [NCT01251263] | Phase 4 | 40 participants (Anticipated) | Interventional | 2010-10-31 | Recruiting | ||
| The Efficacy and Safety of the Dried Biological Amnion Graft Following Hysteroscopic Lysis for the Prevention of Postoperative Adhesions in Patients With Intrauterine Adhesions [NCT02496052] | 300 participants (Anticipated) | Interventional | 2013-01-31 | Recruiting | |||
| Luteal Phase Support With Estradiol In Poor Responders Undergoing In Vitro Fertilization [NCT03788681] | Phase 3 | 170 participants (Anticipated) | Interventional | 2018-04-01 | Recruiting | ||
| Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients [NCT01353846] | Phase 4 | 70 participants (Anticipated) | Interventional | 2011-05-31 | Recruiting | ||
| PRE-GAIN Bone Health Pilot Study - Physiologic Replacement of EstroGen for Adolescent Females With AnorexIa Nervosa for Bone Health Pilot Study [NCT04021017] | Phase 1 | 0 participants (Actual) | Interventional | 2020-01-21 | Withdrawn(stopped due to PI Workload) | ||
| The Effect of Low Dose Estrogen on Cortical Function as a Function of Age in Postmenopausal Women. [NCT01268046] | Phase 1/Phase 2 | 38 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
| Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, to Demonstrate the Efficacy of 12 Weeks of Treatment With USL-221 on Moderate to Severe Vasomotor Symptoms and Vulvar/Vaginal Atrophy in Postmenopausal Patients [NCT00727129] | Phase 3 | 495 participants (Actual) | Interventional | 2004-07-31 | Completed | ||
| A Double-blind, Randomized, Uncontrolled Study to Evaluate Inhibition of Ovulation of Two Oral Estradiol / Drospirenone Regimens in Healthy Young Female Volunteers Over a Period of 3 Treatment Cycles [NCT00631124] | Phase 2 | 103 participants (Actual) | Interventional | 2008-02-29 | Completed | ||
| Comparison of Efficacy and Safety of Tricilest (Norgestimate-ethinyl Estradiol) and Diane-35 (Cyproterone Acetate-ethinyl Estradiol) in the Treatment of Acne Vulgaris [NCT00752635] | Phase 4 | 48 participants (Actual) | Interventional | 2004-09-30 | Completed | ||
| A Multicenter, Open-Label, Randomized, Controlled Study to Compare the Effects on Bone Mineral Density of DR-105 and a 28-Day Cycle Oral Contraceptive Regimen in Healthy, Postmenarchal, Adolescent Females [NCT00924560] | Phase 2 | 1,361 participants (Actual) | Interventional | 2009-06-30 | Completed | ||
| Effect of 17ß-estradiol on Inflammatory-immune Responses in Post-menopausal Women According to Administration Route: Pilot Study [NCT00701337] | Phase 4 | 40 participants (Actual) | Interventional | 2006-09-30 | Completed | ||
| Bioavailability of a Formulation of Estradiol Valerate and Dienogest 2 mg/2 mg Coated Tablets With Regards to the Marketed Reference Product [NCT05332106] | Phase 1 | 10 participants (Actual) | Interventional | 2022-03-12 | Completed | ||
| Effect of Sildenafil on Uterine and Endometrial Vasculature in Women With Thin Endometrium Having Frozen-Thawed IVF Cycles [NCT04283435] | Phase 1 | 100 participants (Anticipated) | Interventional | 2021-09-01 | Not yet recruiting | ||
| Sildenafil Citrate for Endometrial Preparation in Frozen-thawed Embryo Transfer Cycles [NCT02845388] | Phase 2 | 90 participants (Actual) | Interventional | 2015-09-30 | Completed | ||
| Prospective, Controlled, Single-blinded, Longitudinal, Two-arms, Clinical Study Evaluation of Efficacy/Safety of EVE-PMS Skin-Test Panel -Detecting Sensitivity to Sex Hormones in Women With Premenstrual Syndrome [NCT00866437] | Phase 2 | 40 participants (Anticipated) | Interventional | 2009-04-30 | Recruiting | ||
| Biomarkers, Breast Density And Risk Reduction Perspectives In BRCA Carriers [NCT00080756] | Phase 2 | 11 participants (Actual) | Interventional | 2004-03-11 | Active, not recruiting | ||
| Evaluation Des Performances de la Tomographie Par Emission de Positons Avec la 16α-[18F]Fluoro-17β-estradiol ([18F]-FES) Pour le Diagnostic de l'Endometriose [NCT02233621] | Phase 2 | 31 participants (Actual) | Interventional | 2012-06-30 | Terminated(stopped due to not enough enrollement) | ||
| Comparison of Ultra-low-dose Oral Versus Trans-dermal Hormone Therapy on Coagulation Activation and Metabolic Risk Factors for Cardiovascular Disease [NCT02264743] | Phase 4 | 60 participants (Anticipated) | Interventional | 2013-11-30 | Recruiting | ||
| Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent Combined With Estrogen or Dried Biological Amnion Graft for the Therapy of Uterine Adhesion [NCT03346317] | 100 participants (Anticipated) | Interventional | 2017-11-16 | Recruiting | |||
| Progestin-primed Ovarian Stimulation Protocol Versus GnRH Antagonist Protocol in Polycystic Ovary Syndrome Patients Undergoing IVF/ICSI Cycles [NCT05112692] | 200 participants (Anticipated) | Interventional | 2021-11-30 | Not yet recruiting | |||
| A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women [NCT02654054] | Phase 3 | 413 participants (Actual) | Interventional | 2015-12-22 | Completed | ||
| Vaginal Estradiol Pretreatment in Labour Induction With Misoprostol [NCT02485821] | Phase 2/Phase 3 | 200 participants (Actual) | Interventional | 2015-06-30 | Completed | ||
| The Effect of Estradiol Valerate With and Without Oral Sildenafil on Endometrial Thickness and Pregnancy Rates in Infertile Women: A R.C.T [NCT03301233] | 90 participants (Actual) | Interventional | 2017-11-01 | Completed | |||
| Clinical Efficacy of Hormone Replacement Therapy in Treating Perimenopausal Women With Meibomian Gland Dysfunction [NCT04962386] | 30 participants (Anticipated) | Observational | 2019-03-06 | Recruiting | |||
| To Evaluate the Effect of GnRH Agonist Administered in the Luteal Phase on ART Cycle Outcomes in Both GnRH Agonist and GnRH Antagonist Treated Ovarian Stimulation Protocols [NCT02114645] | 100 participants (Anticipated) | Interventional | 2014-04-30 | Not yet recruiting | |||
| Comparison of Pregnancy Outcomes in Frozen Embryo Transfer in Natural and Hormonal Replacement Cycles: a Randomized Controlled Trial [NCT02251925] | Phase 3 | 460 participants (Anticipated) | Interventional | 2012-09-30 | Recruiting | ||
| A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of NGM/EE Tablets Manufactured at 2 Different Facilities [NCT02127593] | Phase 1 | 101 participants (Actual) | Interventional | 2013-06-30 | Completed | ||
| Do Oral Contraceptives Protect Against Anterior Cruciate Ligament Injuries in Female Athletes [NCT04899778] | Phase 4 | 100 participants (Anticipated) | Interventional | 2021-09-29 | Recruiting | ||
| Impact of Individualized Estrogen Therapy on Cardiovascular Disease Risk Parameters in Young Women After Bilateral Oophorectomy: A Randomized Controlled Trial [NCT03815929] | Phase 2 | 47 participants (Actual) | Interventional | 2019-03-15 | Completed | ||
| Duration of Estrogen for Luteal Phase in Pregnant Women Undergone Frozen Embryo Transfer Cycles- Randomized Controlled Trials Phase III [NCT04013438] | Phase 3 | 60 participants (Actual) | Interventional | 2017-11-01 | Completed | ||
| Periurethral vs Intravaginal Estrogen for Prevention of Recurrent Urinary Tract Infections: TAPER (Techniques of APplying Vaginal Estrogen for Prevention of Recurrent Urinary Tract Infections) Trial [NCT05472779] | Phase 2 | 102 participants (Anticipated) | Interventional | 2023-01-03 | Recruiting | ||
| The Impact of Different Administration Routes of Hormonal Contraceptives on Androgen Synthesis, Glucose Metabolism and Inflammation. A Prospective Randomized Trial. [NCT01087879] | 45 participants (Anticipated) | Interventional | 2007-10-31 | Completed | |||
| The Influence of Hormone Replacement Therapy on the Cerebral Serotonin-1A Receptor Distribution and Mood in Postmenopausal Women [NCT00755963] | Phase 4 | 30 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| A Single Site, Placebo and Standard Care Controlled, Double Blind, Randomised Trial to Investigate the Efficacy of Four Doses of Zesteem in Accelerating Early Wound Healing of Punch Biopsy Skin Wounds. [NCT00984386] | Phase 2 | 44 participants (Actual) | Interventional | 2005-03-31 | Completed | ||
| Open-label, Randomized, Cross-over Study to Investigate the Bioequivalence of Estradiol Valerate (EV) and Levomefolate Calcium After Single Oral Administration of a Tablet Formulation Containing 3 mg EV Without and With 0.451 mg Levomefolate Calcium and a [NCT01031355] | Phase 1 | 42 participants (Actual) | Interventional | 2009-12-31 | Completed | ||
| The Role of Estrogen in the Neurobiology of Eating Disorders: A Study of Cognitive Flexibility and Reward in Eating Disorders [NCT03740204] | Phase 2 | 120 participants (Anticipated) | Interventional | 2019-06-13 | Recruiting | ||
| A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Ortho Tri-Cyclen Lo on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment. [NCT00754065] | Phase 3 | 409 participants (Actual) | Interventional | 2008-09-30 | Completed | ||
| A Multi-center, Double-blind, Double-dummy, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of SH T00658ID Compared to SH D593B in the Treatment of Primary Dysmenorrhea [NCT00909857] | Phase 3 | 507 participants (Actual) | Interventional | 2009-04-30 | Completed | ||
| Cryopreserved-thawed Embryo Transfer in Down or Non-down Regulated Hormonally Controlled Cycles: a Prospective, Randomized Study [NCT02736032] | Phase 3 | 310 participants (Actual) | Interventional | 2016-03-31 | Completed | ||
| Drug-drug Interaction Study Between Bictegravir/Emtricitabine/Tenofovir Alafenamide and Feminizing Hormones in Trans Women Living With HIV [NCT05663892] | Phase 4 | 45 participants (Anticipated) | Interventional | 2022-11-23 | Recruiting | ||
| The Influence of Estrogen on the Fear Extinction Network in Humans-R61 [NCT02673606] | Phase 1 | 136 participants (Actual) | Interventional | 2013-01-31 | Completed | ||
| Evaluation of the Adhesion Quality and Primary Dermal Irritation Potential of an Alternate Second Generation Estradiol Transdermal Systems in Normal Healthy Female Volunteers [NCT00650442] | Phase 1 | 39 participants (Actual) | Interventional | 2003-01-31 | Completed | ||
| A Phase III Investigator-Blind, Randomized, Parallel-Group, Placebo- Controlled, Multicentre Study to Evaluate the Therapeutic Equivalence and Safety of Estradiol Vaginal Tablets 10 mcg and Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk Inc.) A [NCT02668796] | Phase 3 | 522 participants (Actual) | Interventional | 2016-01-31 | Completed | ||
| Oral Contraceptive Efficacy and Body Weight: Does Obesity Affect the Risk of Contraceptive Failure? [NCT00662454] | Phase 4 | 120 participants (Actual) | Interventional | 2006-01-31 | Completed | ||
| Endometrial Preparation Using Letrozole Compared to Artificial Cycle for Frozen Embryo Transfer in PCOS Patients [NCT04002635] | Phase 4 | 0 participants (Actual) | Interventional | 2020-12-01 | Withdrawn(stopped due to Practical issues) | ||
| Interactions Between Antiretrovirals and Combined Oral Contraceptive Pills [NCT00829114] | Phase 4 | 370 participants (Anticipated) | Interventional | 2009-03-31 | Completed | ||
| Luteal Phase Estradiol Support for In Vitro Fertilization/Intracytoplasmic Sperm Injection Cycles: a Randomized, Controlled Study [NCT02677259] | Phase 2 | 506 participants (Anticipated) | Interventional | 2016-05-31 | Not yet recruiting | ||
| Comparison of Vascular Findings Between Symptomatic and Asymptomatic Postmenopausal Women Before and During Hormone Therapy: A Randomized, Placebo-controlled Prospective Study [NCT00668603] | 160 participants (Actual) | Interventional | 2005-08-31 | Completed | |||
| Therapeutic Targeting of ER Beta in Triple Negative Breast Cancer [NCT03941730] | Phase 2 | 38 participants (Anticipated) | Interventional | 2019-08-28 | Recruiting | ||
| A Multicenter, Retrospective, Post-Market Clinical Follow-Up Study to Evaluate the Performance and Safety of Suturable DuraGen™ [NCT04923867] | 260 participants (Anticipated) | Observational | 2021-04-28 | Recruiting | |||
| A Phase IIa, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Examine MK-6913 for the Treatment of Vasomotor Symptoms in Postmenopausal Women [NCT01015677] | Phase 2 | 99 participants (Actual) | Interventional | 2009-12-17 | Terminated | ||
| Continuous Versus Cyclic Postoperative Use of Low-Dose Combined Oral Contraceptive Belara® for the Treatment of Endometriosis-Related Chronic Pelvic Pain: a Randomized Controlled Trial. [NCT00844012] | Phase 4 | 60 participants (Anticipated) | Interventional | 2009-05-31 | Not yet recruiting | ||
| Initiating Transdermal Estradiol Therapy in Turner's Syndrome [NCT00870220] | Phase 1 | 1 participants (Actual) | Interventional | 2009-04-30 | Terminated(stopped due to Poor accrual) | ||
| A Phase II Randomized, Two-arms, Single-blind, Cross Controlled Study for Evaluation the Safety and Efficacy of Diagnosis and Treatment of Premenstrual Syndrome by Detecting Skin Reactions Followed by Desensitization to Sex Hormones [NCT00873262] | Phase 2 | 20 participants (Anticipated) | Interventional | 2009-04-30 | Recruiting | ||
| The Effects of Oral vs. Intravaginal Hormonal Contraception on Vaginal Health [NCT00612508] | 14 participants (Actual) | Interventional | 2007-05-31 | Completed | |||
| Bioavailability of a Formulation of Levonorgestrel and Ethinyl Estradiol 15.0 mg/0.03 mg Coated Tablets With Regards to the Marketed Reference Product [NCT04230070] | Phase 1 | 30 participants (Actual) | Interventional | 2020-10-24 | Completed | ||
| A Prospective, Multicenter, Double-Blinded, Randomized Study to Evaluate Bleeding Patterns in Women Using One of Three Different Doses of DR-1031 Oral Contraceptive Compared to Seasonale Oral Contraceptive Regimen [NCT00394771] | Phase 2 | 567 participants (Actual) | Interventional | 2006-10-31 | Completed | ||
| A Two-Way Crossover, Open-Label, Single-Dose, Fed, Bioequivalence Study of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg Versus Activella® (1 mg Estradiol/0.5 mg Norethindrone Acetate) Tablets in Normal, Healthy, Post-Menopausal Female Subjects. [NCT01181726] | Phase 1 | 40 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
| The Effect of Metformin and Medroxyprogesterone Acetate on Apoptotic Signaling Pathways in Wistar-Albino Rats With Induced Endometrial Hyperplasia [NCT02872818] | Phase 4 | 40 participants (Actual) | Interventional | 2014-10-31 | Completed | ||
| Descriptive Analysis of Serum Immunological Markers During an Euploid Frozen Embryo Transfer in a Natural Cycle (NC). [NCT05473273] | 40 participants (Anticipated) | Observational | 2023-04-24 | Recruiting | |||
| A Prospective, Multicenter, Randomized, Double-Blind Study to Evaluate Hormone Patterns and Ovarian Follicular Activity With the Oral Contraceptive Regimen DR-1021 [NCT00544882] | Phase 3 | 61 participants (Actual) | Interventional | 2007-10-31 | Completed | ||
| Status of the Growth Hormone/ Insulin-like Growth Factor-1 (GH/IGF-1) Axis in Relation to Growth Failure, Body Weight and Neuroprotection in Children With Ataxia Telangiectasia [NCT01052623] | Phase 4 | 24 participants (Anticipated) | Interventional | 2010-01-31 | Recruiting | ||
| Comparative Efficacy and Safety Study of Three Different Doses of a Formulation Composed of Crystalline Estradiol and Progesterone Microspheres, Indicated for Monthly IM Injection for the Treatment ot Climacteric Symptoms. [NCT00775242] | Phase 2/Phase 3 | 103 participants (Actual) | Interventional | 2007-04-30 | Completed | ||
| A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, 7 Cycle Duration (196 Days), Phase 3 Study of Oral Estradiol Valerate/Dienogest Tablets for the Treatment of Dysfunctional Uterine Bleeding. [NCT00307801] | Phase 3 | 231 participants (Actual) | Interventional | 2006-02-28 | Completed | ||
| Prospective Double Blind Evaluation of Bioidentical Hormones [NCT00302731] | Phase 2 | 21 participants (Actual) | Interventional | 2006-02-28 | Terminated | ||
| PROMES: PROspective, Non-Interventional, Observational, Longitudinal Study to Describe the Safety Profile of MESIGYNA® (Norethisterone Enantate 50 mg and Estradiol Valerate 5 mg) as a Contraceptive Method for Women in Reproductive Age at the Outpatient Cl [NCT03901131] | 296 participants (Actual) | Observational | 2019-08-26 | Completed | |||
| A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo- Controlled, 7 Cycle Duration (196 Days), Phase 3 Study of Oral Estradiol Valerate/Dienogest Tablets for the Treatment of Dysfunctional Uterine Bleeding. [NCT00293059] | Phase 3 | 190 participants (Actual) | Interventional | 2005-12-31 | Completed | ||
| A Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Effects of Estrogen on Estrogen Receptor Biomarkers in Healthy Postmenopausal Women [NCT00799708] | Phase 1 | 27 participants (Actual) | Interventional | 2008-05-31 | Completed | ||
| A Randomised Controlled Trial of Natural Versus Hormone Replacement Therapy Cycles in Frozen Embryo Replacement IVF: a Pilot Study [NCT00843570] | Phase 4 | 159 participants (Actual) | Interventional | 2009-11-30 | Completed | ||
| An Open Label Study to Evaluate Cycle Control With Ortho Tri-Cyclen Lo (Norgestimate/Ethinyl Estradiol) and Yaz (Drospirenone/Ethinyl Estradiol) in Healthy Sexually Active Females [NCT00745901] | Phase 4 | 355 participants (Actual) | Interventional | 2008-05-31 | Completed | ||
| Estrogen Dosing in Turner Syndrome:Pharmacology & Metabolism [NCT00837616] | Phase 4 | 41 participants (Actual) | Interventional | 2009-01-31 | Completed | ||
| Short-term Effects of Transdermal Estradiol on Female COVID-19 Patients: A Randomized Placebo-Controlled Study [NCT05774405] | Phase 2 | 9,169 participants (Actual) | Interventional | 2020-07-01 | Completed | ||
| A Double Blind, Randomized, Active-control Study to Evaluate Effects of Drospirenone/Estradiol (Angeliq) and Medroxyprogesterone Acetate/Conjugated Equine Estrogen (Prempro) on Blood Pressure and Sodium Sensitivity in Postmenopausal Women With Prehyperten [NCT00420342] | Phase 2 | 92 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
| Multisite Double-Blind Randomized Controlled Study of Estradiol Plus Antipsychotic Versus Placebo Plus Antipsychotic in the Treatment of Psychotic Symptoms in Women With Schizophrenia [NCT00357006] | Phase 2 | 180 participants (Actual) | Interventional | 2006-07-31 | Completed | ||
| A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study Comparing a 2.2mg 17 Beta-Estradiol/0.69mg Levonorgestrel Combination Transdermal Patch, and a 1mg 17 Beta-Estradiol Transdermal Patch With a Placebo Patch in Postmenopausal Women to Determ [NCT00206622] | Phase 4 | 425 participants (Actual) | Interventional | 2004-12-31 | Completed | ||
| [NCT00204074] | Phase 2/Phase 3 | 0 participants | Interventional | 2001-10-31 | Active, not recruiting | ||
| Substituted Frozen Embryo Transfer Cycles With GnRH-agonist Supplementation [NCT01943812] | Phase 4 | 287 participants (Actual) | Interventional | 2013-12-31 | Completed | ||
| A Randomized, Placebo-Controlled, Double-Blind, Multi-National Study to Demonstrate Efficacy of Continuous Combined 0.5 mg Estradiol and 2.5 mg Dydrogesterone in the Treatment of Vasomotor Symptoms in Postmenopausal Women in Comparison to Placebo Over 3 M [NCT00251082] | Phase 3 | 391 participants (Actual) | Interventional | 2005-12-31 | Completed | ||
| Randomized Trial Comparing Functional Digestive Outcomes Related to Two Types of Management of Rectal Endometriosis: Continuous Hormonal Treatment and Curative Surgery [NCT01973816] | Phase 3 | 78 participants (Anticipated) | Interventional | 2014-11-30 | Recruiting | ||
| A Relative Bioavailability Study of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets Under Non-Fasting Conditions. [NCT01182207] | Phase 1 | 33 participants (Actual) | Interventional | 2006-07-31 | Completed | ||
| A Multicenter, Randomized, Open-labe, Controlled Study to Evaluate the Efficacy and Safety of the Combined Levonorgestrel(LNG) 100mcg and Ethinyl Estradiol(EE) 20mcg for Oral Contraception [NCT02021097] | Phase 3 | 1,008 participants (Anticipated) | Interventional | 2012-02-29 | Recruiting | ||
| [NCT00006133] | 970 participants | Interventional | 2000-06-30 | Completed | |||
| A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer [NCT06179303] | Phase 2 | 60 participants (Anticipated) | Interventional | 2024-06-01 | Not yet recruiting | ||
| A Two-Way Crossover, Open-Label, Single-Dose, Fasting, Bioequivalence Study of Estradiol/Norethindrone Acetate Tablets, 1 mg/0.5 mg Versus Activella® (1 mg Estradiol/0.5 mg Norethindrone Acetate) Tablets in Normal, Healthy, Post-Menopausal Female Subjects [NCT01157182] | Phase 1 | 36 participants (Actual) | Interventional | 2007-02-28 | Completed | ||
| The Impact of HIV on Accelerated Aging in the Female Genital Tract: a Pilot Trial of Topical Estradiol to Improve the Vaginal Microbiome and Symptoms of Vaginal Atrophy in Menopausal Women With HIV [NCT04079218] | Phase 4 | 51 participants (Actual) | Interventional | 2020-09-01 | Active, not recruiting | ||
| Progesterone Amplifies Estrogen-stimulated Growth Hormone Secretion in Older Women [NCT02272647] | Phase 1 | 47 participants (Actual) | Interventional | 2014-12-31 | Completed | ||
| A Relative Bioavailability Study of 0.4 mg/35 Mcg Norethindrone and Ethinyl Estradiol Chewable Tablets Under Fasting Conditions [NCT01340625] | Phase 1 | 36 participants (Actual) | Interventional | 2006-12-31 | Completed | ||
| Institute of HIV Research and Innovation (IHRI) [NCT04590417] | 20 participants (Actual) | Interventional | 2020-10-01 | Active, not recruiting | |||
| Evaluation of 304 Danish Girls With Tall Stature: Phenotypic Characteristics and Effects of Oral Administration of Natural 17β-Estradiol [NCT02638922] | 304 participants (Actual) | Observational | 2014-01-31 | Active, not recruiting | |||
| Effects of Estradiol and Soy on Menopausal Symptoms [NCT00997893] | Phase 2 | 96 participants (Actual) | Interventional | 2009-12-31 | Completed | ||
| A Relative Bioavailability Study of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets Under Fasting Conditions. [NCT01182194] | Phase 1 | 32 participants (Actual) | Interventional | 2006-06-30 | Completed | ||
| Effect of Combined Estradiol and Drospirenone Treatment Versus Combined Estradiol and Medroxyprogesterone Acetate Treatment on Endothelial Function: A Crossover Study [NCT01109979] | Phase 4 | 24 participants (Actual) | Interventional | 2009-12-31 | Completed | ||
| A Multicenter, Double-Blind, Controlled, Randomized Study to Compare the Efficacy in Relief of Hot Flushes in Women Receiving Oral Estradiol Acetate Tablets, Oral Estradiol Tablets or Oral Conjugated Equine Estrogens [NCT01070979] | Phase 3 | 249 participants (Actual) | Interventional | 2003-02-28 | Completed | ||
| Fat Mediated Modulation of Reproductive and Endocrine Function in Young Athletes [NCT00946192] | Phase 3 | 121 participants (Actual) | Interventional | 2009-05-31 | Completed | ||
| Programming by Estrogen Treatment in Gonadotropin Releasing Hormone Antagonist Protocol [NCT01419353] | Phase 4 | 63 participants (Actual) | Interventional | 2011-08-31 | Completed | ||
| Polymorphisms in Genes Encoding the Estrogen Metabolism Enzymes and Effects of Hormone Therapy for Oral Low Dose or Not Oral on Variables Related Endothelial Function, Inflammation and Metabolic Profile in Patients in Recent Menopause Study Pharmacogeneti [NCT01432028] | 90 participants (Actual) | Interventional | 2007-03-31 | Completed | |||
| A Randomized Controlled Trial to Evaluate the Efficacy of Low Dose Vaginal Estrogens in the Treatment of Atrophic Vaginitis [NCT00816556] | Phase 3 | 63 participants (Actual) | Interventional | 2008-10-31 | Terminated(stopped due to Funding) | ||
| Coagulation Activation and Fibrinolysis With Sublingual Versus Oral Versus Transdermal Estradiol in Transgender Women [NCT05387577] | Early Phase 1 | 6 participants (Actual) | Interventional | 2021-12-07 | Terminated(stopped due to per MCW IRB) | ||
| The Effects of Oral Contraceptive Pills vs Hormonal Patch on Coagulation Parameters [NCT00554632] | 24 participants (Actual) | Interventional | 2003-04-30 | Completed | |||
| A Randomized, Open-Label Study Comparing the Effect of a Contraceptive Vaginal Ring Delivering Daily Doses of 150 Micrograms Nestorone and 15 Micrograms Ethinyl Estradiol to an Oral Contraceptive Containing 150 Micrograms of Levonorgestrel and 30 Microgra [NCT00213096] | Phase 2 | 50 participants | Interventional | 2003-03-31 | Completed | ||
| Bioavailability of a Formulation of Dienogest and Ethinyl Estradiol 2.0 mg/0.03 mg Coated Tablets With Regards to the Marketed Reference Product [NCT04193852] | Phase 1 | 10 participants (Actual) | Interventional | 2019-11-09 | Completed | ||
| A Phase I, Randomized, Open-Label, Single Center, Cross-over Study to Investigate the Pharmacokinetics and Safety Following a Single Application of Three Different Doses 0.5 gm (0.5 mg Estradiol), 0.75 gm (0.75 mg Estradiol) and 1.25 gm (1.25 mg Estradiol [NCT03556800] | Phase 1 | 20 participants (Anticipated) | Interventional | 2018-05-22 | Recruiting | ||
| A Pharmacokinetic Randomized Study With a Parallel Group Design to Assess the Extent of Systemic Absorption of Estradiol During Treatment With a 10 µg or 25 µg Estradiol Vaginal Tablet Administered Once Daily for 2 Weeks Followed by 10 Weeks of Twice-Week [NCT01486979] | Phase 1 | 58 participants (Actual) | Interventional | 2007-01-31 | Completed | ||
| Interest of a Steroid Pre-treatment Prior to IVF Protocol With Ovarian Stimulation by Recombinant FSH and With LH Surge Blockage by Daily GnRH Antagonist [NCT01489852] | Phase 4 | 472 participants (Actual) | Interventional | 2006-12-31 | Completed | ||
| Blinded Randomised Trial About the Influence of Estradiol Supplementation During the Luteal in Patients Undergoing in Vitro Fertilization (IVF) Treatment [NCT00490308] | Phase 1 | 120 participants (Anticipated) | Interventional | 2007-08-31 | Not yet recruiting | ||
| Optimal Hormone Replacement for Women With Premature Ovarian Insufficiency [NCT02922348] | Phase 3 | 0 participants (Actual) | Interventional | 2016-03-01 | Withdrawn | ||
| Bioavailability of a Formulation of Levonorgestrel and Ethinyl Estradiol 0.1 mg/0.02 mg Coated Tablets With Regards to the Marketed Reference Product [NCT04194905] | Phase 1 | 10 participants (Actual) | Interventional | 2020-11-21 | Completed | ||
| Positron Emission Tomography (PET) With 18F-Fluoroestradiol (FES) as a Predictor of Response in Patients With Breast Cancer Scheduled to be Treated With MK-2206 in Combination With Either an Aromatase Inhibitor or Fulvestrant on NCI Protocol 8762 [NCT01714128] | 0 participants (Actual) | Interventional | 2013-06-30 | Withdrawn(stopped due to Study Funding no longer available) | |||
| A Pilot Study Of Estradiol Followed By Exemestane For Post-Menopausal Hormone Receptor Positive Metastatic Breast Cancer After Prior Failed Endocrine Therapy: Reversing Endocrine Resistance [NCT01385280] | 13 participants (Actual) | Interventional | 2011-02-28 | Completed | |||
| Single Dose, Three-way, Cross-over, Relative Bioavailability Study With 3 Oral Formulations for Hormone Replacement Therapy in Postmenopausal Women: 0.5 mg Estradiol + 0.1 mg Norethisterone Acetate, 0.5 mg Estradiol + 0.25 mg Norethisterone Acetate, and 1 [NCT01477632] | Phase 1 | 24 participants (Actual) | Interventional | 2005-03-31 | Completed | ||
| The Effect of Exenatide on Single and Multiple Doses Oral Contraceptive Pharmacokinetics in Healthy Female Subjects [NCT00254800] | Phase 1 | 38 participants (Actual) | Interventional | 2005-11-30 | Completed | ||
| A Multicenter, Double-blind, Randomized, Placebo-controlled Study Comparing 3 Continuous Oral Angeliq (Drospirenone 3 mg/17ß-estradiol 1 mg, Drospirenone 2 mg /17ß-estradiol 1 mg, Drospirenone 1 mg /17ß-estradiol 1 mg) Combinations and 17ß-estradiol (1 mg [NCT00102141] | Phase 3 | 750 participants (Actual) | Interventional | 2004-04-30 | Completed | ||
| An Open-Label, Randomized, Multicenter Trial to Evaluate Continuation Rates, Side Effects and Acceptability of NuvaRing Versus OrthoEvra [NCT00269620] | Phase 4 | 500 participants (Actual) | Interventional | 2005-06-30 | Completed | ||
| Effects of Tibolone Treatment on the Endometrium [NCT00294463] | Phase 4 | 35 participants | Interventional | 2003-02-28 | Completed | ||
| Continuous Versus Cyclic Use of an Oral Contraceptive Pills in Adolescents [NCT00326404] | Phase 3 | 130 participants (Anticipated) | Interventional | 2006-05-31 | Recruiting | ||
| Hormone Replacement Therapy Versus Minimal Ovarian Stimulation for Endometrial Preparation Prior to Frozen-thawed Embryo Transfer in Polycystic Ovarian Syndrome Patients [NCT02273791] | 126 participants (Actual) | Observational | 2013-12-31 | Completed | |||
| Mechanisms of Skin Repair by Topical Estrogen in Vivo [NCT00113100] | 152 participants (Actual) | Interventional | 2004-08-31 | Completed | |||
| Hormonal Replacement Therapy Plus Letrozole Incorporation Versus Letrozole Mild Ovarian Stimulation in Endometrial Preparation for Frozen Embryo Transfer: A Randomised Controlled Trial [NCT06181305] | Phase 4 | 210 participants (Anticipated) | Interventional | 2023-12-12 | Not yet recruiting | ||
| A Phase I Trial for the Evaluation of the Two-way Pharmacokinetic-pharmacodynamic (PD) Interaction of Gender Affirming Exogenous Estrogen (With Testosterone Suppression) on TDF/FTC PrEP in Transgender Women (TGW) [NCT04760691] | Phase 1 | 20 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting | ||
| A Randomized Controlled Study:the Different Outcomes Between Natural Cycle and Hormon Replacement Cycle in FET [NCT01780558] | 600 participants (Anticipated) | Interventional | 2010-01-31 | Recruiting | |||
| Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery [NCT00741858] | Phase 3 | 34 participants (Actual) | Interventional | 2003-04-30 | Completed | ||
| Improving Contraceptive Effectiveness in Obese Women [NCT01170390] | Phase 4 | 32 participants (Actual) | Interventional | 2009-09-30 | Completed | ||
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis [NCT00465192] | Phase 3 | 230 participants (Anticipated) | Interventional | 1994-08-31 | Completed | ||
| The Frequency and Management of Breakthrough Bleeding During Extended Therapy With the Transvaginal Contraceptive Ring [NCT00475553] | 75 participants (Actual) | Interventional | 2006-05-31 | Completed | |||
| 16α-18F-fluor-17β-østradiol PET/CT Til Visualisering af østrogenreceptor-positive Levermetastaser Fra brystkræft [NCT04150731] | Phase 1/Phase 2 | 8 participants (Actual) | Interventional | 2020-10-23 | Completed | ||
| [NCT01511822] | Phase 4 | 0 participants | Interventional | Completed | |||
| Clinical Efficacy and Metabolic Impact of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Normal-weight Women With Polycystic Ovary Syndrome: a Randomized Study. [NCT01519401] | 50 participants (Actual) | Interventional | 2010-02-28 | Completed | |||
| Alzheimer's Disease: Therapeutic Potential of Estrogen [NCT00066157] | Phase 2/Phase 3 | 42 participants (Actual) | Interventional | 2001-09-30 | Completed | ||
| Estrogen Replacement in Hypogonadal Girls Treated With GH: Differential Effects of Mode of Estrogen Delivery [NCT00140998] | Phase 3 | 16 participants | Interventional | 2001-01-31 | Completed | ||
| Effects of Estrogen Replacement on Atherosclerosis Progression in Recently Menopausal Women [NCT00154180] | Phase 4 | 728 participants (Anticipated) | Interventional | 2005-09-30 | Active, not recruiting | ||
| A Six Month Double-blind, Randomised, Parallel-group, Placebo-controlled, Multi-centre Trial to Investigate the Efficacy and Safety of Two Ultra-low Dose Combinations With 0.5 mg Estradiol and 0.1 mg or 0.25 mg Norethisterone Acetate (Activelle Low Dose 0 [NCT00184795] | Phase 3 | 576 participants (Actual) | Interventional | 2004-05-28 | Completed | ||
| Optimization of Management Tactics for Women With Premature Ovarian Insufficiency, Taking Into Account Their Clinical and Hormonal Profile [NCT05737329] | Phase 1/Phase 2 | 80 participants (Actual) | Interventional | 2019-03-01 | Active, not recruiting | ||
| Randomized Controlled Trial of DuraGen Plus® Adhesion Barrier Matrix to Minimize Adhesions Following Lumbar Discectomy [NCT00387829] | 347 participants (Actual) | Interventional | 2006-10-31 | Terminated(stopped due to Sponsor voluntarily terminated study) | |||
| A Phase II Study of Vaginal Testosterone Cream vs. the ESTRING for Vaginal Dryness or Decreased Libido in Early Breast Cancer Patients Treated With Aromatase Inhibitors [NCT00698035] | Phase 2 | 76 participants (Actual) | Interventional | 2007-03-31 | Completed | ||
| Synthetic vs Natural Estrogen in Combined Oral Contraception- Effect on Insulin Sensitivity, Coagulation, Inflammation and Endometrium - a Comparison With a Progestin-only Preparation. [NCT02352090] | Phase 4 | 59 participants (Actual) | Interventional | 2015-04-01 | Completed | ||
| A Phase 3 Study Safety and Efficacy Study of the Combination Estradiol and Progesterone to Treat Vasomotor Symptoms in Postmenopausal Women With an Intact Uterus [NCT01942668] | Phase 3 | 1,845 participants (Actual) | Interventional | 2013-08-05 | Completed | ||
| Pro-Inflammatory Effects of Two Different Doses of 17 Beta Estradiol in Menopausal Women [NCT00236301] | Phase 3 | 99 participants (Actual) | Interventional | 2004-03-31 | Terminated(stopped due to terminated) | ||
| Bioavailability of Formulation Clormadinone/Ethinyl Estradiol Coated Tablets 2 mg/0.02 mg With Regards to the Marketed Reference Product [NCT04713904] | Phase 1 | 38 participants (Actual) | Interventional | 2021-01-16 | Completed | ||
| Study of Vasomotor Symptoms in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen [NCT00332553] | Phase 2 | 150 participants | Interventional | 2002-02-28 | Completed | ||
| Endometrial Receptivity After GnRH Agonist Triggering From Final Oocyte Maturation [NCT01500863] | Phase 4 | 35 participants (Actual) | Interventional | 2011-11-30 | Completed | ||
| [NCT01501448] | Phase 4 | 118 participants (Actual) | Interventional | 2012-01-31 | Completed | ||
| Safety and Efficacy of Transdermal Estrogen (Gel) Versus Oral Estrogen for Endometrial Preparation in Down-regulated Frozen Embryo Transfer (FET) Cycles-An Open-label Multi Centric Randomized Controlled Trial [NCT05802303] | 510 participants (Anticipated) | Interventional | 2023-04-30 | Not yet recruiting | |||
| Multi-centre Clinical Trial on Hormone Replacement Treatment in China [NCT01698164] | Phase 4 | 1,200 participants (Anticipated) | Interventional | 2008-12-31 | Recruiting | ||
| Induction of Puberty With 17-Beta Estradiol in Girls With Turner Syndrome. An Open Randomized Trial [NCT01710696] | Phase 3 | 50 participants (Actual) | Interventional | 1998-07-23 | Completed | ||
| The Effects of Two Endometrium Preparation Protocols in Frozen-thawed Embryo Transfer in Women With Irregular Cycles [NCT01780610] | 670 participants (Anticipated) | Interventional | 2012-01-31 | Recruiting | |||
| Oestradiol Pre-treatment in an Ultrashort Flare GnRH Agonist/GnRH Antagonist Protocol in Poor Responders Undergoing IVF [NCT01798836] | Phase 2/Phase 3 | 17 participants (Actual) | Interventional | 2013-02-28 | Terminated(stopped due to Obtained results were not good. Protocol was proved ineffective.) | ||
| Atherosclerosis, Immune Mediated Inflammation and Hypoestrogenemia in Young Women [NCT03018366] | Phase 2 | 29 participants (Actual) | Interventional | 2017-01-01 | Completed | ||
| Identification of the Menstrual Cycle-Associated Factors That Modulate Circulating Lipid Levels in Premenopausal Women [NCT01546454] | 5 participants (Actual) | Interventional | 2012-02-29 | Completed | |||
| [NCT02770365] | Phase 3 | 695 participants (Actual) | Interventional | 2016-05-31 | Completed | ||
| A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Estradiol Metered-Dose Transdermal Spray (MDTS) in the Treatment of Vasomotor Symptoms in Postmenopausal Women [NCT01389102] | Phase 3 | 454 participants (Actual) | Interventional | 2004-12-31 | Completed | ||
| Comparison of Pharmacokinetics of 17-Beta-Estradiol Via Oral Administration With Sublingual Placement Versus Oral Administration With Swallowing of 17-Beta-estradiol in Male-to-Female Transgender Patients [NCT05428215] | Phase 4 | 2 participants (Actual) | Interventional | 2022-12-29 | Terminated(stopped due to Inability to adequately recruit participants, need for additional study participants based on preliminary data collection) | ||
| Open Label, Randomized, Comparator-Controlled Study of the Contraceptive Efficacy of Norethindrone Acetate (NA) and Ethinyl Estradiol (EE) [NCT00932321] | Phase 3 | 938 participants (Actual) | Interventional | 2004-01-31 | Completed | ||
| Phytoestrogens as an Alternative to Estradiol in Reversing the Antiestrogenic Effect of Clomid on Endometrium in Ovulation Induction in Cases of Polycystic Ovarian Syndrome [NCT02352597] | Phase 4 | 150 participants (Actual) | Interventional | 2013-01-31 | Completed | ||
| The Efficacy of 17Beta-Estradiol in Postpartum-Related Depressive Illness [NCT00059228] | Phase 2 | 12 participants (Actual) | Interventional | 2003-04-17 | Terminated | ||
| Sex Hormones and Orthostatic Tolerance [NCT01153581] | Phase 2 | 109 participants (Actual) | Interventional | 2006-02-28 | Completed | ||
| Comparison Between Testosterone and Estradiol Over the Homogenization of Follicular Cohort: a Randomized Clinical Trial [NCT03238092] | Phase 3 | 26 participants (Anticipated) | Interventional | 2017-08-31 | Not yet recruiting | ||
| Effects of Estradiol on Neural Reward System and Depression in the Perimenopause [NCT02255175] | Phase 4 | 64 participants (Actual) | Interventional | 2015-10-01 | Completed | ||
| "The Effect of Pretreatment With Dydrogesterone Vs Combined Estradiol Valerate and Dydrogestrone on Clinical Pregnancy Outcome of ICSI in PCOS Patients" [NCT05300841] | Early Phase 1 | 500 participants (Anticipated) | Interventional | 2022-05-01 | Not yet recruiting | ||
| Effect of Transgender Therapy on Hormone Receptors, Adipogenesis, Myogenesis and Inflammation [NCT04551144] | 4 participants (Actual) | Observational | 2020-10-06 | Active, not recruiting | |||
| Effects of Oral and Non-oral Hormonal Therapy on Cardiovascular Risk and Body Composition Parameters in Postmenopausal Women [NCT04453332] | 60 participants (Anticipated) | Interventional | 2015-10-09 | Recruiting | |||
| Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multi-Site Study to Evaluate Therapeutic Equivalence of Estradiol Vaginal Cream, USP, 0.01% (Prasco LLC) to Estrace® Cream (Warner Chilcott) in Treatment of Vulvar and Vaginal Atrophy [NCT03332303] | Phase 3 | 540 participants (Actual) | Interventional | 2017-10-26 | Completed | ||
| Pharmacodynamics of NPC-01( 1mg Norethisterone and 0.02mg Ethinyl Estradiol) and IKH-01( 1mg Norethisterone and 0.035mg Ethinyl Estradiol); Effect of NPC-01 and IKH-01 on Serum Concentrations of Estradiol, Progesterone, FSH and LH. [NCT01253824] | Phase 3 | 14 participants (Actual) | Interventional | 2011-01-31 | Completed | ||
| Postmarketing Study Of Lybrel In Relation To Venous Thromboembolism [NCT01297348] | 598,682 participants (Actual) | Observational | 2007-07-31 | Completed | |||
| Oral Contraceptive Ethinyl Estradiol Dose Effect on Postpartum Depression and Sexual Functioning Scales [NCT02210702] | Phase 4 | 33 participants (Anticipated) | Interventional | 2014-07-31 | Recruiting | ||
| The Effects of Estrogen Replacement Therapy in Postmenopausal Women With Hypercalciuria and Low Bone Mass [NCT01928082] | Phase 2 | 1 participants (Actual) | Interventional | 2013-08-01 | Terminated(stopped due to The fellow conducting the recruitment and screening left the institution) | ||
| Acute Estradiol and Progesterone Therapy in Hospitalized Adults to Reduce Coronavirus Disease (COVID-19) Severity: A Randomized Control Trial [NCT04865029] | Phase 2 | 10 participants (Actual) | Interventional | 2021-07-22 | Terminated(stopped due to Lack of enrollment due to change of COVID 19 variant prevalence) | ||
| Protocol for Randomized Clinical Study Concerning Hormonal Replacement Therapy (HRT) After Previous Radical Breast Cancer Treatment [NCT00003771] | Phase 3 | 1,300 participants (Anticipated) | Interventional | 1997-09-30 | Completed | ||
| Pilot Retrospective Study on the Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters. [NCT04336891] | 81 participants (Actual) | Observational | 2019-03-20 | Completed | |||
| A Randomized Controlled Study to Compare the Outcome of Two Protocols Used to Prepare the Endometrium for Frozen Embryo Transfer [NCT04507022] | Phase 4 | 112 participants (Actual) | Interventional | 2020-08-12 | Completed | ||
| SPIRIT 2: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain [NCT03204331] | Phase 3 | 623 participants (Actual) | Interventional | 2017-11-01 | Completed | ||
| Nanoparticulate Versus Micronized Steroids Delivery for Transdermal Hormone Replacement Therapy: Effects on Blood Pressure, Insulin and C-reactive Protein and in Postmenopausal Women [NCT02467673] | Phase 2 | 185 participants (Actual) | Interventional | 2012-01-31 | Completed | ||
| Effects of Acute Estrogen Therapy on Bone Formation [NCT02349113] | Phase 1 | 20 participants (Actual) | Interventional | 2012-02-29 | Completed | ||
| The Effect of an ASC-seeded Collagen Hydrogel on Cerebrospinal Fluid Leak Rates Following Skull Base Surgery [NCT04503161] | 0 participants (Actual) | Interventional | 2021-09-30 | Withdrawn(stopped due to Investigator left institution) | |||
| Live Birth After Letrozole-stimulated Cycles Versus Hormone Replacement Treatment Cycles for the First Frozen Embryo Transfer in Women With PCOS: a Randomized Controlled Trial [NCT05227391] | 1,078 participants (Anticipated) | Interventional | 2022-03-16 | Recruiting | |||
| Ovulation and Follicular Development Associated With Mid Follicular Phase Initiation of Combined Hormonal Contraception Containing Estradiol Hemihydrate Compared to Ethinyl Estradiol [NCT03077555] | Phase 4 | 69 participants (Actual) | Interventional | 2017-01-21 | Completed | ||
| MsFLASH-03: Comparative Efficacy of Low-Dose Estradiol and the SNRI Venlafaxine XR for Treatment of Menopausal Symptoms [NCT01418209] | 339 participants (Actual) | Interventional | 2011-11-30 | Completed | |||
| A Phase 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of TX-12-004-HR in Postmenopausal Women With Symptoms of Vulvar and Vaginal Atrophy (VVA) [NCT02449902] | Phase 2 | 50 participants (Actual) | Interventional | 2013-07-31 | Completed | ||
| Primary Ovarian Insufficiency: Phenotype and Optimal Treatment [NCT03568708] | Phase 3 | 19 participants (Actual) | Interventional | 2018-11-01 | Completed | ||
| Functional Study of the Hypothalamus in High-resolution Magnetic Resonance Imaging (MRI) in Women With Polycystic Ovary Syndrome (PCOS): a Comparative Study [NCT03043924] | 52 participants (Anticipated) | Interventional | 2017-09-26 | Active, not recruiting | |||
| Comparative Study of the Effect on Acne With Norgestimate Containing Triphasic Oral Contraceptive and Biphasic Preparation Containing Desogestrel [NCT01466673] | Phase 4 | 201 participants (Actual) | Interventional | 2008-12-31 | Completed | ||
| Phase 2a Proof Of Concept Study to Evaluate the Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids [NCT01441635] | Phase 2 | 271 participants (Actual) | Interventional | 2011-09-08 | Completed | ||
| A Multicenter, Randomized, Partially-blinded, Phase IIb Dose-finding Study on Ovarian Function, Vaginal Bleeding Pattern, and Pharmacokinetics Associated With the Use of Combined Vaginal Rings Releasing 17β-estradiol Plus Three Different Doses of Either N [NCT01709318] | Phase 2 | 666 participants (Actual) | Interventional | 2012-12-12 | Completed | ||
| Comparison of Transdermal and Oral Estrogens in Adolescents With Ovarian Failure [NCT01023178] | 20 participants (Actual) | Interventional | 2007-02-28 | Completed | |||
| The Effects of 17β-estradiol on Skeletal Muscle Mass Following Immobilization [NCT03069781] | Early Phase 1 | 0 participants (Actual) | Interventional | 2017-05-31 | Withdrawn(stopped due to Lack of funding) | ||
| A Multi-center Clinical Study on the Efficacy and Safety of Kuntai Capsule Alone and in Combination With Hormones in the Treatment of Early-onset Hypoovarian Function [NCT05021094] | Phase 4 | 120 participants (Anticipated) | Interventional | 2021-10-22 | Recruiting | ||
| Effects of Anorexia Nervosa on Peak Bone Mass [NCT01301183] | Phase 3 | 75 participants (Actual) | Interventional | 2011-02-28 | Completed | ||
| A Prospective, Multi-Center, Randomized, Controlled Clinical Study Comparing SyntheCelTM Dura Replacement to Other Dura Replacements in Patients Requiring Dura Repair Following Cranial Surgery [NCT00859508] | 99 participants (Actual) | Interventional | 2006-02-28 | Completed | |||
| A Randomized Clinical Trial to Evaluate the Effects of Estrogen on Uterine Endometrium in Healthy Postmenopausal Women [NCT00820664] | Phase 1 | 29 participants (Actual) | Interventional | 2008-12-31 | Completed | ||
| Which do You Think is the Best Treatment Choice in Primary Dysmenorrhea? [NCT03124524] | Phase 4 | 99 participants (Actual) | Interventional | 2015-01-15 | Completed | ||
| Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients: A Randomized Trial [NCT03976544] | Phase 4 | 522 participants (Anticipated) | Interventional | 2019-05-25 | Recruiting | ||
| Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent Combined With Estrogen or Dried Biological Amnion Graft in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis [NCT03329898] | 200 participants (Anticipated) | Interventional | 2017-10-31 | Recruiting | |||
| Effects of Adding Oestradiol Supplementation in Luteal Phase in Patients Undergoing in Vitro Fertilization/ Intra Cytoplasmic Sperm Injection (IVF/ICSI ) Long Agonist Fresh Embryo Transfer Cycles [NCT03832894] | Phase 3 | 2 participants (Anticipated) | Interventional | 2018-12-01 | Recruiting | ||
| Efficacy Study Comparing 0.9 g and 1.25 g EstroGel® 0.03% Doses With Placebo in the Treatment of Vasomotor Symptoms and Vulvar and Vaginal Atrophy Associated With Menopause [NCT00160173] | Phase 4 | 221 participants (Actual) | Interventional | 2004-12-02 | Completed | ||
| A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of DR-102 Compared to a 28-day Standard Oral Contraceptive Regimen, on Hemosatic Parameters in Healthy Women [NCT01388491] | Phase 2 | 293 participants (Actual) | Interventional | 2011-10-31 | Completed | ||
| The Association of Hormonal Intake and Demographic Factors With Breast Cancer Risk. An Egyptian Case-controlled Study [NCT05135013] | 200 participants (Anticipated) | Observational | 2021-11-16 | Not yet recruiting | |||
| Randomized, Controlled Trial to Assess the Efficacy of Estrogen Therapy Combined With Disposable Balloon Uterine Stent and Dried Biological Amnion Graft in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis [NCT03351205] | 100 participants (Anticipated) | Interventional | 2017-11-21 | Recruiting | |||
| Addressing Preference as a Patient-centered Outcome to Prevent Recurrent Urinary Tract Infection (rUTI) in Post-menopausal Women: a Cross-over Randomized Controlled Trial [NCT05723601] | Phase 4 | 24 participants (Anticipated) | Interventional | 2024-01-31 | Not yet recruiting | ||
| SPIRIT 1: An International Phase 3 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate Relugolix Administered With and Without Low-Dose Estradiol and Norethindrone Acetate in Women With Endometriosis-Associated Pain [NCT03204318] | Phase 3 | 638 participants (Actual) | Interventional | 2017-12-07 | Completed | ||
| The Effect of the Co-administration of Atazanavir (ATV) and Ritonavir (RTV) on the Pharmacokinetics of a Combined Oral Contraceptive Containing Ethinyl Estradiol and Norgestimate in Healthy Female Subjects [NCT00357604] | Phase 1 | 22 participants | Interventional | 2006-07-31 | Completed | ||
| Endometrial Receptivity Profile in Patients With Endometrial Proliferation Defects [NCT02406690] | 1 participants (Actual) | Observational | 2015-07-31 | Completed | |||
| A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study of BHR-200 (0.36% Transdermal Estradiol Gel) for the Maintenance of Testosterone Suppression in Men With Advanced Androgen-Sensitive Prostate Cancer [NCT02349386] | Phase 2 | 34 participants (Actual) | Interventional | 2015-07-31 | Terminated(stopped due to Inability to recruit patients) | ||
| A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids [NCT01817530] | Phase 2 | 571 participants (Actual) | Interventional | 2013-04-08 | Completed | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
The Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Higher total scores indicate more severe depressive symptoms. The range of scores vary from 0 to 63 (highest possible total) for the whole test. A score of 0 - 10 indicates minimal depression, while a score of over 40 indicates extreme depression. No subscales were used for this outcome. (NCT00059228)
Timeframe: 6 weeks
| Intervention | Units on a scale (Least Squares Mean) |
|---|---|
| Estradiol | 15.84 |
| Placebo | 5.3 |
The Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory for measuring the severity of depression. Higher total scores indicate more severe depressive symptoms. The range of scores vary from 0 to 63 (highest possible total) for the whole test. A score of 0 - 10 indicates minimal depression, while a score of over 40 indicates extreme depression. No subscales were used for this outcome. (NCT00059228)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|---|
| Estradiol | 26 |
| Placebo | 27.67 |
The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment. (NCT00293059)
Timeframe: baseline and reference period of 90 days under treatment
| Intervention | mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -411.9 |
| Placebo | -152.3 |
The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for one cycle. (NCT00293059)
Timeframe: 28 days
| Intervention | mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 206.1 |
| Placebo | 194.7 |
The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 3 cycles. (NCT00293059)
Timeframe: 28 days
| Intervention | mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 67.1 |
| Placebo | 147.4 |
The blood loss volume for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 mL or more during the run-in phase) was determined using the alkaline hematin method after participants were on treatment for 7 cycles. (NCT00293059)
Timeframe: 28 days
| Intervention | mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 47.5 |
| Placebo | 116.9 |
Excessive bleeding was defined as 2 or more bleeding episodes each with blood loss volume of 80 mL or more in a 90-day period. Participants were considered cured if (1) the blood loss volume associated with each episode was less than 80 mL and (2) the blood loss volume associated with each bleeding episode represented a decrease of at least 50% from the average of the qualifying bleeding episodes, where the qualifying bleeding episodes were those with a blood loss volume ≥ 80 mL (per episode) that occurred during the run-in phase. (NCT00293059)
Timeframe: during a time period of 90 days under treatment
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.385 |
| Placebo | 0.05 |
Frequent bleeding was defined as greater than 5 bleeding episodes, with a minimum of 20 bleeding days overall in a 90-day period. Participants were considered cured if they had no more than 4 bleeding episodes and the total number of bleeding days did not exceed 24 days and there was no increase in the total number of bleeding days in the efficacy phase as compared to the run-in phase. (NCT00293059)
Timeframe: during a time period of 90 days under treatment
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.250 |
| Placebo | 0.0 |
Prolonged bleeding was defined as 2 or more bleeding episodes, each lasting 8 or more days in a 90-day period. Participants were considered cured if they had no bleeding episodes lasting more than 7 days and the decrease between the maximum duration during the run-in phase and the maximum duration during the efficacy phase was at least 2 days. (NCT00293059)
Timeframe: during a time period of 90 days under treatment
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.154 |
| Placebo | 0.083 |
The investigators assessed the participants' change in DUB symptoms at day 196 (visit 11) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less. (NCT00293059)
Timeframe: from baseline up to treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.807 |
| Placebo | 0.419 |
Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed. (NCT00293059)
Timeframe: treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.012 |
| Placebo | 0.0 |
End of Study menstrual blood loss (MBL) ≤ 80 mL and a decrease to a value of ≤ 50% of the Baseline MBL was considered as treatment success. (NCT00293059)
Timeframe: during a time period of 28 days under treatment
| Intervention | Proportion of participants (Number) | ||
|---|---|---|---|
| End of study MBL <=80 mL | Decrease MBL >=50% of baseline MBL | Successful treatment | |
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.568 | 0.568 | 0.511 |
| Placebo | 0.183 | 0.217 | 0.133 |
Menstrual blood loss was determined using the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. A negative value indicates a reduction in blood loss after treatment. (NCT00293059)
Timeframe: Baseline and reference period of 90 days under treatment
| Intervention | mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -353.1 |
| Placebo | -130.4 |
Participants assessed their overall improvement at day 196 (visit 11) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less. (NCT00293059)
Timeframe: from baseline up to treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.812 |
| Placebo | 0.383 |
The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 196 is presented. (NCT00293059)
Timeframe: baseline and treatment day 196
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.0052 |
| Placebo | 0.0154 |
The Health State Classification of the EQ-5D comprised 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Participants were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a valuation score of .594. The change from the baseline score at day 84 is presented. (NCT00293059)
Timeframe: baseline and treatment day 84
| Intervention | scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -0.0035 |
| Placebo | -0.0024 |
Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196. (NCT00293059)
Timeframe: baseline and treatment day 196
| Intervention | Percentage of blood volume (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 1.30 |
| Placebo | 0.09 |
Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196. (NCT00293059)
Timeframe: baseline and treatment day 196
| Intervention | g/dL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.57 |
| Placebo | 0.20 |
The investigators assessed the participants' change in DUB symptoms at day 84 (visit 7) compared with admission to the study according to a scale of 1 (very much improved) to 7 (very much worse), using the following information: central laboratory data, physical examination, e-diary data, and participant interview. Improvement was defined as being classified as a score of 3 or less. (NCT00293059)
Timeframe: from baseline up to treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.880 |
| Placebo | 0.509 |
Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84. (NCT00293059)
Timeframe: baseline and treatment day 84
| Intervention | g/dL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.22 |
| Placebo | 0.17 |
The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133. (NCT00293059)
Timeframe: baseline and treatment day 196
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -2.0 |
| Placebo | -0.8 |
The MFSQ was designed to measure aspects of female sexuality and asked about the participants' sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum possible values are 19 and 133. (NCT00293059)
Timeframe: baseline and treatment day 84
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -3.5 |
| Placebo | 0.8 |
The number of bleeding days was determine for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline. (NCT00293059)
Timeframe: baseline and reference period of 90 days under treatment
| Intervention | bleeding days (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -5.2 |
| Placebo | -2.0 |
A bleeding episode was one that lasted for at least 2 days, and where the bleeding days were separated by no more than 1 bleeding-free day. An episode stopped with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. A negative values indicates a reduction from baseline in the number of episodes while under treatment. (NCT00293059)
Timeframe: baseline and reference period of 90 days under treatment
| Intervention | bleeding episodes (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -0.5 |
| Placebo | -0.3 |
The number of total sanitary protection items used during the 90-day run-in phase before treatment (baseline) and the number of total sanitary protection items used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to the number used before treatment. (NCT00293059)
Timeframe: baseline and reference period of 90 days under treatment
| Intervention | Sanitary protection products (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -43.6 |
| Placebo | -21.2 |
The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively. (NCT00293059)
Timeframe: baseline and treatment day 196
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.7 |
| Placebo | 1.0 |
The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum was 132. The higher the score, the better the well being of the participant. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively. (NCT00293059)
Timeframe: baseline and treatment day 84
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -1.0 |
| Placebo | -0.7 |
Serum ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 196. (NCT00293059)
Timeframe: baseline and treatment day 196
| Intervention | ng/mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 5.3 |
| Placebo | 2.0 |
Serum ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in serum ferritin from baseline at treatment day 84. (NCT00293059)
Timeframe: baseline and treatment day 84
| Intervention | ng/mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.2 |
| Placebo | -1.5 |
"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked 'your own health state today' to the appropriate point on the thermometer scale. The change from baseline at day 196 is presented." (NCT00293059)
Timeframe: baseline and treatment day 196
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -0.07 |
| Placebo | -0.51 |
"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Participants rated their current health state by drawing a line from the box marked 'your own health state today' to the appropriate point on the thermometer scale. The change from baseline at day 84 is presented." (NCT00293059)
Timeframe: baseline and treatment day 84
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -2.07 |
| Placebo | -0.26 |
The MBL for each cycle includes intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the mean MBL of measured MBL during three cycles in the run-in Phase. One cycle was defined as 28 days. For this analysis, the run-in Phase was defined by the days 1 to 84 (= 3 cycles each of 28 days). End of Study MBL was measured during Cycle 7 of the Treatment Phase (data imputation and Last Observation Carried Forward was applied). (NCT00293059)
Timeframe: during a time period of 28 days under treatment
| Intervention | mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -114.60 |
| Placebo | -49.944 |
Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for one cycle (NCT00293059)
Timeframe: 28 days
| Intervention | mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 136.5 |
| Placebo | 146.9 |
Menstrual blood loss volume was determined using the alkaline hematin method after participants were on treatment for 3 cycles (NCT00293059)
Timeframe: 28 days
| Intervention | mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 59.9 |
| Placebo | 139.6 |
Menstrual blood loss volume was determined using the alkaline hematin methods after participants were on treatment for 7 cycles (NCT00293059)
Timeframe: 28 days
| Intervention | mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 41.3 |
| Placebo | 113.3 |
Participants assessed their overall improvement at day 84 (visit 7) compared with their condition at admission to the study on a scale of 1 (very much improved) to 7 (very much worse). Improvement was defined as being classified as a score of 3 or less. (NCT00293059)
Timeframe: from baseline up to treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.835 |
| Placebo | 0.426 |
Up to 8 criteria had to be met for complete response during 90-day period. No bleeding episodes (BE) >7 days, no >4 BE, no BE with MBL >=80 mL, no >1 BE increase from baseline, no increase from baseline in an individual participant's total number of bleeding days and total number of bleeding days not >24 days. Additionally, for participants included with prolonged bleeding: decrease between maximum duration during run-in and efficacy >=2 days excessive bleeding: MBL associated with each episode decreased by >=50% from average of qualifying episodes during run-in. (NCT00293059)
Timeframe: during a time period of 90 days under treatment
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.292 |
| Placebo | 0.029 |
Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed. (NCT00293059)
Timeframe: treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.024 |
| Placebo | 0.0 |
Participants were asked if they had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of DUB during the past 12 weeks. The proportion of participants with such procedures is displayed. (NCT00293059)
Timeframe: treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.012 |
| Placebo | 0.0 |
Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed. (NCT00293059)
Timeframe: treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.047 |
| Placebo | 0.043 |
Participants were asked if they had any medical treatment (eg, prescribed medication, other treatment) because of DUB during the past 12 weeks. The proportion of participants with such treatment is displayed. (NCT00293059)
Timeframe: treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.047 |
| Placebo | 0.062 |
Participants were asked if there was any change in employment status in the last 12 weeks. The proportion of participants with a change is displayed. (NCT00293059)
Timeframe: treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.129 |
| Placebo | 0.213 |
Participants were asked if there was any change in her employment status in the last 12 weeks. The proportion of participants with a change is displayed. (NCT00293059)
Timeframe: treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.221 |
| Placebo | 0.106 |
Participants were asked how many days and hours were missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study. (NCT00293059)
Timeframe: treatment day 196
| Intervention | days (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.2 |
| Placebo | 0.4 |
Participants were asked how many days and hours they missed from work during the past 12 weeks because of problems associated with DUB, not including the time missed to participate in this study. (NCT00293059)
Timeframe: treatment day 84
| Intervention | day (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.4 |
| Placebo | 0.7 |
Participants were asked to specify out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication, co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed. (NCT00293059)
Timeframe: treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.241 |
| Placebo | 0.314 |
Participants were asked to specify if they had out-of-pocket expenses because of DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with such expenses is displayed. (NCT00293059)
Timeframe: treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.323 |
| Placebo | 0.407 |
Participants were asked to rate on a scale of 0 to 10, how much DUB affected their productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working. (NCT00293059)
Timeframe: treatment day 196
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 2.40 |
| Placebo | 4.03 |
Participants were asked to rate on a scale of 0 to 10, how much their DUB affected productivity while working during the past 12 weeks, where 0 represented that DUB had no effect on work and 10 represented that DUB completely prevented her from working. (NCT00293059)
Timeframe: treatment day 84
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 2.38 |
| Placebo | 3.07 |
Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who had received such services is displayed. (NCT00293059)
Timeframe: treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.012 |
| Placebo | 0.0 |
Participants were asked if they had received ambulatory services (eg, home help, child care) because of DUB during the past 12 weeks. The proportion of participants who received such services is displayed. (NCT00293059)
Timeframe: treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.0 |
| Placebo | 0.0 |
Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing her daily activities. (NCT00293059)
Timeframe: treatment day 196
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 2.48 |
| Placebo | 4.10 |
Participants were asked to rate on a scale of 0 to 10 how much DUB affected their ability to do their regular daily activities, other than work at a job, during the past 12 weeks where 0 represented that DUB had no effect on daily activities and 10 represented that DUB completely prevented her from doing daily activities. (NCT00293059)
Timeframe: treatment day 84
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 2.81 |
| Placebo | 3.91 |
Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed. (NCT00293059)
Timeframe: treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.012 |
| Placebo | 0.0 |
Participants were asked if they had any unscheduled outpatient visits to a hospital because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed. (NCT00293059)
Timeframe: treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.012 |
| Placebo | 0.0 |
Participants were asked if they had any unscheduled visits to a physician (non-hospital medical care) because of DUB during the past 12 weeks, not including visits that were due to participation in this study. The proportion of participants with such visits is displayed. (NCT00293059)
Timeframe: treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.024 |
| Placebo | 0.0 |
To determine if bioidentical hormone replacement therapy is associated with change in lipid profiles (surrogate marker for cardiovascular disease) when compared to Prempro and provide safety data to proceed to larger trial. This was determined by evaluating lipid levels at baseline and during the 12-month treatment period. Participants' values were averaged at baseline and again at 12 months; the average of the baseline value was subtracted from the average at completion. (NCT00302731)
Timeframe: Baseline and month 12
| Intervention | mg/dL (Mean) |
|---|---|
| Study Arm 1 | 221.5 |
| Study Arm 2 | 221.5 |
| Study Arm 3 | 223 |
| Study Arm 4 | 165.5 |
Baseline and 12 month follow up endovaginal ultrasound(completed at study site only) to evaluate endometrial stripe thickness for change on hormone therapy for all 4 arms. Endometrial thickness was measured in millimeters at baseline and again at 12 month completion. The average of the baseline value was subtracted from the average at completion for each group and reported in mm. Single participant in Arm 2: compared baseline to completion. (NCT00302731)
Timeframe: Baseline and month 12
| Intervention | mm (Mean) |
|---|---|
| Study Arm 1 | 13.0 |
| Study Arm 2 | 10.0 |
| Study Arm 3 | 2.5 |
| Study Arm 4 | 3.1 |
Comparison at baseline and month 12 by descriptive analysis of bone density. Assessing for changes in density related to hormone replacement therapy. Bone density readings for participants completing study in descriptive terms. Looking for significant change in bone density while on hormone therapy for 12 months. Those who had no change are counted below. (NCT00302731)
Timeframe: baseline and 12 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Study Arm 1 | 1 |
| Study Arm 2 | 1 |
| Study Arm 3 | 2 |
| Study Arm 4 | 3 |
Comparison at baseline and month 12 by descriptive analysis of breast mammograms. Assessing for changes in density and/or lesions for risk of breast stimulation from hormone replacement therapy. Mammogram readings for participants completing study in descriptive terms. Looking for significant change in breast tissue while on hormone therapy for 12 months. Those who had no change are counted below. (NCT00302731)
Timeframe: baseline and month 12
| Intervention | Participants (Count of Participants) |
|---|---|
| Study Arm 1 | 2 |
| Study Arm 2 | 1 |
| Study Arm 3 | 2 |
| Study Arm 4 | 4 |
The patient was asked to specify her out-of pocket expenses because of her DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with no out-of pocket expenses are displayed. (NCT00307801)
Timeframe: Treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.920 |
| Placebo | 0.879 |
The patient was asked to specify her out-of pocket expenses because of her DUB during the past 12 weeks, including over-the-counter medication (the name of the medication, the number of packages, and the cost per package), co-payments due to prescribed medication, and costs to travel to and from medical appointments. The proportion of participants with no out-of pocket expenses are displayed. (NCT00307801)
Timeframe: Treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.855 |
| Placebo | 0.881 |
The patient was asked if she had any medical treatment (eg, prescribed medication, other treatment) because of her DUB during the past 12 weeks, and to specify the cost. The proportion of participants with such treatment are displayed. (NCT00307801)
Timeframe: Treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.977 |
| Placebo | 0.985 |
The patient was asked if she had any medical treatment (eg, prescribed medication, other treatment) because of her DUB during the past 12 weeks, and to specify the cost. The proportion of participants with such treatment are displayed. (NCT00307801)
Timeframe: Treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.966 |
| Placebo | 0.954 |
The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her productivity while she was working during the past 12 weeks, where 0 represented that her DUB had no effect on her work and 10 represented that her DUB completely prevented her from working. (NCT00307801)
Timeframe: Treatment day 196
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 1.8 |
| Placebo | 3.1 |
The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her productivity while she was working during the past 12 weeks, where 0 represented that her DUB had no effect on her work and 10 represented that her DUB completely prevented her from working. (NCT00307801)
Timeframe: Treatment day 84
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 2.0 |
| Placebo | 3.1 |
The patient was asked if she received ambulatory services (eg, home help, child care) because of her DUB during the past 12 weeks, and if yes, how many hours per week. The proportion of participants with such services are displayed. (NCT00307801)
Timeframe: Treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.0 |
| Placebo | 0.0 |
The patient was asked if she received ambulatory services (eg, home help, child care) because of her DUB during the past 12 weeks, and if yes, how many hours per week. The proportion of participants with such services are displayed. (NCT00307801)
Timeframe: Treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.0 |
| Placebo | 0.0 |
The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her ability to do her regular daily activities, other than work at a job, during the past 12 weeks, where 0 represented that her DUB had no effect on her daily activities and 10 represented that her DUB completely prevented her from doing her daily activities. (NCT00307801)
Timeframe: Treatment day 196
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 2.0 |
| Placebo | 3.2 |
The patient was asked to rate on a scale of 0 to 10, how much her DUB affected her ability to do her regular daily activities, other than work at a job, during the past 12 weeks, where 0 represented that her DUB had no effect on her daily activities and 10 represented that her DUB completely prevented her from doing her daily activities. (NCT00307801)
Timeframe: Treatment day 84
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 2.1 |
| Placebo | 3.2 |
The patient was asked if she had any unscheduled outpatient visits to a hospital because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with any unscheduled outpatient visits are displayed. (NCT00307801)
Timeframe: Treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.008 |
| Placebo | 0.0 |
The patient was asked if she had any unscheduled outpatient visits to a hospital because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with any unscheduled outpatient visits are displayed. (NCT00307801)
Timeframe: Treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.008 |
| Placebo | 0.0 |
The patient was asked if she had any unscheduled outpatient visits to a physician (non-hospital medical care) because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with such visits are displayed. (NCT00307801)
Timeframe: Treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.031 |
| Placebo | 0.015 |
The patient was asked if she had any unscheduled outpatient visits to a physician (non-hospital medical care) because of her DUB during the past 12 weeks, not including visits that were due to her participation in this study. She was also asked to indicate the number of visits. The proportion of participants with such visits are displayed. (NCT00307801)
Timeframe: Treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.058 |
| Placebo | 0.031 |
End of Study menstrual blood loss (MBL) ≤ 80 mL and a decrease to a value of ≤ 50% of the Baseline MBL was considered as treatment success. (NCT00307801)
Timeframe: during a time period of 28 days under treatment
| Intervention | Proportion of participants (Number) | ||
|---|---|---|---|
| End of study MBL <=80 mL | Decrease MBL >=50% of baseline MBL | Successful treatment | |
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.758 | 0.788 | 0.720 |
| Placebo | 0.133 | 0.133 | 0.107 |
"According to the patient´s global assessment scale improved was defined as being classified as 'very much improved', 'much improved', or 'improved' and not improved was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Patients assessed the overall improvement at day 196 compared with admission to the study condition." (NCT00307801)
Timeframe: From baseline (visit 5, day 1) up to treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.779 |
| Placebo | 0.451 |
A bleeding episode is characterized by the following: • Bleeding for at least 2 days • Bleeding days can be separated by no more than 1 bleeding-free day • An episode stops with 2 consecutive bleeding-free days. The number of episodes was determined for the 90 days before treatment and for the 90 days under treatment. negative value indicates a reduction from baseline in the number of episodes while under treatment. (NCT00307801)
Timeframe: Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
| Intervention | Bleeding episodes (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -0.35 |
| Placebo | -0.38 |
The number of total sanitary protection items used during the 90 days before treatment (baseline) and those used during the 90 days while under treatment was determined. A negative value indicates a reduction in the number of sanitary protection items used while under treatment compared to baseline. (NCT00307801)
Timeframe: Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
| Intervention | Sanitary protection products (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -38.4 |
| Placebo | -16.5 |
The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum 132. The higher the score, the better the well-being of the patient. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 196
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -2.3 |
| Placebo | 4.6 |
The PGWBI questionnaire consisted of 22 questions that were answered using a 6-grade Likert scale. The minimum overall score was 22 and the maximum 132. The higher the score, the better the well-being of the patient. The observation phase was the last 4 weeks. The following 6 dimensions were derived from the questionnaire: anxiety, depressed mood, positive well-being, self-control, health, and vitality and the highest possible scores were 30, 18, 24, 18, 18, and 24, respectively. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 84
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -1.2 |
| Placebo | 2.2 |
"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Patients rated their current health state by drawing a line from the box marked your own health state today to the appropriate point on the thermometer scale." (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 196
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -3.00 |
| Placebo | 2.69 |
"The visual analogue scale (ie, thermometer) had endpoints of 100 (best imaginable health state) at the top, and 0 (worst imaginable health state) at the bottom. Patients rated their current health state by drawing a line from the box marked your own health state today to the appropriate point on the thermometer scale." (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 84
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -1.63 |
| Placebo | 0.62 |
The MBL for each cycle includes intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the mean MBL of measured MBL during three cycles in the run-in Phase. One cycle was defined as 28 days. For this analysis, the run-in Phase was defined by the days 1 to 84 (= 3 cycles each of 28 days). End of Study MBL was measured during Cycle 7 of the Treatment Phase (data imputation and Last Observation Carried Forward was applied). (NCT00307801)
Timeframe: during a time period of 28 days under treatment
| Intervention | mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -169.94 |
| Placebo | 4.628 |
Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. (NCT00307801)
Timeframe: Cycle 1 = 28 days (one cycle)
| Intervention | ml (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 175.6 |
| Placebo | 194.3 |
Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. (NCT00307801)
Timeframe: Cycle 3 = 28 days (one cycle)
| Intervention | ml (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 68.3 |
| Placebo | 195.1 |
Menstrual blood loss volume as assessed by the alkaline hematin method after patients were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. (NCT00307801)
Timeframe: Cycle 7 = 28 days (one cycle)
| Intervention | ml (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 44.6 |
| Placebo | 167.2 |
Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for one cycle. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. (NCT00307801)
Timeframe: Cycle 1 = 28 days (one cycle)
| Intervention | ml (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 207.8 |
| Placebo | 238.9 |
Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 3 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. (NCT00307801)
Timeframe: Cycle 3 = 28 days (one cycle)
| Intervention | ml (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 72.1 |
| Placebo | 188.4 |
Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) after participants were on treatment for 7 cycles. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. (NCT00307801)
Timeframe: Cycle 7 = 28 days (one cycle)
| Intervention | ml (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 46.7 |
| Placebo | 168.6 |
Excessive bleeding:>=2 bleeding episodes each with blood loss volume (MBL) of >=80 mL in 90-day period, assessed by alkaline hematin method. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. Cure from excessive bleeding: MBL in each episode <80 mL + blood loss volume associated with each bleeding episode is decrease of ≥50% from average of qualifying bleeding episodes (with blood loss volume ≥80 mL per episode during run-in) (NCT00307801)
Timeframe: Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.441 |
| Placebo | 0.013 |
A bleeding day is a day on which sanitary protection is required. The number of bleeding days was determined for the 90 days before treatment (baseline) and for 90 days while under treatment. A negative value indicates a reduction in the number of bleeding days while under treatment compared to baseline. (NCT00307801)
Timeframe: Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
| Intervention | Bleeding days (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -5.13 |
| Placebo | -3.08 |
The MFSQ was designed to measure aspects of female sexuality and asked about the patients´sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum values are 19 and 133. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 84
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -1.2 |
| Placebo | 0.4 |
The MFSQ was designed to measure aspects of female sexuality and asked about the patients´sexual experience during the last 4 weeks. Higher scores represent higher, more complete, or better integrated levels of female sexual function. Minimum and maximum values are 19 and 133. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 196
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -4.9 |
| Placebo | -2.4 |
Hemoglobin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 84. (NCT00307801)
Timeframe: Baseline (visit 5) and treatment day 84
| Intervention | g/dL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.36 |
| Placebo | 0.12 |
Hemoglobin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hemoglobin from baseline at treatment day 196. (NCT00307801)
Timeframe: Baseline (visit 5) and treatment day 196
| Intervention | g/dL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.70 |
| Placebo | 0.06 |
Hematocrit was measured before treatment and after 196 days under treatment. A positive value indicates an increase in hematocrit from baseline at treatment day 196. (NCT00307801)
Timeframe: Baseline (visit 5) and treatment day 196
| Intervention | ng/mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 1.63 |
| Placebo | 0.08 |
Ferritin was measured before treatment and after 84 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 84. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 84
| Intervention | ng/mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 2.8 |
| Placebo | 0.0 |
Ferritin was measured before treatment and after 196 days under treatment. A positive value indicates an increase in ferritin from baseline at treatment day 196. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 196
| Intervention | ng/mL (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 8.6 |
| Placebo | 0.5 |
The health state classification of the EQ-5D comprises 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Patients were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a score of .594. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 84
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -0.0041 |
| Placebo | 0.0082 |
Menstrual blood loss volume as assessed by the alkaline hematin method for the 90 days before treatment (baseline) and for 90 days under treatment. This spectrophotometrical method measures hemoglobin (Hb) in fixed amount of alkaline solution, taken from pool of solution in which materials (used sanitary protection) to be tested have been macerated for Hb extraction. A negative value indicates a reduction in blood loss after treatment. (NCT00307801)
Timeframe: Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
| Intervention | ml (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -458.4 |
| Placebo | -93.2 |
Prolonged bleeding: 2 or more bleeding episodes, each lasting 8 or more days. Cure from prolonged bleeding: no bleeding episodes lasting more than 7 days and the decrease between maximum duration during run-in and maximum duration during the efficacy phase was at least 2 days. (NCT00307801)
Timeframe: Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.350 |
| Placebo | 0.100 |
"According to the investigator's global assessment scale improved was defined as being classified as 'very much improved', 'much improved', or 'improved' and not improved was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Central laboratory data, physical examination, e-diary data, and patient interview were used as sources for the assessment at day 196 compared with admission to study data." (NCT00307801)
Timeframe: From baseline (visit 5, day 1) up to treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.847 |
| Placebo | 0.395 |
"According to the investigator's global assessment scale improved was defined as being classified as 'very much improved', 'much improved', or 'improved' and not improved was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Central laboratory data, physical examination, e-diary data, and patient interview were used as sources for the assessment at day 84 compared with admission to study data." (NCT00307801)
Timeframe: From baseline (visit 5, day 1) up to treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.838 |
| Placebo | 0.394 |
"According to the patient's global assessment scale improved was defined as being classified as 'very much improved', 'much improved', or 'improved' and not improved was defined as being classified as 'no change', 'worse', 'much worse', 'very much worse', or 'not assessed'. Patients assessed the overall improvement at day 84 compared with admission to the study condition." (NCT00307801)
Timeframe: From baseline (visit 5, day 1) up to treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.724 |
| Placebo | 0.529 |
At least 6, up to 8 criteria to be met in complete response during 90-day period: no bleeding episodes(BE) >7 days, no >4 BE, no BE with blood loss (menstrual blood loss, MBL) ≥80 mL, no >1 BE increase from baseline, no increase from baseline in individual patient's total number of bleeding days and total number of bleeding days not >24 days. Additionally, for subjects included with prolonged bleeding: decrease between maximum duration during run-in and efficacy ≥2 days excessive bleeding: MBL associated with each episode decreased by ≥50% from average of qualifying episodes during run-in. (NCT00307801)
Timeframe: Efficacy phase was defined as a 90-day period under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.295 |
| Placebo | 0.012 |
The health state classification of the EQ-5D comprises 5 questions addressing mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Patients were asked to indicate their current health state by ticking the most appropriate of 3 statements about each of the questions (ie, no problems, some problems, extreme problems). The best possible answers were (1,1,1,1,1), which equals a valuation score of 1.0. The worst possible answers were (3,3,3,3,3), which equals a score of .594. (NCT00307801)
Timeframe: Baseline (visit 5, day 1) and treatment day 196
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -0.0191 |
| Placebo | 0.0116 |
The patient was asked if she had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of her DUB during the past 12 weeks. The proportion of participants with such procedures are displayed. (NCT00307801)
Timeframe: Treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.0 |
| Placebo | 0.0 |
The patient was asked if she had any unscheduled procedures (eg, laparoscopy, laboratory tests, ultrasound) because of her DUB during the past 12 weeks. The proportion of participants with such procedures are displayed. (NCT00307801)
Timeframe: Treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.0 |
| Placebo | 0.0 |
The patient was asked if there was any change in her employment status in the last 12 weeks and was asked to specify the number of hours per week. The proportion of participants with such changes are displayed. (NCT00307801)
Timeframe: Treatment day 196
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.098 |
| Placebo | 0.087 |
The patient was asked if there was any change in her employment status in the last 12 weeks and was asked to specify the number of hours per week. The proportion of participants with such changes are displayed. (NCT00307801)
Timeframe: Treatment day 84
| Intervention | Proportion of participants (Number) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.095 |
| Placebo | 0.152 |
The patient was asked how many days and hours she missed from work during the past 12 weeks because of her problems associated with her DUB, not including the time missed to participate in this study. (NCT00307801)
Timeframe: Treatment day 196
| Intervention | days (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.13 |
| Placebo | 0.52 |
The patient was asked how many days and hours she missed from work during the past 12 weeks because of her problems associated with her DUB, not including the time missed to participate in this study. (NCT00307801)
Timeframe: Treatment day 84
| Intervention | days (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | 0.14 |
| Placebo | 0.27 |
Blood loss volume as assessed by the alkaline hematin method for participants with excessive bleeding (2 or more bleeding episodes each with blood loss volume of 80 ml or more during the run-in phase) for the 90 days before treatment (ie, run-in phase) and for the 90 days under treatment. A negative value indicates a reduction in blood loss while under treatment compared to before treatment. (NCT00307801)
Timeframe: Baseline and reference period of 90 days under treatment. For patients who completed up to day 6 of treatment cycle 7, the efficacy phase started on the first day of treatment cycle 4, and continued through day 6 of treatment cycle 7
| Intervention | ml (Mean) |
|---|---|
| Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027) | -480.6 |
| Placebo | -94.2 |
The Positive and Negative Syndrome Scale (PANSS) is a well validated, standardized method of evaluating and monitoring psychotic symptoms. The PANSS assesses: positive (hallucinations, delusions, thought disorder), negative (blunted affect, abstract thinking and general symptomatology. The positive and negative subscale each consist of 7 items rated from 1(absent) - 7(extreme) with a minimum score = 7, maximum score = 49. The general subscale consists of 16 items with a minimum score = 16, maximum score = 112. A Total PANSS score (positive+ negative + general scores) has a minimum of 30 and maximum of 210. Higher scores represent more severity in symptoms. (NCT00357006)
Timeframe: Baseline and week 8
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Baseline | Endpoint (day 56) | |
| Adjunctive 100 mcg Transdermal Estradiol | 19.18 | 16.36 |
| Adjunctive 200 mcg Transdermal Estradiol | 18.24 | 14.11 |
| Placebo | 18.18 | 16.36 |
"Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage).~Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain.~Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))*100." (NCT00387829)
Timeframe: 6 months
| Intervention | Outcome scores (Least Squares Mean) | ||
|---|---|---|---|
| MRI Outcome Score | ODI Score | VAS Score | |
| 1- DuraGen Plus During Surgery | 12.375 | 6.974 | 14.010 |
| 2 - Surgery Alone | 12.578 | 7.118 | 16.696 |
"Radiological score (MRI Outcome score): MRI peridural fibrosis in 5 consecutive 2-D axial Spin Echo T1 axial slices. Score consists of the ratio of total available space in each image and the amount of scar identified (percentage).~Pain (VAS): Visual Analog Score used to rate the subject's pain.VAS scale is a 100 mm horizontal line, where the far left side of the scale equals (0) no pain and the far right side of the scale (100) equals the worst possible pain.~Functional outcome score (ODI): Used to assess the effect leg or back pain on everyday life. Questions relate to areas such as walking, lifting, sitting, ability to travel as well as other common activities. Ten questions with scores from 0-5. Calculated as percentage: (Actual score /Maximum overall score (worst disability))*100." (NCT00387829)
Timeframe: 12 months
| Intervention | Outcome scores (Least Squares Mean) | ||
|---|---|---|---|
| MRI Outcome Score | ODI Score | VAS Score | |
| 1- DuraGen Plus During Surgery | 10.046 | 6.048 | 12.926 |
| 2 - Surgery Alone | 9.788 | 6.890 | 14.378 |
Bleeding is defined as a flow heavy enough to require sanitary protection. (NCT00394771)
Timeframe: Day 1-84
| Intervention | days (Median) |
|---|---|
| Low Dose DR-1031 | 3.5 |
| Midrange Dose DR-1031 | 2.5 |
| High Dose DR-1031 | 4 |
| Seasonale | 2 |
Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 1. (NCT00394771)
Timeframe: Day 85-91
| Intervention | participants (Number) | ||
|---|---|---|---|
| 0 day | 1-3 days | 4-7 days | |
| High Dose DR-1031 | 25 | 27 | 54 |
| Low Dose DR-1031 | 14 | 36 | 59 |
| Midrange Dose DR-1031 | 28 | 17 | 63 |
| Seasonale | 27 | 18 | 75 |
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection. (NCT00394771)
Timeframe: Day 1-84
| Intervention | days (Median) |
|---|---|
| Low Dose DR-1031 | 13 |
| Midrange Dose DR-1031 | 13.5 |
| High Dose DR-1031 | 15 |
| Seasonale | 15 |
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability. (NCT00394771)
Timeframe: Day 1-84
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Breast tenderness/pain | Headache | Bloating | Pelvic pain | Anxiety | Depression | Irritability | |
| High Dose DR-1031 | 50 | 86 | 72 | 61 | 34 | 36 | 66 |
| Low Dose DR-1031 | 58 | 83 | 80 | 72 | 42 | 51 | 72 |
| Midrange Dose DR-1031 | 57 | 84 | 76 | 65 | 43 | 40 | 69 |
| Seasonale | 64 | 92 | 84 | 67 | 59 | 52 | 78 |
Bleeding is defined as a flow heavy enough to require sanitary protection. Spotting does not require sanitary protection. (NCT00394771)
Timeframe: Day 92-176
| Intervention | days (Median) |
|---|---|
| Low Dose DR-1031 | 6 |
| Midrange Dose DR-1031 | 7 |
| High Dose DR-1031 | 5 |
| Seasonale | 6 |
Participants are categorized by the duration of bleeding that occurred during the scheduled 7-day withdrawal period for Cycle 2. (NCT00394771)
Timeframe: Day 177-183
| Intervention | participants (Number) | ||
|---|---|---|---|
| 0 day | 1-3 days | 4-7 days | |
| High Dose DR-1031 | 23 | 26 | 45 |
| Low Dose DR-1031 | 15 | 32 | 50 |
| Midrange Dose DR-1031 | 20 | 32 | 44 |
| Seasonale | 21 | 24 | 60 |
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability. (NCT00394771)
Timeframe: Day 177-183
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Breast tenderness/pain | Headache | Bloating | Pelvic pain | Anxiety | Depression | Irritability | |
| High Dose DR-1031 | 15 | 37 | 38 | 31 | 13 | 15 | 25 |
| Low Dose DR-1031 | 29 | 39 | 51 | 52 | 21 | 18 | 39 |
| Midrange Dose DR-1031 | 25 | 42 | 53 | 42 | 22 | 21 | 37 |
| Seasonale | 25 | 48 | 60 | 51 | 22 | 17 | 39 |
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability. (NCT00394771)
Timeframe: Day 85-91
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Breast tenderness/pain | Headache | Bloating | Pelvic pain | Anxiety | Depression | Irritability | |
| High Dose DR-1031 | 17 | 57 | 46 | 37 | 14 | 17 | 23 |
| Low Dose DR-1031 | 33 | 57 | 61 | 50 | 26 | 25 | 44 |
| Midrange Dose DR-1031 | 28 | 50 | 51 | 49 | 17 | 21 | 43 |
| Seasonale | 33 | 50 | 62 | 53 | 22 | 23 | 36 |
Hormone-related symptoms include breast tenderness/pain, headache, bloating, pelvic pain, anxiety, depression, and irritability. (NCT00394771)
Timeframe: Day 92-176
| Intervention | participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| Breast tenderness/pain | Headache | Bloating | Pelvic pain | Anxiety | Depression | Irritability | |
| High Dose DR-1031 | 44 | 72 | 57 | 45 | 31 | 30 | 54 |
| Low Dose DR-1031 | 46 | 74 | 64 | 58 | 40 | 41 | 55 |
| Midrange Dose DR-1031 | 47 | 72 | 64 | 57 | 40 | 39 | 63 |
| Seasonale | 44 | 78 | 70 | 57 | 47 | 44 | 65 |
Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy. (NCT00394771)
Timeframe: Day 92-176
| Intervention | days (Median) |
|---|---|
| Low Dose DR-1031 | 0 |
| Midrange Dose DR-1031 | 0 |
| High Dose DR-1031 | 0 |
| Seasonale | 0 |
Bleeding is defined as a flow heavy enough to require sanitary protection. Participants recorded in the diary days when they had bleeding, and whether they considered the bleeding to be light, moderate or heavy. (NCT00394771)
Timeframe: Day 1-84
| Intervention | days (Median) |
|---|---|
| Low Dose DR-1031 | 0 |
| Midrange Dose DR-1031 | 0 |
| High Dose DR-1031 | 0 |
| Seasonale | 0 |
Bleeding is defined as a flow heavy enough to require sanitary protection. (NCT00394771)
Timeframe: Day 92-176
| Intervention | days (Median) |
|---|---|
| Low Dose DR-1031 | 1 |
| Midrange Dose DR-1031 | 2 |
| High Dose DR-1031 | 1 |
| Seasonale | 2 |
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. (NCT00420342)
Timeframe: Baseline to Week 8
| Intervention | mmHg (Mean) |
|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -1.9 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -1.9 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.4 |
The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the full analysis set. The change from baseline means was adjusted for center and baseline SBP. (NCT00420342)
Timeframe: Baseline to Week 8
| Intervention | mmHg (Mean) |
|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -1.03 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -0.27 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | 2.18 |
The mean change in 24-hr ambulatory systolic blood pressure (SBP) from Baseline to Week 8 was calculated for the per protocol (PP) population. The change from baseline means was adjusted for center and baseline SBP. (NCT00420342)
Timeframe: Baseline to Week 8
| Intervention | mmHg (Mean) |
|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -1.08 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 0.06 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | 2.82 |
The mean change in 24-hr Diastolic Blood Pressure (DBP) from Baseline to Week 8 was calculated for the full analysis set. (NCT00420342)
Timeframe: Baseline to Week 8
| Intervention | mmHg (Mean) |
|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -1.19 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -0.91 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | 0.57 |
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. (NCT00420342)
Timeframe: Baseline to Week 8
| Intervention | mmHg (Mean) |
|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -2.6 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -3.7 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.1 |
Sodium sensitivity was defined as ≥ 10 mmHg drop in mean arterial pressure, calculated from the office cuff BP values from Day 1 to Day 3. The number of subjects shifting from sodium sensitive at Baseline to sodium resistant at Week 8 or sodium resistant at Baseline to sodium sensitive at Week 8 by treatment group was reported. (NCT00420342)
Timeframe: 8 weeks plus 3 days
| Intervention | participants (Number) | |
|---|---|---|
| Baseline | Week 8 | |
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 4 | 1 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | 4 | 2 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | 3 | 2 |
Seated systolic and diastolic office cuff blood pressures were taken at each visit; the mean of three readings were used at each timepoint. (NCT00420342)
Timeframe: Baseline to Week 8
| Intervention | mmHg (Mean) | |
|---|---|---|
| Systolic Blood Pressure (SBP) | Diastolic Blood Pressure (DBP) | |
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -5.25 | -1.34 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | -4.20 | 0.33 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -6.02 | -0.36 |
Systolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle) (NCT00420342)
Timeframe: Baseline to Week 8
| Intervention | mmHg (Mean) | ||
|---|---|---|---|
| mean daytime | mean nighttime | mean trough | |
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -2.08 | 1.57 | -1.91 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.53 | 3.97 | -1.51 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -1.06 | 1.64 | -1.48 |
Diastolic blood pressure means were calculated during the intervals daytime (6 AM - 10 PM); nighttime (10 PM - 6 AM), and trough (mean of last 5 measurements in the 24-hour cycle) (NCT00420342)
Timeframe: Baseline to Week 8
| Intervention | mmHg (Median) | ||
|---|---|---|---|
| mean daytime | mean nighttime | mean trough | |
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -1.95 | 0.20 | -1.04 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | 0.17 | 1.75 | -0.30 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -1.56 | 0.67 | -1.13 |
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. (NCT00420342)
Timeframe: Baseline to Week 8
| Intervention | mmHg (Mean) |
|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -5.2 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -4.0 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.0 |
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. (NCT00420342)
Timeframe: Baseline to Week 8
| Intervention | mmHg (Mean) |
|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -3.4 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -4.4 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | 1.1 |
Mean 24-hour ABPM SBP values were calculated in posthoc subgroup analyses for the following subgroups: Baseline mean 24-hour SBP from ABPM >112 mmHg, >116 mmHg, >120 mmHg, >124 mmHg, and >130 mmHg. (NCT00420342)
Timeframe: Baseline to Week 8
| Intervention | mmHg (Mean) |
|---|---|
| 0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -2.4 |
| 2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891) | -2.2 |
| 1.5 mg MPA / 0.3 mg CEE (Prempro) | 2.0 |
The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries. (NCT00544882)
Timeframe: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
| Intervention | days (Mean) | ||
|---|---|---|---|
| Cycle 2 - Unscheduled (Day 1-21) | Cycle 2 - Scheduled (Day 22-28) | Cycle 3 - Unscheduled (Day 1-21) | |
| DR-1021 | 0.70 | 2.30 | 0.70 |
| Mircette | 0.52 | 2.63 | 0.71 |
The change in the size of the largest documented follicle during combination therapy (Days 1 to 21) and during monotherapy/placebo (Days 21-28) measured by trans-vaginal ultrasound. (NCT00544882)
Timeframe: Cycle 2, Days 1-20 and Cycle 2, Days 21-28
| Intervention | mm (Mean) |
|---|---|
| DR-1021 | -2.02 |
| Mircette | -1.79 |
Levels of inhibin-B were measured throughout the study from blood samples. (NCT00544882)
Timeframe: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
| Intervention | pg/mL (Median) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 2 - Day 2 (n=28, 28) | Cycle 2 - Day 4 (n=28, 28) | Cycle 2 - Day 6 (n=28, 27) | Cycle 2 - Days 19-20 (n=26, 28) | Cycle 2 - Day 23 (n=27, 28) | Cycle 2 - Day 24 (n=25, 28) | Cycle 2 - Day 25 (n=27, 28) | Cycle 2 - Day 27 (n=25, 28) | Cycle 2 - Day 28 (n=26, 28) | Cycle 3 - Day 2 (n=27, 28) | Cycle 3 - Day 4 (n=27, 28) | Cycle 3 - Day 6 (n=24, 26) | |
| DR-1021 | 92.30 | 42.80 | 46.35 | 23.15 | 28.10 | 36.80 | 35.20 | 39.60 | 41.95 | 54.70 | 51.10 | 36.15 |
| Mircette | 99.00 | 64.45 | 41.20 | 28.85 | 32.15 | 55.00 | 62.30 | 49.20 | 55.05 | 57.95 | 52.25 | 29.55 |
Levels of follicle stimulating hormone were measured throughout the study from blood samples. (NCT00544882)
Timeframe: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
| Intervention | mIU/mL (Median) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 2 - Day 2 (n=28, 28) | Cycle 2 - Day 4 (n=28, 28) | Cycle 2 - Day 6 (n=28, 27) | Cycle 2 - Days 19-20 (n=26, 28) | Cycle 2 - Day 23 (n=27, 28) | Cycle 2 - Day 24 (n=25, 28) | Cycle 2 - Day 25 (n=27, 28) | Cycle 2 - Day 27 (n=25, 28) | Cycle 2 - Day 28 (n=26, 28) | Cycle 3 - Day 2 (n=27, 28) | Cycle 3 - Day 4 (n=27, 28) | Cycle 3 - Day 6 (n=24, 26) | |
| DR-1021 | 4.00 | 3.55 | 3.70 | 1.45 | 2.70 | 2.80 | 2.90 | 3.70 | 5.05 | 4.90 | 3.70 | 2.50 |
| Mircette | 4.00 | 3.70 | 3.50 | 1.55 | 2.35 | 3.70 | 3.90 | 3.90 | 4.70 | 4.05 | 3.60 | 2.50 |
Levels of estradiol were measured throughout the study from blood samples. (NCT00544882)
Timeframe: Cycle 2, Day 2 (Baseline), and Days 4, 6, 19-20, 23, 24, 25, 27, 28, Cycle 3, Days 2, 4 and 6.
| Intervention | pg/mL (Median) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 2 - Day 2 (n=28, 28) | Cycle 2 - Day 4 (n=28, 28) | Cycle 2 - Day 6 (n=27, 27) | Cycle 2 - Days 19-20 (n=26, 28) | Cycle 2 - Day 23 (n=27, 28) | Cycle 2 - Day 24 (n=25, 28) | Cycle 2 - Day 25 (n=27, 28) | Cycle 2 - Day 27 (n=25, 28) | Cycle 2 - Day 28 (n=26, 28) | Cycle 3 - Day 2 (n=27, 28) | Cycle 3 - Day 4 (n=27, 27) | Cycle 3 - Day 6 (n=24, 26) | |
| DR-1021 | 47.00 | 62.50 | 43.00 | 19.00 | 24.00 | 25.00 | 24.00 | 30.00 | 36.00 | 34.00 | 66.00 | 28.50 |
| Mircette | 51.50 | 34.50 | 29.00 | 20.50 | 19.00 | 26.50 | 26.00 | 20.00 | 27.50 | 43.00 | 27.00 | 32.00 |
The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries. (NCT00544882)
Timeframe: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Cycle 2 - Unscheduled (Day 1-21) | Cycle 2 - Scheduled (Day 22-28) | Cycle 3 - Unscheduled (Day 1-21) | |
| DR-1021 | 48.1 | 77.8 | 55.6 |
| Mircette | 59.3 | 92.6 | 53.6 |
The percentage of participants with unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding (not including spotting) was derived from participant diaries. (NCT00544882)
Timeframe: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Cycle 2 - Unscheduled (Day 1-21) | Cycle 2 - Scheduled (Day 22-28) | Cycle 3 - Unscheduled (Day 1-21) | |
| DR-1021 | 18.5 | 77.8 | 29.6 |
| Mircette | 33.3 | 77.8 | 25.0 |
Ovarian follicles were measured by trans-vaginal ultrasound. The size of the 3 largest follicles was documented for each participant, and the percentage of follicles greater than 5 mm in diameter was calculated based on the total number follicles present (indicated by n for each time point). (NCT00544882)
Timeframe: Cycle 1, Days 11, 19-20, 23, 25, 27, Cycle 2, Days 4, 11, 19-20, 23, 25, 27, Cycle 3, Day 4.
| Intervention | percentage of follicles (Number) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 - Day 11 (n=63, 48) | Cycle 1 - Day 19-20 (n= 47, 94) | Cycle 1 - Day 23 (n= 30, 76) | Cycle 1 - Day 25 (n= 85, 106) | Cycle 1 - Day 27 (n=135, 145) | Cycle 2 - Day 4 (n=154, 156) | Cycle 2 - Day 11 (n=76, 54) | Cycle 2 - Days 19-20 (n=143, 148) | Cycle 2 - Day 23 (n=91, 62) | Cycle 2 - Day 25 (n=69, 80) | Cycle 2 - Day 27 (n=94, 132) | Cycle 3 - Day 4 (n=138, 117) | |
| DR-1021 | 30.2 | 29.8 | 50.0 | 32.9 | 29.6 | 35.1 | 27.6 | 17.5 | 24.2 | 30.4 | 23.4 | 25.4 |
| Mircette | 29.2 | 27.7 | 26.3 | 31.1 | 35.2 | 31.4 | 31.5 | 18.9 | 24.2 | 18.8 | 20.5 | 27.4 |
The total number of days of unscheduled (Day 1 to Day 21 of each cycle) and scheduled (ie,withdrawal [Day 22 to Day 28 of each cycle]) bleeding or spotting was derived from participant diaries. (NCT00544882)
Timeframe: Cycle 2, Days 1-21, Cycle 2, Days 22-28 and Cycle 3, Days 1-21
| Intervention | days (Mean) | ||
|---|---|---|---|
| Cycle 2 - Unscheduled (Day 1-21) | Cycle 2 - Scheduled (Day 22-28) | Cycle 3 - Unscheduled (Day 1-21) | |
| DR-1021 | 2.19 | 3.19 | 1.96 |
| Mircette | 1.41 | 3.67 | 1.64 |
Histologic evalation of vaginal sections was performed to measured and record the absolute thickness of the vaginal epithelium. Baseline findings were compared to biopsies after three and six cycles of treatment. Mean values were compared using T-test for paired data for baseline and 84 days, and baseline and 168 days (NCT00612508)
Timeframe: baseline, 84 days, 168 days
| Intervention | mm (Mean) | |
|---|---|---|
| mean difference at 84 days | mean difference at 168 days | |
| Desogen | 0.01 | -0.02 |
| NuvaRing | -0.005 | .007 |
Self-reported treatment-related and serious adverse events (NCT00612508)
Timeframe: over 168 days
| Intervention | participants (Number) |
|---|---|
| Oral Contraceptive | 1 |
| Intravaginal Ring Contraceptive | 0 |
During a gynecologic exam, the vaginal epithelium was assessed by an examiner using the Vaginal Atrophy Scoring Scale to evaluate Rugae (lack of), Pallor (pinkness), Petechiae, Mucosal thinning, Dryness. Scores range from 0 (none) to 3 (severe); higher scores indicate less favorable outcomes. (NCT00698035)
Timeframe: Baseline, 12 weeks
| Intervention | units on a scale (Mean) | ||||
|---|---|---|---|---|---|
| Rugae | Pallor | Petechiae | Mucosal thinning | Dryness | |
| Estring | -1.03 | -0.88 | -1.0 | -0.62 | -1.03 |
| Testosterone Cream | -0.71 | -0.91 | -0.74 | -0.88 | -0.71 |
Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol >10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was >10 pg/dl, subsequent levels >10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range. (NCT00698035)
Timeframe: 12 Weeks
| Intervention | participants (Number) |
|---|---|
| Estring | 0 |
| Testosterone Cream | 4 |
By serum ultrasensitive total testosterone test (Quest Diagnostics) (NCT00698035)
Timeframe: 12 weeks
| Intervention | ng/dl (Mean) | ||
|---|---|---|---|
| Testosterone at baseline | Testosterone at 4 weeks | Testosterone at 12 weeks | |
| Testosterone Cream | 33 | 186 | 171 |
"Participants were asked to respond to a Sexual Satisfaction One Item Measure which asked Overall, how satisfactory to you is your sexual relationship with your partner? Response options range from 1 (Extremely unsatisfactory) to 6 (Extremely satisfactory)." (NCT00698035)
Timeframe: Baseline, Week 4, Week 12
| Intervention | units on a scale (Mean) | ||
|---|---|---|---|
| SS (BL) | SS (W4) | SS (W12) | |
| Estring | 2.5 | 3.5 | 4.0 |
| Testosterone Cream | 3.2 | 3.7 | 4.0 |
Cancer Rehabilitation Evaluation System (CARES) Sexual Dysfunction (SD) and Sexual Interest (SI) Subscales range from 0 to 4 and measure the severity of problems, with higher scores indicating more difficulty. (NCT00698035)
Timeframe: Baseline, Week 4, Week 12
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| SI (BL) | SI (W4) | SI (W12) | SD (BL) | SD (W4) | SD (W12) | |
| Estring | 1.2 | 1.3 | 0.9 | 2.9 | 2.4 | 2.0 |
| Testosterone Cream | 1.4 | 1.2 | 1.0 | 2.9 | 2.1 | 1.9 |
serial measurements of serum estradiol (E2) by liquid chromatography tandem mass spectrometry (Quest Diagnostics) (NCT00698035)
Timeframe: 12 weeks
| Intervention | pg/ml (Mean) | ||
|---|---|---|---|
| E2 at baseline | E2 at 4 weeks | E2 at 12 weeks | |
| Estring | 27 | 5 | 9 |
| Testosterone Cream | 9 | 10 | 8 |
Serum estradiol assays sent to the UCSF clinical laboratory are sent out to Quest Diagnostics, which uses LC/MS for their ultra-sensitive estradiol assay. Samples were also sent to a specialized research lab in England which has developed an ultrasensitive assay using radioimmunoassay (RIA) after ether extraction (sensitivity limit of 3pmol/l) to quantify low levels of estradiol found in post-menopausal women (NCT00698035)
Timeframe: baseline, 4 weeks
| Intervention | pg/ml (Mean) | |
|---|---|---|
| Baseline E2 | 4-week E2 | |
| E2 by LC/MS | 17.7 | 7.8 |
| E2 by RIA | 17.9 | 2.9 |
Physical health quality of life (based on SF-36 results) (SF-36 includes 8 scores scaled 0-100; lower score indicating more disability) (NCT00741858)
Timeframe: 7 years
| Intervention | units on a scale (Mean) |
|---|---|
| DuraGen (Sutureless) | 31.4 |
| DuraGuard (Suturable) | 35.61 |
cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. (NCT00745901)
Timeframe: Cycle 2 (day 29 to Day 56)
| Intervention | Days (Mean) |
|---|---|
| NGM/25mcg EE | 5.3 |
| DRSP/20mcg EE | 4.6 |
cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. (NCT00745901)
Timeframe: Cycle 3 (Day 57 to Day 84)
| Intervention | Days (Mean) |
|---|---|
| NGM/25mcg EE | 4.6 |
| DRSP/20mcg EE | 3.6 |
cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)
| Intervention | Days (Mean) |
|---|---|
| NGM/25mcg EE | 1.3 |
| DRSP/20mcg EE | 1.9 |
Number of Days of Unscheduled Blood Loss - Cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)
| Intervention | Days (Mean) |
|---|---|
| NGM/25mcg EE | 1.4 |
| DRSP/20mcg EE | 2.4 |
Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding. (NCT00745901)
Timeframe: Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)
| Intervention | Participants (Number) |
|---|---|
| NGM/25mcg EE | 53 |
| DRSP/20mcg EE | 56 |
cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. (NCT00745901)
Timeframe: Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE)
| Intervention | Days (Mean) |
|---|---|
| NGM/25mcg EE | 3.1 |
| DRSP/20mcg EE | 1.2 |
Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding. (NCT00745901)
Timeframe: Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)
| Intervention | Participants (Number) |
|---|---|
| NGM/25mcg EE | 39 |
| DRSP/20mcg EE | 62 |
Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)
| Intervention | Participants (Number) |
|---|---|
| NGM/25mcg EE | 47 |
| DRSP/20mcg EE | 74 |
Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)
| Intervention | Participants (Number) |
|---|---|
| NGM/25mcg EE | 72 |
| DRSP/20mcg EE | 74 |
Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)
| Intervention | Participants (Number) |
|---|---|
| NGM/25mcg EE | 57 |
| DRSP/20mcg EE | 87 |
cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. (NCT00745901)
Timeframe: Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE)
| Intervention | Days (Mean) |
|---|---|
| NGM/25mcg EE | 4.3 |
| DRSP/20mcg EE | 3.2 |
Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)
| Intervention | Participants (Number) |
|---|---|
| NGM/25mcg EE | 65 |
| DRSP/20mcg EE | 94 |
summary of the overall number of days of scheduled blood loss. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. (NCT00745901)
Timeframe: Cycle 1 to Cycle 3 (Day 8 to Day 84)
| Intervention | Days (Mean) |
|---|---|
| NGM/25mcg EE | 11.2 |
| DRSP/20mcg EE | 7.0 |
cycle control between treatment groups, overall. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. (NCT00745901)
Timeframe: Cycle 1 to 3 (Day 8 to Day 84)
| Intervention | Days (Mean) |
|---|---|
| NGM/25mcg EE | 15.8 |
| DRSP/20mcg EE | 13.2 |
cycle control between treatment groups, for three 28-day cycles. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 1 to Cycle 3 (Day 8 to Day 80)
| Intervention | Days (Mean) |
|---|---|
| NGM/25mcg EE | 4.6 |
| DRSP/20mcg EE | 6.1 |
cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. (NCT00745901)
Timeframe: Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE)
| Intervention | Days (Mean) |
|---|---|
| NGM/25mcg EE | 4.0 |
| DRSP/20mcg EE | 2.8 |
Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day. (NCT00745901)
Timeframe: Cycle 1 to Cycle 3 (Day 8 to Day 80)
| Intervention | Participants (Number) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| 0 Episode | 1 Episode | 2 Episodes | 3 Episodes | 4 Episodes | 5 Episodes | 6 Episodes | 8 Episodes | 9 Episodes | |
| DRSP/20mcg EE | 29 | 41 | 50 | 22 | 11 | 8 | 2 | 3 | 1 |
| NGM/25mcg EE | 55 | 46 | 23 | 21 | 13 | 7 | 0 | 0 | 0 |
patient satisfaction based on 5 questions during three 28-day cycles - Question 1 (Overall Satisfaction). On a scale of 1 to 5 where 1=Very satisfied and 5=Very dissatisfied. (NCT00745901)
Timeframe: Cycle 1 to Cycle 3
| Intervention | Participants (Number) | |||||
|---|---|---|---|---|---|---|
| Number of responses | 1. Very Satisfied | 2. Somewhat satisfied | 3. Neither satisfied or dissatisfied | 4. Dissatisfied | 5. Very dissatisfied | |
| DRSP/20mcg EE | 162 | 115 | 32 | 6 | 8 | 1 |
| NGM/25mcg EE | 159 | 99 | 35 | 12 | 11 | 2 |
cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)
| Intervention | Days (Mean) |
|---|---|
| NGM/25mcg EE | 1.9 |
| DRSP/20mcg EE | 2.0 |
cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. (NCT00745901)
Timeframe: Cycle 1 (Day 8 to Day 28)
| Intervention | Days (Mean) |
|---|---|
| NGM/25mcg EE | 6.2 |
| DRSP/20mcg EE | 5.2 |
Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.5 |
| Ortho Tri-Cyclen Lo | 4.1 |
Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.5 |
| Ortho Tri-Cyclen Lo | 2.8 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: Cycles 2 to 6 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| Yes | No | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 53.8 | 46.2 |
| Ortho Tri-Cyclen Lo | 40.5 | 59.5 |
Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00754065)
Timeframe: From Day 91 to Day 180
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.2 |
| Ortho Tri-Cyclen Lo | 3.1 |
Reference Period 1 is defined as Day 1 to Day 90 during study treatment. (NCT00754065)
Timeframe: From Day 1 to Day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.3 |
| Ortho Tri-Cyclen Lo | 2.8 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 5.0 |
| Ortho Tri-Cyclen Lo | 5.2 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 6.6 |
| Ortho Tri-Cyclen Lo | 4.2 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.0 |
| Ortho Tri-Cyclen Lo | 6.0 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 6.7 |
| Ortho Tri-Cyclen Lo | 6.2 |
Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 5.7 |
| Ortho Tri-Cyclen Lo | 7.1 |
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). (NCT00754065)
Timeframe: Days 22-28 from Baseline to Days 22-28 from Cycle 13 (28 days per Cycle)
| Intervention | mm (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 45.89 |
| Ortho Tri-Cyclen Lo | 39.19 |
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). (NCT00754065)
Timeframe: Days 22-28 from Baseline to Days 22-28 from Cycle 3 (28 days per Cycle)
| Intervention | mm (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 36.92 |
| Ortho Tri-Cyclen Lo | 32.28 |
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (NCT00754065)
Timeframe: From Day 1 to Day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 5.1 |
| Ortho Tri-Cyclen Lo | 5.1 |
Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00754065)
Timeframe: From Day 91 to Day 180
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.3 |
| Ortho Tri-Cyclen Lo | 3.5 |
Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.0 |
| Ortho Tri-Cyclen Lo | 3.1 |
Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 2.7 |
| Ortho Tri-Cyclen Lo | 2.8 |
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (NCT00754065)
Timeframe: From Day 1 to Day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.2 |
| Ortho Tri-Cyclen Lo | 0.5 |
Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00754065)
Timeframe: From Day 91 to Day 180
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.0 |
| Ortho Tri-Cyclen Lo | 0.7 |
Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.4 |
| Ortho Tri-Cyclen Lo | 0.6 |
Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.9 |
| Ortho Tri-Cyclen Lo | 0.2 |
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 4.2 |
| Ortho Tri-Cyclen Lo | 6.0 |
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 4.8 |
| Ortho Tri-Cyclen Lo | 5.5 |
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 4.3 |
| Ortho Tri-Cyclen Lo | 5.8 |
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 4.6 |
| Ortho Tri-Cyclen Lo | 5.7 |
Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.2 |
| Ortho Tri-Cyclen Lo | 4.0 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding) (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.2 |
| Ortho Tri-Cyclen Lo | 0.2 |
Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.2 |
| Ortho Tri-Cyclen Lo | 4.2 |
Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.4 |
| Ortho Tri-Cyclen Lo | 4.0 |
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (NCT00754065)
Timeframe: From Day 1 to Day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 7.8 |
| Ortho Tri-Cyclen Lo | 9.0 |
Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00754065)
Timeframe: From Day 91 to Day 180
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 6.2 |
| Ortho Tri-Cyclen Lo | 7.5 |
Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 6.2 |
| Ortho Tri-Cyclen Lo | 7.4 |
Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 2.75 |
| Ortho Tri-Cyclen Lo | 2.44 |
Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 2.77 |
| Ortho Tri-Cyclen Lo | 2.10 |
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (Episode is a set of days with bleeding/spotting) (NCT00754065)
Timeframe: From Day 1 to Day 90
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.6 |
| Ortho Tri-Cyclen Lo | 3.7 |
Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (Episode is a set of days with bleeding/spotting) (NCT00754065)
Timeframe: From Day 91 to Day 180
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.3 |
| Ortho Tri-Cyclen Lo | 3.4 |
Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (Episode is a set of days with bleeding/spotting) (NCT00754065)
Timeframe: From Day 181 to Day 270
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.0 |
| Ortho Tri-Cyclen Lo | 3.3 |
Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (Episode is a set of days with bleeding/spotting) (NCT00754065)
Timeframe: From Day 271 to Day 360
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.0 |
| Ortho Tri-Cyclen Lo | 3.7 |
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (NCT00754065)
Timeframe: From Day 1 to Day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 19.0 |
| Ortho Tri-Cyclen Lo | 23.7 |
Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00754065)
Timeframe: From Day 91 to Day 180
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.3 |
| Ortho Tri-Cyclen Lo | 18.8 |
Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 14.1 |
| Ortho Tri-Cyclen Lo | 19.1 |
Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 12.8 |
| Ortho Tri-Cyclen Lo | 19.4 |
Reference Period 1 is defined as Day 1 to Day 90 during study treatment. (NCT00754065)
Timeframe: From Day 1 to Day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 9.3 |
| Ortho Tri-Cyclen Lo | 8.6 |
Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00754065)
Timeframe: From Day 91 to Day 180
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 6.8 |
| Ortho Tri-Cyclen Lo | 6.4 |
Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 6.6 |
| Ortho Tri-Cyclen Lo | 6.3 |
Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 5.6 |
| Ortho Tri-Cyclen Lo | 5.6 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.5 |
| Ortho Tri-Cyclen Lo | 0.5 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.5 |
| Ortho Tri-Cyclen Lo | 0.4 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.4 |
| Ortho Tri-Cyclen Lo | 0.7 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.9 |
| Ortho Tri-Cyclen Lo | 1.1 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding) (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.3 |
| Ortho Tri-Cyclen Lo | 0.1 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding) (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.2 |
| Ortho Tri-Cyclen Lo | 0.1 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (Episode is a set of days with intracyclic bleeding) (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.2 |
| Ortho Tri-Cyclen Lo | 0.2 |
Reference Period 1 is defined as Day 1 to Day 90 during study treatment. (NCT00754065)
Timeframe: From Day 1 to Day 90
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.2 |
| Ortho Tri-Cyclen Lo | 0.5 |
Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00754065)
Timeframe: From Day 91 to Day 180
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.0 |
| Ortho Tri-Cyclen Lo | 0.5 |
Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.7 |
| Ortho Tri-Cyclen Lo | 0.3 |
Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.6 |
| Ortho Tri-Cyclen Lo | 0.2 |
Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM). (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 4.7 |
| Ortho Tri-Cyclen Lo | 4.0 |
Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM). (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.1 |
| Ortho Tri-Cyclen Lo | 2.1 |
Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM). (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 4.3 |
| Ortho Tri-Cyclen Lo | 3.3 |
Onset was defined as the number of days between progestogen withdrawal and the first day of the withdrawal bleeding episode (ie, starting on or after Day 25 for EV/DNG and on or after Day 22 for EE/NGM). (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 5.3 |
| Ortho Tri-Cyclen Lo | 3.1 |
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). (NCT00754065)
Timeframe: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
| Intervention | mm (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 43.05 |
| Ortho Tri-Cyclen Lo | 34.97 |
Subject self-assessed pelvic pain or headache per visual analog scale (VAS) values during the menstrual/withdrawal bleeding episode and Baseline. The VAS consists of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). (NCT00754065)
Timeframe: Days 22-28 from Baseline to Days 22-28 from Cycle 6 (28 days per Cycle)
| Intervention | mm (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 43.60 |
| Ortho Tri-Cyclen Lo | 34.55 |
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 13th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst). (NCT00754065)
Timeframe: Day 1-21 from Baseline to Day 1-21 from Cycle 13 (28 days per Cycle)
| Intervention | Days (Mean) | ||||
|---|---|---|---|---|---|
| Headache | Pelvic pain | Bloating or swelling | Breast tenderness | Nausea or vomiting | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -1.121 | -0.274 | -0.492 | -0.274 | -0.298 |
| Ortho Tri-Cyclen Lo | -0.767 | -0.643 | -0.279 | -0.217 | -0.240 |
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the EV/DNG group and min -7 (best), max 7 (worst) for the EE/NGM group. (NCT00754065)
Timeframe: From Baseline to Cycle 13 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)
| Intervention | Days (Mean) | ||||
|---|---|---|---|---|---|
| Headache | Pelvic pain | Bloating or swelling | Breast tenderness | Nausea or vomiting | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -0.537 | -0.322 | -0.107 | -0.033 | -0.033 |
| Ortho Tri-Cyclen Lo | -1.419 | -2.065 | -1.379 | -0.677 | -0.266 |
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 13th treatment cycle (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst). (NCT00754065)
Timeframe: Day 22-28 from Baseline to Day 22-28 from Cycle 13 (28 days per Cycle)
| Intervention | Days (Mean) | ||||
|---|---|---|---|---|---|
| Headache | Pelvic pain | Bloating or swelling | Breast tenderness | Nausea or vomiting | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -1.909 | -2.091 | -0.959 | -0.545 | -0.248 |
| Ortho Tri-Cyclen Lo | -1.419 | -2.065 | -1.379 | -0.677 | -0.266 |
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 1-21. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 1-21 before 1st menstrual bleeding (normalized to a 21-day period). Treatment period: cycle Days 1-21 before WB of 6th treatment cycle (normalized to a 21-day period). Score difference min -21 (best), max 21 (worst). (NCT00754065)
Timeframe: Day 1-21 from Baseline to Day 1-21 from Cycle 6 (28 days per Cycle)
| Intervention | Days (Mean) | ||||
|---|---|---|---|---|---|
| Headache | Pelvic pain | Bloating or swelling | Breast tenderness | Nausea or vomiting | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -1.077 | -0.399 | -0.531 | -0.580 | -0.182 |
| Ortho Tri-Cyclen Lo | -0.968 | -0.624 | -0.210 | -0.248 | -0.172 |
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode (cycle Days 22-28). Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Score difference min -2 (best), max 2 (worst) for the estradiol valerate (EV)/dienogest (DNG) group and min -7 (best), max 7 (worst) for the ethinylestradiol (EE)/norgestimate (NGM) group. (NCT00754065)
Timeframe: From Baseline to Cycle 6 (cycle Days 27 to 28 for EV/DNG and cycle Days 22 to 28 for EE/NGM, 28 days per Cycle)
| Intervention | Days (Mean) | ||||
|---|---|---|---|---|---|
| Headache | Pelvic pain | Bloating or swelling | Breast tenderness | Nausea or vomiting | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -0.424 | -0.273 | -0.137 | -0.043 | -0.043 |
| Ortho Tri-Cyclen Lo | -1.425 | -1.830 | -1.131 | -0.497 | -0.229 |
Pain (pelvic, headache, bloating or swelling, breast tenderness, nausea or vomiting) during menstrual/withdrawal bleeding (WB) episode during cycle Days 22-28. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: cycle Days 22-28 before 1st menstrual bleeding (normalized to a 7-day period). Treatment period: cycle Days 22-28 before WB of 6th treatment cycle until (normalized to a 7-day period). Score difference min -7 (best), max 7 (worst). (NCT00754065)
Timeframe: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
| Intervention | Days (Mean) | ||||
|---|---|---|---|---|---|
| Headache | Pelvic pain | Bloating or swelling | Breast tenderness | Nausea or vomiting | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -1.950 | -1.921 | -1.179 | -0.536 | -0.207 |
| Ortho Tri-Cyclen Lo | -1.425 | -1.830 | -1.131 | -0.497 | -0.229 |
Change from Baseline to Cycle 13 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Global score | Anxiety | Depressed mood | Positive well-being | Self-control | General health | Vitality | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -0.14 | -1.2 | -0.65 | 0.60 | -0.49 | 0.86 | 0.28 |
| Ortho Tri-Cyclen Lo | -0.18 | -0.8 | -0.98 | 0.38 | -0.16 | 1.35 | -0.51 |
Change from Baseline to Cycle 6 in PGWBI Questionnaire's assessment of participant's overall sense of well-being or distress. The PGWBI includes 22 items that, apart from combining into a global overall score, are divided into 6 dimensions: anxiety, depressed mood, positive well-being, self-control, health, and vitality. The response format used a 6-grade Likert scale and the change in the normalized PGWBI global score as well as all the sub-domains score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) | ||||||
|---|---|---|---|---|---|---|---|
| Global score | Anxiety | Depressed mood | Positive well-being | Self-control | General health | Vitality | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.41 | 0.3 | 0.18 | 49.66 | 0.69 | 81.81 | -0.17 |
| Ortho Tri-Cyclen Lo | 1.10 | 2.8 | -1.04 | 50.29 | 0.12 | 81.12 | 0.19 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Spotting | Light | Normal | Heavy | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 46.2 | 23.1 | 15.4 | 15.4 |
| Ortho Tri-Cyclen Lo | 50.0 | 18.8 | 18.8 | 12.5 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Spotting | Light | Normal | Heavy | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 31.6 | 52.6 | 10.5 | 5.3 |
| Ortho Tri-Cyclen Lo | 57.1 | 0.0 | 28.6 | 14.3 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Spotting | Light | Normal | Heavy | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 47.1 | 23.5 | 20.6 | 8.8 |
| Ortho Tri-Cyclen Lo | 57.7 | 15.4 | 23.1 | 3.8 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. Intensity was scored as 1=none, 2=spotting, 3=light, 4=normal, or 5=heavy. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Spotting | Light | Normal | Heavy | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 44.4 | 25.9 | 18.5 | 11.1 |
| Ortho Tri-Cyclen Lo | 61.3 | 3.2 | 19.4 | 16.1 |
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| without withdrawal bleeding | with withdrawal bleeding | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 25.0 | 75.0 |
| Ortho Tri-Cyclen Lo | 12.8 | 87.2 |
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| without withdrawal bleeding | with withdrawal bleeding | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 58.2 | 41.8 |
| Ortho Tri-Cyclen Lo | 19.1 | 80.9 |
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| without withdrawal bleeding | with withdrawal bleeding | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 21.0 | 79.0 |
| Ortho Tri-Cyclen Lo | 7.7 | 92.3 |
Withdrawal bleeding is bleeding that occurs when using oral contraceptives (OCs) caused by falling levels and/or taking away external source of estrogen and progestogen toward cycle end. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| without withdrawal bleeding | with withdrawal bleeding | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 17.7 | 82.3 |
| Ortho Tri-Cyclen Lo | 8.3 | 91.7 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: Cycles 2 to 13 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| Yes | No | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 62.0 | 38.0 |
| Ortho Tri-Cyclen Lo | 49.7 | 50.3 |
CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | ||
|---|---|---|---|
| Very much improved | Much improved | Minimally improved | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 37.9 | 32.3 | 15.3 |
| Ortho Tri-Cyclen Lo | 20.3 | 26.6 | 27.3 |
CGI is used to collect information regarding the subject's total clinical experience. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | ||
|---|---|---|---|
| Very much improved | Much improved | Minimally improved | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 21.1 | 41.5 | 27.2 |
| Ortho Tri-Cyclen Lo | 20.0 | 25.2 | 33.5 |
In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | ||
|---|---|---|---|
| Very much improved | Much improved | Minimally improved | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 33.9 | 35.5 | 16.9 |
| Ortho Tri-Cyclen Lo | 17.2 | 25.0 | 28.1 |
In 1 section of the CGI the subject rates their total improvement and rate of satisfaction with sexuality during treatment. The assessment scale ranges from 0 to 7: (0=not assessed; 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). The scale of 1, 2, and 3 were categorized as improvement. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | ||
|---|---|---|---|
| Very much improved | Much improved | Minimally improved | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 25.2 | 32.7 | 29.3 |
| Ortho Tri-Cyclen Lo | 11.6 | 30.3 | 32.2 |
Rescue medication was standardized intake of 200 mg Ibuprofen tablets. Baseline: 7 days (Day 22) before first menstrual bleeding to Day 28. Treatment: 7 days (Day 22) before withdrawal bleeding of 6th cycle to Day 28 before the same cycle. The visual analog scale (VAS) is a subject-assessed measure of pelvic pain or headache consisting of a 100 mm long straight line, with verbal anchors at either end, representing a continuum of pain intensity. Accordingly, the scale ranges from 0 mm (absence of pain) to 100 mm (unbearable pain), and the change ranges from -100 mm (best) to 100 mm (worst). (NCT00754065)
Timeframe: Day 22-28 from Baseline to Day 22-28 from Cycle 6 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | ||||||
|---|---|---|---|---|---|---|---|
| 15 mm VAS decrease | 30 mm VAS decrease | 45 mm VAS decrease | 25% VAS decrease | 50% VAS decrease | 75% VAS decrease | Half-SD decrease | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 68.1 | 58.1 | 38.2 | 67.0 | 56.0 | 38.2 | 70.2 |
| Ortho Tri-Cyclen Lo | 54.4 | 42.6 | 26.0 | 54.4 | 42.2 | 25.5 | 59.8 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 1 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| with absence of intracyclic bleeding | without absence of intracyclic bleeding | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 78.3 | 21.7 |
| Ortho Tri-Cyclen Lo | 91.5 | 8.5 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 13 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| with absence of intracyclic bleeding | without absence of intracyclic bleeding | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 82.7 | 17.3 |
| Ortho Tri-Cyclen Lo | 93.6 | 6.4 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 3 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| with absence of intracyclic bleeding | without absence of intracyclic bleeding | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 79.6 | 20.4 |
| Ortho Tri-Cyclen Lo | 85.7 | 14.3 |
Intracyclic bleeding is any unexpected bleeding episode occurring in cyclical treatment regimens. (NCT00754065)
Timeframe: At Cycle 6 (28 days per Cycle)
| Intervention | Percentage of participants (Number) | |
|---|---|---|
| with absence of intracyclic bleeding | without absence of intracyclic bleeding | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 81.6 | 18.4 |
| Ortho Tri-Cyclen Lo | 80.3 | 19.7 |
Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 13th treatment cycle until Day 28 before the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation ((SD) derived. (NCT00754065)
Timeframe: From Baseline to Cycle 13 (28 days per Cycle)
| Intervention | Tablets (Mean) | |
|---|---|---|
| Days 1-21 | Days 22-28 | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -2.3 | -5.3 |
| Ortho Tri-Cyclen Lo | -3.5 | -5.2 |
Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 7 days (Day 22) before the first menstrual bleeding until Day 28 (normalized to a standard 28-day cycle). Treatment period: 7 days (Day 22) before the withdrawal bleeding (WB) of the 6th treatment cycle until Day 28 of the same cycle (normalized to a standard 28-day cycle). Number of tablets taken by each subject, and then the Mean and standard deviation (SD) derived. (NCT00754065)
Timeframe: From Baseline to Cycle 6 (28 days per Cycle)
| Intervention | Tablets (Mean) | |
|---|---|---|
| Days 1-21 | Days 22-28 | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -1.6 | -5.8 |
| Ortho Tri-Cyclen Lo | -3.0 | -4.6 |
Reference Period 3 is defined as Day 181 to Day 270 during study treatment. (NCT00754065)
Timeframe: From Day 181 to Day 270
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 4.70 |
| Ortho Tri-Cyclen Lo | 5.85 |
Reference Period 1 is defined as Day 1 to Day 90 during study treatment. (NCT00754065)
Timeframe: From Day 1 to Day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 2.64 |
| Ortho Tri-Cyclen Lo | 2.53 |
Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 4.25 |
| Ortho Tri-Cyclen Lo | 5.65 |
Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00754065)
Timeframe: From Day 91 to Day 180
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 4.46 |
| Ortho Tri-Cyclen Lo | 5.71 |
Reference Period 1 is defined as Day 1 to Day 90 during study treatment and includes the initial bleeding episode that triggered the first intake of study medication, meaning that the first treatment cycle includes 2 bleeding episodes. (NCT00754065)
Timeframe: From Day 1 to Day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 4.82 |
| Ortho Tri-Cyclen Lo | 6.20 |
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.54 |
| Ortho Tri-Cyclen Lo | 0.08 |
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -0.30 |
| Ortho Tri-Cyclen Lo | 0.41 |
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -0.18 |
| Ortho Tri-Cyclen Lo | 5.13 |
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.13 |
| Ortho Tri-Cyclen Lo | 3.44 |
Reference Period 2 is defined as Day 91 to Day 180 during study treatment. (NCT00754065)
Timeframe: From Day 91 to Day 180
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 2.74 |
| Ortho Tri-Cyclen Lo | 2.77 |
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.12 |
| Ortho Tri-Cyclen Lo | 2.19 |
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -0.1 |
| Ortho Tri-Cyclen Lo | 0.0 |
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.22 |
| Ortho Tri-Cyclen Lo | 2.77 |
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -0.1 |
| Ortho Tri-Cyclen Lo | 0.1 |
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.50 |
| Ortho Tri-Cyclen Lo | 3.08 |
Change from Baseline to Cycle 6 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 6 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.56 |
| Ortho Tri-Cyclen Lo | 1.27 |
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (work - yes or no; if yes, then 4 choices, and 13 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -1.38 |
| Ortho Tri-Cyclen Lo | -1.71 |
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (social relationship - 11 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.01 |
| Ortho Tri-Cyclen Lo | 1.75 |
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (school / course work - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -1.97 |
| Ortho Tri-Cyclen Lo | 4.39 |
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (physical health - 13 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.93 |
| Ortho Tri-Cyclen Lo | 2.13 |
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (participant feeling - 14 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -0.44 |
| Ortho Tri-Cyclen Lo | 0.39 |
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (overall life satisfaction and contentment). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -0.1 |
| Ortho Tri-Cyclen Lo | 0.0 |
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (leisure time activities - 6 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 2.72 |
| Ortho Tri-Cyclen Lo | 2.37 |
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (item satisfaction). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.0 |
| Ortho Tri-Cyclen Lo | 0.1 |
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (household duties - yes or no; if yes, then 4 choices, and 10 items with a scale of 1-5 [very poor, poor, fair, good, very good]). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -0.66 |
| Ortho Tri-Cyclen Lo | 2.83 |
Change from Baseline to Cycle 13 in the overall enjoyment and satisfaction experienced during the past week as scored on the Q-LES-Q (general activities - 16 items). 1-5 scale (very poor, poor, fair, good, very good). The normalized score ranges from 0 (worst) to 100 (best). The change in the normalized score ranges from -100 (worst) to 100 (best). (NCT00754065)
Timeframe: Baseline up to Cycle 13 (28 days per Cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.73 |
| Ortho Tri-Cyclen Lo | 1.34 |
Reference Period 4 is defined as Day 271 to Day 360 during study treatment. (NCT00754065)
Timeframe: From Day 271 to Day 360
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.2 |
| Ortho Tri-Cyclen Lo | 2.2 |
Change from baseline in unstimulated labial gland saliva flow rate at Day 7 (NCT00799708)
Timeframe: Baseline and Day 7
| Intervention | μL/min (Least Squares Mean) |
|---|---|
| 17β-estradiol 2.0 Milligrams | -0.26 |
| Placebo | -0.64 |
Subset of genes on the log ratio intensity scale from a microarray platform - signature was pre-specified from an internally conducted study in knock-out mice treated with estrogens- quantified as a ratio of up regulated versus down regulated genes (NCT00799708)
Timeframe: Baseline and Day 7
| Intervention | Fold change (Least Squares Mean) |
|---|---|
| 17β-estradiol 2.0 Milligrams | 0.028 |
| 17β-estradiol 0.5 Milligrams | -0.011 |
| Placebo | 0.080 |
The VVAQ consists of three questions asking the participant to rate the severity and how bothersome each of the symptoms of atrophic vaginitis are (dryness, itching, and burning). It is graded 0 through 10. A higher number indicates less severe and less bothersomeness of the symptom, that is, 0= very severe or bothersome, 10= least severe or bothersome. (NCT00816556)
Timeframe: baseline, 12 weeks
| Intervention | units on a scale (Mean) | |||||
|---|---|---|---|---|---|---|
| Dryness Severity | Dryness Bothersomeness | Itching Severity | Itching Bothersomeness | Burning Severity | Burning Bothersomeness | |
| Estradiol | 2.0 | 2.1 | 2.6 | 2.6 | 1.5 | 1.5 |
| Estriol | 3.2 | 2.3 | 1.4 | 1.3 | 2.1 | 1.9 |
| Placebo | 2.7 | 3.6 | 1.9 | 1.7 | 1.0 | 1.1 |
(NCT00816556)
Timeframe: baseline, 2 weeks, 12 weeks
| Intervention | pg/ml (Mean) | ||
|---|---|---|---|
| Baseline vs. Week 2 | Baseline vs. Week 12 | Week 2 vs. Week 12 | |
| Estradiol | -1.6 | 1.2 | 1.5 |
| Estriol | -0.9 | 1.0 | 2.2 |
| Placebo | 0.5 | 1.1 | 0.6 |
(NCT00816556)
Timeframe: baseline, 2 weeks, 12 weeks
| Intervention | pg/ml (Mean) | ||
|---|---|---|---|
| Baseline vs. Week 2 | Baseline vs. Week 12 | Week 2 vs. Week 12 | |
| Estradiol | -1.7 | 0.6 | 1.9 |
| Estriol | 0.0 | -0.4 | -0.3 |
| Placebo | 0.5 | 0.2 | -0.3 |
Ratio of the total number of positively stained cell nuclei to the total number of cell nuclei. Proliferating endometrial cells express the Ki-67 antigen. The ratio was converted to a percent proliferating cells by taking the number of Ki-67 positive stained nuclei in a given field and dividing by the total number of nuclei in that field and multiplying by 100. At least 5 high power fields were scored in this manner and an aggregate percent Ki-67 positive cells was reported. Square root transformation was taken to make it approximately normally distributed for an ANOVA model to apply. (NCT00820664)
Timeframe: 4 weeks
| Intervention | Square root of % positive stained cells (Least Squares Mean) |
|---|---|
| 17β-estradiol 2.0 Milligrams | 0.73 |
| 17β-estradiol 0.5 Milligrams | 0.43 |
| Placebo | 0.25 |
(NCT00837616)
Timeframe: 12 months
| Intervention | mg/dl (Mean) | |||
|---|---|---|---|---|
| Total Cholesterol | Low Density Lipoprotein | High Density Lipoprotein | Triglycerides | |
| Oral Estradiol | 168 | 93 | 56 | 95 |
| Transdermal Estradiol | 153 | 88 | 50 | 70 |
(NCT00837616)
Timeframe: 12 months
| Intervention | pg/mL (Mean) |
|---|---|
| Oral Estradiol | 63638 |
| Transdermal Estradiol | 1875 |
(NCT00837616)
Timeframe: 12 months
| Intervention | kg (Mean) |
|---|---|
| Oral Estradiol | 1.03 |
| Transdermal Estradiol | 1.67 |
(NCT00837616)
Timeframe: 12 months
| Intervention | Kcal/Fat Free Mass/day (Mean) |
|---|---|
| Oral Estradiol | 10 |
| Transdermal Estradiol | 7.3 |
(NCT00837616)
Timeframe: 12 months
| Intervention | ng/ml (Mean) |
|---|---|
| Oral Estradiol | -16 |
| Transdermal Estradiol | 28 |
(NCT00837616)
Timeframe: 12 months
| Intervention | kilograms (Mean) |
|---|---|
| Oral Estradiol | 1.1 |
| Transdermal Estradiol | 1.9 |
(NCT00837616)
Timeframe: 12 months
| Intervention | percent fat mass (Mean) |
|---|---|
| Oral Estradiol | -0.14 |
| Transdermal Estradiol | -0.64 |
(NCT00837616)
Timeframe: 12 months
| Intervention | kg/m2 (Mean) |
|---|---|
| Oral Estradiol | 0.075 |
| Transdermal Estradiol | 0.65 |
(NCT00837616)
Timeframe: 12 months
| Intervention | pg/ml (Mean) |
|---|---|
| Oral Estradiol | 124 |
| Transdermal Estradiol | 74 |
(NCT00837616)
Timeframe: 12 months
| Intervention | pg/mL (Mean) |
|---|---|
| Oral Estradiol | 504 |
| Transdermal Estradiol | 43 |
The primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site. (NCT00859508)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|---|
| SyntheCel | 57 |
| Other FDA Cleared Dura Replacements | 33 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At final examination (28 days)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 68.2 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 67.2 |
The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Participants were asked to rate their improvement during the course of the study. (NCT00909857)
Timeframe: At cycle 2 (28 days per cycle)
| Intervention | Participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Missing | Not assessed | Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1 | 1 | 60 | 91 | 47 | 18 | 5 | 0 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0 | 1 | 46 | 75 | 57 | 24 | 4 | 3 |
The Clinical Global Impression Scale (CGI) is a widely used rating scale/assessment instrument in psychopharmacology research in general, and in studies on women's health in particular. Investigators were asked to rate the participants' improvement during the course of the study. (NCT00909857)
Timeframe: At cycle 2 (28 days per cycle)
| Intervention | Participants (Number) | |||||||
|---|---|---|---|---|---|---|---|---|
| Missing | Not assessed | Very much improved | Much improved | Minimally improved | No change | Minimally worse | Much worse | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0 | 1 | 63 | 87 | 49 | 17 | 6 | 0 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0 | 1 | 42 | 84 | 54 | 23 | 3 | 6 |
The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle. (NCT00909857)
Timeframe: At Baseline (28 days per cycle)
| Intervention | Percentage of Participants (Number) | ||||
|---|---|---|---|---|---|
| Missing | Never | 4 working hours | 1 working day | >= 2 working days | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.0 | 47.9 | 13.2 | 20.9 | 17.9 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.0 | 51.7 | 11.7 | 23.9 | 12.2 |
The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle. (NCT00909857)
Timeframe: At cycle 2 (28 days per cycle)
| Intervention | Percentage of Participants (Number) | ||||
|---|---|---|---|---|---|
| Missing | Never | 4 working hours | 1 working day | >= 2 working days | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.0 | 78.6 | 8.5 | 6.4 | 2.1 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.0 | 72.6 | 6.5 | 8.7 | 4.3 |
The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle. (NCT00909857)
Timeframe: At final examination (28 days)
| Intervention | Percentage of Participants (Number) | ||||
|---|---|---|---|---|---|
| Missing | Never | 4 working hours | 1 working day | >= 2 working days | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.4 | 85.9 | 5.6 | 3.0 | 1.7 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.0 | 85.2 | 2.6 | 4.8 | 1.7 |
The investigator was asked to interview the participant and record the number of missed hours/days from work due to dysmenorrheic pain in the previous menstrual cycle. (NCT00909857)
Timeframe: At screening (28 days)
| Intervention | Percentage of Participants (Number) | ||||
|---|---|---|---|---|---|
| Missing | Never | 4 working hours | 1 working day | >= 2 working days | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.4 | 38.0 | 16.2 | 26.5 | 18.8 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.0 | 40.4 | 16.1 | 29.6 | 13.9 |
Participants were asked to express the degree of their satisfaction with study treatment. (NCT00909857)
Timeframe: From cycle 1 to cycle 3 (28 days per cycle)
| Intervention | Percentage of participants (Number) | |||||
|---|---|---|---|---|---|---|
| Missing | Very satisfied | Saatisfied | Neither satisfied nor dissatisfied | Dissatisfied | Very dissatisfied | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.9 | 53.4 | 32.1 | 7.3 | 2.1 | 0.4 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 1.3 | 50.4 | 30.0 | 8.3 | 3.5 | 0.4 |
Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
| Intervention | Percentage of Participants (Number) | |||
|---|---|---|---|---|
| Baseline period-daily activities impaired | Baseline period- leisure activities impaired | Treatment period-daily activities impaired | Treatment period- leisure activities impaired | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 93.2 | 92.3 | 54.7 | 52.6 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 92.2 | 90.0 | 60.0 | 61.3 |
Interference of dysmenorrheic pain with work/school and social or other activity was assessed (yes/no). Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Baseline period-daily activities impaired | Baseline period- leisure activities impaired | Treatment period-daily activities impaired | Treatment period- leisure activities impaired | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 92.3 | 90.6 | 51.7 | 47.9 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 91.3 | 89.6 | 56.5 | 56.5 |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Spotting | Light | Normal | Heavy | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 53.5 | 30.2 | 9.3 | 7.0 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 62.2 | 10.8 | 13.5 | 13.5 |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity could be described as spotting, light, normal or heavy. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)
| Intervention | Percentage of participants (Number) | |||
|---|---|---|---|---|
| Spotting | Light | Normal | Heavy | |
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 45.5 | 27.3 | 13.6 | 13.6 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 30.4 | 21.7 | 30.4 | 17.4 |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.9 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 3.6 |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 7.1 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 8.4 |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 5.17 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 5.83 |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.29 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 3.26 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 73.6 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 72.6 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At final examination (28 days)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 77.3 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 76.4 |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 20.0 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 23.6 |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 7.3 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 7.6 |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.9 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 4.1 |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.5 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.4 |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.2 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 1.0 |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. The total number of days during intracyclic bleeding episodes was counted. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.6 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.6 |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.2 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.2 |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)
| Intervention | Episodes (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.1 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.1 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At final examination (28 days)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 89.6 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 87.9 |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.7 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 4.1 |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. Intensity was defined as: 1 = none, 2 = spotting, 3 = light, 4 = normal, 5 = heavy. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.7 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 4.0 |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 4.5 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 5.2 |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 5.2 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 5.4 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At final examination (28 days)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 77.2 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 76.5 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 75.8 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 72.7 |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 1.2 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.7 |
Bleeding/spotting episodes (day[s] with bleeding/spotting preceded and followed by at least 2 bleeding/spotting-free days) were described using the reference period (RP) method (length of RP: 90 days) recommended by the World Health Organization. 1st RP started on the 1st day of study medication. The total number of days during bleeding or spotting episodes was counted. Spotting = less than associated with normal menstruation relative to the subject's experience with no need for sanitary protection (except for panty liners). Bleeding = any bleeding of greater intensity than spotting. (NCT00909857)
Timeframe: From day 1 to day 90
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.6 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 4.6 |
Dysmenorrheic pain: pelvic pain during menstrual/withdrawal bleeding (WB) episode and 2 days before. Scores per day: 0 No pain; 1 Mild pain with no need for painkiller; 2 Moderate pain with need for painkiller; 3 Severe pain with need for painkiller. Baseline period: 2 days before 1st menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of 1st treatment cycle until 3rd day before WB of the cycle after 2nd treatment cycle (normalized to standard 56-day period). Score difference min -168 (best), max 168 (worst) (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -10.6 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | -10.0 |
Dysmenorrheic pain was defined as pelvic pain during the menstrual/withdrawal bleeding episode and the 2 days before this episode. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -4.6 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | -4.2 |
Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
| Intervention | Tablets (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -6.2 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | -6.6 |
Rescue medication use was standardized intake of 200 mg Ibuprofen tablets. Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
| Intervention | Tablets (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -4.5 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | -5.6 |
Baseline period: 2 days before the first menstrual bleeding until 3rd day before the 3rd menstrual bleeding (normalized to a standard 56-day period). Treatment period: 2 days before the withdrawal bleeding (WB) of the 1st evaluable treatment cycle until 3rd day before the WB of the cycle after the 2nd evaluable treatment cycle (normalized to a standard 56-day period). (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | -4.0 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | -3.7 |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 6.0 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 6.2 |
Evaluated was the number of days with bleeding-associated pelvic pain, excluding days during withdrawal bleeding (WB) and the 2 days preceding such WB, and during administration deviation bleeding and the 2 days preceding such bleeding (normalized to a standard 56-day period). Baseline period: 2 days before first menstrual bleeding until 3rd day before 3rd menstrual bleeding (normalized to standard 56-day period). Treatment period: 2 days before WB of the 1st treatment cycle until 3rd day before the WB of the cycle after the 2nd treatment cycle (normalized to standard 56-day period). (NCT00909857)
Timeframe: baseline period (2 baseline cycles, usually 56 days) vs. treatment period (on-treatment cycles 2 and 3, usually 56 days)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.3 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.1 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At final examination (28 days)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 77.0 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 74.0 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 50.7 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 51.8 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 78.85 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 77.35 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At final examination (28 days)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 85.95 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 84.79 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 62.6 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 62.2 |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 4.8 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 4.9 |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 3.1 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 4.3 |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)
| Intervention | Days (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 5.5 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 4.9 |
The participants were asked to complete a resource use questionnaire indicating their own costs of acupuncture per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)
| Intervention | Dollars (Median) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.00 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.00 |
The participants were asked to complete a resource use questionnaire indicating their own costs of alternative medicine per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)
| Intervention | Dollars (Median) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.00 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.00 |
The participants were asked to complete a resource use questionnaire indicating their own costs of herbs/teas per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)
| Intervention | Dollars (Median) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.00 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.00 |
The participants were asked to complete a resource use questionnaire indicating their own costs of massages per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)
| Intervention | Dollars (Median) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.00 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.00 |
The participants were asked to complete a resource use questionnaire indicating their own costs of medical counseling per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)
| Intervention | Dollars (Median) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.00 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.00 |
The participants were asked to complete a resource use questionnaire indicating their own costs of pain medication per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)
| Intervention | Dollars (Median) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 5.46 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 5.04 |
The participants were asked to complete a resource use questionnaire indicating their own costs of physiotherapy per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)
| Intervention | Dollars (Median) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.00 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.00 |
The participants were asked to complete a resource use questionnaire indicating their own costs of vitamins per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)
| Intervention | Dollars (Median) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.00 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.00 |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 19.0 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 16.7 |
Intracyclic bleeding episodes were any bleeding episodes not qualifying as withdrawal bleeding. The latter was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 10.8 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 11.6 |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 1 (28 days per cycle)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 91.2 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 93.2 |
Withdrawal bleeding was defined as the first bleeding episode after complete or partial progestogen withdrawal (i.e. the first episode starting after the last day of progestogen intake). If a bleeding episode was ongoing on the last day of progestogen intake and the following day, this episode was regarded as the withdrawal bleeding episode, as long as it had started not more than 4 days before the progestogen withdrawal. (NCT00909857)
Timeframe: At cycle 3 (28 days per cycle)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 68.1 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 79.3 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 90.2 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 89.6 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: at final examination (28 days)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 93.7 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 92.5 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 81.91 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 79.18 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At final examination (28 days)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 88.64 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 83.87 |
The standard questionnaire SF-36v1, a general health status measure used to evaluate patient populations and to compare health status across different populations, was completed by participants as a self-administered native language version. Percentages of absolute scores were calculated such that 0 represents the lowest possible score (worst outcome) and 100 the highest possible score (best outcome) (NCT00909857)
Timeframe: At baseline cycle (28 days per cycle)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 77.8 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 79.4 |
The participants were asked to complete a resource use questionnaire indicating their other own costs per treatment of dysmenorrheic pain. Costs were converted to U.S. dollars. (NCT00909857)
Timeframe: At screening (average over 3 months before screening)
| Intervention | Dollars (Median) |
|---|---|
| Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027) | 0.00 |
| Ethinyl Estradiol, Levonorgestrel (Miranova) | 0.00 |
Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists. (NCT00924560)
Timeframe: Baseline, Month 6 and Month 12
| Intervention | g/cm^2 (Least Squares Mean) | |
|---|---|---|
| Change from Baseline to Month 6 | Change from Baseline to Month 12 | |
| 28-day Levonorgestrel OC | 0.01 | 0.01 |
| 91-day Levonorgestrel OC | 0.02 | 0.02 |
| Untreated Control | 0.01 | 0.03 |
Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists. (NCT00924560)
Timeframe: Baseline, Month 6 and Month 12
| Intervention | g (Least Squares Mean) | |
|---|---|---|
| Change from Baseline to Month 6 (n=238, 227, 358) | Change from Baseline to Month 12 (n=238, 224, 359) | |
| 28-day Levonorgestrel OC | 0.09 | 0.28 |
| 91-day Levonorgestrel OC | 0.26 | 0.59 |
| Untreated Control | 0.13 | 0.43 |
(NCT00924560)
Timeframe: Baseline, Month 6 and Month 12
| Intervention | nmol/L (Mean) | |
|---|---|---|
| Change from Baseline to Month 6 (n=234, 224, 349) | Change from Baseline to Month 12 (n=233, 226, 348) | |
| 28-day Levonorgestrel OC | -0.1 | 0.1 |
| 91-day Levonorgestrel OC | -0.1 | -0.1 |
| Untreated Control | 0.1 | -0.1 |
(NCT00924560)
Timeframe: Baseline, Month 6 and Month 12
| Intervention | nmol/L (Mean) | |
|---|---|---|
| Change from Baseline to Month 6 (n=236, 224, 354) | Change from Baseline to Month 12 (n=235, 225, 348) | |
| 28-day Levonorgestrel OC | -3.9 | -3.7 |
| 91-day Levonorgestrel OC | -4.8 | -4.5 |
| Untreated Control | -5.1 | -7.1 |
(NCT00924560)
Timeframe: Baseline, Month 6 and Month 12
| Intervention | µg/L (Mean) | |
|---|---|---|
| Change from Baseline to Month 6 (n=237, 225, 355) | Change from Baseline to Month 12 (n=235, 226, 349) | |
| 28-day Levonorgestrel OC | -38.7 | -39.8 |
| 91-day Levonorgestrel OC | -49.9 | -50.4 |
| Untreated Control | -57.8 | -86.0 |
(NCT00924560)
Timeframe: Baseline, Month 6 and Month 12
| Intervention | nM bone collagen equivalents (BCE) (Mean) | |
|---|---|---|
| Change from Baseline to Month 6 (n=235, 224, 356) | Change from Baseline to Month 12 (n=236, 225, 350) | |
| 28-day Levonorgestrel OC | -3.9 | -4.3 |
| 91-day Levonorgestrel OC | -4.8 | -4.5 |
| Untreated Control | -0.7 | -3.1 |
Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists. (NCT00924560)
Timeframe: Baseline, Month 6 and Month 12
| Intervention | g (Least Squares Mean) | |
|---|---|---|
| Change from Baseline to Month 6 (n=130, 126, 149) | Change from Baseline to Month 12 (n=130, 126, 150) | |
| 28-day Levonorgestrel OC | 38.70 | 63.78 |
| 91-day Levonorgestrel OC | 40.77 | 72.86 |
| Untreated Control | 46.26 | 84.95 |
Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists. (NCT00924560)
Timeframe: Baseline, Month 6 and Month 12
| Intervention | g/cm^2 (Least Squares Mean) | |
|---|---|---|
| Change from Baseline to Month 6 (n=130, 126, 149) | Change from Baseline to Month 12 (n=130, 126, 150) | |
| 28-day Levonorgestrel OC | 0.01 | 0.01 |
| 91-day Levonorgestrel OC | 0.01 | 0.01 |
| Untreated Control | 0.01 | 0.02 |
"An adverse event was any untoward medical occurrence in a clinical investigation subject participating in the clinical study, and did not necessarily need to have a causal relationship with treatment or the clinical study. The relationship of each adverse event to study treatment or procedures, and the severity and seriousness of each adverse event was judged by the investigator, as described below.~A severe AE is defined as incapacitating, with inability to perform usual activities.~A serious adverse event is an adverse event occurring at any dose that resulted in any of the following outcomes or actions:~fatal or life-threatening;~required or prolonged inpatient hospitalization;~resulted in persistent or significant disability/incapacity;~congenital anomaly or birth defect;~important medical event." (NCT00924560)
Timeframe: 12 months
| Intervention | participants (Number) | |||||
|---|---|---|---|---|---|---|
| Any adverse event | Severe adverse event | Treat-related adverse event | Deaths | Other serious adverse events | Withdrawn from study due to adverse events | |
| 28-day Levonorgestrel OC | 258 | 20 | 95 | 0 | 12 | 33 |
| 91-day Levonorgestrel OC | 252 | 14 | 100 | 0 | 9 | 34 |
| Untreated Control | 274 | 10 | 7 | 0 | 0 | 1 |
Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists. (NCT00924560)
Timeframe: Baseline, Month 6 and Month 12
| Intervention | g/cm^2 (Least Squares Mean) | |
|---|---|---|
| Change from Baseline to Month 6 (n=238, 227, 358) | Change from Baseline to Month 12 (n=238, 224, 359) | |
| 28-day Levonorgestrel OC | 0.00 | 0.01 |
| 91-day Levonorgestrel OC | 0.01 | 0.02 |
| Untreated Control | 0.01 | 0.01 |
"Bone mineral density was measured by dual energy X-ray absorptiometry (DXA) scan. DXA scans were interpreted centrally by blinded, certified technologists.~Percent change from Baseline was calculated as (BMD at Month 12 - BMD at Baseline)/BMD at Baseline * 100%." (NCT00924560)
Timeframe: Baseline and Month 12
| Intervention | percent change (Least Squares Mean) |
|---|---|
| 91-day Levonorgestrel OC | 2.26 |
| 28-day Levonorgestrel OC | 1.45 |
| Untreated Control | 2.50 |
(NCT00924560)
Timeframe: Baseline, Month 6 and Month 12
| Intervention | µg/L (Mean) | |
|---|---|---|
| Change from Baseline to Month 6 (n=236, 224, 353) | Change from Baseline to Month 12 (n=235, 225, 347) | |
| 28-day Levonorgestrel OC | -5.9 | -6.6 |
| 91-day Levonorgestrel OC | -6.8 | -6.9 |
| Untreated Control | -6.2 | -10.3 |
Bone mineral content was measured by dual energy X-ray absorptiometry (DXA) scans and interpreted centrally by blinded, certified technologists. (NCT00924560)
Timeframe: Baseline, Month 6 and Month 12
| Intervention | g (Least Squares Mean) | |
|---|---|---|
| Change from Baseline to Month 6 | Change from Baseline to Month 12 | |
| 28-day Levonorgestrel OC | 0.69 | 1.20 |
| 91-day Levonorgestrel OC | 1.29 | 1.86 |
| Untreated Control | 1.12 | 1.94 |
Pearl Index = 1300 * number of pregnancies/number of women-cycles of treatment (NCT00932321)
Timeframe: 5.6 months (6 - 28 day cycles)
| Intervention | Pearl Index (Number) |
|---|---|
| 24 Day NA/EE | 1.823 |
| 21 Day NA/EE | 2.978 |
Self-reported via patient completed diary (none - no vaginal bleeding, light - less than normal menstruation, normal - like normal menstruation, heavy - more than normal menstruation) along with daily use of sanitary protection (other than panty liners). Light bleeding requiring no more than single pad or tampon will be spotting. (NCT00932321)
Timeframe: 5.6 months (6 - 28 day cycles)
| Intervention | Days (Mean) |
|---|---|
| 24 Day NA/EE | 6.31 |
| 21 Day NA/EE | 7.31 |
Change in total volumetric bone density at the tibia with transdermal estrogen versus oral estrogen or no estrogen in amenorrheic athletes (NCT00946192)
Timeframe: 12 months
| Intervention | mg HA/cm^3 (Mean) |
|---|---|
| Estrogen Patch | 7.01 |
| Estrogen Pill | 1.17 |
| Control | 3.71 |
Change in bone density with transdermal estrogen versus oral estrogen or no estrogen in amenorrheic athletes (NCT00946192)
Timeframe: 12 months
| Intervention | g/cm^2 (Mean) |
|---|---|
| Estrogen Patch | 0.025 |
| Estrogen Pill | 0.008 |
| Control | 0.012 |
Delayed recall on the Logical Memory subset of the Wechsler Memory Scale-Revised, in which higher scores indicate a better recall and outcome. The minimum value is 0 and maximum value is 25. (NCT00997893)
Timeframe: Baseline and 12 weeks
| Intervention | Test scores on the Logical Memory test (Mean) |
|---|---|
| Estradiol/Medroxyprogesterone Acetate | .87 |
| Phytoestrogen | 1.61 |
| Placebo | 1.08 |
STAI-6; State-Trait Anxiety Inventory- Short Form is a measure of anxiety where higher scores indicate higher/elevated anxiety. Minimum value 6 is and maximum value is 24. (NCT00997893)
Timeframe: Week 0, 10, 12, and 16-18
| Intervention | score on STAI scale (Mean) | |||
|---|---|---|---|---|
| Baseline (Week 0) | Early-Treatment(Week 10) | Late-Treatment(Week 12) | Post-Treatment (Week 16-18) | |
| Estradiol/Medroxyprogesterone Acetate | 12.31 | 11.69 | 12.88 | 11.84 |
| Phytoestrogen | 11.85 | 11.38 | 10.99 | 11.19 |
| Placebo | 10.76 | 11.24 | 10.55 | 11.15 |
Immediate recall on the Logical Memory subset of the Wechsler Memory Scale-Revised, in which higher scores indicate a better recall and outcome. The minimum value is 0 and maximum value is 25. (NCT00997893)
Timeframe: Baseline and 12 weeks
| Intervention | test scores on the Logical Memory test (Mean) |
|---|---|
| Estradiol/Medroxyprogesterone Acetate | -.02 |
| Phytoestrogen | 2.31 |
| Placebo | 2.08 |
Proportion correct out of 18 word pairs (6 positive, 6 negative and 6 neutral) after laboratory-induced stress using Trier Social Stress Test (TSST). Maximum score is 18 and minimum score is 0; higher scores indicate a better score. (NCT00997893)
Timeframe: Baseline (Week 0) and Treatment (Week 12)
| Intervention | Proportion Correct (Mean) | |||
|---|---|---|---|---|
| Baseline (Week 0)- Control | Baseline (Week 0)- TSST | Post-Treatment (Week 12)- Control | Post-Treatment (Week 12)-TSST | |
| Estradiol/Medroxyprogesterone Acetate | 0.45 | 0.48 | 0.47 | 0.51 |
| Phytoestrogen | 0.45 | 0.40 | 0.42 | 0.46 |
| Placebo | 0.38 | 0.47 | 0.37 | 0.44 |
STAI-6; State-Trait Anxiety Inventory- Short Form is a measure of anxiety where higher scores indicate higher/elevated anxiety. Minimum value 6 is and maximum value is 24. (NCT00997893)
Timeframe: Baseline (Week 0) and Treatment (Week 12)
| Intervention | score on STAI scale (Mean) | |||
|---|---|---|---|---|
| Baseline (Week 0), Before Stressor | Baseline (Week 0), After Stressor | Post-Treatment (Week 12), Before Stressor | Post-Treatment (Week 12), After Stressor | |
| Estradiol/Medroxyprogesterone Acetate | 8.73 | 12.61 | 8.25 | 13.70 |
| Phytoestrogen | 8.69 | 12.92 | 10.87 | 15.37 |
| Placebo | 9.77 | 12.23 | 9.61 | 12.69 |
FSH was measured to assess estrogen receptor (ER) selectivity (a biomarker for ERα activity and a pharmacodynamic endpoint). (NCT01015677)
Timeframe: Baseline and Week 4
| Intervention | mIU/mL (Least Squares Mean) |
|---|---|
| MK-6913 75 mg | -2.02 |
| 17-β Estradiol 1 mg | -17.48 |
| Placebo | -2.96 |
Hot flash severity score is calculated by the sum of: the number of mild hot flashes, 2 times number of moderate hot flashes, 3 times the number of severe hot flashes, and 4 times the number of very severe hot flashes. This sum was standardized to a 7-day week if there were any missing days in the e-diary. The severity of each hot flash was recorded by the Hot Flash e-diary. (NCT01015677)
Timeframe: Baseline and Week 4
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| MK-6913 75 mg | -39.92 |
| 17-β Estradiol 1 mg | -45.09 |
| Placebo | -33.87 |
Hot flashes were recorded in real time and hot flashes recorded retrospectively in the morning and evening reports in a diary day via the Hot Flash e-diary were summed to determine the total number of hot flashes over a diary day. The total number of weekly moderate or worse hot flashes were calculated as the sum of the total number of hot flashes that occur over a diary week (non-missing diary day), divided by the number of days of diary completion, and multiplied by 7 (standardized week). At least 4 non-missing diary days were required to define the total number of weekly moderate or worse hot flashes. Hot flash data was excluded for participants whose number of moderate to severe hot flashes per week were in the top 1% of number of hot flashes reported to exclude any outlier effect. (NCT01015677)
Timeframe: Baseline and Week 4
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| MK-6913 75 mg | -40.69 |
| 17-β Estradiol 1 mg | -51.86 |
| Placebo | -34.41 |
An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT01015677)
Timeframe: Up to 6 weeks
| Intervention | Participants (Number) |
|---|---|
| MK-6913 75 mg | 17 |
| 17-β Estradiol 1 mg | 15 |
| Placebo | 16 |
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. (NCT01015677)
Timeframe: Up to 4 weeks
| Intervention | Participants (Number) |
|---|---|
| MK-6913 75 mg | 0 |
| 17-β Estradiol 1 mg | 1 |
| Placebo | 0 |
Estradiol blood levels at end of study compared across groups to determine effect of dosing methods. Significance of levels depends on the stage of puberty and goals of therapy. (NCT01023178)
Timeframe: end of study (up to 2 years)
| Intervention | pg/mL (Mean) |
|---|---|
| Transdermal 17Beta Estradiol | 53 |
| Oral Conjugated Equine Estrogen | 14 |
| Oral 17beta Estradiol | 12 |
Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep (NCT01070979)
Timeframe: Baseline to Week 12
| Intervention | Change in Hot Flush Count (Least Squares Mean) |
|---|---|
| Estradiol Acetate (E3A) | -63.6 |
| Estradiol | -72.2 |
| Conjugated Equine Estrogens (CEE) | -67.2 |
Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes. (NCT01070979)
Timeframe: Baseline to Week 12
| Intervention | Change in Score (Least Squares Mean) |
|---|---|
| Estradiol Acetate (E3A) | -1.05 |
| Estradiol | -1.34 |
| Conjugated Equine Estrogens (CEE) | -1.17 |
Patient self-reported outcome. Severity of hot flush definitions: mild (1) - sensation of heat without perspiration, moderate (2) - sensation of heat with perspiration, able to continue activity, severe (3) - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep. Minimum 0/no hot flushes, Maximum 3/all severe hot flushes. Lower the score the greater the improvement in reducing hot flushes. (NCT01070979)
Timeframe: Baseline to Week 4
| Intervention | Change in Score (Least Squares Mean) |
|---|---|
| Estradiol Acetate (E3A) | -0.53 |
| Estradiol | -0.51 |
| Conjugated Equine Estrogens (CEE) | -0.59 |
Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3. (NCT01070979)
Timeframe: Baseline to Week 4
| Intervention | Change in Score (Least Squares Mean) |
|---|---|
| Estradiol Acetate (E3A) | -1.89 |
| Estradiol | -2.26 |
| Conjugated Equine Estrogens (CEE) | -1.96 |
Severity of hot flush definitions: mild - sensation of heat without perspiration, moderate - sensation of heat with perspiration, able to continue activity, severe - sensation of heat with perspiration, causing the subject to stop activity or awaken from sleep (NCT01070979)
Timeframe: Baseline to Week 4
| Intervention | Change in Hot Flush Count (Least Squares Mean) |
|---|---|
| Estradiol Acetate (E3A) | -54.1 |
| Estradiol | -62.0 |
| Conjugated Equine Estrogens (CEE) | -54.5 |
Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3. (NCT01070979)
Timeframe: Baseline to Week 12
| Intervention | Change in Score (Least Squares Mean) |
|---|---|
| Estradiol Acetate (E3A) | -2.49 |
| Estradiol | -2.59 |
| Conjugated Equine Estrogens (CEE) | -2.52 |
Urogenital Symptom Severity scored none=0, mild=1, moderate=2, severe=3. (NCT01070979)
Timeframe: Baseline to Week 8
| Intervention | Change in Score (Least Squares Mean) |
|---|---|
| Estradiol Acetate (E3A) | -1.96 |
| Estradiol | -2.58 |
| Conjugated Equine Estrogens (CEE) | -2.42 |
This crossover study examined the effects of E+MPA versus E+DRSP on brachial artery reactivity (BAR) assessed after six weeks of treatment. BAR is a noninvasive measure of endothelium-dependent flow-mediated vasodilation (FMD) of the brachial artery. With this technique, inflation of an arm blood pressure cuff to suprasystolic blood pressure causes relative ischemia downstream to the cuff. Upon deflation, a brief state of increased blood flow occurs (reactive hyperemia), and the resulting increase in shear stress causes nitric oxide release and resulting vasodilation of the brachial artery (flow-mediated vasodilation). The flow-mediated changes in brachial artery diameter can be imaged by ultrasound and measured as an index of peripheral vasomotor function. BAR correlates with invasive assessments of coronary endothelial function as well as multiple cardiovascular risk factors. (NCT01109979)
Timeframe: %FMD after 6 weeks of treatment
| Intervention | % FMD after 6 weeks of treatment (Mean) |
|---|---|
| E+MPA | 5.49 |
| E+DRSP | 3.39 |
"Changes in blood flow in the small vessel in the skin are measured in response to sequential heat and drug stimulation. It is measured in volts, and then corrected for a maximum level and expressed as % max. This is measured with a Laser Doppler probes, which measures volts." (NCT01153581)
Timeframe: 2 months
| Intervention | Percent of max volts (Mean) |
|---|---|
| Women With Orthostatic Intolerance | 4.02 |
| Women Without Orthostatic Tolerance | 5.18 |
We used a measure called cumulative stress index to determine orthostatic tolerance, which is the amount of time at a level of negative pressure each subject can maintain before feeling as if she is going to pass out. This is calculated by multiplying the pressure in mm Hg by the time in min. (NCT01153581)
Timeframe: 2 months
| Intervention | mmHg*min (Mean) |
|---|---|
| Women With and Without Orthostatic Intolerance | 634 |
"This is a measure of how the body responds to changes in pressure induced by changes in position such as sitting, lying standing. The pressure changes are induced by gravity. The measurement described below to assess baroreceptor function is units of change in forearm vascular resistance for a given change in lower body negative pressure. This allows us to determine how good the body is at sending signals to the periphery to respond to postural changes.~Baroreflex sensitivity is defined as the change in interbeat interval (IBI) in milliseconds per unit change in BP. For example, when the BP rises by 10 mmHg and IBI increases by 100 ms, BRS would be 100/10 = 10 ms/mmHg." (NCT01153581)
Timeframe: 2 months
| Intervention | ms/mm Hg (Mean) |
|---|---|
| Low Orthostatic Tolerance | 0.140 |
| High Orthostatic Tolerant | 0.128 |
Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estradiol. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 1739.31 |
| Activella® (Reference) | 1905.28 |
Informational comparison of Cmax values for Uncorrected Unconjugated Estrone. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 475.44 |
| Activella® (Reference) | 502.24 |
Informational comparison of Cmax values for Uncorrected Unconjugated Estradiol. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 52.09 |
| Activella® (Reference) | 56.26 |
Bioequivalence based on Norethindrone Cmax. (NCT01157182)
Timeframe: Blood samples collected over a 36 hour period.
| Intervention | ng/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 10.08 |
| Activella® (Reference) | 9.90 |
Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estrone. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 12387.14 |
| Activella® (Reference) | 12646.49 |
Informational comparison of AUC0-inf values for Uncorrected Total Estrone. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 387085.29 |
| Activella® (Reference) | 400726.94 |
Bioequivalence based on Norethindrone AUC0-inf. (NCT01157182)
Timeframe: Blood samples collected over a 36 hour period.
| Intervention | ng*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 39.94 |
| Activella® (Reference) | 40.40 |
Informational comparison of AUC0-inf values for Corrected Unconjugated Estrone. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 10267.03 |
| Activella® (Reference) | 10214.23 |
Informational comparison of AUC0-inf values for Corrected Unconjugated Estradiol. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 1359.50 |
| Activella® (Reference) | 1410.51 |
Bioequivalence based on Corrected Total Estrone AUC0-inf. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 375439.71 |
| Activella® (Reference) | 384535.16 |
Bioequivalence based on Corrected Total Estrone Cmax. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 43997.17 |
| Activella® (Reference) | 47015.47 |
Informational comparison of Cmax values for Corrected Unconjugated Estradiol. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 47.80 |
| Activella® (Reference) | 51.59 |
Informational comparison of AUC0-t values for Uncorrected Unconjugated Estradiol. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 1575.01 |
| Activella® (Reference) | 1656.16 |
Informational comparison of AUC0-t values for Uncorrected Total Estrone. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 372088.37 |
| Activella® (Reference) | 385829.05 |
Bioequivalence based on Norethindrone AUC0-t. (NCT01157182)
Timeframe: Blood samples collected over a 36 hour period.
| Intervention | ng*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 36.59 |
| Activella® (Reference) | 37.05 |
Informational comparison of Cmax values for Uncorrected Total Estrone. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 43723.53 |
| Activella® (Reference) | 47170.59 |
Informational comparison of AUC0-t values for Corrected Unconjugated Estrone. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 9409.59 |
| Activella® (Reference) | 9762.49 |
Informational comparison of AUC0-t values for Corrected Unconjugated Estradiol. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 1267.50 |
| Activella® (Reference) | 1323.70 |
Informational comparison of AUC0-t values for Uncorrected Unconjugated Estrone. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 10870.03 |
| Activella® (Reference) | 11252.64 |
Bioequivalence based on Corrected Total Estrone AUC0-t. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 365242.88 |
| Activella® (Reference) | 374730.12 |
Informational comparison of Cmax values for Corrected Unconjugated Estrone. (NCT01157182)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 455.16 |
| Activella® (Reference) | 481.46 |
Area under the curve post-randomization for levonorgestrel. AUC was calculated and extrapolated using post randomization in single daily samples drawn during Cycle 4 days 20-26. Serial repeat sampling to obtain a detailed PK curve was not performed to obtain this AUC. Subjects could provide samples during these days at times convenient to them and PK software accounted for the time between when the drug was dosed versus when the sample was drawn. (NCT01170390)
Timeframe: post-randomization (4 months)
| Intervention | hr*ng/mL (Mean) |
|---|---|
| Aviane & Aviane | 412 |
| Aviane and Portia | 283 |
Baseline measurements of levonorgestrel AUC (on Aviane). Area under the curve at baseline for levonorgestrel. AUC was calculated from time zero to 168 hours and extrapolated to infinity from serial repeat sampling (0,0.5,1.1.5,2,3,4,6,8,12 hours and then single samples daily for 4 days between Cycles 1 and 2. (NCT01170390)
Timeframe: baseline (2 months)
| Intervention | hr*ng/mL (Mean) |
|---|---|
| Aviane and Aviane | 267 |
| Aviane and Portia | 199 |
The main goal is to test whether key pharmacokinetic parameters of levonordestrel (LNG) differ between obese women taking traditionally dosed OCs versus the interventional arms (i.e. using each obese subject as their own control). (NCT01170390)
Timeframe: baseline (2 months) and post-randomization (4 months)
| Intervention | ng/mL (Mean) | |
|---|---|---|
| LNG steady state levels at baseline | After randomization (4 months) | |
| Aviane & Aviane | 3.82 | 3.01 |
| Aviane and Portia | 3.13 | 3.58 |
Steady state levels of ethinyl estradiol (EE) at baseline (2 months) (NCT01170390)
Timeframe: Baseline (2 months)
| Intervention | ng/mL (Mean) |
|---|---|
| Aviane & Aviane | 0.12 |
| Aviane and Portia | 0.1 |
Steady state levels of ethinyl estradiol (EE) post- randomization (NCT01170390)
Timeframe: Post-randomiziation 4 months
| Intervention | ng/mL (Mean) |
|---|---|
| Aviane & Aviane | 0.08 |
| Aviane and Portia | 0.11 |
Bioequivalence based on Corrected Total Estrone Cmax. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 27076.08 |
| Activella® (Reference) | 27240.03 |
Informational comparison of AUC0-inf values for Uncorrected Total Estrone. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 398139.63 |
| Activella® (Reference) | 425739.45 |
Informational comparison of AUC0-t values for Uncorrected Unconjugated Estrone. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 12444.22 |
| Activella® (Reference) | 12977.00 |
Bioequivalence based on Corrected Total Estrone AUC0-inf. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 380131.12 |
| Activella® (Reference) | 424801.99 |
Informational comparison of AUC0-inf values for Corrected Unconjugated Estradiol. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 1823.43 |
| Activella® (Reference) | 1871.56 |
Informational comparison of AUC0-inf values for Corrected Unconjugated Estrone. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 11293.21 |
| Activella® (Reference) | 11747.97 |
Bioequivalence based on Norethindrone AUC0-inf. (NCT01181726)
Timeframe: Blood samples collected over a 36 hour period.
| Intervention | ng*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 49.55 |
| Activella® (Reference) | 50.68 |
Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estradiol. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 2301.59 |
| Activella® (Reference) | 2274.04 |
Informational comparison of AUC0-inf values for Uncorrected Unconjugated Estrone. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 13592.44 |
| Activella® (Reference) | 14155.46 |
Bioequivalence based on Corrected Total Estrone AUC0-t. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 384547.68 |
| Activella® (Reference) | 407028.98 |
Informational comparison of AUC0-t values for Corrected Unconjugated Estradiol. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 1723.44 |
| Activella® (Reference) | 1793.04 |
Informational comparison of AUC0-t values for Corrected Unconjugated Estrone. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 10952.25 |
| Activella® (Reference) | 11369.60 |
Bioequivalence based on Norethindrone AUC0-t. (NCT01181726)
Timeframe: Blood samples collected over a 36 hour period.
| Intervention | ng*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 45.03 |
| Activella® (Reference) | 46.13 |
Informational comparison of AUC0-t values for Uncorrected Total Estrone. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 397537.88 |
| Activella® (Reference) | 420763.02 |
Informational comparison of AUC0-t values for Uncorrected Unconjugated Estradiol. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 2016.26 |
| Activella® (Reference) | 2086.39 |
Informational comparison of Cmax values for Uncorrected Unconjugated Estrone. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 513.56 |
| Activella® (Reference) | 529.23 |
Informational comparison of Cmax values for Uncorrected Unconjugated Estradiol. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 59.24 |
| Activella® (Reference) | 60.33 |
Informational comparison of Cmax values for Uncorrected Total Estrone. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 27256.41 |
| Activella® (Reference) | 27430.77 |
Bioequivalence based on Norethindrone Cmax. (NCT01181726)
Timeframe: Blood samples collected over a 36 hour period.
| Intervention | ng/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 6.54 |
| Activella® (Reference) | 6.06 |
Informational comparison of Cmax values for Corrected Unconjugated Estrone. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 492.81 |
| Activella® (Reference) | 509.81 |
Informational comparison of Cmax values for Corrected Unconjugated Estradiol. (NCT01181726)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Estradiol/Norethindrone Acetate (Test) | 55.18 |
| Activella® (Reference) | 56.24 |
Bioequivalence based on Ethinyl Estradiol AUC0-inf. (NCT01182194)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Drospirenone/Ethinyl Estradiol (Test) | 1236.96 |
| YAZ® (Reference) | 1235.91 |
Bioequivalence based on Drospirenone Cmax. (NCT01182194)
Timeframe: Blood samples collected over a 120 hour period.
| Intervention | ng/mL (Mean) |
|---|---|
| Drospirenone/Ethinyl Estradiol (Test) | 67.69 |
| YAZ® (Reference) | 74.33 |
Bioequivalence based on Drospirenone AUC0-t. (NCT01182194)
Timeframe: Blood samples collected over a 120 hour period.
| Intervention | ng*h/mL (Mean) |
|---|---|
| Drospirenone/Ethinyl Estradiol (Test) | 814.32 |
| YAZ® (Reference) | 824.41 |
Bioequivalence based on Ethinyl Estradiol AUC0-t. (NCT01182194)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Drospirenone/Ethinyl Estradiol (Test) | 1145.90 |
| YAZ® (Reference) | 1155.31 |
Bioequivalence based on Ethinyl Estradiol Cmax. (NCT01182194)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Drospirenone/Ethinyl Estradiol (Test) | 128.87 |
| YAZ® (Reference) | 126.03 |
Bioequivalence based on Drospirenone AUC0-inf. (NCT01182194)
Timeframe: Blood samples collected over a 120 hour period.
| Intervention | ng*h/mL (Mean) |
|---|---|
| Drospirenone/Ethinyl Estradiol (Test) | 866.91 |
| YAZ® (Reference) | 884.24 |
Bioequivalence based on Ethinyl Estradiol Cmax. (NCT01182207)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Drospirenone/Ethinyl Estradiol (Test) | 87.95 |
| YAZ® (Reference) | 91.23 |
Bioequivalence based on Drospirenone Cmax. (NCT01182207)
Timeframe: Blood samples collected over a 120 hour period.
| Intervention | ng/mL (Mean) |
|---|---|
| Drospirenone/Ethinyl Estradiol (Test) | 52.77 |
| YAZ® (Reference) | 53.65 |
Bioequivalence based on Ethinyl Estradiol AUC0-t. (NCT01182207)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Drospirenone/Ethinyl Estradiol (Test) | 1066.24 |
| YAZ® (Reference) | 1079.54 |
Bioequivalence based on Drospirenone AUC0-t. (NCT01182207)
Timeframe: Blood samples collected over a 120 hour period.
| Intervention | ng*h/mL (Mean) |
|---|---|
| Drospirenone/Ethinyl Estradiol (Test) | 889.67 |
| YAZ® (Reference) | 867.10 |
Bioequivalence based on Ethinyl Estradiol AUC0-inf. (NCT01182207)
Timeframe: Blood samples collected over a 72 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Drospirenone/Ethinyl Estradiol (Test) | 1155.69 |
| YAZ® (Reference) | 1175.76 |
Bioequivalence based on Drospirenone AUC0-inf. (NCT01182207)
Timeframe: Blood samples collected over a 120 hour period.
| Intervention | ng*h/mL (Mean) |
|---|---|
| Drospirenone/Ethinyl Estradiol (Test) | 951.18 |
| YAZ® (Reference) | 930.38 |
Estradiol was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data (NCT01253824)
Timeframe: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
| Intervention | pg･day/mL, (Mean) | |
|---|---|---|
| Difference of estradiol AUC (BL-SDA) | Difference of estradiol AUC(FU-SDA) | |
| IKH-01 | 2478.0 | 2434.9 |
| NPC-01 | 1654.7 | 1872.6 |
FSH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data (NCT01253824)
Timeframe: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
| Intervention | mIU･day/mL (Mean) | |
|---|---|---|
| Differnce of FSH (BL-SDA) | Difference of FSH(FP-SDA) | |
| IKH-01 | -4.380 | 0.538 |
| NPC-01 | -9.609 | -4.404 |
LH was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data (NCT01253824)
Timeframe: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
| Intervention | mIU･day/mL (Mean) | |
|---|---|---|
| Difference of LH(BL-SDA) | Difference of LH(FU-SDA) | |
| IKH-01 | 57.124 | 59.837 |
| NPC-01 | 60.874 | 61.571 |
Progesterone was measured on day 3, 6, 9, 12, 15, 18, 21, 24 on 3 consecutive menstrual period (pre administration/Baseline(BL), study drug administration(SDA), post administration/follow up(FU)) and calculated AUC from these data (NCT01253824)
Timeframe: Day 3, 6, 9, 12, 15, 18, 21, 24 of menstrual cycles
| Intervention | ng･day/mL (Mean) | |
|---|---|---|
| Difference of progesterone(BL-SDA) | Difference of progesterone(FU-SDA) | |
| IKH-01 | 93.148 | 59.344 |
| NPC-01 | 54.171 | 89.711 |
Change in extracted beta coefficients of the blood oxygen level dependent (BOLD) signal response to a cognitive task (N-back) in the DLPFC (x,y,z coordinates = -34 44 16) from baseline to 1 month as a function of aging and estrogen (young vs older and estrogen vs placebo). A positive change indicates an increase in oxygen utilization (inferring increased neuronal functioning) between baseline and treatment during the cognitive task, while a negative change indicates a decrease in oxygen utilization between baseline and treatment during the cognitive task. (NCT01268046)
Timeframe: baseline to 1 month
| Intervention | linear beta extractions (Mean) |
|---|---|
| Young Postmenopausal Women - Estrogen | 455.8 |
| Older Postmenopausal Women - Estrogen | -214.4 |
| Young Postmenopausal Women - Placebo | -348.1 |
| Older Postmenopausal Women - Placebo | 90.1 |
Idiopathic VTE=deep vein thrombosis (DVT), pulmonary embolism (PE), or cerebral venous sinus thrombosis (CVST) occurring in absence of known risk factors. Incidence rate reported for current, past users. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control. (NCT01297348)
Timeframe: Index date (date of VTE diagnosis for case and corresponding date for matched control)
| Intervention | incidence rate per 100000 person-years (Number) | |
|---|---|---|
| Current users | Past users | |
| Lybrel | 176.2 | 54.1 |
| Other OCs: Ethinyl Estradiol 20 Mcg (EE-20) | 87.5 | 18.0 |
| Other OCs: Levonorgestrel, Ethinyl Estradiol 20 Mcg (Levo-20) | 50.5 | 17.6 |
Idiopathic VTE cases=new DVT, PE or CVST occurring in absence of known risk factors. Matched Control was defined as participants with no diagnosis of VTE matched for age, calendar time, exposure status and database. Current user=had claim for study OC prescription (Lybrel or other OCs containing ethinyl estradiol 20 mcg) whose filled use occurred within 30 days prior to or at index date. Past user=had claim for a study OC prescription whose filled use occurred between 90 to 31 days prior to index date. Index date=date of VTE diagnosis for case and corresponding date for matched control. (NCT01297348)
Timeframe: Index date (date of VTE diagnosis for case and corresponding date for matched control)
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Current user: Case | Current user: Matched Control | Past user: Case | Past user: Matched Control | |
| Lybrel | 17 | 47 | 1 | 1 |
| Other OCs: Ethinyl Estradiol 20 Mcg (EE-20) | 276 | 1144 | 14 | 39 |
| Other OCs: Levonorgestrel, Ethinyl Estradiol 20 Mcg (Levo-20) | 53 | 254 | 4 | 10 |
Change in trabecular number at the ultradistal radius over 12 months as assessed by high resolution peripheral quantitative computed tomography (HRpQCT) (NCT01301183)
Timeframe: 12 months
| Intervention | 1/mm (Median) |
|---|---|
| Rh IGF-1 + Transdermal Estradiol | -0.10 |
| Placebo + Transdermal Estradiol | -0.02 |
Change in lumbar spine BMD z-score over 12 months as assessed by dual energy x-ray absorptiometry (DXA) The z-score indicates the number of standard deviations that BMD is away from the mean for age, sex and race. A z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher values. A positive change in z-scores indicates a favorable outcome whereas a negative change in z-scores indicates an unfavorable outcome. (NCT01301183)
Timeframe: 12 months
| Intervention | score on a scale (Median) |
|---|---|
| Rh IGF-1 + Transdermal Estradiol | 0.045 |
| Placebo + Transdermal Estradiol | 0.280 |
Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma). (NCT01340625)
Timeframe: Blood samples collected over a 60 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Norethindrone/Ethinyl Estradiol (Test) | 230.56 |
| Ovcon® 35 Fe (Reference) | 237.00 |
Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma). (NCT01340625)
Timeframe: Blood samples collected over a 60 hour period.
| Intervention | ng/mL (Mean) |
|---|---|
| Norethindrone/Ethinyl Estradiol (Test) | 10.94 |
| Ovcon® 35 Fe (Reference) | 10.00 |
Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity). (NCT01340625)
Timeframe: Blood samples collected over a 60 hour period.
| Intervention | ng*h/mL (Mean) |
|---|---|
| Norethindrone/Ethinyl Estradiol (Test) | 48.67 |
| Ovcon® 35 Fe (Reference) | 45.43 |
Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration). (NCT01340625)
Timeframe: Blood samples collected over a 60 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Norethindrone/Ethinyl Estradiol (Test) | 1976.72 |
| Ovcon® 35 Fe (Reference) | 1989.82 |
Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration). (NCT01340625)
Timeframe: Blood samples collected over a 60 hour period.
| Intervention | ng*h/mL (Mean) |
|---|---|
| Norethindrone/Ethinyl Estradiol (Test) | 43.83 |
| Ovcon® 35 Fe (Reference) | 40.73 |
Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity). (NCT01340625)
Timeframe: Blood samples collected over a 60 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Norethindrone/Ethinyl Estradiol (Test) | 2129.43 |
| Ovcon® 35 Fe (Reference) | 2131.84 |
Bioequivalence based on Ethinyl Estradiol AUC0-inf (area under the concentration-time curve from time zero to infinity). (NCT01344369)
Timeframe: Blood samples collected over a 60 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Norethindrone/Ethinyl Estradiol (Test) | 2072.5423 |
| FEMCON® Fe (Reference) | 2152.3775 |
Bioequivalence based on Norethindrone AUC0-inf (area under the concentration-time curve from time zero to infinity). (NCT01344369)
Timeframe: Blood samples collected over a 60 hour period.
| Intervention | ng*h/mL (Mean) |
|---|---|
| Norethindrone/Ethinyl Estradiol (Test) | 43.9982 |
| FEMCON® Fe (Reference) | 43.8819 |
Bioequivalence based on Ethinyl Estradiol AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration). (NCT01344369)
Timeframe: Blood samples collected over a 60 hour period.
| Intervention | pg*h/mL (Mean) |
|---|---|
| Norethindrone/Ethinyl Estradiol (Test) | 1916.2311 |
| FEMCON® Fe (Reference) | 1987.6311 |
Bioequivalence based on Norethindrone AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration). (NCT01344369)
Timeframe: Blood samples collected over a 60 hour period.
| Intervention | ng*h/mL (Mean) |
|---|---|
| Norethindrone/Ethinyl Estradiol (Test) | 37.8065 |
| FEMCON® Fe (Reference) | 37.3991 |
Bioequivalence based on Ethinyl Estradiol Cmax (maximum observed concentration of drug substance in plasma). (NCT01344369)
Timeframe: Blood samples collected over a 60 hour period.
| Intervention | pg/mL (Mean) |
|---|---|
| Norethindrone/Ethinyl Estradiol (Test) | 137.6758 |
| FEMCON® Fe (Reference) | 137.8485 |
Bioequivalence based on Norethindrone Cmax (maximum observed concentration of drug substance in plasma). (NCT01344369)
Timeframe: Blood samples collected over a 60 hour period.
| Intervention | ng/mL (Mean) |
|---|---|
| Norethindrone/Ethinyl Estradiol (Test) | 4.3306 |
| FEMCON® Fe (Reference) | 4.2282 |
Normal range for this hemostatic parameter was 75% to 130%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. (NCT01388491)
Timeframe: Baseline through Month 6
| Intervention | percentage of normal (Least Squares Mean) |
|---|---|
| Treatment I: (DR-102) | -1.6 |
| Treatment II | -3.2 |
This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 2.00 to 3.36. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. (NCT01388491)
Timeframe: Baseline through Month 6
| Intervention | ratio (Least Squares Mean) |
|---|---|
| Treatment I: (DR-102) | -0.3 |
| Treatment II | -0.4 |
The normal range for this hemostatic parameter was 50% to 147%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. (NCT01388491)
Timeframe: Baseline through Month 6
| Intervention | percentage of normal 50% to 147% (Least Squares Mean) |
|---|---|
| Treatment I: (DR-102) | -11.4 |
| Treatment II | -6.6 |
Normal range for this hemostatic parameter was 70% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. (NCT01388491)
Timeframe: Baseline through Month 6
| Intervention | percentage of normal (Least Squares Mean) |
|---|---|
| Treatment I: (DR-102) | 3.3 |
| Treatment II | 3.0 |
Normal range for this parameter was 0.35 to 5.5 mIU/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. (NCT01388491)
Timeframe: Baseline through Month 6
| Intervention | mIU/L (Least Squares Mean) |
|---|---|
| Treatment I: (DR-102) | 0.2 |
| Treatment II | 0.3 |
Normal range for this parameter was 28 to 146 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. (NCT01388491)
Timeframe: Baseline through Month 6
| Intervention | nmol/L (Least Squares Mean) |
|---|---|
| Treatment I: (DR-102) | 163.4 |
| Treatment II | 149.1 |
Normal range for this adrenal parameter was 85.6 to 618.2 nmol/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. (NCT01388491)
Timeframe: Baseline through Month 6
| Intervention | nmol/L (Least Squares Mean) |
|---|---|
| Treatment I: (DR-102) | 239.0 |
| Treatment II | 230.8 |
Normal range for this hemostatic parameter was 41 to 372 pmol/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. (NCT01388491)
Timeframe: Baseline through Month 6
| Intervention | pmol/L (Least Squares Mean) |
|---|---|
| Treatment I: (DR-102) | 45.0 |
| Treatment II | 56.8 |
The normal range for this hemostatic parameter was 70% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. (NCT01388491)
Timeframe: Baseline through Month 6
| Intervention | percentage of normal (Least Squares Mean) |
|---|---|
| Treatment I: (DR-102) | 16.3 |
| Treatment II | 13.0 |
Normal range for this hemostatic parameter was 50% to 180%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. (NCT01388491)
Timeframe: Baseline through Month 6
| Intervention | percentage of normal (Least Squares Mean) |
|---|---|
| Treatment I: (DR-102) | 11.1 |
| Treatment II | 10.6 |
Normal range for this hemostatic parameter was 60% to 150%. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. (NCT01388491)
Timeframe: Baseline through Month 6
| Intervention | percentage of normal (Least Squares Mean) |
|---|---|
| Treatment I: (DR-102) | 17.9 |
| Treatment II | 15.1 |
This hemostatic parameter is calculated by dividing the clotting time with APC by the clotting time without APC. Normal range for this measure was defined as a ratio of 0.32 to 1.79. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. (NCT01388491)
Timeframe: Baseline through Month 6
| Intervention | ratio (Least Squares Mean) |
|---|---|
| Treatment I: (DR-102) | 0.8 |
| Treatment II | 0.7 |
Normal range for this hemostatic parameter was 0 to 729 mcg/L. Participants were in a fasting state and had refrained from moderate to vigorous exercise prior to phlebotomy on the day of this lab draw. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. (NCT01388491)
Timeframe: Baseline through Month 6
| Intervention | mcg/L (Least Squares Mean) |
|---|---|
| Treatment I: (DR-102) | 16.4 |
| Treatment II | 13.4 |
Normal range for this adrenal parameter was 1906.448 to 4520.504 mg/L. Change from baseline was analyzed using a repeated measures analysis of covariance with covariate adjustment for baseline, treatment, month, and the treatment by month interaction. (NCT01388491)
Timeframe: Baseline through Month 6
| Intervention | mg/L (Least Squares Mean) |
|---|---|
| Treatment I: (DR-102) | 4083.3 |
| Treatment II | 3721.8 |
"Patients completed a daily diary to record the number of mild, moderate and severe vasomotor symptoms experienced each day.~Mild, moderate and severe were defined as follows:~Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity Severity of hot flushes was measured on a scale of none = 0, mild = 1, moderate = 2 and severe = 3." (NCT01389102)
Timeframe: baseline to week 12 (12 weeks)
| Intervention | Scores on a scale (Mean) |
|---|---|
| Placebo Transdermal Three 90 μL Sprays | -0.31 |
| Placebo Transdermal Two 90 μL Sprays | -0.54 |
| Placebo Transdermal One 90 μL Spray | -0.26 |
| Estradiol Transdermal Three 90 μL Sprays | -1.07 |
| Estradiol Transdermal Two 90 μL Sprays | -0.92 |
| Estradiol Transdermal One 90 μL Spray | -1.04 |
"Patients completed a daily diary to record the number of mild, moderate and number of moderate or severe vasomotor symptoms [hot flushes and sweating] experienced each day.~Mild, moderate and severe hot flushes and sweating were defined as follows:~Mild = sensation of heat without sweating Moderate = sensation of heat with sweating, ability to continue activity Severe = sensation of heat with sweating, causing discontinuation of activity" (NCT01389102)
Timeframe: baseline to week 12
| Intervention | Vasomotor symptoms per day (Mean) |
|---|---|
| Placebo Transdermal Three 90 μL Sprays | -5.32 |
| Placebo Transdermal Two 90 μL Sprays | -6.19 |
| Placebo Transdermal One 90 μL Spray | -4.76 |
| Estradiol Transdermal Three 90 μL Sprays | -8.44 |
| Estradiol Transdermal Two 90 μL Sprays | -8.66 |
| Estradiol Transdermal One 90 μL Spray | -8.10 |
Measured by self-report diary twice daily (day and night). The day and night frequencies were summed to produce a single number of hot flashes per day. The single number of hot flashes per day were summed and averaged for one week prior to the week 8 study assessment to produce a mean daily frequency for week 8. (NCT01418209)
Timeframe: Week 8
| Intervention | number of hot flashes per day (Mean) |
|---|---|
| Low-dose 17-ß-estradiol With Progesterone Taper | 3.9 |
| Venlafaxine XR | 4.4 |
| Placebo | 5.5 |
Measured by self-report diary twice daily (day and night) for 7 days. Bothersomeness ratings ranged from 0 to 3 with lower numbers being less bothersome and higher numbers being more bothersome. Data from the day and night bothersomeness ratings were averaged for a single daily score. The single daily scores for the week prior to the week 8 study assessment were summed and averaged to produce a mean daily VMS bothersomeness for week 8. (NCT01418209)
Timeframe: Week 8
| Intervention | units on a scale (Mean) |
|---|---|
| Low-dose 17-ß-estradiol With Progesterone Taper | 1.4 |
| Venlafaxine XR | 1.4 |
| Placebo | 1.6 |
Measured by self-report diary twice daily (day and night) for 7 days. Bothersomeness ratings ranged from 0 to 3 with lower numbers being less bothersome and higher numbers being more bothersome. Data from the day and night bothersomeness ratings were averaged for a single daily score. The single daily scores for the week prior to the week 4 study assessment were summed and averaged to produce a mean daily VMS bothersomeness for week 4. (NCT01418209)
Timeframe: Week 4
| Intervention | units on a scale (Mean) |
|---|---|
| Low-dose 17-ß-estradiol With Progesterone Taper | 1.6 |
| Venlafaxine XR | 1.6 |
| Placebo | 1.7 |
Measured by self-report diary twice daily (day and night). The day and night frequencies were summed to produce a single number of hot flashes per day. The single number of hot flashes per day were summed and averaged for one week prior to the week 4 study assessment to produce a mean daily frequency for week 4. (NCT01418209)
Timeframe: Week 4
| Intervention | number of hot flashes per day (Mean) |
|---|---|
| Low-dose 17-ß-estradiol With Progesterone Taper | 5.3 |
| Venlafaxine XR | 5.1 |
| Placebo | 5.8 |
The perceived hot flash related daily interference scale (HFRDIS) is a tool for assessing the impact of hot flashes on quality of life. There are 10 questions with each having a score ranging from 0 to 10. The scores from each question are summed for a total score ranging from 0 to 100. Lower numbers indicate less interference and higher numbers indicate more interference. (NCT01418209)
Timeframe: Week 4
| Intervention | units on a scale (Mean) |
|---|---|
| Low-dose 17-ß-estradiol With Progesterone Taper | 18.3 |
| Venlafaxine XR | 19.8 |
| Placebo | 24.2 |
The perceived hot flash related daily interference scale (HFRDIS) is a tool for assessing the impact of hot flashes on quality of life. There are 10 questions with each having a score ranging from 0 to 10. The scores from each question are summed for a total score ranging from 0 to 100. Lower numbers indicate less interference and higher numbers indicate more interference. (NCT01418209)
Timeframe: Week 8
| Intervention | units on a scale (Mean) |
|---|---|
| Low-dose 17-ß-estradiol With Progesterone Taper | 14.6 |
| Venlafaxine XR | 18.3 |
| Placebo | 21.5 |
Measured by self-report diary twice daily (day and night) for 7 days. Severity ratings ranged from 0 to 3 with lower numbers being less severe and higher numbers being more severe. Data from the day and night severity ratings were averaged for a single daily score. The single daily scores for the week prior to the week 4 study assessment were summed and averaged to produce a mean daily VMS severity for week 4. (NCT01418209)
Timeframe: Week 4
| Intervention | units on a scale (Mean) |
|---|---|
| Low-dose 17-ß-estradiol With Progesterone Taper | 0.7 |
| Venlafaxine XR | 0.7 |
| Placebo | 0.8 |
Measured by self-report diary twice daily (day and night) for 7 days. Severity ratings ranged from 0 to 3 with lower numbers being less severe and higher numbers being more severe. Data from the day and night severity ratings were averaged for a single daily score. The single daily scores for the week prior to the week 8 study assessment were summed and averaged to produce a mean daily VMS severity for week 8. (NCT01418209)
Timeframe: Week 8
| Intervention | units on a scale (Mean) |
|---|---|
| Low-dose 17-ß-estradiol With Progesterone Taper | 0.6 |
| Venlafaxine XR | 0.6 |
| Placebo | 0.7 |
"Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:~1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.~2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.~3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.~4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.~5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.~6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.~A day with moderate to very heavy bleeding is defined as a days with a bleeding score ≥ 3." (NCT01441635)
Timeframe: Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)
| Intervention | percentage of days (Mean) |
|---|---|
| Cohort 4 Elagolix 400 mg QD | -7.22 |
| Cohort 4 Elagolix 100 mg BID | -5.00 |
| Cohort 4 Placebo | -4.00 |
| Cohort 1 Elagolix 200 mg BID | -7.03 |
| Cohort 1 Placebo | -3.08 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | -7.92 |
| Cohort 5 Elagolix 600 mg QD | -6.15 |
| Cohort 2 Elagolix 300 mg BID | -8.02 |
| Cohort 2 Placebo | -3.31 |
| Cohort 6 Elagolix 300 mg BID + CEP | -6.80 |
"Suppression of bleeding is defined as no record of bleeding (spotting allowed) in the e-diary and no record of bleeding Indicated in the alkaline hematin data during the last 56 days of treatment.~Amenorrhea is defined as no record of bleeding or spotting indicated in the e-diary and no record of bleeding or spotting Indicated in the alkaline hematin data during the last 56 days of treatment." (NCT01441635)
Timeframe: The last 56 days of treatment (approximately days 33 to 90)
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Suppression of bleeding | Amenorrhea | |
| Cohort 1 Elagolix 200 mg BID | 66 | 44 |
| Cohort 1 Placebo | 0 | 0 |
| Cohort 2 Elagolix 300 mg BID | 79 | 66 |
| Cohort 2 Placebo | 0 | 0 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | 31 | 19 |
| Cohort 4 Elagolix 100 mg BID | 45 | 31 |
| Cohort 4 Elagolix 400 mg QD | 66 | 60 |
| Cohort 4 Placebo | 0 | 0 |
| Cohort 5 Elagolix 600 mg QD | 77 | 73 |
| Cohort 6 Elagolix 300 mg BID + CEP | 32 | 19 |
"The percentage of subjects with changes in hemoglobin concentration from Baseline to Month 3 in each of the following categories:~No change from baseline in hemoglobin~Decrease from baseline in hemoglobin ≥ -0.5 g/dL~Decrease from baseline in hemoglobin ≥ -1.0 g/dL~Increase from baseline in hemoglobin ≥ 0.5 g/dL~Increase from baseline in hemoglobin ≥ 1.0 g/dL~The above categories are not all mutually exclusive or exhaustive." (NCT01441635)
Timeframe: Baseline and Month 3
| Intervention | percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| No Change | Decreases from -0.5 to 0 g/dL | Decreases from -1.0 to -0.5 g/dL | Increase ≥ 0.5 g/dL | Increase ≥ 1.0 g/dL | |
| Cohort 1 Elagolix 200 mg BID | 0 | 4 | 11 | 67 | 59 |
| Cohort 1 Placebo | 0 | 21 | 14 | 29 | 29 |
| Cohort 2 Elagolix 300 mg BID | 0 | 0 | 0 | 76 | 52 |
| Cohort 2 Placebo | 0 | 21 | 7 | 29 | 29 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | 0 | 14 | 0 | 75 | 43 |
| Cohort 4 Elagolix 100 mg BID | 0 | 17 | 4 | 71 | 71 |
| Cohort 4 Elagolix 400 mg QD | 0 | 9 | 4 | 78 | 61 |
| Cohort 4 Placebo | 9 | 0 | 27 | 18 | 9 |
| Cohort 5 Elagolix 600 mg QD | 4 | 4 | 4 | 83 | 57 |
| Cohort 6 Elagolix 300 mg BID + CEP | 5 | 5 | 10 | 71 | 62 |
"Participants recorded the previous days' presence and severity of bleeding every morning in an eDiary according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:~1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.~2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.~3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.~4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.~5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.~6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.~Any bleeding is defined as a score ≥ 1 and moderate to very heavy bleeding is defined as a score ≥ 3." (NCT01441635)
Timeframe: Month 3 (average bleeding score over days 61 to 90)
| Intervention | percentage of participants (Number) | |
|---|---|---|
| Any bleeding | Moderate to Very Heavy Bleeding | |
| Cohort 1 Elagolix 200 mg BID | 47 | 28 |
| Cohort 1 Placebo | 94 | 82 |
| Cohort 2 Elagolix 300 mg BID | 26 | 7 |
| Cohort 2 Placebo | 80 | 73 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | 78 | 31 |
| Cohort 4 Elagolix 100 mg BID | 57 | 40 |
| Cohort 4 Elagolix 400 mg QD | 37 | 27 |
| Cohort 4 Placebo | 93 | 87 |
| Cohort 5 Elagolix 600 mg QD | 27 | 15 |
| Cohort 6 Elagolix 300 mg BID + CEP | 69 | 35 |
The uterine fibroid daily symptom scale is self-administered questionnaire, with a scale that ranges from 0 to 10 for the symptoms of pelvic pain, fatigue, and cramping and the impact of uterine fibroids on the subject's daily life, with 0 being the absence of the symptom and 10 being the worst severity of the symptoms or completely preventing the subjects from performing daily activities. Participants self-reported values daily in the e-Diary. (NCT01441635)
Timeframe: Baseline (average score over the 30 days prior to first dose) and month 3 (average score over days 61 to 90)
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| Pelvic pain | Fatigue | Menstrual cramping | Impact of uterine fibroids | |
| Cohort 1 Elagolix 200 mg BID | -0.6 | -0.6 | -0.9 | -1.0 |
| Cohort 1 Placebo | -1.4 | -0.5 | -1.2 | -1.0 |
| Cohort 2 Elagolix 300 mg BID | -1.0 | -1.5 | -1.2 | -1.3 |
| Cohort 2 Placebo | -1.2 | -0.5 | -1.0 | -1.0 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | -1.1 | -1.2 | -0.9 | -0.9 |
| Cohort 4 Elagolix 100 mg BID | -0.2 | -0.0 | -0.7 | -0.4 |
| Cohort 4 Elagolix 400 mg QD | -1.0 | -0.5 | -1.2 | -1.1 |
| Cohort 4 Placebo | -0.3 | -0.6 | -0.5 | -0.8 |
| Cohort 5 Elagolix 600 mg QD | -0.9 | -1.0 | -1.1 | -1.7 |
| Cohort 6 Elagolix 300 mg BID + CEP | -2.4 | -2.1 | -1.3 | -3.1 |
"The UFS-QoL is a disease-specific, self-administered, validated questionnaire developed to evaluate the symptoms associated with uterine fibroids and their impact on health-related quality of life (HRQL) in women with symptomatic uterine fibroids. The questionnaire consists of 37 questions, divided into 2 parts: 1) an 8-item symptom severity scale and 2) a 29-item HRQL subscale comprising 6 domains (concern, activities, energy/mood, control, self-consiousness, and sexual function), with a 4-week recall. All items are scored on a 5-point scale, ranging from not at all to a very great deal for symptom severity items and none of the time to all of the time for the HRQL items. Symptom severity and HRQL subscale scores were summed and transformed into a 0 to 100 point scale to provide a total score for each of the 2 components.~Lower symptom severity scores indicate better quality of life and higher total HRQL scores indicate better quality of life." (NCT01441635)
Timeframe: Baseline and month 3
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Symptom severity | HRQL total | |
| Cohort 1 Elagolix 200 mg BID | -31.6 | 36.0 |
| Cohort 1 Placebo | -21.4 | 18.3 |
| Cohort 2 Elagolix 300 mg BID | -44.1 | 33.5 |
| Cohort 2 Placebo | -12.0 | 11.0 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | -20.3 | 28.6 |
| Cohort 4 Elagolix 100 mg BID | -33.2 | 29.1 |
| Cohort 4 Elagolix 400 mg QD | -39.0 | 35.3 |
| Cohort 4 Placebo | -19.6 | 16.3 |
| Cohort 5 Elagolix 600 mg QD | -36.4 | 29.9 |
| Cohort 6 Elagolix 300 mg BID + CEP | -39.1 | 33.1 |
"The Subject Intention Questionnaire (SSIQ) is a non-validated, exploratory questionnaires intended to evaluate the subject's intent to undergo surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to consider surgery) to 10 (very likely to consider surgery).~SSIQ included the 2 following questions:~How likely are you to consider having myomectomy surgery to treat your uterine fibroid if your symptoms continue as they are now?~How likely are you to consider hysterectomy surgery if your uterine fibroid symptoms continue as they are now?" (NCT01441635)
Timeframe: Baseline and month 3
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Likelihood of having myomectomy | Likelihood of having hysterectomy | |
| Cohort 1 Elagolix 200 mg BID | -1.8 | -0.8 |
| Cohort 1 Placebo | 2.3 | -0.3 |
| Cohort 2 Elagolix 300 mg BID | -0.6 | 0.2 |
| Cohort 2 Placebo | 0.4 | 0.0 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | -1.4 | -0.7 |
| Cohort 4 Elagolix 100 mg BID | -3.1 | -1.9 |
| Cohort 4 Elagolix 400 mg QD | -1.2 | 0.0 |
| Cohort 4 Placebo | 1.0 | 2.0 |
| Cohort 5 Elagolix 600 mg QD | -1.7 | -0.8 |
| Cohort 6 Elagolix 300 mg BID + CEP | 0.1 | -1.5 |
"The Physician Intention Questionnaire (PSIQ) is a non-validated, exploratory questionnaire intended to evaluate the investigator's intent to recommend surgical procedures if current endometriosis-associated symptoms continued. The scoring scale ranged from 0 (not at all likely to recommend surgery) to 10 (very likely to recommend surgery).~The PSIQ included the 2 following questions:~How likely are you to recommend myomectomy to treat this patient's uterine fibroid if her symptoms continue as they are now?~How likely are you to recommend definitive surgery hysterectomy for this patient if her uterine fibroid symptoms continue as they are now?" (NCT01441635)
Timeframe: Baseline and month 3
| Intervention | units on a scale (Mean) | |
|---|---|---|
| Likelihood to recommend myomectomy | Likelihood to recommend hysterectomy | |
| Cohort 1 Elagolix 200 mg BID | -0.8 | -2.2 |
| Cohort 1 Placebo | 0.7 | 0.4 |
| Cohort 2 Elagolix 300 mg BID | -1.2 | -1.5 |
| Cohort 2 Placebo | 0.0 | -0.6 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | -0.6 | -1.4 |
| Cohort 4 Elagolix 100 mg BID | -1.3 | -1.8 |
| Cohort 4 Elagolix 400 mg QD | -0.9 | -0.8 |
| Cohort 4 Placebo | -2.7 | -0.2 |
| Cohort 5 Elagolix 600 mg QD | -1.3 | -2.3 |
| Cohort 6 Elagolix 300 mg BID + CEP | 0.0 | -2.8 |
"The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.~Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero." (NCT01441635)
Timeframe: The last 28 days of treatment (approximately days 61 to 90)
| Intervention | percentage of participants (Number) |
|---|---|
| Cohort 4 Elagolix 400 mg QD | 84 |
| Cohort 4 Elagolix 100 mg BID | 74 |
| Cohort 4 Placebo | 13 |
| Cohort 1 Elagolix 200 mg BID | 85 |
| Cohort 1 Placebo | 22 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | 88 |
| Cohort 5 Elagolix 600 mg QD | 93 |
| Cohort 2 Elagolix 300 mg BID | 97 |
| Cohort 2 Placebo | 47 |
| Cohort 6 Elagolix 300 mg BID + CEP | 88 |
"The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.~Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero." (NCT01441635)
Timeframe: Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)
| Intervention | percentage of participants (Number) |
|---|---|
| Cohort 4 Elagolix 400 mg QD | 84 |
| Cohort 4 Elagolix 100 mg BID | 74 |
| Cohort 4 Placebo | 13 |
| Cohort 1 Elagolix 200 mg BID | 85 |
| Cohort 1 Placebo | 17 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | 85 |
| Cohort 5 Elagolix 600 mg QD | 93 |
| Cohort 2 Elagolix 300 mg BID | 97 |
| Cohort 2 Placebo | 33 |
| Cohort 6 Elagolix 300 mg BID + CEP | 85 |
The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center. (NCT01441635)
Timeframe: Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued.
| Intervention | percentage of participants (Number) |
|---|---|
| Cohort 4 Elagolix 400 mg QD | 57 |
| Cohort 4 Elagolix 100 mg BID | 52 |
| Cohort 4 Placebo | 33 |
| Cohort 1 Elagolix 200 mg BID | 68 |
| Cohort 1 Placebo | 35 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | 58 |
| Cohort 5 Elagolix 600 mg QD | 60 |
| Cohort 2 Elagolix 300 mg BID | 55 |
| Cohort 2 Placebo | 27 |
| Cohort 6 Elagolix 300 mg BID + CEP | 48 |
Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center. (NCT01441635)
Timeframe: Baseline and month 3 or the final visit during the treatment period for participants who prematurely discontinued.
| Intervention | percentage of participants (Number) |
|---|---|
| Cohort 4 Elagolix 400 mg QD | 53 |
| Cohort 4 Elagolix 100 mg BID | 43 |
| Cohort 4 Placebo | 7 |
| Cohort 1 Elagolix 200 mg BID | 48 |
| Cohort 1 Placebo | 11 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | 42 |
| Cohort 5 Elagolix 600 mg QD | 56 |
| Cohort 2 Elagolix 300 mg BID | 69 |
| Cohort 2 Placebo | 7 |
| Cohort 6 Elagolix 300 mg BID + CEP | 25 |
"The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.~Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero." (NCT01441635)
Timeframe: Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)
| Intervention | percent change (Mean) |
|---|---|
| Cohort 4 Elagolix 400 mg QD | -83.83 |
| Cohort 4 Elagolix 100 mg BID | -71.85 |
| Cohort 4 Placebo | -6.98 |
| Cohort 1 Elagolix 200 mg BID | -81.03 |
| Cohort 1 Placebo | -11.12 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | -79.60 |
| Cohort 5 Elagolix 600 mg QD | -88.58 |
| Cohort 2 Elagolix 300 mg BID | -97.31 |
| Cohort 2 Placebo | -42.64 |
| Cohort 6 Elagolix 300 mg BID + CEP | -85.39 |
The volume of the largest fibroid was determined using transabdominal ultrasound. The images were analyzed by a central imaging center. (NCT01441635)
Timeframe: Baseline and month 3
| Intervention | percent change (Mean) |
|---|---|
| Cohort 4 Elagolix 400 mg QD | 14.23 |
| Cohort 4 Elagolix 100 mg BID | -22.19 |
| Cohort 4 Placebo | -7.26 |
| Cohort 1 Elagolix 200 mg BID | -38.52 |
| Cohort 1 Placebo | -2.05 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | -25.77 |
| Cohort 5 Elagolix 600 mg QD | -16.60 |
| Cohort 2 Elagolix 300 mg BID | -35.79 |
| Cohort 2 Placebo | 6.70 |
| Cohort 6 Elagolix 300 mg BID + CEP | -4.94 |
"The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.~Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero." (NCT01441635)
Timeframe: Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)
| Intervention | mL (Mean) | |
|---|---|---|
| Baseline | Change from Baseline | |
| Cohort 1 Elagolix 200 mg BID | 335.11 | -272.97 |
| Cohort 1 Placebo | 251.72 | -79.00 |
| Cohort 2 Elagolix 300 mg BID | 206.27 | -202.57 |
| Cohort 2 Placebo | 349.17 | -175.31 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | 247.70 | -192.33 |
| Cohort 4 Elagolix 100 mg BID | 269.36 | -184.69 |
| Cohort 4 Elagolix 400 mg QD | 213.70 | -183.97 |
| Cohort 4 Placebo | 321.73 | -10.46 |
| Cohort 5 Elagolix 600 mg QD | 215.62 | -189.05 |
| Cohort 6 Elagolix 300 mg BID + CEP | 257.99 | -216.15 |
Uterine volume was determined using transabdominal ultrasound. The images were analyzed by a central imaging center. (NCT01441635)
Timeframe: Baseline and month 3
| Intervention | percent change (Mean) |
|---|---|
| Cohort 4 Elagolix 400 mg QD | -21.01 |
| Cohort 4 Elagolix 100 mg BID | -21.37 |
| Cohort 4 Placebo | 18.72 |
| Cohort 1 Elagolix 200 mg BID | -21.68 |
| Cohort 1 Placebo | -8.62 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | -17.43 |
| Cohort 5 Elagolix 600 mg QD | -27.99 |
| Cohort 2 Elagolix 300 mg BID | -33.25 |
| Cohort 2 Placebo | -1.92 |
| Cohort 6 Elagolix 300 mg BID + CEP | -10.06 |
(NCT01441635)
Timeframe: Baseline and Month 3
| Intervention | g/dL (Mean) |
|---|---|
| Cohort 4 Elagolix 400 mg QD | 1.18 |
| Cohort 4 Elagolix 100 mg BID | 1.30 |
| Cohort 4 Placebo | -0.43 |
| Cohort 1 Elagolix 200 mg BID | 1.13 |
| Cohort 1 Placebo | 0.28 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | 0.92 |
| Cohort 5 Elagolix 600 mg QD | 1.40 |
| Cohort 2 Elagolix 300 mg BID | 1.19 |
| Cohort 2 Placebo | 0.31 |
| Cohort 6 Elagolix 300 mg BID + CEP | 1.54 |
"The alkaline hematin method was used for the assessment of MBL. Sanitary products were collected at screening and for any spotting or bleeding episodes that occurred during treatment.~Participants with missing MBL volume for the last treatment period and no bleeding indicated in the electronic daily bleeding diary (eDiary) in the last treatment period, and participants with no post-baseline MBL data were assigned an MBL value of zero." (NCT01441635)
Timeframe: Baseline (last menstrual cycle during the screening period) and the last 28 days of treatment (approximately days 61 to 90)
| Intervention | percentage of participants (Number) |
|---|---|
| Cohort 4 Elagolix 400 mg QD | 84 |
| Cohort 4 Elagolix 100 mg BID | 74 |
| Cohort 4 Placebo | 13 |
| Cohort 1 Elagolix 200 mg BID | 91 |
| Cohort 1 Placebo | 28 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | 85 |
| Cohort 5 Elagolix 600 mg QD | 93 |
| Cohort 2 Elagolix 300 mg BID | 97 |
| Cohort 2 Placebo | 40 |
| Cohort 6 Elagolix 300 mg BID + CEP | 88 |
"Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:~1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.~2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.~3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.~4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.~5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.~6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2." (NCT01441635)
Timeframe: Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)
| Intervention | units on a scale (Mean) |
|---|---|
| Cohort 4 Elagolix 400 mg QD | -0.50 |
| Cohort 4 Elagolix 100 mg BID | -0.37 |
| Cohort 4 Placebo | -0.19 |
| Cohort 1 Elagolix 200 mg BID | -0.52 |
| Cohort 1 Placebo | -0.22 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | -0.24 |
| Cohort 5 Elagolix 600 mg QD | -0.44 |
| Cohort 2 Elagolix 300 mg BID | -0.53 |
| Cohort 2 Placebo | -0.38 |
| Cohort 6 Elagolix 300 mg BID + CEP | -0.25 |
"Participants recorded the previous days' presence and severity of bleeding every morning in an electronic diary (eDiary) according to the Mansfield-Voda-Jorgenson Menstrual Bleeding Scale:~1 (Spotting): A drop or 2 of blood, not even requiring sanitary protection.~2 (Very light): Needing to change the least absorbent tampon or pad 1 to 2 times per day.~3 (Light): Needing to change a low or regular absorbency tampon or pad 2 or 3 times per day.~4 (Moderate): Needing to change a regular absorbency tampon or pad every 3 to 4 hours.~5 (Heavy): Needing to change a high absorbency tampon or pad every 3 to 4 hours.~6 (Very heavy/gushing): Very heavy bleeding, protection hardly works at all; needing to change the highest absorbency tampon or pad every hour or 2.~A day with any uterine bleeding is defined as a days with a bleeding score ≥ 1." (NCT01441635)
Timeframe: Baseline (average bleeding score over the 30 days prior to first dose) and month 3 (average bleeding score over days 61 to 90)
| Intervention | percentage of days (Mean) |
|---|---|
| Cohort 4 Elagolix 400 mg QD | -15.22 |
| Cohort 4 Elagolix 100 mg BID | -11.00 |
| Cohort 4 Placebo | -5.78 |
| Cohort 1 Elagolix 200 mg BID | -15.82 |
| Cohort 1 Placebo | -6.99 |
| Cohort 3 Elagolix 200 mg BID + LD E2/NETA | 3.63 |
| Cohort 5 Elagolix 600 mg QD | -15.38 |
| Cohort 2 Elagolix 300 mg BID | -16.91 |
| Cohort 2 Placebo | -13.95 |
| Cohort 6 Elagolix 300 mg BID + CEP | 1.73 |
Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 3. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count. (NCT01466673)
Timeframe: Baseline and Month 3
| Intervention | Lesions (Mean) | ||||
|---|---|---|---|---|---|
| Comedones Counts: Change at Month 3 (n=93, 96) | Papules Counts: Change at Month 3 (n=93, 96) | Pustules Counts: Change at Month 3 (n=93, 96) | Nodules Counts: Change at Month 3 (n=93, 96) | Total Counts: Change at Month 3 (n=93, 96) | |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | 5.60 | 1.89 | 0.70 | 0.00 | 8.19 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 5.71 | 2.83 | 0.63 | 0.12 | 8.84 |
Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 1. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count. (NCT01466673)
Timeframe: Baseline and Month 1
| Intervention | Lesions (Mean) | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Comedones Counts: Baseline | Papules Counts: Baseline | Pustules Counts: Baseline | Nodules Counts: Baseline | Total Counts: Baseline | Comedones Counts: Change at Month 1 | Papules Counts: Change at Month 1 | Pustules Counts: Change at Month 1 | Nodules Counts: Change at Month 1 | Total Counts: Change at Month 1 | |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | 11.43 | 4.46 | 1.12 | 0.00 | 17.00 | 3.44 | 0.62 | 0.18 | -0.02 | 4.22 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 10.97 | 4.32 | 0.90 | 0.12 | 16.31 | 3.43 | 0.20 | 0.35 | 0.12 | 4.10 |
Total acne (pimples) lesion (abnormal area of tissue, such as a wound, sore, rash, or boil) count is summation of all lesions which includes all comedones (open and closed), papules, pustules, and nodules. Change from Baseline means lesions at Baseline minus lesions at Month 6. Positive value indicates decrease in lesion count while negative value indicates increase in lesion count. (NCT01466673)
Timeframe: Baseline and Month 6
| Intervention | Lesions (Mean) | ||||
|---|---|---|---|---|---|
| Comedones Counts: Change at Month 6 (n=93, 95) | Papules Counts: Change at Month 6 (n=93, 95) | Pustules Counts: Change at Month 6 (n=93, 95) | Nodules Counts: Change at Month 6 (n=93, 95) | Total Counts: Change at Month 6 (n=93, 95) | |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | 8.21 | 2.77 | 0.96 | 0.00 | 11.94 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 9.02 | 3.52 | 0.77 | 0.13 | 13.44 |
Change from Baseline in body weight is the value at Month 6 minus value at Baseline. (NCT01466673)
Timeframe: Baseline and Month 6
| Intervention | Kilograms (Mean) | |
|---|---|---|
| Baseline (n=100,101) | Change at Month 6 (n=93,95) | |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | 54.24 | -0.20 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 55.62 | -0.08 |
Blood pressure is the pressure of blood flowing through blood vessels. Change from Baseline in blood pressure is the value at Month 6 minus value at Baseline. (NCT01466673)
Timeframe: Baseline and Month 6
| Intervention | Millimeters of Mercury (Mean) | |||
|---|---|---|---|---|
| Systolic BP: Baseline (n=100/101) | Diastolic BP: Baseline (n=100/101) | Systolic BP: Change at Month 6 (n=93, 95) | Diastolic BP: Change at Month 6 (n=93, 95) | |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | 110.2 | 69.47 | -0.24 | -0.48 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 110.6 | 70.23 | 0.33 | -0.80 |
Percentage of participants showing treatment response on the Investigator's global assessment was graded on a 5-point scale as 0=worse, 1=no change, 2=fair, 3=good, and 4=excellent. (NCT01466673)
Timeframe: Month 6
| Intervention | Percentage of participants (Number) | ||||
|---|---|---|---|---|---|
| 0 (Worse) | 1 (No Change) | 2 (Fair) | 3 (Good) | 4 (Excellent) | |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | 1.03 | 1.03 | 23.71 | 52.58 | 21.65 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 5.05 | 4.04 | 4.04 | 43.43 | 43.43 |
Sebum assessment that is facial seborrhea (very oily skin) was assessed using sebutape strip on the forehead. Percentage of participants with facial seborrhea were assessed using categorical scores ranging from level 1 (lowest) to level 5 (highest). Highest level indicates worsening. (NCT01466673)
Timeframe: Baseline and Month 1, 3 and 6
| Intervention | Percentage of Participants (Number) | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Level 1: Baseline (n=100,101) | Level 2: Baseline (n=100,101) | Level 3: Baseline (n=100,101) | Level 4: Baseline (n=100,101) | Level 5: Baseline (n=100,101) | Level 1: Month 1 (n=100,101) | Level 2: Month 1 (n=100,101) | Level 3: Month 1 (n=100,101) | Level 4: Month 1 (n=100,101) | Level 5: Month 1 (n=100,101) | Level 1: Month 3 (n=93, 96) | Level 2: Month 3 (n=93, 96) | Level 3: Month 3 (n=93, 96) | Level 4: Month 3 (n=93, 96) | Level 5: Month 3 (n=93, 96) | Level 1: Month 6 (n=93, 95) | Level 2: Month 6 (n=93, 95) | Level 3: Month 6 (n=93, 95) | Level 4: Month 6 (n=93, 95) | Level 5: Month 6 (n=93, 95) | |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | 3.96 | 12.87 | 44.55 | 34.65 | 3.96 | 8.91 | 11.88 | 45.54 | 32.67 | 0.99 | 10.42 | 14.58 | 59.38 | 14.58 | 1.04 | 22.11 | 43.16 | 29.47 | 5.26 | 0.00 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 3.00 | 10.00 | 43.00 | 31.00 | 13.00 | 7.00 | 13.00 | 47.00 | 30.00 | 3.00 | 6.45 | 34.41 | 45.16 | 11.83 | 2.15 | 44.09 | 27.96 | 20.43 | 6.45 | 1.08 |
Participant's self-assessment at end-of-therapy was measured by using the self-assessment questionnaire which included 3 questions, about the rating of acne improvement since start of study; comparison of this acne treatment with the one used in past and the continuity of treatment on physician's prescription to evaluate efficacy and acceptability of the study medication. The score was graded at 4 parameters as excellent, better, no change and worse. (NCT01466673)
Timeframe: Month 6
| Intervention | Participants (Number) | |||
|---|---|---|---|---|
| Excellent | Better | No Change | Worse | |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | 35 | 58 | 3 | 1 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 47 | 45 | 3 | 4 |
Vaginal blood loss encompasses spotting and bleeding. Spotting is defined as a bleeding requiring no or at most one sanitary pad per day; however, bleeding requires two or more sanitary pads per day. (NCT01466673)
Timeframe: Month 1, 3 and 6
| Intervention | Participants (Number) | |||||
|---|---|---|---|---|---|---|
| Spotting at Month 1 (n=100,101) | Spotting at Month 3 (n=93, 96) | Spotting at Month 6 (n=93, 95) | Bleeding at Month 1 (n=100,101) | Bleeding at Month 3 (n=93, 96) | Bleeding at Month 6 (n=93, 95) | |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | 2 | 4 | 3 | 4 | 7 | 3 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 5 | 6 | 4 | 13 | 4 | 6 |
Compliance was assessed by transforming the data of forgotten tablets listed in the diary cards. Number of participants who forgot to take the drug was reported. (NCT01466673)
Timeframe: Month 1, 3 and 6
| Intervention | Participants (Number) | ||
|---|---|---|---|
| At Month 1 (n=100, 101) | At Month 3 (n=93, 96) | At Month 6 (n=93, 95) | |
| Ethinyl Estradiol/Desogestrel (EE/DSG) | 5 | 10 | 6 |
| Ethinyl Estradiol/Norgestimate (EE/NGM) | 7 | 13 | 10 |
(NCT01546454)
Timeframe: Entire Study
| Intervention | Total to HDL Cholesterol Ratio (Mean) |
|---|---|
| Non-steroidal Effects | 0.146 |
| Contraceptive Effects | 0.148 |
| Steroid Effects | -0.89 |
Intensity of breakthrough bleeding and/or spotting (BTB-S) during Cycle 3 was defined as the ratio of the number of breakthrough bleeding days divided by the number of breakthrough bleeding and/or spotting days. Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day. (NCT01709318)
Timeframe: Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~ 28 days)
| Intervention | Ratio (Mean) |
|---|---|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 0.42 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 0.80 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 0.68 |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 0.73 |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 0.67 |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 0.33 |
| NuvaRing® | 0.67 |
Maximum progesterone (Max P) was defined as the maximum progesterone value. Ovulation was defined as 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days during the 3 treatment cycles, supported by ultrasound evidence of ovulation. The Max P values greater than 16 nmol/L are presented by vaginal ring group and cycle. (NCT01709318)
Timeframe: Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)
| Intervention | Percentage of Participants (Number) | ||
|---|---|---|---|
| Cycle 1 Max P > 16 nmol/L | Cycle 2 Max P > 16 nmol/L | Cycle 3 Max P > 16 nmol/L | |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 0 | 0 | 0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 0 | 0 | 0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 0 | 0 | 0 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 0 | 0 | 0 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 0 | 0 | 0 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 0 | 0 | 0 |
| NuvaRing® | 0 | 0 | 0 |
Ovulation was defined as having 2 or more consecutive progesterone concentrations >16 nmol/L within 5 days, confirmed by ultrasound evidence of ovulation (follicular rupture or preceding presence of a follicle-like structure >15 mm in size). (NCT01709318)
Timeframe: Day 1 of Treatment Cycle 1 through Day 28 of Treatment Cycle 3 (Up to ~92 days)
| Intervention | Percentage of Participants (Number) | ||
|---|---|---|---|
| Cycle 1 | Cycle 2 | Cycle 3 | |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 0 | 0 | 0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 0 | 0 | 0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 0 | 0 | 0 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 0 | 0 | 0 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 0 | 0 | 0 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 0 | 0 | 0 |
| NuvaRing® | 0 | 0 | 0 |
Breakthrough bleeding and/or spotting (BTB-S) is defined as any bleeding or spotting episode that occurred during the expected non-bleeding period that was neither an early nor a continued withdrawal bleeding. Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day. (NCT01709318)
Timeframe: Day 1 Cycle 3 through Day 28 Cycle 3 (Up to ~28 days)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 14.6 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 13.3 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 17.5 |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 13.6 |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 16.3 |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 6.4 |
| NuvaRing® | 6.2 |
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment. A drug-related SAE was defined as any SAE for which there is reasonable possibility of drug relationship as assessed by the Investigator. (NCT01709318)
Timeframe: Up to ~92 days
| Intervention | Percentage of Participants (Number) |
|---|---|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 0.0 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 0.0 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 0.0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 0.0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 0.0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 0.0 |
| NuvaRing® | 0.0 |
Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed. (NCT01709318)
Timeframe: Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)
| Intervention | Percentage of Participants (Number) |
|---|---|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 5.5 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 1.9 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 4.4 |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 7.8 |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 3.7 |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 1.9 |
| NuvaRing® | 1.8 |
A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is a cancer, is associated with an overdose; or is another important medical event deemed such by medical or scientific judgment. (NCT01709318)
Timeframe: Up to ~92 days
| Intervention | Percentage of Participants (Number) |
|---|---|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 0.0 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 0.0 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 0.0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 0.0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 0.0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 0.0 |
| NuvaRing® | 0.0 |
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01709318)
Timeframe: Up to ~92 days
| Intervention | Percentage of Participants (Number) |
|---|---|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 43.0 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 40.0 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 43.6 |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 37.7 |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 39.0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 46.5 |
| NuvaRing® | 39.3 |
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. A drug-related AE was defined as any AE for which there is reasonable possibility of drug relationship as assessed by the Investigator. (NCT01709318)
Timeframe: Up to ~92 days
| Intervention | Percentage of Participants (Number) |
|---|---|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 26.6 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 23.5 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 26.9 |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 29.9 |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 26.0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 31.4 |
| NuvaRing® | 20.8 |
An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. (NCT01709318)
Timeframe: Up to ~92 days
| Intervention | Percentage of Participants (Number) |
|---|---|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 3.8 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 4.7 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 2.6 |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 2.6 |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 1.2 |
| NuvaRing® | 1.1 |
Venous or arterial thrombotic/thrombo-embolic events, (VTEs or ATEs) (e.g., deep venous thrombosis, pulmonary embolism, myocardial infarction, cerebrovascular accident) were assessed. (NCT01709318)
Timeframe: From Cycle 1 Day 1 up to 8 days after Day 28 of Cycle 3 (Up to ~92 days)
| Intervention | Participants (Count of Participants) |
|---|---|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 0.0 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 0.0 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 0.0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 0.0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 0.0 |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 0.0 |
| NuvaRing® | 0.0 |
Intensity of withdrawal bleeding during Cycle 2 was defined as the ratio of the number of withdrawal bleeding days divided by the number of withdrawal bleeding and/or spotting days. Withdrawal bleeding and/or spotting is considered any bleeding or spotting episode that starts during or continues into the expected bleeding period (i.e., when the ring has been removed the last week of the cycle). Absence of withdrawal bleeding is no withdrawal bleeding and/or spotting episodes during an expected bleeding period when the ring has been removed. (NCT01709318)
Timeframe: Day 1 Cycle 2 through Day 28 Cycle 2 (Up to ~28 days)
| Intervention | Ratio (Mean) |
|---|---|
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 500/300 μg/Day | 0.87 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 700/300 μg/Day | 0.92 |
| Nomegestrol Acetate-17β-Estradiol (NOMAC-E2) 900/300 μg/Day | 0.86 |
| Etonogestrel-17β-Estradiol (ENG-E2) 75/300 μg/Day | 0.90 |
| Etonogestrel-17β-Estradiol (ENG-E2) 100/300 μg/Day | 0.92 |
| Etonogestrel-17β-Estradiol (ENG-E2) 125/300 μg/Day | 0.93 |
| NuvaRing® | 0.95 |
Volume of the largest fibroid (primary fibroid), as measured by transvaginal ultrasound, or transabdominal ultrasound. (NCT01817530)
Timeframe: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
| Intervention | percentage change (Mean) | ||
|---|---|---|---|
| Month 3 | Month 6 | Final Visit | |
| Cohort 1: Elagolix 300 mg BID | -35.5 | -36.1 | -35.6 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | -20.3 | -19.6 | 20.0 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | -3.7 | 0.0 | -2.7 |
| Cohort 1: Placebo | 6.9 | 13.2 | 9.0 |
| Cohort 2: Elagolix 600 mg QD | -33.6 | -33.5 | -34.8 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | -17.2 | -12.2 | -12.8 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | -1.9 | -0.7 | 0.0 |
| Cohort 2: Placebo | 6.7 | 1.4 | 3.0 |
The NBUFSQ (8 items) is a brief patient-reported daily diary that assesses non-bleeding symptoms experienced by women with uterine fibroids. It includes 6 items, asking women to rate their symptoms (abdominal/pelvic pain, pressure, and cramping, back pain, bloating, and urinary problems) in the past 24 hours using an 11-point numeric response scale that ranges from 0 (i.e., no symptom) to 10 (i.e., worst possible symptom) and 2 items to address urinary frequency during the daytime and at night. Data presented in the sum of scores to the 6 symptom questions, ranging from 0 (no symptoms) to 60 (worst possible symptoms). Baseline is defined as the last 28 days prior to the first day of study drug. Final Month is defined as the last 28 days prior to and including the last dose date of study drug. (NCT01817530)
Timeframe: Baseline, Days 1-28, Days 29-56, Days 57-84, Days 85-112, Days 113-140, Days 141-168, Final Month of treatment, Post-treatment (PT) Days 1-28, PT Days 29-56, PT Days 57-84, PT Days 85-112, PT Days 113-140, PT Days 141-168
| Intervention | units on a scale (Least Squares Mean) | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Days 1-28 | Days 29-56 | Days 57-84 | Days 85-112 | Days 113-140 | Days 141-168 | Final Month | PT Days 1-28 | PT Days 29-56 | PT Days 57-84 | PT Days 85-112 | PT Days 113-140 | PT Days 141-168 | |
| Cohort 1: Elagolix 300 mg BID | -3.4 | -5.8 | -7.2 | -7.8 | -7.6 | -8.0 | -6.7 | -5.2 | -4.1 | -4.0 | -6.4 | -3.1 | -8.0 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | -3.1 | -4.4 | -4.1 | -5.2 | -5.3 | -5.1 | -4.1 | -3.8 | -1.0 | -2.1 | -4.8 | 1.3 | 4.1 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | -1.4 | -2.9 | -3.2 | -3.7 | -3.4 | -3.3 | -3.5 | -3.0 | 0.0 | -1.1 | 0.7 | 1.4 | -3.3 |
| Cohort 1: Placebo | -3.3 | -4.5 | -5.6 | -7.0 | -4.1 | -6.8 | -5.3 | -5.6 | -5.7 | -5.4 | -4.4 | 3.4 | 7.5 |
| Cohort 2: Elagolix 600 mg QD | -2.7 | -4.2 | -4.5 | -5.1 | -5.5 | -5.9 | -4.0 | -3.8 | -2.8 | -2.0 | -2.4 | -17.3 | -3.1 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | -2.1 | -2.2 | -2.2 | -3.6 | -4.0 | -4.4 | -3.3 | -2.0 | -2.7 | -1.6 | -3.0 | -5.6 | -3.3 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 0.0 | -2.3 | -3.8 | -4.1 | -5.3 | -4.8 | -2.3 | -2.3 | -2.5 | -3.9 | -5.0 | -7.0 | -6.4 |
| Cohort 2: Placebo | 0.4 | -0.3 | 0.1 | -0.2 | 0.1 | -0.4 | -0.8 | -0.8 | -0.2 | -0.5 | -2.7 | -6.2 | -10.5 |
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume < 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 84 to 57 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period. (NCT01817530)
Timeframe: Baseline, third last 28 days of treatment (last 84 to 57 days of treatment)
| Intervention | percentage of participants (Number) |
|---|---|
| Cohort 1: Placebo | 19.67 |
| Cohort 1: Elagolix 300 mg BID | 96.43 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 89.47 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 79.31 |
| Cohort 2: Placebo | 21.62 |
| Cohort 2: Elagolix 600 mg QD | 86.36 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 74.19 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 72.31 |
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL Volume of < 80 mL at the Final Month and a ≥50% Reduction in MBL Volume from Baseline to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period. (NCT01817530)
Timeframe: Baseline, Final Month (last 28 days of treatment)
| Intervention | percentage of participants (Number) |
|---|---|
| Cohort 1: Placebo | 26.56 |
| Cohort 1: Elagolix 300 mg BID | 91.94 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 85.25 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 79.03 |
| Cohort 2: Placebo | 31.58 |
| Cohort 2: Elagolix 600 mg QD | 90.14 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 72.6 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 81.58 |
The percentage of participants meeting a composite endpoint consisting of these 2 bleeding assessments: a MBL volume < 80 mL and a ≥ 50% reduction in MBL volume from baseline during the last 56 to 29 days of last treatment. Baseline is defined as the last qualified menstrual cycle during the screening period. (NCT01817530)
Timeframe: Baseline, second last 28 days of treatment (last 56 to 29 days of treatment)
| Intervention | percentage of participants (Number) |
|---|---|
| Cohort 1: Placebo | 11.29 |
| Cohort 1: Elagolix 300 mg BID | 94.83 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 88.14 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 85.00 |
| Cohort 2: Placebo | 18.42 |
| Cohort 2: Elagolix 600 mg QD | 85.29 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 67.19 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 77.14 |
Percentage of participants with a >= 50% reduction from baseline in MBL to the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period. (NCT01817530)
Timeframe: Baseline, Final Month (last 28 days of treatment)
| Intervention | percentage of participants (Number) |
|---|---|
| Cohort 1: Placebo | 31.25 |
| Cohort 1: Elagolix 300 mg BID | 93.55 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 86.89 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 82.26 |
| Cohort 2: Placebo | 35.53 |
| Cohort 2: Elagolix 600 mg QD | 90.14 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 79.45 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 85.53 |
Suppression of bleeding is defined as having 0 days of bleeding based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding (spotting is allowed) based on imputed electronic diary data during the last 56 days of treatment. (NCT01817530)
Timeframe: Last 56 days of treatment (after 10 days from first dose date)
| Intervention | percentage of participants (Number) |
|---|---|
| Cohort 1: Placebo | 1.6 |
| Cohort 1: Elagolix 300 mg BID | 75.4 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 52.6 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 43.3 |
| Cohort 2: Placebo | 2.7 |
| Cohort 2: Elagolix 600 mg QD | 67.2 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 31.7 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 34.8 |
Percentage of participants who achieved an MBL volume of < 80 mL at the Final Month (last 28 days of treatment). Baseline is defined as the last qualified menstrual cycle during the screening period. (NCT01817530)
Timeframe: Final Month (last 28 days of treatment)
| Intervention | percentage of participants (Number) |
|---|---|
| Cohort 1: Placebo | 32.81 |
| Cohort 1: Elagolix 300 mg BID | 91.94 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 88.52 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 79.03 |
| Cohort 2: Placebo | 36.84 |
| Cohort 2: Elagolix 600 mg QD | 91.55 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 72.6 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 85.53 |
Amenorrhea is defined as having 0 days of bleeding or spotting based on observed validated and nonvalidated alkaline hematin data and having 0 days of bleeding or spotting, based on imputed electronic diary data during the last 56 days of treatment. Participants needed to have at least 66 days on treatment. (NCT01817530)
Timeframe: Last 56 days of treatment (after 10 days from first dose date)
| Intervention | percentage of participants (Number) |
|---|---|
| Cohort 1: Placebo | 1.6 |
| Cohort 1: Elagolix 300 mg BID | 56.1 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 33.3 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 28.3 |
| Cohort 2: Placebo | 1.3 |
| Cohort 2: Elagolix 600 mg QD | 50.7 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 17.5 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 22.7 |
The number of days with heavy bleeding (either heavy or very heavy/gushing bleeding) was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug. (NCT01817530)
Timeframe: Baseline, Month 6
| Intervention | days (Least Squares Mean) |
|---|---|
| Cohort 1: Placebo | -1.0 |
| Cohort 1: Elagolix 300 mg BID | -2.0 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | -1.9 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | -1.7 |
| Cohort 2: Placebo | -0.7 |
| Cohort 2: Elagolix 600 mg QD | -1.2 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | -1.4 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | -1.8 |
The number of days with any bleeding including spotting was calculated using data collected on daily bleeding diary. Baseline is defined as the last 28 days prior to the first dose day of study drug. (NCT01817530)
Timeframe: Baseline, Month 6
| Intervention | days (Least Squares Mean) |
|---|---|
| Cohort 1: Placebo | -1.2 |
| Cohort 1: Elagolix 300 mg BID | -4.9 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | -2.7 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | -1.1 |
| Cohort 2: Placebo | -1.4 |
| Cohort 2: Elagolix 600 mg QD | -3.3 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | -1.3 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | -1.8 |
Baseline is defined as the last measurement prior to the first dose of study drug. (NCT01817530)
Timeframe: Baseline, Final Visit during treatment period (Month 6 or early termination)
| Intervention | g/dL (Least Squares Mean) |
|---|---|
| Cohort 1: Placebo | 0.6 |
| Cohort 1: Elagolix 300 mg BID | 1.9 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 1.9 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 1.4 |
| Cohort 2: Placebo | 0.3 |
| Cohort 2: Elagolix 600 mg QD | 1.4 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 1.1 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 1.2 |
The average bleeding score was calculated for each 28-day interval starting on Day 29 using data collected on daily bleeding diary using the Mansfield-Voda-Jorgenson (MVJ) Menstrual Bleeding Scale (1=spotting, 2 = very light bleeding, 3 = light bleeding, 4 = moderate bleeding, 5 = heavy bleeding, 6 = very heavy/gushing bleeding). Baseline is defined as the last 28 days prior to the first day of study drug. (NCT01817530)
Timeframe: Baseline, Final Month (last 28 days of treatment)
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Cohort 1: Placebo | -0.3 |
| Cohort 1: Elagolix 300 mg BID | -0.7 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | -0.4 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | -0.1 |
| Cohort 2: Placebo | -0.2 |
| Cohort 2: Elagolix 600 mg QD | -0.4 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | -0.3 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | -0.1 |
Volume of the largest fibroid (primary fibroid) was measured by transvaginal ultrasound or transabdominal ultrasound. (NCT01817530)
Timeframe: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Month 3 | Month 6 | Final Visit | |
| Cohort 1: Elagolix 300 mg BID | 67.3 | 70.5 | 69.8 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 46.2 | 47.9 | 50.0 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 23.4 | 26.2 | 27.5 |
| Cohort 1: Placebo | 13.2 | 24.4 | 24.5 |
| Cohort 2: Elagolix 600 mg QD | 63.2 | 64.0 | 66.1 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 37.7 | 38.6 | 40.0 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 22.4 | 34.8 | 30.0 |
| Cohort 2: Placebo | 10.9 | 14.5 | 13.6 |
Total fibroid volume (3 largest fibroids) was measured by transvaginal ultrasound, or transabdominal ultrasound. (NCT01817530)
Timeframe: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Month 3 | Month 6 | Final Visit | |
| Cohort 1: Elagolix 300 mg BID | 79.6 | 75.0 | 73.6 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 50.0 | 54.2 | 57.4 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 31.9 | 40.5 | 41.2 |
| Cohort 1: Placebo | 13.2 | 24.4 | 24.5 |
| Cohort 2: Elagolix 600 mg QD | 66.7 | 62.0 | 64.4 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 34.0 | 40.9 | 40.0 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 22.4 | 34.8 | 30.0 |
| Cohort 2: Placebo | 9.4 | 18.2 | 16.7 |
Uterine volume was measured by transvaginal ultrasound or transabdominal ultrasound. (NCT01817530)
Timeframe: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
| Intervention | percentage of participants (Number) | ||
|---|---|---|---|
| Month 3 | Month 6 | Final Visit | |
| Cohort 1: Elagolix 300 mg BID | 73.1 | 78.7 | 73.2 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | 42.9 | 58.0 | 58.9 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | 18.5 | 31.9 | 26.8 |
| Cohort 1: Placebo | 5.2 | 2.0 | 3.4 |
| Cohort 2: Elagolix 600 mg QD | 57.1 | 62.5 | 63.1 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | 36.8 | 32.7 | 29.3 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | 17.5 | 26.0 | 23.4 |
| Cohort 2: Placebo | 1.4 | 1.6 | 1.4 |
Uterine volume, as measured by transvaginal ultrasound or transabdominal ultrasound. (NCT01817530)
Timeframe: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
| Intervention | percentage change (Mean) | ||
|---|---|---|---|
| Month 3 | Month 6 | Final Visit | |
| Cohort 1: Elagolix 300 mg BID | -30.9 | -35.6 | -31.5 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | -19.4 | -21.9 | -22.0 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | -7.3 | -13.2 | -11.8 |
| Cohort 1: Placebo | 7.3 | 17.5 | 15.9 |
| Cohort 2: Elagolix 600 mg QD | -24.7 | -26.00 | -26.6 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | -15.7 | -13.5 | -11.5 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | -6.1 | -9.0 | -6.7 |
| Cohort 2: Placebo | 8.4 | 10.7 | 11.6 |
Volume of the total fibroid volume (3 largest fibroids), as measured by transvaginal ultrasound, or transabdominal ultrasound. (NCT01817530)
Timeframe: Baseline, Month 3, Month 6, and Final Visit during treatment period (Month 6 or early termination)
| Intervention | percentage change (Mean) | ||
|---|---|---|---|
| Month 3 | Month 6 | Final Visit | |
| Cohort 1: Elagolix 300 mg BID | -41.9 | -40.2 | -39.6 |
| Cohort 1: Elagolix 300 mg BID Plus LD E2/NETA QD | -24.6 | -23.3 | -24.0 |
| Cohort 1: Elagolix 300 mg BID Plus SD E2/NETA QD | -9.8 | -8.8 | -12.9 |
| Cohort 1: Placebo | 1.7 | 8.3 | 4.6 |
| Cohort 2: Elagolix 600 mg QD | -34.4 | -34.2 | -36.4 |
| Cohort 2: Elagolix 600 mg QD Plus LD E2/NETA QD | -17.5 | -17.8 | -16.6 |
| Cohort 2: Elagolix 600 mg QD Plus SD E2/NETA QD | -4.6 | -1.1 | -1.6 |
| Cohort 2: Placebo | 5.4 | -1.8 | 0.1 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 12. (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 95 | 58 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 94 | 64 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 90 | 50 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 97 | 73 |
| Placebo | 55 | 32 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 2. (NCT01942668)
Timeframe: Baseline and Week 2
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 39 | 17 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 24 | 7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 30 | 9 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 36 | 15 |
| Placebo | 21 | 4 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 3. (NCT01942668)
Timeframe: Baseline and Week 3
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 61 | 22 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 49 | 14 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 50 | 15 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 63 | 33 |
| Placebo | 33 | 6 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 4. (NCT01942668)
Timeframe: Baseline and Week 4
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 73 | 33 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 62 | 28 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 65 | 24 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 80 | 44 |
| Placebo | 35 | 6 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 5. (NCT01942668)
Timeframe: Baseline and Week 5
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 82 | 37 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 72 | 34 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 69 | 27 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 86 | 48 |
| Placebo | 47 | 13 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 6. (NCT01942668)
Timeframe: Baseline and Week 6
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 83 | 43 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 78 | 39 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 76 | 39 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 92 | 61 |
| Placebo | 52 | 16 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 7. (NCT01942668)
Timeframe: Baseline and Week 7
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 95 | 47 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 87 | 46 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 81 | 44 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 93 | 63 |
| Placebo | 49 | 16 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 8. (NCT01942668)
Timeframe: Baseline and Week 8
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 93 | 51 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 85 | 53 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 90 | 45 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 98 | 64 |
| Placebo | 54 | 20 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 9. (NCT01942668)
Timeframe: Baseline and Week 9
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 94 | 56 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 95 | 63 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 91 | 54 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 95 | 69 |
| Placebo | 58 | 22 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe VMS from Baseline to Week 1. (NCT01942668)
Timeframe: Baseline and Week 1
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 25 | 5 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 17 | 4 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 15 | 4 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 15 | 3 |
| Placebo | 16 | 1 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 10. (NCT01942668)
Timeframe: Baseline and Week 10
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 101 | 64 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 102 | 69 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 100 | 62 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 95 | 78 |
| Placebo | 68 | 37 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 11. (NCT01942668)
Timeframe: Baseline and Week 11
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 104 | 68 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 105 | 74 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 97 | 65 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 95 | 79 |
| Placebo | 59 | 34 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 12. (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 99 | 68 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 104 | 75 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 94 | 66 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 98 | 84 |
| Placebo | 67 | 37 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 2. (NCT01942668)
Timeframe: Baseline and Week 2
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 49 | 20 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 35 | 12 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 34 | 15 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 44 | 21 |
| Placebo | 35 | 6 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 3. (NCT01942668)
Timeframe: Baseline and Week 3
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 71 | 29 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 59 | 24 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 54 | 21 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 68 | 38 |
| Placebo | 42 | 15 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 4. (NCT01942668)
Timeframe: Baseline and Week 4
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 81 | 45 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 70 | 34 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 74 | 32 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 82 | 55 |
| Placebo | 41 | 15 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 5. (NCT01942668)
Timeframe: Baseline and Week 5
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 90 | 54 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 80 | 47 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 74 | 38 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 93 | 55 |
| Placebo | 55 | 27 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 6. (NCT01942668)
Timeframe: Baseline and Week 6
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 95 | 56 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 85 | 51 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 82 | 47 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 98 | 68 |
| Placebo | 55 | 30 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 7. (NCT01942668)
Timeframe: Baseline and Week 7
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 101 | 58 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 93 | 63 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 88 | 56 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 96 | 71 |
| Placebo | 58 | 32 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 8. (NCT01942668)
Timeframe: Baseline and Week 8
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 100 | 62 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 98 | 64 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 90 | 59 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 102 | 78 |
| Placebo | 60 | 37 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of moderate to severe vasomotor symptoms from Baseline to Week 9. (NCT01942668)
Timeframe: Baseline and Week 9
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 101 | 63 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 107 | 73 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 92 | 63 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 98 | 72 |
| Placebo | 63 | 35 |
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time. (NCT01942668)
Timeframe: Cycle 5 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 224 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 265 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 278 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 253 |
| Placebo | 86 |
Change from Baseline (BL) to Month 12 in MOS Optimal Sleep Score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm. (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | Proportion of Net Change (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 0.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0.3 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 0.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0.1 |
| Placebo | 0.2 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -55.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -53.7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -50.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -52.4 |
| Placebo | -40.2 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 4
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -40.6 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -35.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -33.6 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -38.9 |
| Placebo | -26.4 |
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.12 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.90 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.76 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.71 |
| Placebo | -0.56 |
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 4
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.48 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.51 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.40 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.44 |
| Placebo | -0.34 |
Endometrial biopsies centrally evaluated by 3 primary pathologists using criteria described in Blaustein's Pathology text. Pathologists classified biopsy into 1 of following 3 categories: Cat.1: Non-endometrial malignancy/non-hyperplasia; Cat.2: Endometrial hyperplasia; Cat.3: Endometrial malignancy. Consensus was reached when the 2 of 3 pathologist readers agreed on any of the above categories; if all three reads were disparate, the final diagnosis was based on the most severe diagnosis. Incidence rate calculated as: I=A/B where I=incidence rate at M12 evaluation, A=all new subjects with biopsies positive for endometrial hyperplasia during study but post-Baseline, B=all subjects with biopsies following M11 meeting the criteria specified plus all subjects with biopsies positive for endometrial hyperplasia by any of the pathologists before M11. (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 0 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 0 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0 |
| Placebo | 0 |
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 1. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 1
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -12.9 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -12.4 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -12.5 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -17.7 |
| Placebo | -12.2 |
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 10. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 10
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -58.5 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -56.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -53.7 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -55.7 |
| Placebo | -38.3 |
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 11. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 11
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -58.8 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -57.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -54.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -56.1 |
| Placebo | -38.4 |
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -60.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -58.8 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -54.8 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -57.0 |
| Placebo | -41.7 |
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 2. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 2
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -28.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -22.4 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -21.8 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -27.8 |
| Placebo | -21.7 |
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 3. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 3
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -37.4 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -30.7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -31.3 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -35.6 |
| Placebo | -25.8 |
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 4
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -44.4 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -37.7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -35.4 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -41.5 |
| Placebo | -26.8 |
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 5. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 5
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -49.9 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -42.3 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -40.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -46.8 |
| Placebo | -33.3 |
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 6. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 6
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -53.9 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -44.9 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -43.0 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -49.4 |
| Placebo | -34.1 |
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 7. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 7
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -56.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -48.8 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -47.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -51.5 |
| Placebo | -33.4 |
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 8. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 8
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -57.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -50.6 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -49.5 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -52.4 |
| Placebo | -36.9 |
Mean change in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 9. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of mild, moderate and severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of mild, moderate and severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 9
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -57.6 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -54.7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -52.8 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -54.5 |
| Placebo | -38.3 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 1. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 1
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -12.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -11.5 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -11.0 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -16.3 |
| Placebo | -13.0 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 10. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 10
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -53.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -51.9 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -49.0 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -50.6 |
| Placebo | -37.1 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 11. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 11
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -53.7 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -52.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -49.4 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -50.9 |
| Placebo | -36.7 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -55.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -53.7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -50.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -52.4 |
| Placebo | -40.2 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 2. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 2
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -26.6 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -21.2 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -19.0 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -25.4 |
| Placebo | -21.3 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 3. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 3
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -34.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -29.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -28.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -33.6 |
| Placebo | -25.1 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 4
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -40.6 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -35.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -33.6 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -38.9 |
| Placebo | -26.4 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 5. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 5
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -45.9 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -39.5 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -37.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -43.5 |
| Placebo | -31.6 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 6. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 6
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -49.4 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -41.7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -40.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -45.5 |
| Placebo | -32.7 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 7. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 7
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -51.5 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -45.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -43.8 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -47.7 |
| Placebo | -33.4 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 8. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 8
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -52.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -46.8 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -45.4 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -48.4 |
| Placebo | -36.0 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 9. The baseline was the most recent 7 consecutive days of data prior to randomization. The weekly frequency of moderate to severe hot flushes was calculated from the daily diary record using a forward counting process of 7 day intervals beginning with the baseline date. Weekly frequency equals total number of moderate to severe hot flushes for the subject week. (NCT01942668)
Timeframe: Baseline and Week 9
| Intervention | weekly hot flushes (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -52.6 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -50.5 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -47.4 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -50.1 |
| Placebo | -36.4 |
Change from Baseline to Month 12 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome. (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 10.4 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 10.5 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 17.6 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 13.7 |
| Placebo | 10.0 |
Change from Baseline to Month 12 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome. (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 9.8 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 12.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 12.6 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 14.1 |
| Placebo | 10.0 |
Change from Baseline to Month 6 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome. (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 13.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 15.2 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 14.7 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 15.2 |
| Placebo | 9.5 |
Change from Baseline to Month 6 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome. (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 10.5 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 11.7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 11.0 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 14.5 |
| Placebo | 9.5 |
Change from Baseline to Wk 12 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome. (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 12.8 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 11.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 17.3 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 10.7 |
| Placebo | 11.3 |
Change from Baseline to Wk 12 in MOS Sleep Adequacy individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Adequacy includes items Q4, Q12. Scoring method: Answers for Q4 and Q12 are reversed and rescaled to 0-100 as follows: MOS_4_new = (6-MOS_4_old) x 20; MOS_12_new = (6-MOS_12_old) x 20. Score is the average of item scores; score range = 0 to 100, where higher score means better outcome. (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 11.9 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 9.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 11.4 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 11.9 |
| Placebo | 11.3 |
"Change from Baseline to Month 12 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -20.0 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -22.3 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -26.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -26.1 |
| Placebo | -14.1 |
"Change from Baseline to Month 12 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -20.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -19.9 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -19.9 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -19.7 |
| Placebo | -14.1 |
"Change from Baseline to Month 6 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -23.5 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -21.3 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -26.9 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -22.4 |
| Placebo | -15.4 |
"Change from Baseline to Month 6 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -22.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -20.2 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -20.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -19.4 |
| Placebo | -15.4 |
"Change from Baseline to Wk 12 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -21.0 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -18.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -18.7 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -17.3 |
| Placebo | -14.9 |
"Change from Baseline to Wk 12 in MOS Sleep Disturbance individual score as compared with Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep disturbance includes items Q1, Q3, Q7, Q8. Scoring method: Answer to Q1 is rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25. Answers to Q3, 7, 8 are reversed & rescaled to realign to be same direction and range(0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Score is average of item scores; score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -22.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -17.7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -23.6 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -19.3 |
| Placebo | -15.1 |
"Change from Baseline to Month 12 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -13.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -13.5 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -18.9 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -16.1 |
| Placebo | -9.1 |
"Change from Baseline to Month 12 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -12.8 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -13.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -13.7 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -14.0 |
| Placebo | -9.1 |
"Change from Baseline to Month 6 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -16.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -14.3 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -18.0 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -15.7 |
| Placebo | -9.8 |
"Change from Baseline to Month 6 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -14.0 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -12.9 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -13.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -13.8 |
| Placebo | -9.8 |
"Change from Baseline to Wk 12 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -15.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -11.3 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -17.7 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -13.5 |
| Placebo | -9.9 |
"Change from Baseline to Wk 12 in MOS Sleep Problems Index I individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index I includes items Q4, Q5, Q7, Q8, Q9, Q12. Scoring method: Answers to Q, 5, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q4, & 12 are rescaled to 0-100 as follows: MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -13.5 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -11.4 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -12.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -12.8 |
| Placebo | -9.8 |
"Change from Baseline to Month 12 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -14.7 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -15.7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -20.5 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -17.4 |
| Placebo | -10.5 |
"Change from Baseline to Month 12 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -14.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -14.6 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -15.4 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -15.1 |
| Placebo | -10.5 |
"Change from Baseline to Month 6 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -17.5 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -16.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -19.8 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -17.0 |
| Placebo | -11.6 |
"Change from Baseline to Wk 12 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -16.8 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -13.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -18.5 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -14.4 |
| Placebo | -11.8 |
"Change from Baseline to Wk 12 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -15.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -13.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -13.9 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -13.4 |
| Placebo | -11.8 |
"Change from Baseline to Month 12 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -8.9 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -7.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -12.4 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -10.8 |
| Placebo | -2.8 |
"Change from Baseline to Month 12 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -6.6 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -6.4 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -7.9 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -6.5 |
| Placebo | -2.8 |
"Change from Baseline to Month 6 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -9.7 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -5.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -11.0 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -7.3 |
| Placebo | -2.1 |
"Change from Baseline to Month 6 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -6.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -5.9 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -7.5 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -5.7 |
| Placebo | -2.1 |
"Change from Baseline to Wk 12 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -7.7 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -4.3 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -12.3 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -7.9 |
| Placebo | -3.6 |
"Change from Baseline to Wk 12 in MOS Sleep Short of Breath or Headache(SOBHA) individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. SOBHA item is Q5. Scoring method: Answer to Q5 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -6.0 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -6.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -7.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -6.3 |
| Placebo | -3.4 |
"Change from Baseline to Month 12 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -8.0 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -11.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -13.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -13.4 |
| Placebo | -6.7 |
"Change from Baseline to Month 12 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -8.5 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -9.2 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -9.9 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -9.4 |
| Placebo | -6.7 |
"Change from Baseline to Month 6 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -10.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -10.8 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -12.4 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -10.5 |
| Placebo | -9.6 |
"Change from Baseline to Month 6 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -9.4 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -8.4 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -9.6 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -8.7 |
| Placebo | -9.6 |
"Change from Baseline to Wk 12 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -11.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -9.2 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -10.4 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -10.8 |
| Placebo | -8.7 |
"Change from Baseline to Wk 12 in MOS Sleep Somnolence individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Sleep Somnolence items include Q6, Q9, Q11. Scoring method: Answers to Q6, Q 9 and Q11 are reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -9.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -8.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -7.6 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -8.9 |
| Placebo | -8.7 |
"Change from Baseline to Month 12 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -10.5 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -6.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -8.0 |
| Placebo | -4.5 |
"Change from Baseline to Month 12 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -3.4 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -7.5 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -5.0 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -4.5 |
| Placebo | -4.5 |
"Change from Baseline to Month 6 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 0.7 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -5.5 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -8.8 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -6.1 |
| Placebo | -3.5 |
"Change from Baseline to Month 6 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -2.4 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -6.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -6.8 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -3.7 |
| Placebo | -3.5 |
"Change from Baseline to Wk 12 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.5 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -3.6 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -7.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -5.7 |
| Placebo | -5.7 |
"Change from Baseline to Wk 12 in MOS Snoring individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self-reported hours of sleep per night. Q3-Q12 are scored 1-6 ranging from 1=All of the time to 6=None of the time. Snoring item is Q10. Scoring method: Answer to Q10 is reversed & rescaled to 0 to 100 such that 0=best possible & 100=worst possible. MOS_n_new <- (6-MOS_n_old) x 20. Score range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -2.6 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -4.7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -4.5 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -3.4 |
| Placebo | -5.6 |
Summary of the number of days with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 1
| Intervention | Days (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 1.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0.5 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 0.5 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0.4 |
| Placebo | 0.2 |
Change from Baseline (BL) to Month 12 in MOS Optimal Sleep Score as compared with Placebo.The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm. (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | Proportion of Net Change (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 0.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0.2 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 0.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0.1 |
| Placebo | 0.2 |
Change from Baseline (BL) to Month 6 in MOS Optimal Sleep Score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm. (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | Proportion of Net Change (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 0.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0.2 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 0.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0.1 |
| Placebo | 0.2 |
Change from Baseline (BL) to Month 6 in MOS Optimal Sleep Score as compared with Placebo.The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm. (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | Proportion of Net Change (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 0.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0.2 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 0.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0.1 |
| Placebo | 0.2 |
Change from Baseline (BL) to Week 12 in MOS Optimal Sleep Score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm. (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | Proportion of Net Change (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 0.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0.2 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 0.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0.2 |
| Placebo | 0.2 |
Change from Baseline (BL) to Wk 12 in MOS Optimal Sleep Score as compared with Placebo.The MOS-Sleep Self Report Questionnaire is composed of 12 items measuring 6 dimensions of sleep over the past 4 wks. Optimal sleep is based on Q2 (self-reported average hrs sleep per night in past 4 wks). Scoring method: hrs of sleep coded 0 (non-optimal) or 1 (optimal) where 1-6 hrs & 9-23 hrs = 0, 7-8 hrs = 1. Change from BL: subject sleeps 7-8 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = -1; subject sleeps 1-6 or 9-23 hrs at BL & 7-8 hrs at follow-up, change = +1; subject sleeps 1-6 or 9-23 hrs at BL & 1-6 or 9-23 hrs at follow-up, change = 0. Mean change from BL: changes are summed to give the Net Total (equivalent to the number subjects w/ improved sleep hrs minus the number subjects w/ worsened sleep hrs), which is divided by the number of subjects to give the mean proportion of net change, where >0 = overall improvement and <0 = overall worsening in the study arm. (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | Proportion of Net Change (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 0.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 0.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0.1 |
| Placebo | 0.2 |
"Change from Baseline to Month 6 in MOS Sleep Problems Index II individual score as compared with Placebo. The MOS-Sleep Self Report Questionnaire is composed of 12 items that measure 6 dimensions of sleep over the past 4 weeks. Q1 is scored on a scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 is self reported hours of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Sleep Problems Index II items include Q1, Q3, Q4, Q5, Q6, Q7, Q8, Q9, Q12. Scoring method: Answers to Q3, 5, 6, 7, 8, & 9 are reversed & rescaled to realign to be same direction and range 0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20, for n=Q3, 5, 6, 7, 8, and 9. Answers to Q1, 4 & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Score is the average of item scores; score range range=0 to 100, where higher score means worse outcome." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -15.5 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -14.6 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -14.9 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -14.8 |
| Placebo | -11.6 |
"Change from Baseline to Month 12 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -14.9 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -15.8 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -20.6 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -17.6 |
| Placebo | -10.3 |
"Change from Baseline to Month 12 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -14.4 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -14.5 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -15.3 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -15.3 |
| Placebo | -10.3 |
"Change from Baseline to Month 6 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -17.8 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -16.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -19.8 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -16.6 |
| Placebo | -11.7 |
"Change from Baseline to Month 6 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -15.6 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -14.8 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -14.7 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -14.6 |
| Placebo | -11.7 |
"Change from Baseline to Wk 12 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -16.7 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -13.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -18.5 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -14.6 |
| Placebo | -11.5 |
"Change from Baseline to Wk 12 in MOS Total Sleep Score as compared w/Placebo. MOS-Sleep Self Report Questionnaire is 12 items that measure 6 dimensions of sleep over past 4 wks. Q1 scored on scale 1-5: 1=0-15 min, 2=16-30 min...5=>60 mins. Q2 self-reported hrs of sleep per night. Q3-12 scored 1-6 where 1=All of the time to 6=None of the time. Total score includes items Q1, 3, 4, 5, 6, 7, 8, 9, & 12. Scoring method: Answers to Q3, 5, 6, 7, 8, 9 are reversed & rescaled to realign to be same direction and range (0 to 100 with 0=best possible & 100=worst possible as follows: MOS_n_new = (6-MOS_n_old) x 20. Answers to Q1, 4, & 12 are rescaled to 0-100 as follows: MOS_1_new =(MOS_1_old - 1) x 25; MOS_4_new =(MOS_4_old - 1) x 20; MOS_12_new=(MOS_12_old - 1) x 20. Total score= average of item scores; ranges =0 to 100, where higher score means worse outcome. If any of individual questions used to obtain total score is missing, total score will be set to missing value." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -15.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -13.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -13.9 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -13.3 |
| Placebo | -11.5 |
"Changes in Overall Scores from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.8 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -2.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -2.0 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.7 |
| Placebo | -1.5 |
"Change in Overall Scores from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.8 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.8 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.7 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.6 |
| Placebo | -1.5 |
"Changes in Overall Scores from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -2.0 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.8 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -2.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.7 |
| Placebo | -1.6 |
"Change in Overall Scores from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -2.0 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.8 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.8 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.7 |
| Placebo | -1.6 |
"Changes in Overall Scores from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.9 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.6 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.9 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.7 |
| Placebo | -1.4 |
"Change in Overall Scores from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. The scale contains four domains: vasomotor, psychosocial, physical and sexual. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The Overall Score is the mean of the 4 domain scores with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.8 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.6 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.7 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.6 |
| Placebo | -1.4 |
"Changes in Physical Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.0 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.2 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.4 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.1 |
| Placebo | -0.9 |
"Changes in Physical Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.1 |
| Placebo | -0.9 |
"Changes in Physical Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.5 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.0 |
| Placebo | -1.1 |
"Changes in Physical Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.2 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.0 |
| Placebo | -1.1 |
"Changes in Physical Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.5 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.0 |
| Placebo | -1.0 |
"Changes in Physical Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Physical domain score is mean of = Q11 to Q26, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.3 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.1 |
| Placebo | -1.0 |
"Changes in Psychosocial Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.3 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.0 |
| Placebo | -1.0 |
"Changes in Psychosocial Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.0 |
| Placebo | -1.0 |
"Changes in Psychosocial Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.0 |
| Placebo | -1.0 |
"Changes in Psychosocial Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.0 |
| Placebo | -1.0 |
"Changes in Psychosocial Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.9 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.1 |
| Placebo | -1.0 |
"Changes in Psychosocial Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Psychosocial domain score is mean of = Q4 to Q10, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.0 |
| Placebo | -1.0 |
"Changes in Sexual Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.0 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.5 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.5 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.4 |
| Placebo | -1.1 |
"Changes in Sexual Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.4 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.3 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.2 |
| Placebo | -1.1 |
"Changes in Sexual Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.2 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.6 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.4 |
| Placebo | -1.3 |
"Changes in Sexual Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.4 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.4 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.4 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.3 |
| Placebo | -1.3 |
"Changes in Sexual Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.5 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.7 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.4 |
| Placebo | -1.3 |
"Changes in Sexual Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Sexual domain score is mean of = Q27 to Q29, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.4 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -1.3 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -1.5 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -1.5 |
| Placebo | -1.3 |
"Changes in Vasomotor Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -4.0 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -4.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -4.0 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -3.4 |
| Placebo | -2.8 |
"Changes in Vasomotor Domain Score from Baseline to Month 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -3.8 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -3.7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -3.4 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -3.3 |
| Placebo | -2.8 |
"Changes in Vasomotor Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -4.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -4.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -4.0 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -3.5 |
| Placebo | -3.0 |
"Changes in Vasomotor Domain Score from Baseline to Month 6. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Month 6
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -4.0 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -3.7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -3.5 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -3.3 |
| Placebo | -3.0 |
"Changes in Vasomotor Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | Score on a Scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -3.8 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -3.3 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -3.3 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -3.2 |
| Placebo | -2.2 |
"Changes in Vasomotor Domain Score from Baseline to Week 12. The MENQOL is self-administered questionnaire which assessed changes in quality of life over a one-month period. It is composed of 29 questions indicating if subject experienced the problem (Yes/No) and if Yes, rating scale ranged from 0=Not bothered at all to 6=Extremely bothered. For analysis, the original scores were converted to the analysis score ranging from 1-8 where No=1, 0=2, 1=3...and 6=8. The scale contains four domains: vasomotor, psychosocial, physical and sexual. Each domain is scored separately. Vasomotor domain score is mean of = Q1,Q2, Q3, with 1 being not at all bothered and 8 being extremely bothered." (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | score on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -3.5 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -3.1 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -3.1 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -2.9 |
| Placebo | -2.2 |
Summary of the number of days with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 2
| Intervention | Days (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 0.9 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0.4 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 0.4 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0.2 |
| Placebo | 0.1 |
Summary of the number of days with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 3
| Intervention | Days (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 0.5 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0.5 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 0.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0.1 |
| Placebo | 0.0 |
Summary of the number of days with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 4
| Intervention | Days (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 0.8 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0.4 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 0.2 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0.0 |
| Placebo | 0.1 |
Summary of the number of days with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 1
| Intervention | Days (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 3.0 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 1.7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 1.3 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0.8 |
| Placebo | 0.6 |
Summary of the number of days with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 2
| Intervention | Days (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 2.9 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0.9 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 1.5 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0.7 |
| Placebo | 0.1 |
Summary of the number of days with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 3
| Intervention | Days (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 2.5 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0.7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 0.9 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0.3 |
| Placebo | 0.0 |
Summary of the number of days with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 4
| Intervention | Days (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 1.9 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0.5 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 0.8 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0.3 |
| Placebo | 0.1 |
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 1 to 13 was calculated and compared between active and placebo treatments. (NCT01942668)
Timeframe: Cycle 1 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 156 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 202 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 207 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 196 |
| Placebo | 71 |
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 10 to 13 was calculated and compared between active and placebo treatments. (NCT01942668)
Timeframe: Cycle 10 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 222 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 271 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 273 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 248 |
| Placebo | 85 |
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 11 to 13 was calculated and compared between active and placebo treatments. (NCT01942668)
Timeframe: Cycle 11 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 231 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 275 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 277 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 249 |
| Placebo | 85 |
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 12 to 13 was calculated and compared between active and placebo treatments. (NCT01942668)
Timeframe: Cycle 12 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 238 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 278 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 278 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 252 |
| Placebo | 86 |
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 2 to 13 was calculated and compared between active and placebo treatments. (NCT01942668)
Timeframe: Cycle 2 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 166 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 220 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 215 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 212 |
| Placebo | 74 |
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 3 to 13 was calculated and compared between active and placebo treatments. (NCT01942668)
Timeframe: Cycle 3 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 174 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 227 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 225 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 218 |
| Placebo | 77 |
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 4 to 13 was calculated and compared between active and placebo treatments. (NCT01942668)
Timeframe: Cycle 4 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 177 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 236 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 233 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 229 |
| Placebo | 80 |
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 5 to 13 was calculated and compared between active and placebo treatments. (NCT01942668)
Timeframe: Cycle 5 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 183 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 244 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 240 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 234 |
| Placebo | 80 |
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 6 to 13 was calculated and compared between active and placebo treatments. (NCT01942668)
Timeframe: Cycle 6 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 186 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 250 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 249 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 236 |
| Placebo | 80 |
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 7 to 13 was calculated and compared between active and placebo treatments. (NCT01942668)
Timeframe: Cycle 7 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 200 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 253 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 255 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 238 |
| Placebo | 82 |
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 8 to 13 was calculated and compared between active and placebo treatments. (NCT01942668)
Timeframe: Cycle 8 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 209 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 262 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 262 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 242 |
| Placebo | 84 |
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from Cycle 9 to 13 was calculated and compared between active and placebo treatments. (NCT01942668)
Timeframe: Cycle 9 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 214 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 267 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 266 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 246 |
| Placebo | 84 |
Cumulative amenorrhea is defined as the absence of bleeding or spotting for a cumulative period. Cumulative rates of amenorrhea were defined as the percentage of women who reported consecutive cycles of amenorrhea for a given cycle of time. Within each treatment arm, the percentage of subjects with cumulative amenorrhea from the 13th Cycle was calculated and compared between active and placebo treatments. (NCT01942668)
Timeframe: The 13th Cycle
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 249 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 282 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 283 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 254 |
| Placebo | 88 |
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time. (NCT01942668)
Timeframe: Cycle 1 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 204 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 251 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 263 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 239 |
| Placebo | 82 |
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time. (NCT01942668)
Timeframe: Cycle 10 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 248 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 281 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 292 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 261 |
| Placebo | 88 |
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time. (NCT01942668)
Timeframe: Cycle 11 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 251 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 284 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 294 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 261 |
| Placebo | 88 |
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time. (NCT01942668)
Timeframe: Cycle 12 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 260 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 284 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 295 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 260 |
| Placebo | 88 |
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time. (NCT01942668)
Timeframe: Cycle 2 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 209 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 256 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 265 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 244 |
| Placebo | 84 |
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time. (NCT01942668)
Timeframe: Cycle 3 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 214 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 258 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 267 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 246 |
| Placebo | 85 |
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time. (NCT01942668)
Timeframe: Cycle 4 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 217 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 261 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 273 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 253 |
| Placebo | 86 |
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time. (NCT01942668)
Timeframe: Cycle 6 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 227 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 268 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 280 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 256 |
| Placebo | 86 |
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time. (NCT01942668)
Timeframe: Cycle 7 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 237 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 271 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 282 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 256 |
| Placebo | 87 |
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time. (NCT01942668)
Timeframe: Cycle 8 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 242 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 276 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 285 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 258 |
| Placebo | 88 |
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time. (NCT01942668)
Timeframe: Cycle 9 to 13
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 245 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 279 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 288 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 259 |
| Placebo | 88 |
No bleeding was defined as the absence of bleeding. Cumulative rates for no bleeding was defined as the percentage of women who reported consecutive cycles of no bleeding for a given cycle of time. (NCT01942668)
Timeframe: The 13th Cycle
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 268 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 287 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 296 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 261 |
| Placebo | 89 |
Endometrial biopsies centrally evaluated by 2 primary pathologists using criteria from Blaustein's Pathology text. Pathologists classified bx into 1 of following 3 categories: Cat.1: Non-endometrial malignancy/non-hyperplasia; Cat.2: Endometrial hyperplasia; Cat.3: Endometrial malignancy. Consensus reached when 2 primary pathologist agreed on any of above categories; if primary pathologists disagreed on presence of hyperplasia, result of 3rd pathologist was utilized and final decision regarding presence of hyperplasia was based on diagnosis of majority. If all 3 reads disparate, final diagnosis based on most severe dx. Incidence rate calculated as: I=A/B where I=incidence rate at M12 evaluation, A=all new subjects with biopsies positive for endometrial hyperplasia during study but post-Baseline, B=all subjects w/biopsies following M11 meeting criteria specified plus all subjects w/biopsies positive for endometrial hyperplasia by any pathologists before M11. (NCT01942668)
Timeframe: Baseline and Month 12
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 0 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 0 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 0 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 0 |
| Placebo | 0 |
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 1. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 1
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.06 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.05 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.02 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.08 |
| Placebo | -0.07 |
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 10. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 10
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.87 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.58 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.57 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.45 |
| Placebo | -0.35 |
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 11. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 11
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.86 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.67 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.56 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.50 |
| Placebo | -0.36 |
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.94 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.71 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.54 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.54 |
| Placebo | -0.39 |
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 2. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 2
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.16 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.14 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.06 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.12 |
| Placebo | -0.11 |
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 3. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 3
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.25 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.24 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.11 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.20 |
| Placebo | -0.15 |
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 4
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.31 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.31 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.19 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.27 |
| Placebo | -0.17 |
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 5. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 5
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.46 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.37 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.23 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.36 |
| Placebo | -0.24 |
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 6. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 6
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.62 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.42 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.33 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.46 |
| Placebo | -0.27 |
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 7. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 7
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.65 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.50 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.42 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.47 |
| Placebo | -0.27 |
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 8. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 8
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.70 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.51 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.44 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.47 |
| Placebo | -0.33 |
Mean change in severity of mild, moderate and severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 9. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score =(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 9
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.78 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.55 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.51 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.54 |
| Placebo | -0.31 |
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 1. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 1
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.24 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.25 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.23 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.25 |
| Placebo | -0.25 |
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 10. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 10
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.05 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.77 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.78 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.62 |
| Placebo | -0.53 |
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 11. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 11
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.04 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.86 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.78 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.68 |
| Placebo | -0.54 |
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 12. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -1.12 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.90 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.76 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.71 |
| Placebo | -0.56 |
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 2. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 2
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.34 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.34 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.27 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.29 |
| Placebo | -0.28 |
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 3. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 3
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.43 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.44 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.32 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.37 |
| Placebo | -0.32 |
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 4. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 4
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.48 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.51 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.40 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.44 |
| Placebo | -0.34 |
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 5. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 5
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.64 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.56 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.44 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.53 |
| Placebo | -0.42 |
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 6. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 6
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.80 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.61 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.54 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.63 |
| Placebo | -0.45 |
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 7. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 7
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.81 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.69 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.63 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.64 |
| Placebo | -0.44 |
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 8. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 8
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.88 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.70 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.65 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.64 |
| Placebo | -0.51 |
Mean change in severity of moderate to severe vasomotor symptoms at Baseline to mild, moderate to severe vasomotor symptoms at Week 9. The baseline was the most recent 7 consecutive days of data prior to randomization. The severity score was derived as follows: mild = 1, moderate = 2, severe = 3. Baseline Weekly Severity Score = (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of moderate to severe hot flushes over 7 days). On Treatment Weekly Severity Score = [(number of mild hot flushes for 7 days) x 1 + (number of moderate hot flushes for 7 days) x 2 + (number of severe hot flushes for 7 days) x 3] / (total number of mild, moderate and severe hot flushes over 7 days). (NCT01942668)
Timeframe: Baseline and Week 9
| Intervention | scores on a scale (Mean) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | -0.96 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -0.74 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -0.73 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -0.71 |
| Placebo | -0.48 |
Summary of subject incidence with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 1
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 48 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 29 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 25 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 24 |
| Placebo | 4 |
Summary of subject incidence with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 2
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 45 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 23 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 19 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 5 |
| Placebo | 2 |
Summary of subject incidence with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 3
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 25 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 21 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 16 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 7 |
| Placebo | 1 |
Summary of subject incidence with bleeding per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 4
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 27 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 16 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 9 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 5 |
| Placebo | 2 |
Summary of subject incidence with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 1
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 90 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 74 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 68 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 58 |
| Placebo | 10 |
Summary of subject incidence with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 2
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 76 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 40 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 48 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 24 |
| Placebo | 4 |
Summary of subject incidence with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 3
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 54 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 33 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 29 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 18 |
| Placebo | 2 |
Summary of subject incidence with spotting per trimester as recorded in a daily diary. A trimester is defined as every 90 days since Day 1. (NCT01942668)
Timeframe: Trimester 4
| Intervention | Participants (Count of Participants) |
|---|---|
| Combined Estradiol 1 mg / Progesterone 100 mg | 47 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 21 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 27 |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 18 |
| Placebo | 4 |
The number and percentage of subjects for each possible response to the CGI at Week 12. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo. (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| (Very) Much Improved | Minimally Improved | No Change or Worse | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 101 | 24 | 14 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 97 | 29 | 7 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 102 | 22 | 7 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 101 | 17 | 5 |
| Placebo | 62 | 26 | 28 |
The number and percentage of subjects for each possible response to the CGI at Week 4. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo. (NCT01942668)
Timeframe: Baseline and Week 4
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| (Very) Much Improved | Minimally Improved | No Change or Worse | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 75 | 51 | 22 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 71 | 49 | 21 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 72 | 49 | 23 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 86 | 37 | 13 |
| Placebo | 41 | 49 | 35 |
The number and percentage of subjects for each possible response to the CGI at Week 8. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo. (NCT01942668)
Timeframe: Baseline and Week 8
| Intervention | Participants (Count of Participants) | ||
|---|---|---|---|
| (Very) Much Improved | Minimally Improved | No Change or Worse | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 93 | 35 | 13 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 103 | 24 | 12 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 98 | 23 | 13 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 101 | 23 | 6 |
| Placebo | 62 | 25 | 30 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 12 for the respective CGI category. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo. (NCT01942668)
Timeframe: Baseline and Week 12
| Intervention | weekly hot flushes (Mean) | ||
|---|---|---|---|
| (Very) Much Improved | Minimally Improved | No Change or Worse | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -59.9 | -40.6 | -8.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -60.0 | -34.9 | -38.8 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -58.2 | -28.8 | -8.6 |
| Combined Estradiol 1 mg / Progesterone 100 mg | -58.8 | -35.9 | -30.7 |
| Placebo | -56.2 | -35.7 | -9.2 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 4 for the respective CGI category. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo. (NCT01942668)
Timeframe: Baseline and Week 4
| Intervention | weekly hot flushes (Mean) | ||
|---|---|---|---|
| (Very) Much Improved | Minimally Improved | No Change or Worse | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -55.7 | -28.9 | -5.3 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -48.6 | -25.9 | -6.6 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -46.2 | -29.2 | -2.7 |
| Combined Estradiol 1 mg / Progesterone 100 mg | -52.5 | -24.1 | -6.5 |
| Placebo | -47.0 | -26.8 | -5.3 |
Mean change in frequency of moderate to severe vasomotor symptoms from Baseline to Week 8 for the respective CGI category. The CGI score is a seven point scale where subjects were asked to rate the total improvement, whether or not in her judgment it was due entirely to drug treatment, compared to her condition at admission to the study. Scale: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. Results for the top two responses (Very Much Improved and Much Improved) and No Change or Worsening (Minimally worse, Much worse, Very much worse) were combined for each group and active treatment groups compare to placebo. (NCT01942668)
Timeframe: Baseline and Week 8
| Intervention | weekly hot flushes (Mean) | ||
|---|---|---|---|
| (Very) Much Improved | Minimally Improved | No Change or Worse | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | -57.8 | -36.8 | -7.4 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | -55.1 | -27.3 | -15.2 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | -55.4 | -27.2 | -1.6 |
| Combined Estradiol 1 mg / Progesterone 100 mg | -60.8 | -28.7 | -0.2 |
| Placebo | -52.6 | -27.0 | -7.1 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 1. (NCT01942668)
Timeframe: Baseline and Week 1
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 19 | 4 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 10 | 2 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 12 | 1 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 14 | 2 |
| Placebo | 10 | 1 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 10. (NCT01942668)
Timeframe: Baseline and Week 10
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 93 | 57 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 94 | 60 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 92 | 57 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 93 | 73 |
| Placebo | 54 | 23 |
Number of Subjects with >=50%, and separately, >=75% reduction in frequency of mild, moderate and severe vasomotor symptoms from Baseline to Week 11. (NCT01942668)
Timeframe: Baseline and Week 11
| Intervention | Participants (Count of Participants) | |
|---|---|---|
| >=50% Reduction | >=75% Reduction | |
| Combined Estradiol 0.25 mg / Progesterone 50 mg | 95 | 62 |
| Combined Estradiol 0.5 mg / Progesterone 100 mg | 97 | 64 |
| Combined Estradiol 0.5 mg / Progesterone 50 mg | 94 | 52 |
| Combined Estradiol 1 mg / Progesterone 100 mg | 94 | 71 |
| Placebo | 55 | 26 |
"Putamen reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups at pre-treatment." (NCT02255175)
Timeframe: Pre-treatment (visit 3)
| Intervention | percent signal change (Mean) |
|---|---|
| Perimenopausal Women, Depressed | .015 |
| Perimenopausal Women, Non-depressed | .004 |
"The Dysphoria Scale of the Inventory of Depression and Anxiety Symptoms (IDAS) will be used to assess the change in depressive symptom severity. The IDAS Dysphoria Scale consists of 10 items and uses a 5-point Likert-type scale, ranging from 1 to 5 with 1 indicating not at all and 5 indicating extremely. As such, the range of possible scores is 10 to 50. The Dysphoria scale includes items assessing feelings of depression, inadequacy, psychomotor agitation, guilt, discouragement, anhedonia, poor concentration, difficulty with decision-making, psychomotor retardation, and worry. Higher scores indicate worse depression symptoms." (NCT02255175)
Timeframe: Assessed at pre- and post-treatment (visits 3 and 6)
| Intervention | score on a scale (Mean) |
|---|---|
| Perimenopausal Women, Depressed, Baseline | 24.56 |
| Perimenopausal Women, Non-depressed, Baseline | 13.79 |
| Perimenopausal Women, Depressed, Following Estradiol Treatment | 15.25 |
| Perimenopausal Women, Non-depressed, Following Estradiol | 11.84 |
"Caudate reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups following treatment." (NCT02255175)
Timeframe: Post-treatment (visit 6)
| Intervention | percent signal change (Mean) |
|---|---|
| Perimenopausal Women, Depressed | .005 |
| Perimenopausal Women, Non-depressed | .026 |
"Caudate reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups at pre-treatment." (NCT02255175)
Timeframe: Pre-treatment (visit 3)
| Intervention | percent signal change (Mean) |
|---|---|
| Perimenopausal Women, Depressed | .027 |
| Perimenopausal Women, Non-depressed | .043 |
"Time (ms) between stimulus and response will be measured during reward trials of the Monetary Incentive Delay (MID) task. During MID the task, participants need to select the correct response during win and lose conditions by pressing a button on a button box in the MRI." (NCT02255175)
Timeframe: Post-treatment (visit 6)
| Intervention | Milliseconds (Mean) |
|---|---|
| Perimenopausal Women, Depressed | 190.68 |
| Perimenopausal Women, Non-depressed | 193.43 |
"Time (ms) between stimulus and response will be measured during the Monetary Incentive Delay (MID) task during the win trials. During MID the task, participants need to select the correct response during win and lose conditions by pressing a button on a button box in the MRI." (NCT02255175)
Timeframe: Pre-treatment (visit 3)
| Intervention | Milliseconds (Mean) |
|---|---|
| Perimenopausal Women, Depressed | 204.17 |
| Perimenopausal Women, Non-depressed | 209.63 |
"Putamen reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups following treatment." (NCT02255175)
Timeframe: Post-treatment (visit 6)
| Intervention | percent signal change (Mean) |
|---|---|
| Perimenopausal Women, Depressed | -.030 |
| Perimenopausal Women, Non-depressed | .032 |
"Nucleus accumbens (NAcc) reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups following treatment." (NCT02255175)
Timeframe: Post-treatment (visit 6)
| Intervention | percent signal change (Mean) |
|---|---|
| Perimenopausal Women, Depressed | .040 |
| Perimenopausal Women, Non-depressed | .059 |
"Nucleus Accumbens (NAcc) reactivity to reward during the Monetary Incentive Delay (MID) task was measured between the two groups. During MID the task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when the see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared between the two groups at pre-treatment." (NCT02255175)
Timeframe: Pre-treatment (visit 3)
| Intervention | percent signal change (Mean) |
|---|---|
| Perimenopausal Women, Depressed | .045 |
| Perimenopausal Women, Non-depressed | .052 |
"Primary Efficacy Endpoint was the percentage of patients failing to maintain castrate levels of T (T < 50 ng/dL).~Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 12." (NCT02349386)
Timeframe: Week 12
| Intervention | Participants (Count of Participants) |
|---|---|
| BHR-200 Low Dose | 3 |
| BHR-200 Mid Dose | 3 |
| BHR-200 High Dose | 5 |
| Placebo | 2 |
Serum concentrations of prostate specific antigen (PSA) (NCT02349386)
Timeframe: To Week 52/End of Study: Both 24-Week Main Study and Optional 28-Week Extension Study
| Intervention | ng/ML (Mean) | ||||
|---|---|---|---|---|---|
| Baseline PSA | Week 4 PSA | Week 8 PSA | Week 12 PSA | Week 16 PSA | |
| Placebo | 0.334 | 0.481 | 0.870 | 1.395 | 0.090 |
Serum concentrations of follicle-stimulating hormone (FSH) (NCT02349386)
Timeframe: Reported for Baseline, Week 12, Week 24, Week 36 and Week 48
| Intervention | IU/L (Mean) | |
|---|---|---|
| Baseline FSH | Week 12 FSH | |
| Placebo | 5.700 | 9.450 |
Serum concentrations of sex hormone binding globulin (SHBG) (NCT02349386)
Timeframe: Reported for Baseline, Week 12, Week 24, Week 36 and Week 48
| Intervention | nmol/L (Mean) | ||||
|---|---|---|---|---|---|
| Baseline SHBG | Week 12 SHBG | Week 24 SHBG | Week 36 SHBG | Week 48 SHBG | |
| BHR-200 High Dose | 45.8 | 55.2 | 71.3 | 47.0 | 58.0 |
| BHR-200 Low Dose | 49.7 | 48.7 | 50.3 | 37.0 | 46.0 |
| BHR-200 Mid Dose | 52.8 | 55.7 | 52.0 | 53.5 | 42.5 |
Serum concentrations of sex hormone binding globulin (SHBG) (NCT02349386)
Timeframe: Reported for Baseline, Week 12, Week 24, Week 36 and Week 48
| Intervention | nmol/L (Mean) | |
|---|---|---|
| Baseline SHBG | Week 12 SHBG | |
| Placebo | 48.8 | 27.0 |
Serum concentrations of prostate specific antigen (PSA) (NCT02349386)
Timeframe: To Week 52/End of Study: Both 24-Week Main Study and Optional 28-Week Extension Study
| Intervention | ng/ML (Mean) | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline PSA | Week 4 PSA | Week 8 PSA | Week 12 PSA | Week 16 PSA | Week 20 PSA | Week 24 PSA | Week 28 PSA | Week 32 PSA | Week 36 PSA | Week 40 PSA | Week 44 PSA | Week 48 PSA | Week 52 PSA | |
| BHR-200 High Dose | 8.058 | 5.170 | 4.995 | 4.380 | 6.960 | 5.345 | 4.745 | 4.863 | 4.563 | 7.050 | 7.800 | 12.600 | 12.800 | 13.300 |
| BHR-200 Low Dose | 0.374 | 0.459 | 0.545 | 0.330 | 0.297 | 0.330 | 0.363 | 0.430 | 0.463 | 0.650 | 0.750 | 0.500 | 0.700 | 0.700 |
| BHR-200 Mid Dose | 0.921 | 1.483 | 1.145 | 0.227 | 0.160 | 0.127 | 0.145 | 0.090 | 0.145 | 0.145 | 0.145 | 0.145 | 0.145 | 0.145 |
Serum concentrations of luteinizing hormone (LH) (NCT02349386)
Timeframe: Reported for Baseline, Week 12, Week 24, Week 36 and Week 48
| Intervention | IU/L (Mean) | ||||
|---|---|---|---|---|---|
| Baseline LH | Week 12 LH | Week 24 LH | Week 36 LH | Week 48 LH | |
| BHR-200 High Dose | 0.190 | 1.597 | 0.393 | 3.750 | 0.300 |
| BHR-200 Low Dose | 0.380 | 0.227 | 0.997 | 0.645 | 0.600 |
| BHR-200 Mid Dose | 0.470 | 0.527 | 0.395 | 0.345 | 0.300 |
Serum concentrations of luteinizing hormone (LH) (NCT02349386)
Timeframe: Reported for Baseline, Week 12, Week 24, Week 36 and Week 48
| Intervention | IU/L (Mean) | |
|---|---|---|
| Baseline LH | Week 12 LH | |
| Placebo | 0.530 | 2.050 |
Serum concentrations of follicle-stimulating hormone (FSH) (NCT02349386)
Timeframe: Reported for Baseline, Week 12, Week 24, Week 36 and Week 48
| Intervention | IU/L (Mean) | ||||
|---|---|---|---|---|---|
| Baseline FSH | Week 12 FSH | Week 24 FSH | Week 36 FSH | Week 48 FSH | |
| BHR-200 High Dose | 3.963 | 3.848 | 0.848 | 10.600 | 1.500 |
| BHR-200 Low Dose | 4.478 | 0.630 | 1.600 | 2.050 | 2.00 |
| BHR-200 Mid Dose | 5.225 | 0.493 | 0.795 | 1.095 | 0.795 |
Number of patients and severity of thromboembolic adverse events (NCT02349386)
Timeframe: To Week 52/End of Study: Both 24-Week Main Study and Optional 28-Week Extension Study
| Intervention | Participants (Count of Participants) |
|---|---|
| BHR-200 Low Dose | 0 |
| BHR-200 Mid Dose | 0 |
| BHR-200 High Dose | 0 |
| Placebo | 0 |
Proportion of patients failing to maintain castrate levels of T (T < 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 24 to 52/End of Study (NCT02349386)
Timeframe: Double-blind 28-Week Optional Extension Study from Week 24 to Week 52/End of Study
| Intervention | Participants (Count of Participants) |
|---|---|
| BHR-200 Low Dose | 1 |
| BHR-200 Mid Dose | 2 |
| BHR-200 High Dose | 2 |
| Placebo | 0 |
Pproportion of patients failing to maintaincastrate levels of T (T < 50 ng/dL). Testosterone suppression, defined as the absence of any T level measurement over 50 ng/dL during Weeks 4 to 24. (NCT02349386)
Timeframe: Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| BHR-200 Low Dose | 3 |
| BHR-200 Mid Dose | 2 |
| BHR-200 High Dose | 3 |
| Placebo | 0 |
"Matsuda index is calculated from the standard 2h Oral Glucose Tolerance Test and corresponding insulin values.~Matsuda index = 10,000/square root of [fasting glucose x fasting insulin] x [mean glucose x mean insulin during OGTT]) The Matsuda index is correlated (r = 0.73) with the rate of whole-body glucose disposal during the euglycemic insulin clamp.~Matsuda index <2.5 is considered insulin resistant, higher values indicate less insulin resistance. A decrease in matsuda index over the study period would indicate decreased insulin sensitivity." (NCT02352090)
Timeframe: We calculated the change in Matsuda index from baseline to 9 weeks.
| Intervention | units on a scale (Mean) |
|---|---|
| Synthetic Estrogen + Progestin | -1.02 |
| Natural Estrogen + Progestin | -0.10 |
| Progestin-Only | -1.45 |
Markers of coagulation activation (NCT02352090)
Timeframe: baseline and 9 weeks
| Intervention | percentage change from baseline (Mean) |
|---|---|
| Synthetic Estrogen + Progestin | 12.6 |
| Natural Estrogen + Progestin | 2.4 |
| Progestin-Only | -1.6 |
Change in Serum concentrations of anti-mullerian hormone reflecting ovarian reserve from baseline to nine weeks (NCT02352090)
Timeframe: baseline and 9 weeks
| Intervention | ng/mL (Mean) |
|---|---|
| Synthetic Estrogen + Progestin | -0.8 |
| Natural Estrogen + Progestin | -0.4 |
| Progestin-Only | 0.07 |
Change in plasma concentrations of F1+2 a marker of coagulation activation (NCT02352090)
Timeframe: baseline and 9 weeks
| Intervention | percentage change from baseline (Mean) |
|---|---|
| Synthetic Estrogen + Progestin | 24.1 |
| Natural Estrogen + Progestin | -5.5 |
| Progestin-Only | -8.5 |
Change in concentrations of total cholesterol from baseline to nine weeks (NCT02352090)
Timeframe: baseline and 9 weeks
| Intervention | mmol/L (Mean) |
|---|---|
| Synthetic Estrogen + Progestin | 0.10 |
| Natural Estrogen + Progestin | -0.16 |
| Progestin-Only | 0.11 |
Change in triglyceride concentrations from baseline to nine weeks (NCT02352090)
Timeframe: baseline and 9 weeks
| Intervention | mmol/L (Mean) |
|---|---|
| Synthetic Estrogen + Progestin | 0.45 |
| Natural Estrogen + Progestin | 0.18 |
| Progestin-Only | 0.06 |
Change from baseline in thrombin generation, measured by thrombin generation assay-Calibrated automated thrombogram (NCT02352090)
Timeframe: baseline and 9 weeks
| Intervention | percentage change from baseline (Mean) |
|---|---|
| Synthetic Estrogen + Progestin | 63.9 |
| Natural Estrogen + Progestin | 26.4 |
| Progestin-Only | 7.1 |
Change in concentration of Low-Density Lipoprotein LDL from baseline to nine weeks (NCT02352090)
Timeframe: baseline and 9 weeks
| Intervention | mmol/L (Mean) |
|---|---|
| Synthetic Estrogen + Progestin | -0.16 |
| Natural Estrogen + Progestin | -0.14 |
| Progestin-Only | 0.01 |
Change in plasma concentrations of acute phase protein 'C reactive protein' (CRP), a marker of chronic inflammation. (NCT02352090)
Timeframe: baseline and 9 weeks
| Intervention | mg/L (Mean) |
|---|---|
| Synthetic Estrogen + Progestin | 1.10 |
| Natural Estrogen + Progestin | -0.06 |
| Progestin-Only | 0.13 |
Change in concentration of High-Density Lipoprotein HDL from baseline to nine weeks (NCT02352090)
Timeframe: baseline and 9 weeks
| Intervention | mmol/L (Mean) |
|---|---|
| Synthetic Estrogen + Progestin | 0.20 |
| Natural Estrogen + Progestin | -0.02 |
| Progestin-Only | -0.02 |
Mean change in fasting serum insulin from baseline to nine weeks (NCT02352090)
Timeframe: baseline and 9 weeks
| Intervention | mU/l (Mean) |
|---|---|
| Synthetic Estrogen + Progestin | 1.4 |
| Natural Estrogen + Progestin | 1.02 |
| Progestin-Only | 1.99 |
Total number (N=10) of participants analyzed within each treatment group who were sexually active at both Baseline and Day 15 and provided a response at both visits. (NCT02449902)
Timeframe: Baseline to 15 days post-treatment
| Intervention | participants (Number) | |||
|---|---|---|---|---|
| Bleeding/ No Bleeding (Success) | Bleeding/ Bleeding (Failure) | No Bleeding/ Bleeding (Failure) | No Bleeding/ No Bleeding (No Change) | |
| Placebo | 1 | 3 | 1 | 5 |
| TX-12-004-HR 10μg | 2 | 0 | 0 | 8 |
(NCT02449902)
Timeframe: Baseline to 15 days post-treatment
| Intervention | Percentage of Intermediate Cells (Least Squares Mean) |
|---|---|
| TX-12-004-HR 10μg | 18.7 |
| Placebo | -3.5 |
Outcome was measured by using a severity scale. No Atrophy has rogation and elasticity of vault(0). Mild atrophy has poor rogation with some elasticity noted of vaginal vault(1). Moderate atrophy is smooth, some elasticity of vaginal vault(2). Severe atrophy is smooth, no elasticity, constriction of the upper one third of vagina or loss of vaginal tone (cystocele and rectocele)(3). (NCT02449902)
Timeframe: Baseline to 15 days post-treatment
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Treatment 1 | -0.034 |
| Treatment 2 | -0.133 |
Outcome was measured by using a severity scale. No Atrophy=normal(0). Mild atrophy=vaginal surface bleeds with scraping(1). Moderate atrophy=vaginal surface bleeds with light contact(2). Severe atrophy=vaginal surface has petechiae before contact and bleeds with light contact(3). (NCT02449902)
Timeframe: Baseline to 15 days post-treatment
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| TX-12-004-HR 10μg | -0.342 |
| Placebo | 0.176 |
(NCT02449902)
Timeframe: Baseline to 15 days post-treatment
| Intervention | Percentage of Parabasal Cells (Least Squares Mean) |
|---|---|
| TX-12-004-HR 10μg | -54.4 |
| Placebo | -4.8 |
Outcome was measured by using a severity scale. No Atrophy has normal clear secretions noted on vaginal walls(0). Mild atrophy has superficial coating of secretions, difficulty with speculum insertion(1). Moderate atrophy is scant not covering the entire vaginal vault, may need lubrication with speculum insertion to prevent pain(2). Severe atrophy has none, inflamed, ulceration noted, need lubrication with speculum insertion to prevent pain(3). (NCT02449902)
Timeframe: Baseline to 15 days post-treatment
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| TX-12-004-HR 10μg | -0.643 |
| Placebo | -0.274 |
Outcome was measured by using a severity scale. No Atrophy is pink in color (0). Mild atrophy is lighter in color (1). Moderate atrophy is pale in color (2). Severe atrophy is transparent, either no color or inflamed (3). (NCT02449902)
Timeframe: Baseline to 15 days post-treatment
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| TX-12-004-HR 10μg | -0.199 |
| Placebo | -0.009 |
(NCT02449902)
Timeframe: Baseline to 15 days post-treatment
| Intervention | Percentage of Superficial Cells (Least Squares Mean) |
|---|---|
| TX-12-004-HR 10μg | 35.2 |
| Placebo | 8.8 |
The severity of the most bothersome VVA symptom was self-assessed by each subject using a VVA questionnaire. The questionnaire has a 4-point scoring scale with: None=0, Mild=1, Moderate=2, and Severe=3. The lower the score, the least bothersome it is to the subject. (NCT02449902)
Timeframe: Baseline to 15 days post-treatment
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| TX-12-004-HR 10μg | -1.043 |
| Placebo | -1.042 |
(NCT02449902)
Timeframe: Baseline to 15 days post-treatment
| Intervention | pH (Least Squares Mean) |
|---|---|
| TX-12-004-HR 10μg | -0.97 |
| Placebo | -0.34 |
The Primary Efficacy Outcome Measure for this study was contraceptive efficacy, or the prevention of in-treatment pregnancy. The total incidence of in-treatment pregnancies was expressed as the Pearl Index, which is defined as the number of in-treatment pregnancies per 100 woman-years of exposure (one woman-year defined as a period of 365.25 days). NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. (NCT02616146)
Timeframe: Up to 1 year (13 28-day cycles)
| Intervention | Pregnancies per 100 woman years (Number) |
|---|---|
| ENG-E2 125 μg/300 μg | 1.54 |
| LNG-EE 150 μg/30 μg | 2.93 |
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. (NCT02616146)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|---|
| ENG-E2 125 μg/300 μg | 61 |
| LNG-EE 150 μg/30 μg | 23 |
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. (NCT02616146)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) |
|---|---|
| ENG-E2 125 μg/300 μg | 530 |
| LNG-EE 150 μg/30 μg | 140 |
Participants were asked to keep a daily diary to record vaginal bleeding events. AWB was defined as no bleeding/spotting during the expected bleeding period. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. (NCT02616146)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 | Cycle 2 | Cycle 3 | Cycle 4 | Cycle 5 | Cycle 6 | Cycle 7 | Cycle 8 | Cycle 9 | |
| ENG-E2 125 μg/300 μg | 76 | 34 | 26 | 17 | 3 | 3 | 0 | 0 | 0 |
| LNG-EE 150 μg/30 μg | 15 | 10 | 10 | 6 | 0 | 1 | 2 | 1 | 0 |
BTB-S was considered any bleeding/spotting that occurred during expected non-bleeding interval that was neither early nor continued withdrawal bleeding. BTB-S was classified as follows: Bleeding = any bloody vaginal discharge that required one or more sanitary pads or tampons per day; Spotting = any bloody vaginal discharge that required no sanitary pads or tampons per day. NOTE: Due to early termination of this study, the ENG-E2 reporting group received only up to 10 cycles of treatment, and the LNG-EE reporting group received only up to 9 cycles of treatment. (NCT02616146)
Timeframe: Up to 1 year
| Intervention | Participants (Count of Participants) | |||||||
|---|---|---|---|---|---|---|---|---|
| Cycle 2 | Cycle 3 | Cycle 4 | Cycle 5 | Cycle 6 | Cycle 7 | Cycle 8 | Cycle 9 | |
| ENG-E2 125 μg/300 μg | 166 | 112 | 79 | 42 | 29 | 13 | 8 | 1 |
| LNG-EE 150 μg/30 μg | 54 | 36 | 20 | 13 | 8 | 7 | 2 | 0 |
(NCT02654054)
Timeframe: Month 0 (Baseline), Month 6
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 16.1 |
| Elagolix | 65.9 |
| Elagolix + E2/NETA | 61.5 |
"Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11.~The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date." (NCT02654054)
Timeframe: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 4.4 |
| Elagolix | 84.0 |
| Elagolix + E2/NETA | 56.8 |
"Percentage of responders, defined as participants who met the following conditions:~Menstrual blood loss (MBL) volume < 80 mL during the Final Month (the last 28 days prior to and including the Reference Day, which is defined as the last visit date during the Treatment Period [last treatment visit date] or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date), and~≥ 50% reduction in MBL volume from Baseline to the Final Month.~Participants who prematurely discontinued study drug due to lack of efficacy, requires surgery or invasive intervention for treatment of uterine fibroids, or adverse events were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not." (NCT02654054)
Timeframe: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 8.7 |
| Elagolix | 84.1 |
| Elagolix + E2/NETA | 68.5 |
(NCT02654054)
Timeframe: Month 0 (Baseline), Month 1
| Intervention | mL (Least Squares Mean) |
|---|---|
| Placebo | -19.0 |
| Elagolix | -209.0 |
| Elagolix + Estradiol/Norethindrone Acetate | -135.2 |
(NCT02654054)
Timeframe: Month 0 (Baseline), Month 3
| Intervention | mL (Least Squares Mean) |
|---|---|
| Placebo | 6.1 |
| Elagolix | -234.7 |
| Elagolix + E2/NETA | -192.2 |
(NCT02654054)
Timeframe: Month 0 (Baseline), Month 6
| Intervention | mL (Least Squares Mean) |
|---|---|
| Placebo | -2.3 |
| Elagolix | -236.2 |
| Elagolix + E2/NETA | -194.7 |
"Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.~The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date." (NCT02654054)
Timeframe: Month 0 (Baseline), Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
| Intervention | mL (Least Squares Mean) |
|---|---|
| Placebo | 0.8 |
| Elagolix | -221.5 |
| Elagolix + E2/NETA | -176.7 |
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who discontinued study treatment due to an AE is presented. (NCT02668783)
Timeframe: Up to approximately 128 days
| Intervention | Participants (Number) |
|---|---|
| ENG-E2 125 μg/300 μg | 0 |
| Placebo | 0 |
An AE was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of study treatment. The number of participants who experienced an AE is presented. (NCT02668783)
Timeframe: Up to approximately 158 days
| Intervention | Participants (Number) |
|---|---|
| ENG-E2 125 μg/300 μg | 1 |
| Placebo | 2 |
"Percentage of responders, defined as participants who met the following conditions:~Menstrual blood loss (MBL) volume < 80 mL during the Final Month (the last 28 days prior to and including the Reference Day, which is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date), and~≥ 50% reduction in MBL volume from Baseline to the Final Month.~Participants who prematurely discontinued study drug due to lack of efficacy, requires surgery or invasive intervention for treatment of uterine fibroids, or adverse events were considered non-responders regardless of whether she meets the two aforementioned responder criteria or not." (NCT02691494)
Timeframe: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 10.5 |
| Elagolix | 76.9 |
| Elagolix + E2/NETA | 76.5 |
"Suppression of bleeding is defined as having 0 days of bleeding (spotting is allowed) during the Final Month with the interval starting from Study Day 11.~The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date." (NCT02691494)
Timeframe: Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 4.7 |
| Elagolix | 88.9 |
| Elagolix + E2/NETA | 61.0 |
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL. (NCT02691494)
Timeframe: Month 0 (Baseline), Month 1
| Intervention | mL (Least Squares Mean) |
|---|---|
| Placebo | -2.1 |
| Elagolix | -196.6 |
| Elagolix + E2/NETA | -127.0 |
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL. (NCT02691494)
Timeframe: Month 0 (Baseline), Month 3
| Intervention | mL (Least Squares Mean) |
|---|---|
| Placebo | -14.2 |
| Elagolix | -211.1 |
| Elagolix + E2/NETA | -200.3 |
Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL. (NCT02691494)
Timeframe: Month 0 (Baseline), Month 6
| Intervention | mL (Least Squares Mean) |
|---|---|
| Placebo | 28.5 |
| Elagolix | -223.7 |
| Elagolix + E2/NETA | -198.1 |
"Baseline MBL volume was defined as the mean of total MBL volume from all the qualified menstrual cycles during the Screening Period, in which the total MBL volume is from all validated and non-validated sanitary products and the MBL volume of validated sanitary products only (excluding non-validated sanitary products) was greater than 80 mL.~The Reference Day is defined as the last visit date during the Treatment Period (last treatment visit date) or the last dose date if there are evaluable alkaline hematin data after the last treatment visit date and prior to or on the last dose date." (NCT02691494)
Timeframe: Baseline and Final Month (the last 28 days prior to and including the Reference Day), up to Month 6
| Intervention | mL (Least Squares Mean) |
|---|---|
| Placebo | -4.3 |
| Elagolix | -198.8 |
| Elagolix + E2/NETA | -168.8 |
(NCT02691494)
Timeframe: Month 0 (Baseline), Month 6
| Intervention | percentage of participants (Number) |
|---|---|
| Placebo | 20.8 |
| Elagolix | 40.0 |
| Elagolix + E2/NETA | 50.0 |
A responder is a subject meeting specific vaginal cytology criteria AND a vaginal pH < 5.0 with a change from Visit 1 of at least 0.5. (NCT02770365)
Timeframe: Day 8
| Intervention | percentage of responders (Number) |
|---|---|
| Test Product | 36.8 |
| Reference Product | 32.0 |
| Placebo Product | 0.8 |
Percentage of subjects based on the improvement (change from Visit 2) of the Most Bothersome Symptom at Visit 3. (NCT02770365)
Timeframe: Day 8
| Intervention | Participants (Count of Participants) |
|---|---|
| Test Product | 116 |
| Reference Product | 123 |
"The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all [1], mild limitation [2], moderate limitation [3], quite a bit of limitation [4], and extreme limitation [5]).~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -1.6 |
| Placebo (Group C) | -0.5 |
"Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -1.5 |
| Placebo (Group C) | -0.4 |
"LS means and p-value for test of difference is relugolix plus E2/NETA minus Placebo based on mixed-effect model with treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Week 24
| Intervention | percent change (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 20.8 |
| Placebo (Group C) | 10.0 |
"The volume of the uterus was measured by transvaginal or transabdominal ultrasound.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | percent change (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -12.9 |
| Placebo (Group C) | 2.2 |
"An adverse event was defined as an unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term.~Reported percentages based on the total number of participants in each treatment group.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline through Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 14.8 |
| Placebo (Group C) | 9.4 |
"An adverse event was defined as an unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term.~Reported CI based on exact binomial 95% CI (Clopper-Pearson).~As per the objective of the study, this secondary analysis compared relugolix plus E2/NETA with relugolix plus delayed E2/NETA at Week 12 and are presented below." (NCT03049735)
Timeframe: Baseline through Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 10.94 |
| Relugolix Plus Delayed E2/NETA (Group B) | 36.36 |
"A responder was a participant who had MBL volume of < 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 24). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 24/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented.~As per the objective of the study, the pre-specified primary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: From Baseline up to last 35 days of treatment (up to Week 24)
| Intervention | Percentage of participants (Number) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 73.4 |
| Placebo (Group C) | 18.9 |
"Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin ≤ 10.5 gram (g)/deciliter (dL) at Baseline and reported at Week 24.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA with placebo arms are presented." (NCT03049735)
Timeframe: From Baseline up to Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 50.0 |
| Placebo (Group C) | 21.74 |
"Uterine fibroid-associated pain was assessed by a pain numerical rating scale (NRS). The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain).~Participants were asked to document, in an e-Diary, the worst pain associated with their uterine fibroids that they experienced during the last 24 hours, every day until the end of study drug administration. Pain evaluable participants, defined as those who had maximum NRS score ≥ 4 at Baseline and had at least 28 days (80% of the last 35 days of treatment) of pain scores recorded in the e-Diary, were analyzed.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: From Baseline up to Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 43.10 |
| Placebo (Group C) | 10.14 |
"Amenorrhea was defined as meeting 1 of the following criteria for 2 consecutive visits:~No feminine product returned due to reported amenorrhea;~No feminine product returned due to reports of spotting/negligible bleeding coupled with electronic diary (eDiary) data indicating infrequent non-cyclic bleeding/spotting;~Feminine product collection with a negligible observed MBL volume coupled with eDiary data indicating infrequent non-cyclic bleeding/spotting.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: From Baseline up to last 35 days of treatment (up to Week 24)
| Intervention | percentage of participants (Number) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 52.34 |
| Placebo (Group C) | 5.51 |
"Blood samples for determination of E2 serum concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology.~Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented." (NCT03049735)
Timeframe: Week 24
| Intervention | pg/mL (Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 48.34 |
"Sustained amenorrhea is defined as participants time to achieve and maintain amenorrhea until the date of last study drug.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 67 |
| Placebo (Group C) | 7 |
"Time to amenorrhea was defined as the weeks from date of first dose of study drug to the start of amenorrhea.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: From Baseline through Week 24
| Intervention | weeks (Median) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 5.3 |
| Placebo (Group C) | NA |
"Sustained amenorrhea status as determined based on time to achieve and maintain amenorrhea status.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: From Baseline through Week 24
| Intervention | weeks (Median) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 11.3 |
| Placebo (Group C) | NA |
"Defined as the time to achieve an MBL volume of < 80 mL and a ≥ 50% reduction from Baseline MBL volume as measured by the alkaline hematin method. MBL volume was measured using the alkaline hematin method.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: From Baseline through Week 24
| Intervention | weeks (Median) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 8.3 |
| Placebo (Group C) | 25.1 |
"The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all [1], mild limitation [2], moderate limitation [3], quite a bit of limitation [4], and extreme limitation [5]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: From Baseline through Week 24
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| 1 Category improvement (-1) | 2 Category improvement (-2) | 3 Category improvement (-3) | 4 Category improvement (-4) | |
| Placebo (Group C) | 28 | 14 | 1 | 5 |
| Relugolix Plus E2/NETA (Group A) | 14 | 29 | 22 | 8 |
"The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all [1], mild limitation [2], moderate limitation [3], quite a bit of limitation [4], and extreme limitation [5]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: From Baseline through Week 24
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| 1 Category improvement (-1) | 2 Category improvement (-2) | 3 Category improvement (-3) | 4 Category improvement (-4) | |
| Placebo (Group C) | 16 | 9 | 4 | 4 |
| Relugolix Plus E2/NETA (Group A) | 21 | 18 | 23 | 2 |
"Blood samples for determination of relugolix and NET plasma concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology.~Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics.~As per the objective of the study, only relugolix plus E2/NETA concentration is presented." (NCT03049735)
Timeframe: Week 24
| Intervention | ng/mL (Mean) | |
|---|---|---|
| Relugolix | NET | |
| Relugolix Plus E2/NETA (Group A) | 2.13 | 0.33 |
"BMD was assessed by DXA at the lumbar spine (L1, L2, L3, and L4), total hip, and femoral neck at Baseline and at Week 24. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | percent change (Least Squares Mean) | ||
|---|---|---|---|
| Lumbar Spine (L1 to L4) | Total Hip | Femoral Neck | |
| Placebo (Group C) | 0.052 | 0.549 | 0.307 |
| Relugolix Plus E2/NETA (Group A) | -0.356 | 0.023 | -0.262 |
"The volume of the primary uterine fibroid was measured by transvaginal or transabdominal ultrasound.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | Percent change (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -12.4 |
| Placebo (Group C) | -0.3 |
MBL volume was measured using the alkaline hematin method. As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | percent change (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -84.3 |
| Placebo (Group C) | -23.2 |
"Bone mineral density (BMD) was assessed by dual-energy x-ray absorptiometry (DXA) at the lumbar spine (L1, L2, L3, and L4) at Baseline and at Week 12. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD.~As per the objective of the study, the pre-specified secondary analyses compared relugolix plus E2/NETA with relugolix plus delayed E2/NETA at Week 12 and are presented below." (NCT03049735)
Timeframe: Baseline, Week 12
| Intervention | percent change (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -0.470 |
| Relugolix Plus Delayed E2/NETA (Group B) | -1.995 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03049735)
Timeframe: From Baseline through Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 78 |
| Placebo (Group C) | 45 |
"A Responder was defined as meeting a meaningful change threshold, set as a 20-point change from Baseline, in the Bleeding And Pelvic Discomfort Scale at Week 24 on the transformed score.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 79 |
| Placebo (Group C) | 35 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03049735)
Timeframe: Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 34 |
| Placebo (Group C) | 17 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03049735)
Timeframe: From Baseline through Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 15 |
| Placebo (Group C) | 5 |
"Uterine fibroid-associated pain was assessed by a pain NRS. The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain).~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 42 |
| Placebo (Group C) | 27 |
"Uterine fibroid-associated pain was assessed by a pain NRS. The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain).~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: From Baseline up to the last 35 days of treatment (up to 24 weeks)
| Intervention | Participants (Count of Participants) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 33 |
| Placebo (Group C) | 11 |
"Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -30.9 |
| Placebo (Group C) | -10.5 |
"The UFS-QoL total score was the sum of 6 subscales (concern, activities, energy/mood, control, self-conscious, and sexual function). The raw scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good).~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 38.0 |
| Placebo (Group C) | 12.8 |
"The Bleeding and Pelvic Discomfort Scale consists of 3 items proximal to uterine fibroids that are experienced by most patients (heavy bleeding during the menstrual period [Question 1], passing blood clots during the menstrual period [Question 2], and feeling tightness or pressure in the pelvic area [Question 5]).Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -45.0 |
| Placebo (Group C) | -16.1 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | ng/mL (Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -0.05 |
| Placebo (Group C) | 3.00 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | IU/L (Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -1.90 |
| Placebo (Group C) | 3.62 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | IU/L (Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -6.25 |
| Placebo (Group C) | 0.10 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | pg/mL (Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -22.95 |
| Placebo (Group C) | 51.72 |
"The Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL) Bleeding and Pelvic Discomfort (BPD) Scale has been derived from the UFS-QoL Symptoms Scale. The scale consists of the following 3 symptoms proximal to uterine fibroids: Heavy bleeding during your menstrual period (Question [Q] 1), passing blood clots during your menstrual period (Q2), and feeling tightness or pressure in your pelvic area (Q5). raw scores were transformed to a normalized score: Transformed Score = [(Actual raw score - lowest possible raw score)/(Possible raw score range)] * 100 Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity.~As per the study objective, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only these two arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -45.0 |
| Placebo (Group C) | -16.1 |
"Transformed score ranges from 0 to 100 based on Likert scale (none of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 45.8 |
| Placebo (Group C) | 15.1 |
"Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 44.4 |
| Placebo (Group C) | 14.6 |
"The Menorrhagia Impact was evaluated using a 5-point response scale to assess level of improvement from Baseline to Week 24. Response scale: Not at all, 2. Slightly, 3.Moderately, 4. Quite a bit and 5. Extremely.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -1.9 |
| Placebo (Group C) | -0.8 |
"The Menorrhagia Impact was evaluated using a 5-point response scale to assess level of improvement from Baseline to Week 24. Response scale: Not at all, 2. Slightly, 3.Moderately, 4. Quite a bit and 5. Extremely.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -2.0 |
| Placebo (Group C) | -0.9 |
"Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -1.7 |
| Placebo (Group C) | -0.7 |
"Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -2.1 |
| Placebo (Group C) | -0.6 |
"The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all [1], mild limitation [2], moderate limitation [3], quite a bit of limitation [4], and extreme limitation [5]).~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -2.1 |
| Placebo (Group C) | -0.8 |
"Blood samples for determination of serum concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology.~Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented." (NCT03049735)
Timeframe: Baseline, Week 24
| Intervention | pg/mL (Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -22.95 |
"MBL volume was measured using the alkaline hematin method. Least square (LS) means for test of difference is Relugolix plus E2/NETA minus Placebo based on mixed-effect model with treatment, visit, region, Baseline MBL, and treatment by visit interaction included as fixed effects.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | percent change (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -84.3 |
| Placebo (Group C) | -15.1 |
"Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -1.4 |
| Placebo (Group C) | -0.7 |
"PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all [1], mild limitation [2], moderate limitation [3], quite a bit of limitation [4], and extreme limitation [5]).~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -1.7 |
| Placebo (Group C) | -0.8 |
"Blood samples for determination of E2 serum concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology.~Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | pg/mL (Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -22.30 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | percent change (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 24.3 |
| Placebo (Group C) | 4.3 |
"Bone mineral density (BMD) was assessed by dual-energy x-ray absorptiometry (DXA) at the lumbar spine (L1, L2, L3, and L4) at Baseline and at Week 12. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. The LS means were based on a mixed-effect model with visit, region, Baseline MBL volume, age at Baseline, body mass index at Baseline, BMD at Baseline, race, and treatment by visit interaction included as fixed effects.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: From Baseline up to Week 12
| Intervention | percent change (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -0.819 |
| Relugolix Plus Delayed E2/NETA (Group B) | -1.919 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03103087)
Timeframe: From Baseline through Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 78 |
| Placebo (Group C) | 42 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | pg/mL (Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -22.30 |
| Placebo (Group C) | 39.85 |
"Responder was defined as meeting a meaningful change threshold, set as a 20-point change from Baseline, in the Bleeding And Pelvic Discomfort Scale at Week 24 on the transformed score.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 79 |
| Placebo (Group C) | 37 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03103087)
Timeframe: Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 35 |
| Placebo (Group C) | 18 |
"Uterine fibroid-associated pain was assessed by a pain NRS. The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain).~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 48 |
| Placebo (Group C) | 34 |
"Uterine fibroid-associated pain was assessed by a pain NRS. The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain).~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: From Baseline up to the last 35 days of treatment (up to 24 weeks)
| Intervention | Participants (Count of Participants) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 34 |
| Placebo (Group C) | 17 |
"The UFS-QoL total score was the sum of 6 subscales (concern, activities, energy/mood, control, self-conscious, and sexual function). The raw scores were transformed to normalized scores. Transformed score ranges from 0 to 100. Higher scores are indicative of better health-related quality of life (high = good).~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 37.8 |
| Placebo (Group C) | 13.8 |
"The Bleeding and Pelvic Discomfort Scale consists of 3 items proximal to uterine fibroids that are experienced by most participants (heavy bleeding during the menstrual period [Question 1], passing blood clots during the menstrual period [Question 2], and feeling tightness or pressure in the pelvic area [Question 5]).Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -51.7 |
| Placebo (Group C) | -18.3 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | ng/mL (Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 0.12 |
| Placebo (Group C) | 3.48 |
"Blood samples for determination of relugolix and NET plasma concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology.~Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented." (NCT03103087)
Timeframe: Week 24
| Intervention | ng/mL (Mean) | |
|---|---|---|
| Relugolix | NET | |
| Relugolix Plus E2/NETA (Group A) | 1.96 | 0.28 |
"BMD was assessed by DXA at the lumbar spine (L1, L2, L3, and L4), total hip, and femoral neck (same leg across participants) at Baseline and at Week 24. The scans were read by the central radiology laboratory in accordance with the imaging charter. The same DXA machine was used at the local imaging center at each site and operated in the same scan mode for all images procured for an individual participant. All images were submitted for central reading. The central radiology laboratory collected and evaluated all DXA scans for acceptability and measured BMD. The LS means were based on a mixed-effect model with visit, region, Baseline MBL volume, age at Baseline, body mass index at Baseline, BMD at Baseline, race, and treatment by visit interaction included as fixed effects. For Relugolix plus E2/NETA Lumbar Spine (L1 to L4), number (n)=95.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only rel" (NCT03103087)
Timeframe: Baseline through Week 24
| Intervention | percent change (Least Squares Mean) | ||
|---|---|---|---|
| Lumbar Spine (L1-L4) | Total Hip | Femoral Neck | |
| Placebo (Group C) | 0.315 | -0.044 | 0.019 |
| Relugolix Plus E2/NETA (Group A) | -0.126 | -0.173 | -0.684 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | IU/L (Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -3.10 |
| Placebo (Group C) | 3.04 |
"The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all [1], mild limitation [2], moderate limitation [3], quite a bit of limitation [4], and extreme limitation [5]). Category improvements for symptoms are presented. A 1-category improvement would be severe at Baseline to moderate.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: From Baseline through Week 24
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| 1 Category improvement (-1) | 2 Category improvement (-2) | 3 Category improvement (-3) | 4 Category improvement (-4) | |
| Placebo (Group C) | 19 | 13 | 10 | 2 |
| Relugolix Plus E2/NETA (Group A) | 13 | 30 | 18 | 4 |
"Defined as the time to achieve an MBL volume of < 80 mL and a ≥ 50% reduction from Baseline MBL volume as measured by the alkaline hematin method.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: From Baseline through Week 24
| Intervention | weeks (Median) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 8.4 |
| Placebo (Group C) | 27.1 |
"Sustained amenorrhea status as determined based on time to achieve and maintain amenorrhea status.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: From Baseline through Week 24
| Intervention | weeks (Median) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 16.3 |
| Placebo (Group C) | NA |
"Time to amenorrhea was defined as the weeks from date of first dose of study drug to the start of amenorrhea.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: From Baseline through Week 24
| Intervention | weeks (Median) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 8.9 |
| Placebo (Group C) | NA |
"Sustained amenorrhea is defined as participants time to achieve and maintain amenorrhea until the date of last study drug.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 63 |
| Placebo (Group C) | 4 |
"Blood samples for determination of relugolix and NET plasma concentrations were collected predose at Week 24. Relugolix and NET plasma concentrations were determined using validated bioanalytical methodology.~Concentrations below the quantification limit (BQL) were set to 0 for analysis of summary statistics. As per the objective of the study, only relugolix plus E2/NETA concentration is presented." (NCT03103087)
Timeframe: Week 24
| Intervention | pg/mL (Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 45.34 |
"Amenorrhea was defined as meeting 1 of the following criteria for 2 consecutive visits:~No feminine product returned due to reported amenorrhea;~No feminine product returned due to reports of spotting/negligible bleeding coupled with electronic diary (e-Diary) data indicating infrequent non-cyclic bleeding/spotting;~Feminine product collection with a negligible observed MBL volume coupled with e-Diary data indicating infrequent non-cyclic bleeding/spotting.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: From Baseline up to last 35 days of treatment (up to Week 24)
| Intervention | Percentage of participants (Number) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 50.40 |
| Placebo (Group C) | 3.10 |
"Uterine fibroid-associated pain was assessed by a pain numerical rating scale (NRS). The pain NRS is a validated, single-item, self-reported measure, which asks respondents to rank their pain on an 11-point scale as follows: 0 (no pain), 1 to 3 (mild pain), 4 to 6 (moderate pain), and 7 to 10 (severe pain).~Participants were asked to document, in an e-Diary, the worst pain associated with their uterine fibroids that they experienced during the last 24 hours, every day until the end of study drug administration. Pain evaluable participants, defined as those who had maximum NRS score ≥ 4 at baseline and had at least 28 days (80% of the last 35 days of treatment) of pain scores recorded in the e-Diary, were analyzed.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: From Baseline up to Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 47.06 |
| Placebo (Group C) | 17.07 |
"Blood samples were collected from participants for hemoglobin measurements. Percentages are based on number of participants with hemoglobin ≤ 10.5 gram (g)/deciliter (dL) at Baseline and reported at Week 24.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA with placebo arms are presented." (NCT03103087)
Timeframe: From Baseline up to Week 24
| Intervention | Percentage of participants (Number) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 61.29 |
| Placebo (Group C) | 5.41 |
"A responder was a participant who had MBL volume of < 80 mL and at least a 50% reduction from baseline MBL volume over the last 35 days of treatment (up to Week 24). All returned feminine products collected at each clinical visit were analyzed by the alkaline hematin method to obtain the MBL volume. MBL volume was measured over the Week 24/early termination feminine product collection interval (up to 35 days prior to the last dose of treatment). The percentage of participants who were responders are presented.~As per the objective of the study, the pre-specified primary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: From Baseline up to the last 35 days of treatment (up to Week 24)
| Intervention | Percentage of participants (Number) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 71.2 |
| Placebo (Group C) | 14.73 |
"The PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all [1], mild limitation [2], moderate limitation [3], quite a bit of limitation [4], and extreme limitation [5]). Category improvements for symptoms are presented. A 1-category improvement would be severe at baseline to moderate.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: From Baseline through Week 24
| Intervention | Participants (Count of Participants) | |||
|---|---|---|---|---|
| 1 Category improvement (-1) | 3 Category improvement (-3) | 2 Category improvement (-2) | 4 Category improvement (-4) | |
| Placebo (Group C) | 21 | 8 | 18 | 2 |
| Relugolix Plus E2/NETA (Group A) | 7 | 22 | 29 | 10 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03103087)
Timeframe: From Baseline through Week 24
| Intervention | Participants (Count of Participants) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 19 |
| Placebo (Group C) | 2 |
"The Uterine Fibroid Symptom and Health-Related Quality of Life (UFS-QoL) Bleeding and Pelvic Discomfort (BPD) Scale has been derived from the UFS-QoL Symptoms Scale. The scale consists of the following 3 symptoms proximal to uterine fibroids: Heavy bleeding during your menstrual period (Question [Q] 1), passing blood clots during your menstrual period (Q2), and feeling tightness or pressure in your pelvic area (Q5), raw scores were transformed to a normalized score: Transformed Score = [(Actual raw score - lowest possible raw score)/(Possible raw score range)]*100 Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates symptom severity.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms" (NCT03103087)
Timeframe: Baseline Week 24
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -51.7 |
| Placebo (Group C) | -18.3 |
"Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of time, most of the time and all of the time.) Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -36.1 |
| Placebo (Group C) | -13.7 |
"Transformed score ranges from 0 to 100 based on Likert scale (none of time, a little of time, some of the time, most of the time and all of the time). Higher scores are indicative of better health-related quality of life (high score = good). LS means and p-value for test of difference was relugolix plus E2/NETA minus placebo based on mixed-effect model with treatment, visit, region, Baseline MBL and treatment by visit interaction included as fixed effects.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | units on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 44.4 |
| Placebo (Group C) | 16.5 |
"Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Higher scores are indicative of better health-related quality of life (high score = good).~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 43.6 |
| Placebo (Group C) | 17.1 |
"The Menorrhagia Impact was evaluated using a 5-point response scale to assess level of improvement from Baseline to Week 24. Response scale: Not at all, 2. Slightly, 3.Moderately, 4. Quite a bit and 5. Extremely.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -1.8 |
| Placebo (Group C) | -1.0 |
"The Menorrhagia Impact was evaluated using a 5-point response scale to assess level of improvement from Baseline to Week 24. Response scale: Not at all, 2. Slightly, 3.Moderately, 4. Quite a bit and 5. Extremely.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -1.8 |
| Placebo (Group C) | -0.9 |
"Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -1.8 |
| Placebo (Group C) | -0.6 |
As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented. (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | IU/L (Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -5.47 |
| Placebo (Group C) | -0.67 |
"Transformed score ranges from 0 to 100 based on Likert scale (None of time, a little of time, some of the time, most of the time and all of the time). Lower score indicates minimal symptom severity and higher score indicates maximum symptom severity. A negative change from baseline indicates improvement.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -2.0 |
| Placebo (Group C) | -0.7 |
"PGAs assessed participants' limitation in activities and the severity of symptoms due to uterine fibroids over the previous 4 weeks, as perceived by the participant. The PGA for symptoms is a 1-item questionnaire designed to assess participant's impression of the severity of their symptoms related to uterine fibroids. The PGA for function and symptoms was evaluated using a 5-point response scale (no limitation at all [1], mild limitation [2], moderate limitation [3], quite a bit of limitation [4], and extreme limitation [5]).~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline, Week 24
| Intervention | score on a scale (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -2.0 |
| Placebo (Group C) | -0.8 |
"An adverse event was defined as an unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term.~Reported percentages based on the total number of participants in each treatment group.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline through Week 24
| Intervention | percentage of participants (Number) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 6.3 |
| Placebo (Group C) | 3.9 |
An adverse event was defined as an unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not related to the medicinal product. The preferred terms of hyperhidrosis, feeling hot, hot flush, night sweats, and flushing were combined to describe vasomotor symptoms. Participants with multiple events for a given preferred term were counted only once for each preferred term. Reported confidence interval (CI) based on exact binomial 95% CI (Clopper-Pearson). As per the objective of the study, the secondary analysis compared relugolix plus E2/NETA with relugolix plus delayed E2/NETA at Week 12 and are presented below. (NCT03103087)
Timeframe: Baseline through Week 12
| Intervention | percentage of participants (Number) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | 5.56 |
| Relugolix Plus Delayed E2/NETA (Group B) | 35.71 |
"The volume of the uterus was measured by transvaginal or transabdominal ultrasound.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: From Baseline up to Week 24
| Intervention | percent change (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -13.8 |
| Placebo (Group C) | -1.5 |
"The volume of the primary uterine fibroid was measured by transvaginal or transabdominal ultrasound.~As per the objective of the study, the pre-specified secondary efficacy analyses compared relugolix plus E2/NETA with placebo. Therefore, only relugolix plus E2/NETA and placebo arms are presented." (NCT03103087)
Timeframe: Baseline Week 24
| Intervention | percent change (Least Squares Mean) |
|---|---|
| Relugolix Plus E2/NETA (Group A) | -17.4 |
| Placebo (Group C) | -7.4 |
Change in median dyspareunia pain scores between baseline and 4 weeks of use of nightly use of study medication. Pain will be assessed using 11-point Numerical Rating Scale (NRS) where 0 = no pain and 10 = worst possible pain. (NCT03240081)
Timeframe: Baseline to 4 weeks
| Intervention | score on a scale (Median) |
|---|---|
| 50mcg Estradiol Cream | -1.5 |
| 100mcg Estradiol Cream | -3 |
Difference in median dyspareunia pain scores between arms for intercourse at 12 weeks after use of nightly study medication for 90d. Pain will be assessed using 11-point Numerical Rating Scale (NRS) where 0 = no pain and 10 = worst possible pain. (NCT03240081)
Timeframe: Baseline and 12 weeks
| Intervention | score on a scale (Median) |
|---|---|
| 50mcg Estradiol Cream | -4 |
| 100mcg Estradiol Cream | -5.5 |
Treatment comparison of the number of participants in the PP population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder. (NCT03294538)
Timeframe: Up to Day 9
| Intervention | Participants (Count of Participants) |
|---|---|
| Generic Estradiol Vaginal Cream USP, 0.01% | 49 |
| Estrace Vaginal Cream USP, 0.01% | 44 |
Treatment comparison of the number of participants in the mITT population that were identified as responders at the end of the treatment period evaluated on Day 8 + 1 is presented. A responder was defined as a participant with at least a 25% reduction from baseline in the sum of percent basal/parabasal + percent intermediate cells on vaginal cytology and vaginal pH ≤5.0 with a change from baseline vaginal pH of at least 0.5. (NCT03294538)
Timeframe: Up to Day 9
| Intervention | Participants (Count of Participants) |
|---|---|
| Generic Estradiol Vaginal Cream USP, 0.01% | 53 |
| Estrace Vaginal Cream USP, 0.01% | 53 |
| Vehicle Vaginal Cream | 0 |
The number of participants in the PP population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation was based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding. Any participant who withdrew from the study because of lack of efficacy was included as a non-responder. (NCT03294538)
Timeframe: Up to Day 9
| Intervention | Participants (Count of Participants) |
|---|---|
| Generic Estradiol Vaginal Cream USP, 0.01% | 161 |
| Estrace Vaginal Cream USP, 0.01% | 153 |
The number of participants in the mITT Population that are identified as Treatment Success at the end of the treatment period evaluated on Day 8 ± 1 is presented. A Treatment Success is defined as a score of 0 or 1 at Day 8 ± 1 for the symptom identified at baseline as the most bothersome. This evaluation is to be based on participant self-assessed symptoms of vulvar and vaginal atrophy on a scale of 0 to 3 where 0 = none and 3 = severe. The symptoms that were evaluated were vaginal dryness, vaginal/vulvar irritation/itching, dysuria, vaginal pain associated with sexual activity, and vaginal bleeding. (NCT03294538)
Timeframe: Up to 9 months
| Intervention | Participants (Count of Participants) |
|---|---|
| Generic Estradiol Vaginal Cream USP, 0.01% | 175 |
| Estrace Vaginal Cream USP, 0.01% | 169 |
| Vehicle Vaginal Cream | 80 |
The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the readmission rates. (NCT04865029)
Timeframe: Baseline to day 60
| Intervention | participants (Number) | |
|---|---|---|
| COVID related readmission number | Non-COVID related readmission number | |
| Estradiol and Progesterone Arm | 0 | 0 |
| Normal Saline and Folic Acid Arm | 0 | 1 |
The investigators will review patients' medical records on day 14 and day 28 and determine the cause of death. Then, the investigators will call patients on day 60. This will be done to determine the cause of death. (NCT04865029)
Timeframe: Baseline to day 60
| Intervention | participants (Number) | |
|---|---|---|
| Death from COVID-19 | Death from bacteremia | |
| Estradiol and Progesterone Arm | 0 | 0 |
| Normal Saline and Folic Acid Arm | 0 | 1 |
Subjects will be followed daily for 7 days after initiation of treatment for serious adverse events. The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the frequency of serious adverse events in treatment arm vs. control arm. (NCT04865029)
Timeframe: Baseline to day 60
| Intervention | Participants (Number) |
|---|---|
| Estradiol and Progesterone Arm | 0 |
| Normal Saline and Folic Acid Arm | 1 |
"The proportion will be calculated based on WHO ordinal scale for clinical improvement. The scale is from 0 to 8, with a higher score indicating worse clinical status.~Uninfected: No clinical or virological evidence of infection 0~Ambulatory: No limitation of activities 1 Limitation of activities 2~Hospitalized Mild Disease Hospitalized, no oxygen therapy 3 Oxygen by mask or nasal prongs 4~Hospitalized Severe Disease Non-invasive ventilation or high flow oxygen 5 Intubation and mechanical ventilation 6 Ventilation + additional organ support - 7 pressors, Renal Replacement Therapy (RRT), Extracorporeal Membrane Oxygenation (ECMO)~Dead Death 8" (NCT04865029)
Timeframe: At discharge, measured up to Day 21
| Intervention | Participants (Count of Participants) |
|---|---|
| Estradiol and Progesterone Arm | 5 |
| Normal Saline and Folic Acid Arm | 4 |
The investigators will review patients' medical records on day 14 and day 28 and calculate number of deaths that occurred after admission. Then, the investigators will call patients on day 60. This will be done to determine the number of days death occurred after admission. (NCT04865029)
Timeframe: Baseline to day 60
| Intervention | Days (Number) |
|---|---|
| Normal Saline and Folic Acid Arm | 19 |
The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the efficiency of treatment on length of hospital stay. (NCT04865029)
Timeframe: Baseline to day 60
| Intervention | Days (Mean) |
|---|---|
| Estradiol and Progesterone Arm | 7.2 |
| Normal Saline and Folic Acid Arm | 10.2 |
The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the number of patients requiring invasive mechanical ventilation (NCT04865029)
Timeframe: Baseline to day 60
| Intervention | Participants (Number) |
|---|---|
| Estradiol and Progesterone Arm | 0 |
| Normal Saline and Folic Acid Arm | 1 |
Subjects will be followed daily for 7 days after initiation of treatment for adverse events. The investigators will review patients' medical records on day 14 and day 28. Then, the investigators will call patients on day 60. This will be done to determine the frequency and severity of adverse events in treatment arm vs. control arm. (NCT04865029)
Timeframe: Baseline to day 60
| Intervention | Participants (Number) |
|---|---|
| Estradiol and Progesterone Arm | 0 |
| Normal Saline and Folic Acid Arm | 0 |
| Substance | Relationship Strength | Studies | Trials | Classes | Roles |
|---|---|---|---|---|---|
| gamma-aminobutyric acid gamma-Aminobutyric Acid: The most common inhibitory neurotransmitter in the central nervous system.. gamma-aminobutyric acid : A gamma-amino acid that is butanoic acid with the amino substituent located at C-4. | 3.63 | 9 | 0 | amino acid zwitterion; gamma-amino acid; monocarboxylic acid | human metabolite; neurotransmitter; Saccharomyces cerevisiae metabolite; signalling molecule |
| acetic acid Acetic Acid: Product of the oxidation of ethanol and of the destructive distillation of wood. It is used locally, occasionally internally, as a counterirritant and also as a reagent. (Stedman, 26th ed). acetic acid : A simple monocarboxylic acid containing two carbons. | 2.43 | 2 | 0 | monocarboxylic acid | antimicrobial food preservative; Daphnia magna metabolite; food acidity regulator; protic solvent |
| carnitine [no description available] | 2.25 | 1 | 0 | amino-acid betaine | human metabolite; mouse metabolite |
| citric acid, anhydrous Citric Acid: A key intermediate in metabolism. It is an acid compound found in citrus fruits. The salts of citric acid (citrates) can be used as anticoagulants due to their calcium chelating ability.. citric acid : A tricarboxylic acid that is propane-1,2,3-tricarboxylic acid bearing a hydroxy substituent at position 2. It is an important metabolite in the pathway of all aerobic organisms. | 2.86 | 4 | 0 | tricarboxylic acid | antimicrobial agent; chelator; food acidity regulator; fundamental metabolite |
| chlorine chloride : A halide anion formed when chlorine picks up an electron to form an an anion. | 2.34 | 2 | 0 | halide anion; monoatomic chlorine | cofactor; Escherichia coli metabolite; human metabolite |
| salicylic acid Scalp: The outer covering of the calvaria. It is composed of several layers: SKIN; subcutaneous connective tissue; the occipitofrontal muscle which includes the tendinous galea aponeurotica; loose connective tissue; and the pericranium (the PERIOSTEUM of the SKULL). | 2 | 1 | 0 | monohydroxybenzoic acid | algal metabolite; antifungal agent; antiinfective agent; EC 1.11.1.11 (L-ascorbate peroxidase) inhibitor; keratolytic drug; plant hormone; plant metabolite |
| bupropion Bupropion: A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.. bupropion : An aromatic ketone that is propiophenone carrying a tert-butylamino group at position 2 and a chloro substituent at position 3 on the phenyl ring. | 2.02 | 1 | 0 | aromatic ketone; monochlorobenzenes; secondary amino compound | antidepressant; environmental contaminant; xenobiotic |
| 3,4-dihydroxyphenylacetic acid 3,4-Dihydroxyphenylacetic Acid: A deaminated metabolite of LEVODOPA.. (3,4-dihydroxyphenyl)acetic acid : A dihydroxyphenylacetic acid having the two hydroxy substituents located at the 3- and 4-positions. It is a metabolite of dopamine.. dihydroxyphenylacetic acid : A dihydroxy monocarboxylic acid consisting of phenylacetic acid having two phenolic hydroxy substituents. | 3.4 | 7 | 0 | catechols; dihydroxyphenylacetic acid | human metabolite |
| aminocaproic acid Aminocaproic Acid: An antifibrinolytic agent that acts by inhibiting plasminogen activators which have fibrinolytic properties.. 6-aminohexanoic acid : An epsilon-amino acid comprising hexanoic acid carrying an amino substituent at position C-6. Used to control postoperative bleeding, and to treat overdose effects of the thrombolytic agents streptokinase and tissue plasminogen activator. | 2.02 | 1 | 0 | amino acid zwitterion; epsilon-amino acid; omega-amino fatty acid | antifibrinolytic drug; hematologic agent; metabolite |
| creatine [no description available] | 2.37 | 2 | 0 | glycine derivative; guanidines; zwitterion | geroprotector; human metabolite; mouse metabolite; neuroprotective agent; nutraceutical |
| lactic acid Lactic Acid: A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed). 2-hydroxypropanoic acid : A 2-hydroxy monocarboxylic acid that is propanoic acid in which one of the alpha-hydrogens is replaced by a hydroxy group. | 2.11 | 1 | 0 | 2-hydroxy monocarboxylic acid | algal metabolite; Daphnia magna metabolite |
| glutaric acid glutaric acid: RN given refers to parent cpd. glutaric acid : An alpha,omega-dicarboxylic acid that is a linear five-carbon dicarboxylic acid. | 2.01 | 1 | 0 | alpha,omega-dicarboxylic acid; dicarboxylic fatty acid | Daphnia magna metabolite; human metabolite |
| glycine [no description available] | 2.25 | 1 | 0 | alpha-amino acid; amino acid zwitterion; proteinogenic amino acid; serine family amino acid | EC 2.1.2.1 (glycine hydroxymethyltransferase) inhibitor; fundamental metabolite; hepatoprotective agent; micronutrient; neurotransmitter; NMDA receptor agonist; nutraceutical |
| histamine [no description available] | 2.07 | 1 | 0 | aralkylamino compound; imidazoles | human metabolite; mouse metabolite; neurotransmitter |
| dihydroxyphenylalanine Dihydroxyphenylalanine: A beta-hydroxylated derivative of phenylalanine. The D-form of dihydroxyphenylalanine has less physiologic activity than the L-form and is commonly used experimentally to determine whether the pharmacological effects of LEVODOPA are stereospecific.. dopa : A hydroxyphenylalanine carrying hydroxy substituents at positions 3 and 4 of the benzene ring. | 2 | 1 | 0 | hydroxyphenylalanine; non-proteinogenic alpha-amino acid; tyrosine derivative | human metabolite |
| methanol Methanol: A colorless, flammable liquid used in the manufacture of FORMALDEHYDE and ACETIC ACID, in chemical synthesis, antifreeze, and as a solvent. Ingestion of methanol is toxic and may cause blindness.. primary alcohol : A primary alcohol is a compound in which a hydroxy group, -OH, is attached to a saturated carbon atom which has either three hydrogen atoms attached to it or only one other carbon atom and two hydrogen atoms attached to it.. methanol : The primary alcohol that is the simplest aliphatic alcohol, comprising a methyl and an alcohol group. | 2.03 | 1 | 0 | alkyl alcohol; one-carbon compound; primary alcohol; volatile organic compound | amphiprotic solvent; Escherichia coli metabolite; fuel; human metabolite; mouse metabolite; Mycoplasma genitalium metabolite |
| melatonin [no description available] | 3.1 | 5 | 0 | acetamides; tryptamines | anticonvulsant; central nervous system depressant; geroprotector; hormone; human metabolite; immunological adjuvant; mouse metabolite; radical scavenger |
| n-acetylserotonin N-acetylserotonin : An N-acylserotonin resulting from the formal condensation of the primary amino group of serotonin with the carboxy group of acetic acid. | 1.99 | 1 | 0 | acetamides; N-acylserotonin; phenols | antioxidant; human metabolite; mouse metabolite; tropomyosin-related kinase B receptor agonist |
| niacinamide nicotinamide : A pyridinecarboxamide that is pyridine in which the hydrogen at position 3 is replaced by a carboxamide group. | 2.34 | 2 | 0 | pyridine alkaloid; pyridinecarboxamide; vitamin B3 | anti-inflammatory agent; antioxidant; cofactor; EC 2.4.2.30 (NAD(+) ADP-ribosyltransferase) inhibitor; EC 3.5.1.98 (histone deacetylase) inhibitor; Escherichia coli metabolite; geroprotector; human urinary metabolite; metabolite; mouse metabolite; neuroprotective agent; Saccharomyces cerevisiae metabolite; Sir2 inhibitor |
| urea pseudourea: clinical use; structure. isourea : A carboximidic acid that is the imidic acid tautomer of urea, H2NC(=NH)OH, and its hydrocarbyl derivatives. | 2.01 | 1 | 0 | isourea; monocarboxylic acid amide; one-carbon compound | Daphnia magna metabolite; Escherichia coli metabolite; fertilizer; flour treatment agent; human metabolite; mouse metabolite; Saccharomyces cerevisiae metabolite |
| 2-amino-5-phosphonovalerate 2-Amino-5-phosphonovalerate: The D-enantiomer is a potent and specific antagonist of NMDA glutamate receptors (RECEPTORS, N-METHYL-D-ASPARTATE). The L form is inactive at NMDA receptors but may affect the AP4 (2-amino-4-phosphonobutyrate; APB) excitatory amino acid receptors. | 2.05 | 1 | 0 | non-proteinogenic alpha-amino acid | NMDA receptor antagonist |
| 8-hydroxy-2-(di-n-propylamino)tetralin 8-Hydroxy-2-(di-n-propylamino)tetralin: A serotonin 1A-receptor agonist that is used experimentally to test the effects of serotonin.. 8-OH-DPAT : A tetralin substituted at positions 1 and 7 by hydroxy and dipropylamino groups respectively | 3.81 | 11 | 0 | phenols; tertiary amino compound; tetralins | serotonergic antagonist |
| alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid alpha-Amino-3-hydroxy-5-methyl-4-isoxazolepropionic Acid: An IBOTENIC ACID homolog and glutamate agonist. The compound is the defining agonist for the AMPA subtype of glutamate receptors (RECEPTORS, AMPA). It has been used as a radionuclide imaging agent but is more commonly used as an experimental tool in cell biological studies. | 2.11 | 1 | 0 | non-proteinogenic alpha-amino acid | |
| 4-iodo-2,5-dimethoxyphenylisopropylamine 4-iodo-2,5-dimethoxyphenylisopropylamine: RN given refers to unlabeled parent cpd without isomeric designation; a serotonin agonist. 2-(4-iodo-2,5-dimethoxyphenyl)-1-methylethylamine : An organoiodine compound that is amphetamine bearing two methoxy substituents at positions 2 and 5 as well as an iodo substituent at position 4. | 2.43 | 2 | 0 | amphetamines; dimethoxybenzene; organoiodine compound | |
| ibotenic acid Ibotenic Acid: A neurotoxic isoxazole (similar to KAINIC ACID and MUSCIMOL) found in AMANITA mushrooms. It causes motor depression, ataxia, and changes in mood, perceptions and feelings, and is a potent excitatory amino acid agonist. | 2.01 | 1 | 0 | non-proteinogenic alpha-amino acid | neurotoxin |
| 2-(n-phenethyl-n-propyl)amino-5-hydroxytetralin 2-(N-phenethyl-N-propyl)amino-5-hydroxytetralin: potent, specific D2 dopamine receptor agonist; RN given refers to parent cpd | 2 | 1 | 0 | tetralins | |
| sk&f-38393 2,3,4,5-Tetrahydro-7,8-dihydroxy-1-phenyl-1H-3-benzazepine: A selective D1 dopamine receptor agonist used primarily as a research tool.. 1-phenyl-2,3,4,5-tetrahydro-1H-3-benzazepine-7,8-diol : A benzazepine that is 2,3,4,5-tetrahydro-3-benzazepine bearing a phenyl substituent at position 1 and two hydroxy substituents at positions 7 and 8.. SKF 38393 : A racemate comprising equimolar amounts of (R)- and (S)-SKF 38393 | 2.42 | 2 | 0 | benzazepine; catechols; secondary amino compound | |
| pk 11195 PK-11195 : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 1-(2-chlorophenyl)isoquinoline-3-carboxylic acid with the amino group of sec-butylmethylamine | 2.01 | 1 | 0 | aromatic amide; isoquinolines; monocarboxylic acid amide; monochlorobenzenes | antineoplastic agent |
| 3-hydroxybenzylhydrazine 3-hydroxybenzylhydrazine: decarboxylase inhibitor; RN given refers to parent cpd; structure | 2 | 1 | 0 | phenols | |
| homovanillic acid Homovanillic Acid: A 3-O-methyl ETHER of (3,4-dihydroxyphenyl)acetic acid.. homovanillate : A hydroxy monocarboxylic acid anion which is obtained by deprotonation of the carboxy group of homovanillic acid.. homovanillic acid : A monocarboxylic acid that is the 3-O-methyl ether of (3,4-dihydroxyphenyl)acetic acid. It is a catecholamine metabolite. | 2 | 1 | 0 | guaiacols; monocarboxylic acid | human metabolite; mouse metabolite |
| 4-nonylphenol 4-nonylphenol: structure in first source; see also record for nonylphenol. 4-nonylphenol : A member of the class of phenols that is phenol which is para-substituted with a nonyl group. | 2.04 | 1 | 0 | phenols | environmental contaminant |
| phenytoin [no description available] | 2.02 | 1 | 0 | imidazolidine-2,4-dione | anticonvulsant; drug allergen; sodium channel blocker; teratogenic agent |
| 5-carboxamidotryptamine 5-carboxamidotryptamine: agonist of 5-HT receptor; structure given in first source | 2.03 | 1 | 0 | tryptamines | |
| hydroxyindoleacetic acid (5-hydroxyindol-3-yl)acetic acid : A member of the class of indole-3-acetic acids that is indole-3-acetic acid substituted by a hydroxy group at C-5. | 2.41 | 2 | 0 | indole-3-acetic acids | drug metabolite; human metabolite; mouse metabolite |
| tacrine Tacrine: A cholinesterase inhibitor that crosses the blood-brain barrier. Tacrine has been used to counter the effects of muscle relaxants, as a respiratory stimulant, and in the treatment of Alzheimer's disease and other central nervous system disorders.. tacrine : A member of the class of acridines that is 1,2,3,4-tetrahydroacridine substituted by an amino group at position 9. It is used in the treatment of Alzheimer's disease. | 2.02 | 1 | 0 | acridines; aromatic amine | EC 3.1.1.7 (acetylcholinesterase) inhibitor |
| acebutolol Acebutolol: A cardioselective beta-1 adrenergic antagonist with little effect on the bronchial receptors. The drug has stabilizing and quinidine-like effects on cardiac rhythm, as well as weak inherent sympathomimetic action.. acebutolol : An ether that is the 2-acetyl-4-(butanoylamino)phenyl ether of the primary hydroxy group of 3-(propan-2-ylamino)propane-1,2-diol. | 2.02 | 1 | 0 | aromatic amide; ethanolamines; ether; monocarboxylic acid amide; propanolamine; secondary amino compound | anti-arrhythmia drug; antihypertensive agent; beta-adrenergic antagonist; sympathomimetic agent |
| acetaminophen Acetaminophen: Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.. paracetamol : A member of the class of phenols that is 4-aminophenol in which one of the hydrogens attached to the amino group has been replaced by an acetyl group. | 2.02 | 1 | 0 | acetamides; phenols | antipyretic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; cyclooxygenase 3 inhibitor; environmental contaminant; ferroptosis inducer; geroprotector; hepatotoxic agent; human blood serum metabolite; non-narcotic analgesic; non-steroidal anti-inflammatory drug; xenobiotic |
| acetohydroxamic acid acetohydroxamic acid: urease inhibitor. oxime : Compounds of structure R2C=NOH derived from condensation of aldehydes or ketones with hydroxylamine. Oximes from aldehydes may be called aldoximes; those from ketones may be called ketoximes.. N-hydroxyacetimidic acid : A carbohydroximic acid consisting of acetimidic acid having a hydroxy group attached to the imide nitrogen.. acetohydroxamic acid : A member of the class of acetohydroxamic acids that is acetamide in which one of the amino hydrogens has been replaced by a hydroxy group. | 2.02 | 1 | 0 | acetohydroxamic acids; carbohydroximic acid | algal metabolite; EC 3.5.1.5 (urease) inhibitor |
| albuterol Albuterol: A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol.. albuterol : A member of the class of phenylethanolamines that is 4-(2-amino-1-hydroxyethyl)-2-(hydroxymethyl)phenol having a tert-butyl group attached to the nirogen atom. It acts as a beta-adrenergic agonist used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). | 2.02 | 1 | 0 | phenols; phenylethanolamines; secondary amino compound | beta-adrenergic agonist; bronchodilator agent; environmental contaminant; xenobiotic |
| alendronate alendronic acid : A 1,1-bis(phosphonic acid) that is methanebis(phosphonic acid) in which the two methylene hydrogens are replaced by hydroxy and 3-aminopropyl groups. | 2.02 | 1 | 0 | 1,1-bis(phosphonic acid); primary amino compound | bone density conservation agent; EC 2.5.1.1 (dimethylallyltranstransferase) inhibitor |
| alprazolam Alprazolam: A triazolobenzodiazepine compound with antianxiety and sedative-hypnotic actions, that is efficacious in the treatment of PANIC DISORDERS, with or without AGORAPHOBIA, and in generalized ANXIETY DISORDERS. (From AMA Drug Evaluations Annual, 1994, p238). alprazolam : A member of the class of triazolobenzodiazepines that is 4H-[1,2,4]triazolo[4,3-a][1,4]benzodiazepine carrying methyl, phenyl and chloro substituents at positions 1, 6 and 8 respectively. Alprazolam is only found in individuals that have taken this drug. | 2.02 | 1 | 0 | organochlorine compound; triazolobenzodiazepine | anticonvulsant; anxiolytic drug; GABA agonist; muscle relaxant; sedative; xenobiotic |
| altretamine Altretamine: A hexamethyl-2,4,6-triamine derivative of 1,3,5-triazine. | 2.02 | 1 | 0 | triamino-1,3,5-triazine | |
| amantadine amant: an antiviral compound consisting of an adamantane derivative chemically linked to a water-solube polyanioic matrix; structure in first source | 2.02 | 1 | 0 | adamantanes; primary aliphatic amine | analgesic; antiparkinson drug; antiviral drug; dopaminergic agent; NMDA receptor antagonist; non-narcotic analgesic |
| amifostine anhydrous Amifostine: A phosphorothioate proposed as a radiation-protective agent. It causes splenic vasodilation and may block autonomic ganglia.. amifostine : An organic thiophosphate that is the S-phospho derivative of 2-[(3-aminopropyl)amino]ethanethiol. A prodrug for the free thiol, WR-1065, which is used as a cytoprotectant in cancer chemotherapy and radiotherapy. | 2.02 | 1 | 0 | diamine; organic thiophosphate | antioxidant; prodrug; radiation protective agent |
| aminoglutethimide Aminoglutethimide: An aromatase inhibitor that is used in the treatment of advanced BREAST CANCER.. aminoglutethimide : A dicarboximide that is a six-membered cyclic compound having ethyl and 4-aminophenyl substituents at the 3-position. | 2.02 | 1 | 0 | dicarboximide; piperidones; substituted aniline | adrenergic agent; anticonvulsant; antineoplastic agent; EC 1.14.14.14 (aromatase) inhibitor |
| theophylline [no description available] | 2.02 | 1 | 0 | dimethylxanthine | adenosine receptor antagonist; anti-asthmatic drug; anti-inflammatory agent; bronchodilator agent; drug metabolite; EC 3.1.4.* (phosphoric diester hydrolase) inhibitor; fungal metabolite; human blood serum metabolite; immunomodulator; muscle relaxant; vasodilator agent |
| amiodarone Amiodarone: An antianginal and class III antiarrhythmic drug. It increases the duration of ventricular and atrial muscle action by inhibiting POTASSIUM CHANNELS and VOLTAGE-GATED SODIUM CHANNELS. There is a resulting decrease in heart rate and in vascular resistance.. amiodarone : A member of the class of 1-benzofurans that is 1-benzofuran substituted by a butyl group at position 2 and a 4-[2-(diethylamino)ethoxy]-3,5-diiodobenzoyl group at position 3. It is a cardiovascular drug used for the treatment of cardiac dysrhythmias. | 2.02 | 1 | 0 | 1-benzofurans; aromatic ketone; organoiodine compound; tertiary amino compound | cardiovascular drug |
| amitriptyline Amitriptyline: Tricyclic antidepressant with anticholinergic and sedative properties. It appears to prevent the re-uptake of norepinephrine and serotonin at nerve terminals, thus potentiating the action of these neurotransmitters. Amitriptyline also appears to antagonize cholinergic and alpha-1 adrenergic responses to bioactive amines.. amitriptyline : An organic tricyclic compound that is 10,11-dihydro-5H-dibenzo[a,d][7]annulene substituted by a 3-(dimethylamino)propylidene group at position 5. | 2.02 | 1 | 0 | carbotricyclic compound; tertiary amine | adrenergic uptake inhibitor; antidepressant; environmental contaminant; tropomyosin-related kinase B receptor agonist; xenobiotic |
| amlexanox amlexanox: SRA-A antagonist;structure given in first source. amlexanox : A pyridochromene-derived monocarboxylic acid having an amino substituent at the 2-position, an oxo substituent at the 5-position and an isopropyl substituent at the 7-position. | 2.02 | 1 | 0 | monocarboxylic acid; pyridochromene | anti-allergic agent; anti-ulcer drug; non-steroidal anti-inflammatory drug |
| amlodipine Amlodipine: A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.. amlodipine : A fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative, which is used for the treatment of hypertension, chronic stable angina and confirmed or suspected vasospastic angina. | 2.02 | 1 | 0 | dihydropyridine; ethyl ester; methyl ester; monochlorobenzenes; primary amino compound | antihypertensive agent; calcium channel blocker; vasodilator agent |
| amoxapine Amoxapine: The N-demethylated derivative of the antipsychotic agent LOXAPINE that works by blocking the reuptake of norepinephrine, serotonin, or both; it also blocks dopamine receptors. Amoxapine is used for the treatment of depression.. amoxapine : A dibenzooxazepine compound having a chloro substituent at the 2-position and a piperazin-1-yl group at the 11-position. | 2.02 | 1 | 0 | dibenzooxazepine | adrenergic uptake inhibitor; antidepressant; dopaminergic antagonist; geroprotector; serotonin uptake inhibitor |
| anastrozole [no description available] | 2.02 | 1 | 0 | nitrile; triazoles | antineoplastic agent; EC 1.14.14.14 (aromatase) inhibitor |
| apraclonidine apraclonidine: relieves postoperative intraocular pressure following trabeculoplasty; RN given refers to parent cpd. apraclonidine : An imidazoline that is 2-amino 4,5-dihydro-1H-imidazoline in which one of the exocyclic amino hydrogens has been replaced by a 4-amino-2,6-dichlorophenyl group. | 2.02 | 1 | 0 | dichlorobenzene; guanidines; imidazolines | alpha-adrenergic agonist; antiglaucoma drug; beta-adrenergic agonist; diagnostic agent; ophthalmology drug |
| aspirin Aspirin: The prototypical analgesic used in the treatment of mild to moderate pain. It has anti-inflammatory and antipyretic properties and acts as an inhibitor of cyclooxygenase which results in the inhibition of the biosynthesis of prostaglandins. Aspirin also inhibits platelet aggregation and is used in the prevention of arterial and venous thrombosis. (From Martindale, The Extra Pharmacopoeia, 30th ed, p5). acetylsalicylate : A benzoate that is the conjugate base of acetylsalicylic acid, arising from deprotonation of the carboxy group.. acetylsalicylic acid : A member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group. A non-steroidal anti-inflammatory drug with cyclooxygenase inhibitor activity. | 2.41 | 2 | 0 | benzoic acids; phenyl acetates; salicylates | anticoagulant; antipyretic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; drug allergen; EC 1.1.1.188 (prostaglandin-F synthase) inhibitor; geroprotector; non-narcotic analgesic; non-steroidal anti-inflammatory drug; plant activator; platelet aggregation inhibitor; prostaglandin antagonist; teratogenic agent |
| astemizole Astemizole: Antihistamine drug now withdrawn from the market in many countries because of rare but potentially fatal side effects.. astemizole : A piperidine compound having a 2-(4-methoxyphenyl)ethyl group at the 1-position and an N-[(4-fluorobenzyl)benzimidazol-2-yl]amino group at the 4-position. | 2.42 | 2 | 0 | benzimidazoles; piperidines | anti-allergic agent; anticoronaviral agent; H1-receptor antagonist |
| atenolol Atenolol: A cardioselective beta-1 adrenergic blocker possessing properties and potency similar to PROPRANOLOL, but without a negative inotropic effect.. atenolol : An ethanolamine compound having a (4-carbamoylmethylphenoxy)methyl group at the 1-position and an N-isopropyl substituent. | 2.02 | 1 | 0 | ethanolamines; monocarboxylic acid amide; propanolamine | anti-arrhythmia drug; antihypertensive agent; beta-adrenergic antagonist; environmental contaminant; sympatholytic agent; xenobiotic |
| atrazine [no description available] | 2.02 | 1 | 0 | chloro-1,3,5-triazine; diamino-1,3,5-triazine | environmental contaminant; herbicide; xenobiotic |
| azathioprine Azathioprine: An immunosuppressive agent used in combination with cyclophosphamide and hydroxychloroquine in the treatment of rheumatoid arthritis. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), this substance has been listed as a known carcinogen. (Merck Index, 11th ed). azathioprine : A thiopurine that is 6-mercaptopurine in which the mercapto hydrogen is replaced by a 1-methyl-4-nitroimidazol-5-yl group. It is a prodrug for mercaptopurine and is used as an immunosuppressant, prescribed for the treatment of inflammatory conditions and after organ transplantation and also for treatment of Crohn's didease and MS. | 2.02 | 1 | 0 | aryl sulfide; C-nitro compound; imidazoles; thiopurine | antimetabolite; antineoplastic agent; carcinogenic agent; DNA synthesis inhibitor; hepatotoxic agent; immunosuppressive agent; prodrug |
| azelaic acid nonanedioic acid : An alpha,omega-dicarboxylic acid that is heptane substituted at positions 1 and 7 by carboxy groups. | 2.02 | 1 | 0 | alpha,omega-dicarboxylic acid; dicarboxylic fatty acid | antibacterial agent; antineoplastic agent; dermatologic drug; plant metabolite |
| azelastine azelastine: azeptin is azelastine hydrochloride; structure; eye drop formulation effective in relieving symptoms of allergic conjunctivitis; do not confuse with 5-loxin which is an extract of Boswellia. azelastine : A phthalazine compound having an oxo substituent at the 1-position, a 1-methylazepan-4-yl group at the 2-position and a 4-chlorobenzyl substituent at the 4-position. | 2.02 | 1 | 0 | monochlorobenzenes; phthalazines; tertiary amino compound | anti-allergic agent; anti-asthmatic drug; bronchodilator agent; EC 1.13.11.34 (arachidonate 5-lipoxygenase) inhibitor; H1-receptor antagonist; platelet aggregation inhibitor |
| baclofen [no description available] | 2.02 | 1 | 0 | amino acid zwitterion; gamma-amino acid; monocarboxylic acid; monochlorobenzenes; primary amino compound | central nervous system depressant; GABA agonist; muscle relaxant |
| bepridil Bepridil: A long-acting calcium-blocking agent with significant anti-anginal activity. The drug produces significant coronary vasodilation and modest peripheral effects. It has antihypertensive and selective anti-arrhythmia activities and acts as a calmodulin antagonist.. bepridil : A tertiary amine in which the substituents on nitrogen are benzyl, phenyl and 3-(2-methylpropoxy)-2-(pyrrolidin-1-yl)propyl. | 2.02 | 1 | 0 | pyrrolidines; tertiary amine | anti-arrhythmia drug; antihypertensive agent; calcium channel blocker; vasodilator agent |
| betaxolol [no description available] | 2.02 | 1 | 0 | propanolamine | antihypertensive agent; beta-adrenergic antagonist; sympatholytic agent |
| bicalutamide bicalutamide: approved for treatment of advanced prostate cancer. N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide : A member of the class of (trifluoromethyl)benzenes that is 4-amino-2-(trifluoromethyl)benzonitrile in which one of the amino hydrogens is substituted by a 3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanoyl group.. bicalutamide : A racemate comprising of equal amounts of (R)-bicalutamide and (S)-bicalutamide. It is an oral non-steroidal antiandrogen used in the treatment of prostate cancer and hirsutism. | 2.02 | 1 | 0 | (trifluoromethyl)benzenes; monocarboxylic acid amide; monofluorobenzenes; nitrile; sulfone; tertiary alcohol | |
| bisoprolol Bisoprolol: A cardioselective beta-1 adrenergic blocker. It is effective in the management of HYPERTENSION and ANGINA PECTORIS. | 2.02 | 1 | 0 | secondary alcohol; secondary amine | anti-arrhythmia drug; antihypertensive agent; beta-adrenergic antagonist; sympatholytic agent |
| brimonidine [no description available] | 2.02 | 1 | 0 | imidazoles; quinoxaline derivative; secondary amine | adrenergic agonist; alpha-adrenergic agonist; antihypertensive agent |
| bumetanide [no description available] | 2.02 | 1 | 0 | amino acid; benzoic acids; sulfonamide | diuretic; EC 3.6.3.49 (channel-conductance-controlling ATPase) inhibitor |
| buspirone Buspirone: An anxiolytic agent and serotonin receptor agonist belonging to the azaspirodecanedione class of compounds. Its structure is unrelated to those of the BENZODIAZAPINES, but it has an efficacy comparable to DIAZEPAM.. buspirone : An azaspiro compound that is 8-azaspiro[4.5]decane-7,9-dione substituted at the nitrogen atom by a 4-(piperazin-1-yl)butyl group which in turn is substituted by a pyrimidin-2-yl group at the N(4) position. | 2.02 | 1 | 0 | azaspiro compound; N-alkylpiperazine; N-arylpiperazine; organic heteropolycyclic compound; piperidones; pyrimidines | anxiolytic drug; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; sedative; serotonergic agonist |
| busulfan [no description available] | 2.02 | 1 | 0 | methanesulfonate ester | alkylating agent; antineoplastic agent; carcinogenic agent; insect sterilant; teratogenic agent |
| butenafine butenafine: studied on experimental dermatophytosis. butenafine : Trimethylamine in which hydrogen atoms attached to different methyl groups are substituted by 1-naphthyl and 4-tert-butylphenyl groups. It is an inhibitor of squalene epoxidase, an enzyme responsible for the creation of sterols needed in fungal cell membranes, and is used as its hydrochloride salt for treatment of dermatological fungal infections. | 2.02 | 1 | 0 | naphthalenes; tertiary amine | antifungal drug; EC 1.14.13.132 (squalene monooxygenase) inhibitor |
| caffeine [no description available] | 2.31 | 1 | 0 | purine alkaloid; trimethylxanthine | adenosine A2A receptor antagonist; adenosine receptor antagonist; adjuvant; central nervous system stimulant; diuretic; EC 2.7.11.1 (non-specific serine/threonine protein kinase) inhibitor; EC 3.1.4.* (phosphoric diester hydrolase) inhibitor; environmental contaminant; food additive; fungal metabolite; geroprotector; human blood serum metabolite; mouse metabolite; mutagen; plant metabolite; psychotropic drug; ryanodine receptor agonist; xenobiotic |
| verapamil Verapamil: A calcium channel blocker that is a class IV anti-arrhythmia agent.. verapamil : A racemate comprising equimolar amounts of dexverapamil and (S)-verapamil. An L-type calcium channel blocker of the phenylalkylamine class, it is used (particularly as the hydrochloride salt) in the treatment of hypertension, angina pectoris and cardiac arrhythmia, and as a preventive medication for migraine.. 2-(3,4-dimethoxyphenyl)-5-{[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino}-2-(propan-2-yl)pentanenitrile : A tertiary amino compound that is 3,4-dimethoxyphenylethylamine in which the hydrogens attached to the nitrogen are replaced by a methyl group and a 4-cyano-4-(3,4-dimethoxyphenyl)-5-methylhexyl group. | 2.02 | 1 | 0 | aromatic ether; nitrile; polyether; tertiary amino compound | |
| candesartan candesartan: a nonpeptide angiotensin II receptor antagonist. candesartan : A benzimidazolecarboxylic acid that is 1H-benzimidazole-7-carboxylic acid substituted by an ethoxy group at position 2 and a ({2'-(1H-tetrazol-5-yl)[1,1'-biphenyl]-4-yl}methyl) group at position 1. It is a angiotensin receptor antagonist used for the treatment of hypertension. | 2.07 | 1 | 0 | benzimidazolecarboxylic acid; biphenylyltetrazole | angiotensin receptor antagonist; antihypertensive agent; environmental contaminant; xenobiotic |
| carbamazepine Carbamazepine: A dibenzazepine that acts as a sodium channel blocker. It is used as an anticonvulsant for the treatment of grand mal and psychomotor or focal SEIZURES. It may also be used in the management of BIPOLAR DISORDER, and has analgesic properties.. carbamazepine : A dibenzoazepine that is 5H-dibenzo[b,f]azepine carrying a carbamoyl substituent at the azepine nitrogen, used as an anticonvulsant. | 2.02 | 1 | 0 | dibenzoazepine; ureas | analgesic; anticonvulsant; antimanic drug; drug allergen; EC 3.5.1.98 (histone deacetylase) inhibitor; environmental contaminant; glutamate transporter activator; mitogen; non-narcotic analgesic; sodium channel blocker; xenobiotic |
| carmustine Carmustine: A cell-cycle phase nonspecific alkylating antineoplastic agent. It is used in the treatment of brain tumors and various other malignant neoplasms. (From Martindale, The Extra Pharmacopoeia, 30th ed, p462) This substance may reasonably be anticipated to be a carcinogen according to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985). (From Merck Index, 11th ed). carmustine : A member of the class of N-nitrosoureas that is 1,3-bis(2-chloroethyl)urea in which one of the nitrogens is substituted by a nitroso group. | 2.02 | 1 | 0 | N-nitrosoureas; organochlorine compound | alkylating agent; antineoplastic agent |
| carteolol Carteolol: A beta-adrenergic antagonist used as an anti-arrhythmia agent, an anti-angina agent, an antihypertensive agent, and an antiglaucoma agent. | 2.02 | 1 | 0 | quinolone; secondary alcohol | anti-arrhythmia drug; antiglaucoma drug; antihypertensive agent; beta-adrenergic antagonist; sympatholytic agent |
| carvedilol [no description available] | 2.02 | 1 | 0 | carbazoles; secondary alcohol; secondary amino compound | alpha-adrenergic antagonist; antihypertensive agent; beta-adrenergic antagonist; cardiovascular drug; vasodilator agent |
| cetirizine Cetirizine: A potent second-generation histamine H1 antagonist that is effective in the treatment of allergic rhinitis, chronic urticaria, and pollen-induced asthma. Unlike many traditional antihistamines, it does not cause drowsiness or anticholinergic side effects.. cetirizine : A member of the class of piperazines that is piperazine in which the hydrogens attached to nitrogen are replaced by a (4-chlorophenyl)(phenyl)methyl and a 2-(carboxymethoxy)ethyl group respectively. | 2.02 | 1 | 0 | ether; monocarboxylic acid; monochlorobenzenes; piperazines | anti-allergic agent; environmental contaminant; H1-receptor antagonist; xenobiotic |
| chlormezanone Chlormezanone: A non-benzodiazepine that is used in the management of anxiety. It has been suggested for use in the treatment of muscle spasm.. chlormezanone : A 1,3-thiazine that is 1,3-thiazinan-4-one S,S-dioxide in which a hydrogen at position 2 is substituted by a 4-chlorophenyl group and the hydrogen attached to the nitrogen is substituted by methyl. A non-benzodiazepine muscle relaxant, it was used in the management of anxiety and in the treatment of muscle spasms until being discontinued worldwide by its manufacturer in 1996, due to rare but serious cutaneous reactions. | 2.02 | 1 | 0 | 1,3-thiazine; lactam; monochlorobenzenes; sulfone | antipsychotic agent; anxiolytic drug; muscle relaxant |
| ciclopirox [no description available] | 2.02 | 1 | 0 | cyclic hydroxamic acid; hydroxypyridone antifungal drug; pyridone | antibacterial agent; antiseborrheic |
| cimetidine Cimetidine: A histamine congener, it competitively inhibits HISTAMINE binding to HISTAMINE H2 RECEPTORS. Cimetidine has a range of pharmacological actions. It inhibits GASTRIC ACID secretion, as well as PEPSIN and GASTRIN output.. cimetidine : A member of the class of guanidines that consists of guanidine carrying a methyl substituent at position 1, a cyano group at position 2 and a 2-{[(5-methyl-1H-imidazol-4-yl)methyl]sulfanyl}ethyl group at position 3. It is a H2-receptor antagonist that inhibits the production of acid in stomach. | 2.01 | 1 | 0 | aliphatic sulfide; guanidines; imidazoles; nitrile | adjuvant; analgesic; anti-ulcer drug; H2-receptor antagonist; P450 inhibitor |
| cinoxacin Cinoxacin: Synthetic antimicrobial related to OXOLINIC ACID and NALIDIXIC ACID and used in URINARY TRACT INFECTIONS.. cinoxacin : A member of the class of cinnolines that is 6,7-methylenedioxycinnolin-4(1H)-one bearing an ethyl group at position 1 and a carboxylic acid group at position 3. An analogue of oxolinic acid, it has similar antibacterial actions. It was formerly used for the treatment of urinary tract infections. | 2.02 | 1 | 0 | cinnolines; oxacycle; oxo carboxylic acid | antibacterial drug; antiinfective agent |
| ciprofloxacin Ciprofloxacin: A broad-spectrum antimicrobial carboxyfluoroquinoline.. ciprofloxacin : A quinolone that is quinolin-4(1H)-one bearing cyclopropyl, carboxylic acid, fluoro and piperazin-1-yl substituents at positions 1, 3, 6 and 7, respectively. | 2.02 | 1 | 0 | aminoquinoline; cyclopropanes; fluoroquinolone antibiotic; N-arylpiperazine; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone; zwitterion | antibacterial drug; antiinfective agent; antimicrobial agent; DNA synthesis inhibitor; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor; environmental contaminant; topoisomerase IV inhibitor; xenobiotic |
| cisapride Cisapride: A substituted benzamide used for its prokinetic properties. It is used in the management of gastroesophageal reflux disease, functional dyspepsia, and other disorders associated with impaired gastrointestinal motility. (Martindale The Extra Pharmacopoeia, 31st ed). cisapride : The amide resulting from formal condensation of 4-amino-5-chloro-2-methoxybenzoic acid with cis-1-[3-(4-fluorophenoxy)propyl]-3-methoxypiperidin-4-amine. It has been used (as its monohydrate or as its tartrate) for the treatment of gastro-oesophageal reflux disease and for non-ulcer dyspepsia, but its propensity to cause cardiac arrhythmias resulted in its complete withdrawal from many countries, including the U.K., and restrictions on its use elsewhere. | 2.02 | 1 | 0 | benzamides | |
| clofazimine Clofazimine: A fat-soluble riminophenazine dye used for the treatment of leprosy. It has been used investigationally in combination with other antimycobacterial drugs to treat Mycobacterium avium infections in AIDS patients. Clofazimine also has a marked anti-inflammatory effect and is given to control the leprosy reaction, erythema nodosum leprosum. (From AMA Drug Evaluations Annual, 1993, p1619). clofazimine : 3-Isopropylimino-3,5-dihydro-phenazine in which the hydrogen at position 5 is substituted substituted by a 4-chlorophenyl group, and that at position 2 is substituted by a (4-chlorophenyl)amino group. A dark red crystalline solid, clofazimine is an antimycobacterial and is one of the main drugs used for the treatment of multi-bacillary leprosy. However, it can cause red/brown discolouration of the skin, so other treatments are often preferred in light-skinned patients. | 2.02 | 1 | 0 | monochlorobenzenes; phenazines | dye; leprostatic drug; non-steroidal anti-inflammatory drug |
| clomipramine Clomipramine: A tricyclic antidepressant similar to IMIPRAMINE that selectively inhibits the uptake of serotonin in the brain. It is readily absorbed from the gastrointestinal tract and demethylated in the liver to form its primary active metabolite, desmethylclomipramine.. clomipramine : A dibenzoazepine that is 10,11-dihydro-5H-dibenzo[b,f]azepine which is substituted by chlorine at position 3 and in which the hydrogen attached to the nitrogen is replaced by a 3-(dimethylamino)propyl group. One of the more sedating tricyclic antidepressants, it is used as the hydrochloride salt for the treatment of depression as well as obsessive-compulsive disorder and phobias. | 2.02 | 1 | 0 | dibenzoazepine | anticoronaviral agent; antidepressant; EC 1.8.1.12 (trypanothione-disulfide reductase) inhibitor; serotonergic antagonist; serotonergic drug; serotonin uptake inhibitor |
| clonidine Clonidine: An imidazoline sympatholytic agent that stimulates ALPHA-2 ADRENERGIC RECEPTORS and central IMIDAZOLINE RECEPTORS. It is commonly used in the management of HYPERTENSION.. clonidine (amino form) : A clonidine that is 4,5-dihydro-1H-imidazol-2-amine in which one of the amino hydrogens is replaced by a 2,6-dichlorophenyl group. | 2.44 | 2 | 0 | clonidine; imidazoline | |
| chlorazepate clorazepic acid : A 1,4-benzodiazepinone in which the oxo group is at position 2, and which is substituted at positions 3, 5, and 7 by carboxy, phenyl and chloro groups, respectively. | 2.02 | 1 | 0 | 1,4-benzodiazepinone | anticonvulsant; anxiolytic drug; GABA modulator; prodrug |
| phenylalanyl-cyclo(cysteinyltyrosyl-tryptophyl-ornithyl-threonyl-penicillamine)threoninamide phenylalanyl-cyclo(cysteinyltyrosyl-tryptophyl-ornithyl-threonyl-penicillamine)threoninamide: cyclic somatostatin octapeptide analog with high affinity & selectivity toward mu opioid receptors | 2 | 1 | 0 | ||
| cyclobenzaprine cyclobenzaprine: RN given refers to parent cpd; Lisseril is synonymous for HCl; structure. cyclobenzaprine : 5-Methylidene-5H-dibenzo[a,d]cycloheptene in which one of the hydrogens of the methylidene group is substituted by a 2-(dimethylamino)ethyl group. A centrally acting skeletal muscle relaxant, it is used as its hydrochloride salt in the symptomatic treatment of painful muscle spasm. | 2.02 | 1 | 0 | carbotricyclic compound | antidepressant; muscle relaxant; tranquilizing drug |
| desipramine Desipramine: A tricyclic dibenzazepine compound that potentiates neurotransmission. Desipramine selectively blocks reuptake of norepinephrine from the neural synapse, and also appears to impair serotonin transport. This compound also possesses minor anticholinergic activity, through its affinity to muscarinic receptors.. desipramine : A dibenzoazepine consisting of 10,11-dihydro-5H-dibenzo[b,f]azepine substituted on nitrogen with a 3-(methylamino)propyl group. | 2.44 | 2 | 0 | dibenzoazepine; secondary amino compound | adrenergic uptake inhibitor; alpha-adrenergic antagonist; antidepressant; cholinergic antagonist; drug allergen; EC 3.1.4.12 (sphingomyelin phosphodiesterase) inhibitor; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; H1-receptor antagonist; serotonin uptake inhibitor |
| amphetamine Amphetamine: A powerful central nervous system stimulant and sympathomimetic. Amphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulation of release of monamines, and inhibiting monoamine oxidase. Amphetamine is also a drug of abuse and a psychotomimetic. The l- and the d,l-forms are included here. The l-form has less central nervous system activity but stronger cardiovascular effects. The d-form is DEXTROAMPHETAMINE.. 1-phenylpropan-2-amine : A primary amine that is isopropylamine in which a hydrogen attached to one of the methyl groups has been replaced by a phenyl group.. amphetamine : A racemate comprising equimolar amounts of (R)-amphetamine (also known as levamphetamine or levoamphetamine) and (S)-amphetamine (also known as dexamfetamine or dextroamphetamine. | 3.18 | 5 | 0 | primary amine | |
| diazepam Diazepam: A benzodiazepine with anticonvulsant, anxiolytic, sedative, muscle relaxant, and amnesic properties and a long duration of action. Its actions are mediated by enhancement of GAMMA-AMINOBUTYRIC ACID activity.. diazepam : A 1,4-benzodiazepinone that is 1,3-dihydro-2H-1,4-benzodiazepin-2-one substituted by a chloro group at position 7, a methyl group at position 1 and a phenyl group at position 5. | 2.95 | 4 | 0 | 1,4-benzodiazepinone; organochlorine compound | anticonvulsant; anxiolytic drug; environmental contaminant; sedative; xenobiotic |
| dibutyl phthalate Dibutyl Phthalate: A plasticizer used in most plastics and found in water, air, soil, plants and animals. It may have some adverse effects with long-term exposure.. dibutyl phthalate : A phthalate ester that is the diester obtained by the formal condensation of the carboxy groups of phthalic acid with two molecules of butan-1-ol. Although used extensively as a plasticiser, it is a ubiquitous environmental contaminant that poses a risk to humans. | 2.05 | 1 | 0 | diester; phthalate ester | EC 3.2.1.20 (alpha-glucosidase) inhibitor; environmental contaminant; metabolite; plasticiser; teratogenic agent |
| diclofenac Diclofenac: A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.. diclofenac : A monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position. | 2.02 | 1 | 0 | amino acid; aromatic amine; dichlorobenzene; monocarboxylic acid; secondary amino compound | antipyretic; drug allergen; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; environmental contaminant; non-narcotic analgesic; non-steroidal anti-inflammatory drug; xenobiotic |
| diflunisal Diflunisal: A salicylate derivative and anti-inflammatory analgesic with actions and side effects similar to those of ASPIRIN.. diflunisal : An organofluorine compound comprising salicylic acid having a 2,4-difluorophenyl group at the 5-position. | 2.02 | 1 | 0 | monohydroxybenzoic acid; organofluorine compound | non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| dipivefrin dipivefrin: used in treatment of both primary & open angle glaucoma; RN given refers to (+-)-isomer. dipivefrin : The dipivalate ester of (+-)-epinephrine (racepinephrine). A pro-drug of epinephrine, the hydrochloride is used topically as eye drops to reduce intra-ocular pressure in the treatment of open-angle glaucoma or ocular hypertension. | 2.02 | 1 | 0 | ethanolamines; pivalate ester | adrenergic agonist; antiglaucoma drug; ophthalmology drug; prodrug; sympathomimetic agent |
| disopyramide Disopyramide: A class I anti-arrhythmic agent (one that interferes directly with the depolarization of the cardiac membrane and thus serves as a membrane-stabilizing agent) with a depressant action on the heart similar to that of guanidine. It also possesses some anticholinergic and local anesthetic properties.. disopyramide : A monocarboxylic acid amide that is butanamide substituted by a diisopropylamino group at position 4, a phenyl group at position 2 and a pyridin-2-yl group at position 2. It is used as a anti-arrhythmia drug. | 2.02 | 1 | 0 | monocarboxylic acid amide; pyridines; tertiary amino compound | anti-arrhythmia drug |
| disulfiram [no description available] | 2.02 | 1 | 0 | organic disulfide; organosulfur acaricide | angiogenesis inhibitor; antineoplastic agent; apoptosis inducer; EC 1.2.1.3 [aldehyde dehydrogenase (NAD(+))] inhibitor; EC 3.1.1.1 (carboxylesterase) inhibitor; EC 3.1.1.8 (cholinesterase) inhibitor; EC 5.99.1.2 (DNA topoisomerase) inhibitor; ferroptosis inducer; fungicide; NF-kappaB inhibitor |
| valproic acid Valproic Acid: A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.. valproic acid : A branched-chain saturated fatty acid that comprises of a propyl substituent on a pentanoic acid stem. | 2.02 | 1 | 0 | branched-chain fatty acid; branched-chain saturated fatty acid | anticonvulsant; antimanic drug; EC 3.5.1.98 (histone deacetylase) inhibitor; GABA agent; neuroprotective agent; psychotropic drug; teratogenic agent |
| racemetirosine alpha-Methyltyrosine: An inhibitor of the enzyme TYROSINE 3-MONOOXYGENASE, and consequently of the synthesis of catecholamines. It is used to control the symptoms of excessive sympathetic stimulation in patients with PHEOCHROMOCYTOMA. (Martindale, The Extra Pharmacopoeia, 30th ed) | 2 | 1 | 0 | ||
| doxazosin Doxazosin: A prazosin-related compound that is a selective alpha-1-adrenergic blocker.. doxazosin : A member of the class of quinazolines that is quinazoline substituted by an amino group at position 4, methoxy groups at positions 6 and 7 and a piperazin-1-yl group at position 2 which in turn is substituted by a 2,3-dihydro-1,4-benzodioxin-2-ylcarbonyl group at position 4. An antihypertensive agent, it is used in the treatment of high blood pressure. | 2.43 | 2 | 0 | aromatic amine; benzodioxine; monocarboxylic acid amide; N-acylpiperazine; N-arylpiperazine; quinazolines | alpha-adrenergic antagonist; antihyperplasia drug; antihypertensive agent; antineoplastic agent; vasodilator agent |
| doxepin Doxepin: A dibenzoxepin tricyclic compound. It displays a range of pharmacological actions including maintaining adrenergic innervation. Its mechanism of action is not fully understood, but it appears to block reuptake of monoaminergic neurotransmitters into presynaptic terminals. It also possesses anticholinergic activity and modulates antagonism of histamine H(1)- and H(2)-receptors.. doxepin : A dibenzooxepine that is 6,11-dihydrodibenzo[b,e]oxepine substituted by a 3-(dimethylamino)propylidene group at position 11. It is used as an antidepressant drug. | 2.02 | 1 | 0 | dibenzooxepine; tertiary amino compound | antidepressant |
| droperidol Droperidol: A butyrophenone with general properties similar to those of HALOPERIDOL. It is used in conjunction with an opioid analgesic such as FENTANYL to maintain the patient in a calm state of neuroleptanalgesia with indifference to surroundings but still able to cooperate with the surgeon. It is also used as a premedicant, as an antiemetic, and for the control of agitation in acute psychoses. (From Martindale, The Extra Pharmacopoeia, 29th ed, p593). droperidol : An organofluorine compound that is haloperidol in which the hydroxy group has been eliminated with the introduction of a double bond in the piperidine ring, and the 4-chlorophenyl group has been replaced by a benzimidazol-2-on-1-yl group. It is used in the management of chemotherapy-induced nausea and vomiting, and in conjunction with an opioid analgesic such as fentanyl to maintain the patient in a calm state of neuroleptanalgesia with indifference to surroundings but still able to cooperate with the surgeon. | 2.02 | 1 | 0 | aromatic ketone; benzimidazoles; organofluorine compound | anaesthesia adjuvant; antiemetic; dopaminergic antagonist; first generation antipsychotic |
| econazole Econazole: An imidazole derivative that is commonly used as a topical antifungal agent.. econazole : A racemate composed of equimolar amounts of (R)- and (S)-econazole. Used (as its nitrate salt) to treat skin infections such as athlete's foot, jock itch, ringworm and other fungal skin infections.. 1-{2-(4-chlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl}imidazole : A member of the class of imidazoles that is 1-(2,4-dichlorophenyl)-2-(imidazol-1-yl)ethanol in which the hydroxyl hydrogen is replaced by a 4-chlorobenzyl group. | 2.02 | 1 | 0 | dichlorobenzene; ether; imidazoles; monochlorobenzenes | |
| enflurane Enflurane: An extremely stable inhalation anesthetic that allows rapid adjustments of anesthesia depth with little change in pulse or respiratory rate.. enflurane : An ether in which the oxygen atom is connected to 2-chloro-1,1,2-trifluoroethyl and difluoromethyl groups. | 2.02 | 1 | 0 | ether; organochlorine compound; organofluorine compound | anaesthetic |
| enoxacin Enoxacin: A broad-spectrum 6-fluoronaphthyridinone antibacterial agent that is structurally related to NALIDIXIC ACID.. enoxacin : A 1,8-naphthyridine derivative that is 1,4-dihydro-1,8-naphthyridine with an ethyl group at the 1 position, a carboxy group at the 3-position, an oxo sustituent at the 4-position, a fluoro substituent at the 5-position and a piperazin-1-yl group at the 7 position. An antibacterial, it is used in the treatment of urinary-tract infections and gonorrhoea. | 2.02 | 1 | 0 | 1,8-naphthyridine derivative; amino acid; fluoroquinolone antibiotic; monocarboxylic acid; N-arylpiperazine; quinolone antibiotic | antibacterial drug; DNA synthesis inhibitor |
| estazolam Estazolam: A benzodiazepine with anticonvulsant, hypnotic, and muscle relaxant properties. It has been shown in some cases to be more potent than DIAZEPAM or NITRAZEPAM.. estazolam : A triazolo[4,3-a][1,4]benzodiazepine having a phenyl group at position 6 and a chloro substituent at position 8. A short-acting benzodiazepine with general properties similar to diazepam, it is given by mouth as a hypnotic in the short-term management of insomnia. | 2.02 | 1 | 0 | triazoles; triazolobenzodiazepine | anticonvulsant; anxiolytic drug; GABA modulator |
| etidronate Etidronic Acid: A diphosphonate which affects calcium metabolism. It inhibits ectopic calcification and slows down bone resorption and bone turnover.. etidronic acid : A 1,1-bis(phosphonic acid) that is (ethane-1,1-diyl)bis(phosphonic acid) having a hydroxy substituent at the 1-position. It inhibits the formation, growth, and dissolution of hydroxyapatite crystals by chemisorption to calcium phosphate surfaces. | 2.02 | 1 | 0 | 1,1-bis(phosphonic acid) | antineoplastic agent; bone density conservation agent; chelator |
| etodolac Etodolac: A non-steroidal anti-inflammatory agent and cyclooxygenase-2 (COX-2) inhibitor with potent analgesic and anti-arthritic properties. It has been shown to be effective in the treatment of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; ANKYLOSING SPONDYLITIS; and in the alleviation of postoperative pain (PAIN, POSTOPERATIVE).. etodolac : A monocarboxylic acid that is acetic acid in which one of the methyl hydrogens is substituted by a 1,8-diethyl-1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl moiety. A preferential inhibitor of cyclo-oxygenase 2 and non-steroidal anti-inflammatory, it is used for the treatment of rheumatoid arthritis and osteoarthritis, and for the alleviation of postoperative pain. Administered as the racemate, only the (S)-enantiomer is active. | 2.02 | 1 | 0 | monocarboxylic acid; organic heterotricyclic compound | antipyretic; cyclooxygenase 2 inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| brl 42810 [no description available] | 2.02 | 1 | 0 | 2-aminopurines; acetate ester | antiviral drug; prodrug |
| felbamate Felbamate: A PEGylated phenylcarbamate derivative that acts as an antagonist of NMDA RECEPTORS. It is used as an anticonvulsant, primarily for the treatment of SEIZURES in severe refractory EPILEPSY.. felbamate : The bis(carbamate ester) of 2-phenylpropane-1,3-diol. An anticonvulsant, it is used in the treatment of epilepsy. | 2.02 | 1 | 0 | carbamate ester | anticonvulsant; neuroprotective agent |
| felodipine Felodipine: A dihydropyridine calcium antagonist with positive inotropic effects. It lowers blood pressure by reducing peripheral vascular resistance through a highly selective action on smooth muscle in arteriolar resistance vessels.. felodipine : The mixed (methyl, ethyl) diester of 4-(2,3-dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylic acid. A calcium-channel blocker, it lowers blood pressure by reducing peripheral vascular resistance through a highly selective action on smooth muscle in arteriolar resistance vessels. It is used in the management of hypertension and angina pectoris. | 2.02 | 1 | 0 | dichlorobenzene; dihydropyridine; ethyl ester; methyl ester | anti-arrhythmia drug; antihypertensive agent; calcium channel blocker; vasodilator agent |
| fenfluramine Fenfluramine: A centrally active drug that apparently both blocks serotonin uptake and provokes transport-mediated serotonin release.. fenfluramine : A secondary amino compound that is 1-phenyl-propan-2-amine in which one of the meta-hydrogens is substituted by trifluoromethyl, and one of the hydrogens attached to the nitrogen is substituted by an ethyl group. It binds to the serotonin reuptake pump, causing inhbition of serotonin uptake and release of serotonin. The resulting increased levels of serotonin lead to greater serotonin receptor activation which in turn lead to enhancement of serotoninergic transmission in the centres of feeding behavior located in the hypothalamus. This suppresses the appetite for carbohydrates. Fenfluramine was used as the hydrochloride for treatment of diabetes and obesity. It was withdrawn worldwide after reports of heart valve disease and pulmonary hypertension. | 2.42 | 2 | 0 | (trifluoromethyl)benzenes; secondary amino compound | appetite depressant; serotonergic agonist; serotonin uptake inhibitor |
| fentanyl Fentanyl: A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078). fentanyl : A monocarboxylic acid amide resulting from the formal condensation of the aryl amino group of N-phenyl-1-(2-phenylethyl)piperidin-4-amine with propanoic acid. | 2.02 | 1 | 0 | anilide; monocarboxylic acid amide; piperidines | adjuvant; anaesthesia adjuvant; anaesthetic; intravenous anaesthetic; mu-opioid receptor agonist; opioid analgesic |
| fexofenadine fexofenadine: a second generation antihistamine; metabolite of the antihistaminic drug terfenadine; structure in first source; RN refers to HCl. fexofenadine : A piperidine-based anti-histamine compound. | 2.02 | 1 | 0 | piperidines; tertiary amine | anti-allergic agent; H1-receptor antagonist |
| flecainide Flecainide: A potent anti-arrhythmia agent, effective in a wide range of ventricular and atrial ARRHYTHMIAS and TACHYCARDIAS.. flecainide : A monocarboxylic acid amide obtained by formal condensation of the carboxy group of 2,5-bis(2,2,2-trifluoroethoxy)benzoic acid with the primary amino group of piperidin-2-ylmethylamine. An antiarrhythmic agent used (in the form of its acetate salt) to prevent and treat tachyarrhythmia (abnormal fast rhythm of the heart). | 2.02 | 1 | 0 | aromatic ether; monocarboxylic acid amide; organofluorine compound; piperidines | anti-arrhythmia drug |
| fluconazole Fluconazole: Triazole antifungal agent that is used to treat oropharyngeal CANDIDIASIS and cryptococcal MENINGITIS in AIDS.. fluconazole : A member of the class of triazoles that is propan-2-ol substituted at position 1 and 3 by 1H-1,2,4-triazol-1-yl groups and at position 2 by a 2,4-difluorophenyl group. It is an antifungal drug used for the treatment of mucosal candidiasis and for systemic infections including systemic candidiasis, coccidioidomycosis, and cryptococcosis. | 2.02 | 1 | 0 | conazole antifungal drug; difluorobenzene; tertiary alcohol; triazole antifungal drug | environmental contaminant; P450 inhibitor; xenobiotic |
| flucytosine Flucytosine: A fluorinated cytosine analog that is used as an antifungal agent.. flucytosine : An organofluorine compound that is cytosine that is substituted at position 5 by a fluorine. A prodrug for the antifungal 5-fluorouracil, it is used for the treatment of systemic fungal infections. | 2.02 | 1 | 0 | aminopyrimidine; nucleoside analogue; organofluorine compound; pyrimidine antifungal drug; pyrimidone | prodrug |
| fluphenazine [no description available] | 2.02 | 1 | 0 | N-alkylpiperazine; organofluorine compound; phenothiazines | anticoronaviral agent; dopaminergic antagonist; phenothiazine antipsychotic drug |
| flumazenil Flumazenil: A potent benzodiazepine receptor antagonist. Since it reverses the sedative and other actions of benzodiazepines, it has been suggested as an antidote to benzodiazepine overdoses.. flumazenil : An organic heterotricyclic compound that is 5,6-dihydro-4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted at positions 3, 5, 6, and 8 by ethoxycarbonyl, methyl, oxo, and fluoro groups, respectively. It is used as an antidote to benzodiazepine overdose. | 2.02 | 1 | 0 | ethyl ester; imidazobenzodiazepine; organofluorine compound | antidote to benzodiazepine poisoning; GABA antagonist |
| fluorouracil Fluorouracil: A pyrimidine analog that is an antineoplastic antimetabolite. It interferes with DNA synthesis by blocking the THYMIDYLATE SYNTHETASE conversion of deoxyuridylic acid to thymidylic acid.. 5-fluorouracil : A nucleobase analogue that is uracil in which the hydrogen at position 5 is replaced by fluorine. It is an antineoplastic agent which acts as an antimetabolite - following conversion to the active deoxynucleotide, it inhibits DNA synthesis (by blocking the conversion of deoxyuridylic acid to thymidylic acid by the cellular enzyme thymidylate synthetase) and so slows tumour growth. | 2.02 | 1 | 0 | nucleobase analogue; organofluorine compound | antimetabolite; antineoplastic agent; environmental contaminant; immunosuppressive agent; radiosensitizing agent; xenobiotic |
| fluoxetine Fluoxetine: The first highly specific serotonin uptake inhibitor. It is used as an antidepressant and often has a more acceptable side-effects profile than traditional antidepressants.. fluoxetine : A racemate comprising equimolar amounts of (R)- and (S)-fluoxetine. A selective serotonin reuptake inhibitor (SSRI), it is used (generally as the hydrochloride salt) for the treatment of depression (and the depressive phase of bipolar disorder), bullimia nervosa, and obsessive-compulsive disorder.. N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine : An aromatic ether consisting of 4-trifluoromethylphenol in which the hydrogen of the phenolic hydroxy group is replaced by a 3-(methylamino)-1-phenylpropyl group. | 3.44 | 7 | 0 | (trifluoromethyl)benzenes; aromatic ether; secondary amino compound | |
| fluphenazine depot fluphenazine decanoate : The prodrug of fluphenazine, an antipsychotic drug used for the symptomatic management of psychosis in patients with schizophrenia. | 2.02 | 1 | 0 | decanoate ester; N-alkylpiperazine; organofluorine compound; phenothiazines | dopaminergic antagonist; phenothiazine antipsychotic drug; prodrug |
| fluphenazine enanthate [no description available] | 2.02 | 1 | 0 | phenothiazines | |
| flurbiprofen Flurbiprofen: An anti-inflammatory analgesic and antipyretic of the phenylalkynoic acid series. It has been shown to reduce bone resorption in periodontal disease by inhibiting CARBONIC ANHYDRASE.. flurbiprofen : A monocarboxylic acid that is a 2-fluoro-[1,1'-biphenyl-4-yl] moiety linked to C-2 of propionic acid. A non-steroidal anti-inflammatory, analgesic and antipyretic, it is used as a pre-operative anti-miotic as well as orally for arthritis or dental pain. | 2.02 | 1 | 0 | fluorobiphenyl; monocarboxylic acid | antipyretic; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| flutamide Flutamide: An antiandrogen with about the same potency as cyproterone in rodent and canine species. | 8.41 | 7 | 0 | (trifluoromethyl)benzenes; monocarboxylic acid amide | androgen antagonist; antineoplastic agent |
| foscarnet Foscarnet: An antiviral agent used in the treatment of cytomegalovirus retinitis. Foscarnet also shows activity against human herpesviruses and HIV.. phosphonoformic acid : Phosphoric acid in which one of the hydroxy groups is replaced by a carboxylic acid group. It is used as the trisodium salt as an antiviral agent in the treatment of cytomegalovirus retinitis (CMV retinitis, an inflamation of the retina that can lead to blindness) and as an alternative to ganciclovir for AIDS patients who require concurrent antiretroviral therapy but are unable to tolerate ganciclovir due to haematological toxicity. | 2.02 | 1 | 0 | carboxylic acid; one-carbon compound; phosphonic acids | antiviral drug; geroprotector; HIV-1 reverse transcriptase inhibitor; sodium-dependent Pi-transporter inhibitor |
| furosemide Furosemide: A benzoic-sulfonamide-furan. It is a diuretic with fast onset and short duration that is used for EDEMA and chronic RENAL INSUFFICIENCY.. furosemide : A chlorobenzoic acid that is 4-chlorobenzoic acid substituted by a (furan-2-ylmethyl)amino and a sulfamoyl group at position 2 and 5 respectively. It is a diuretic used in the treatment of congestive heart failure. | 2.74 | 3 | 0 | chlorobenzoic acid; furans; sulfonamide | environmental contaminant; loop diuretic; xenobiotic |
| gabapentin Gabapentin: A cyclohexane-gamma-aminobutyric acid derivative that is used for the treatment of PARTIAL SEIZURES; NEURALGIA; and RESTLESS LEGS SYNDROME.. gabapentin : A gamma-amino acid that is cyclohexane substituted at position 1 by aminomethyl and carboxymethyl groups. Used for treatment of neuropathic pain and restless legs syndrome. | 2.02 | 1 | 0 | gamma-amino acid | anticonvulsant; calcium channel blocker; environmental contaminant; xenobiotic |
| gemfibrozil [no description available] | 2.02 | 1 | 0 | aromatic ether | antilipemic drug |
| glimepiride glimepiride: structure given in first source | 2.02 | 1 | 0 | sulfonamide | |
| glipizide Glipizide: An oral hypoglycemic agent which is rapidly absorbed and completely metabolized.. glipizide : An N-sulfonylurea that is glyburide in which the (5-chloro-2-methoxybenzoyl group is replaced by a (5-methylpyrazin-2-yl)carbonyl group. An oral hypoglycemic agent, it is used in the treatment of type 2 diabetes mellitus. | 2.02 | 1 | 0 | aromatic amide; monocarboxylic acid amide; N-sulfonylurea; pyrazines | EC 2.7.1.33 (pantothenate kinase) inhibitor; hypoglycemic agent; insulin secretagogue |
| glyburide Glyburide: An antidiabetic sulfonylurea derivative with actions like those of chlorpropamide. glyburide : An N-sulfonylurea that is acetohexamide in which the acetyl group is replaced by a 2-(5-chloro-2-methoxybenzamido)ethyl group. | 2.02 | 1 | 0 | monochlorobenzenes; N-sulfonylurea | anti-arrhythmia drug; EC 2.7.1.33 (pantothenate kinase) inhibitor; EC 3.6.3.49 (channel-conductance-controlling ATPase) inhibitor; hypoglycemic agent |
| gossypol Gossypol: A dimeric sesquiterpene found in cottonseed (GOSSYPIUM). The (-) isomer is active as a male contraceptive (CONTRACEPTIVE AGENTS, MALE) whereas toxic symptoms are associated with the (+) isomer. | 2.04 | 1 | 0 | ||
| granisetron [no description available] | 2.02 | 1 | 0 | aromatic amide; indazoles | |
| guanfacine Guanfacine: A centrally acting antihypertensive agent with specificity towards ADRENERGIC ALPHA-2 RECEPTORS. | 2.02 | 1 | 0 | acetamides | |
| haloperidol Haloperidol: A phenyl-piperidinyl-butyrophenone that is used primarily to treat SCHIZOPHRENIA and other PSYCHOSES. It is also used in schizoaffective disorder, DELUSIONAL DISORDERS, ballism, and TOURETTE SYNDROME (a drug of choice) and occasionally as adjunctive therapy in INTELLECTUAL DISABILITY and the chorea of HUNTINGTON DISEASE. It is a potent antiemetic and is used in the treatment of intractable HICCUPS. (From AMA Drug Evaluations Annual, 1994, p279). haloperidol : A compound composed of a central piperidine structure with hydroxy and p-chlorophenyl substituents at position 4 and an N-linked p-fluorobutyrophenone moiety. | 2.46 | 2 | 0 | aromatic ketone; hydroxypiperidine; monochlorobenzenes; organofluorine compound; tertiary alcohol | antidyskinesia agent; antiemetic; dopaminergic antagonist; first generation antipsychotic; serotonergic antagonist |
| halothane [no description available] | 2.02 | 1 | 0 | haloalkane; organobromine compound; organochlorine compound; organofluorine compound | inhalation anaesthetic |
| hydrochlorothiazide Hydrochlorothiazide: A thiazide diuretic often considered the prototypical member of this class. It reduces the reabsorption of electrolytes from the renal tubules. This results in increased excretion of water and electrolytes, including sodium, potassium, chloride, and magnesium. It is used in the treatment of several disorders including edema, hypertension, diabetes insipidus, and hypoparathyroidism.. hydrochlorothiazide : A benzothiadiazine that is 3,4-dihydro-2H-1,2,4-benzothiadiazine 1,1-dioxide substituted by a chloro group at position 6 and a sulfonamide at 7. It is diuretic used for the treatment of hypertension and congestive heart failure. | 2.02 | 1 | 0 | benzothiadiazine; organochlorine compound; sulfonamide | antihypertensive agent; diuretic; environmental contaminant; xenobiotic |
| hydroxyurea [no description available] | 2.02 | 1 | 0 | one-carbon compound; ureas | antimetabolite; antimitotic; antineoplastic agent; DNA synthesis inhibitor; EC 1.17.4.1 (ribonucleoside-diphosphate reductase) inhibitor; genotoxin; immunomodulator; radical scavenger; teratogenic agent |
| hydroxyzine Hydroxyzine: A histamine H1 receptor antagonist that is effective in the treatment of chronic urticaria, dermatitis, and histamine-mediated pruritus. Unlike its major metabolite CETIRIZINE, it does cause drowsiness. It is also effective as an antiemetic, for relief of anxiety and tension, and as a sedative.. hydroxyzine : A N-alkylpiperazine that is piperzine in which the nitrogens atoms are substituted by 2-(2-hydroxyethoxy)ethyl and (4-chlorophenyl)(phenyl)methyl groups respectively. | 2.02 | 1 | 0 | hydroxyether; monochlorobenzenes; N-alkylpiperazine | anticoronaviral agent; antipruritic drug; anxiolytic drug; dermatologic drug; H1-receptor antagonist |
| ibuprofen Midol: combination of cinnamedrine, phenacetin, aspirin & caffeine | 2.02 | 1 | 0 | monocarboxylic acid | antipyretic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; drug allergen; environmental contaminant; geroprotector; non-narcotic analgesic; non-steroidal anti-inflammatory drug; radical scavenger; xenobiotic |
| phenelzine Phenelzine: One of the MONOAMINE OXIDASE INHIBITORS used to treat DEPRESSION; PHOBIC DISORDERS; and PANIC. | 2.02 | 1 | 0 | primary amine | |
| ifosfamide [no description available] | 2.02 | 1 | 0 | ifosfamides | alkylating agent; antineoplastic agent; environmental contaminant; immunosuppressive agent; xenobiotic |
| imipramine Imipramine: The prototypical tricyclic antidepressant. It has been used in major depression, dysthymia, bipolar depression, attention-deficit disorders, agoraphobia, and panic disorders. It has less sedative effect than some other members of this therapeutic group.. imipramine : A dibenzoazepine that is 5H-dibenzo[b,f]azepine substituted by a 3-(dimethylamino)propyl group at the nitrogen atom. | 3.36 | 2 | 0 | dibenzoazepine | adrenergic uptake inhibitor; antidepressant; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor |
| amrinone Amrinone: A positive inotropic cardiotonic (CARDIOTONIC AGENTS) with vasodilator properties, phosphodiesterase 3 inhibitory activity, and the ability to stimulate calcium ion influx into the cardiac cell.. amrinone : A 3,4'-bipyridine substituted at positions 5 and 6 by an amino group and a keto function respectively. A pyridine phosphodiesterase 3 inhibitor, it is a drug that may improve the prognosis in patients with congestive heart failure. | 2.02 | 1 | 0 | bipyridines | EC 3.1.4.* (phosphoric diester hydrolase) inhibitor |
| indapamide Indapamide: A benzamide-sulfonamide-indole derived DIURETIC that functions by inhibiting SODIUM CHLORIDE SYMPORTERS.. indapamide : A sulfonamide formed by condensation of the carboxylic group of 4-chloro-3-sulfamoylbenzoic acid with the amino group of 2-methyl-2,3-dihydro-1H-indol-1-amine. | 2.02 | 1 | 0 | indoles; organochlorine compound; sulfonamide | antihypertensive agent; diuretic |
| indomethacin Indomethacin: A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES.. indometacin : A member of the class of indole-3-acetic acids that is indole-3-acetic acid in which the indole ring is substituted at positions 1, 2 and 5 by p-chlorobenzoyl, methyl, and methoxy groups, respectively. A non-steroidal anti-inflammatory drug, it is used in the treatment of musculoskeletal and joint disorders including osteoarthritis, rheumatoid arthritis, gout, bursitis and tendinitis. | 2.41 | 2 | 0 | aromatic ether; indole-3-acetic acids; monochlorobenzenes; N-acylindole | analgesic; drug metabolite; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; environmental contaminant; gout suppressant; non-steroidal anti-inflammatory drug; xenobiotic metabolite; xenobiotic |
| iodixanol iodixanol: dimeric contrast media; structure given in first source. iodixanol : A dimeric, non-ionic, water-soluble, radiographic contrast agent, used particularly in coronary angiography. | 2.02 | 1 | 0 | organoiodine compound | radioopaque medium |
| iohexol Iohexol: An effective non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiographic procedures. Its low systemic toxicity is the combined result of low chemotoxicity and low osmolality.. iohexol : A benzenedicarboxamide compound having N-(2,3-dihydroxypropyl)carbamoyl groups at the 1- and 3-positions, iodo substituents at the 2-, 4- and 6-positions and an N-(2,3-dihydroxypropyl)acetamido group at the 5-position. | 2.02 | 1 | 0 | benzenedicarboxamide; organoiodine compound | environmental contaminant; radioopaque medium; xenobiotic |
| iopromide iopromide: structure given in first source. iopromide : A dicarboxylic acid diamide that consists of N-methylisophthalamide bearing three iodo substituents at positions 2, 4 and 6, a methoxyacetyl substituent at position 5 and two 2,3-dihydroxypropyl groups attached to the amide nitrogens. A water soluble x-ray contrast agent for intravascular administration. | 2.02 | 1 | 0 | dicarboxylic acid diamide; organoiodine compound | environmental contaminant; nephrotoxic agent; radioopaque medium; xenobiotic |
| ioversol [no description available] | 2.02 | 1 | 0 | amidobenzoic acid | |
| 1-methyl-3-isobutylxanthine 1-Methyl-3-isobutylxanthine: A potent cyclic nucleotide phosphodiesterase inhibitor; due to this action, the compound increases cyclic AMP and cyclic GMP in tissue and thereby activates CYCLIC NUCLEOTIDE-REGULATED PROTEIN KINASES. 3-isobutyl-1-methylxanthine : An oxopurine that is xanthine which is substituted at positions 1 and 3 by methyl and isobutyl groups, respectively. | 2 | 1 | 0 | 3-isobutyl-1-methylxanthine | |
| isoflurane Isoflurane: A stable, non-explosive inhalation anesthetic, relatively free from significant side effects. | 2.02 | 1 | 0 | organofluorine compound | inhalation anaesthetic |
| isoniazid Hydra: A genus of freshwater polyps in the family Hydridae, order Hydroida, class HYDROZOA. They are of special interest because of their complex organization and because their adult organization corresponds roughly to the gastrula of higher animals.. hydrazide : Compounds derived from oxoacids RkE(=O)l(OH)m (l =/= 0) by replacing -OH by -NRNR2 (R groups are commonly H). (IUPAC). | 2.02 | 1 | 0 | carbohydrazide | antitubercular agent; drug allergen |
| isoproterenol Isoproterenol: Isopropyl analog of EPINEPHRINE; beta-sympathomimetic that acts on the heart, bronchi, skeletal muscle, alimentary tract, etc. It is used mainly as bronchodilator and heart stimulant.. isoprenaline : A secondary amino compound that is noradrenaline in which one of the hydrogens attached to the nitrogen is replaced by an isopropyl group. A sympathomimetic acting almost exclusively on beta-adrenergic receptors, it is used (mainly as the hydrochloride salt) as a bronghodilator and heart stimulant for the management of a variety of cardiac disorders. | 2.03 | 1 | 0 | catechols; secondary alcohol; secondary amino compound | beta-adrenergic agonist; bronchodilator agent; cardiotonic drug; sympathomimetic agent |
| isradipine Isradipine: A potent antagonist of CALCIUM CHANNELS that is highly selective for VASCULAR SMOOTH MUSCLE. It is effective in the treatment of chronic stable angina pectoris, hypertension, and congestive cardiac failure. | 2.02 | 1 | 0 | benzoxadiazole; dihydropyridine; isopropyl ester; methyl ester | |
| itraconazole [no description available] | 2.02 | 1 | 0 | piperazines | |
| ketanserin Ketanserin: A selective serotonin receptor antagonist with weak adrenergic receptor blocking properties. The drug is effective in lowering blood pressure in essential hypertension. It also inhibits platelet aggregation. It is well tolerated and is particularly effective in older patients.. ketanserin : A member of the class of quinazolines that is quinazoline-2,4(1H,3H)-dione which is substituted at position 3 by a 2-[4-(p-fluorobenzoyl)piperidin-1-yl]ethyl group. | 2.41 | 2 | 0 | aromatic ketone; organofluorine compound; piperidines; quinazolines | alpha-adrenergic antagonist; antihypertensive agent; cardiovascular drug; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; serotonergic antagonist |
| ketoconazole 1-acetyl-4-(4-{[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine : A dioxolane that is 1,3-dioxolane which is substituted at positions 2, 2, and 4 by imidazol-1-ylmethyl, 2,4-dichlorophenyl, and [para-(4-acetylpiperazin-1-yl)phenoxy]methyl groups, respectively. | 2.02 | 1 | 0 | dichlorobenzene; dioxolane; ether; imidazoles; N-acylpiperazine; N-arylpiperazine | |
| ketoprofen Ketoprofen: An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It is used in the treatment of rheumatoid arthritis and osteoarthritis.. ketoprofen : An oxo monocarboxylic acid that consists of propionic acid substituted by a 3-benzoylphenyl group at position 2. | 2.02 | 1 | 0 | benzophenones; oxo monocarboxylic acid | antipyretic; drug allergen; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; environmental contaminant; non-steroidal anti-inflammatory drug; xenobiotic |
| ketorolac Ketorolac: A pyrrolizine carboxylic acid derivative structurally related to INDOMETHACIN. It is an NSAID and is used principally for its analgesic activity. (From Martindale The Extra Pharmacopoeia, 31st ed). ketorolac : A racemate comprising equimolar amounts of (R)-(+)- and (S)-(-)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid. While only the (S)-(-) enantiomer is a COX1 and COX2 inhibitor, the (R)-(+) enantiomer exhibits potent analgesic activity. A non-steroidal anti-inflammatory drug, ketorolac is mainly used (generally as the tromethamine salt) for its potent analgesic properties in the short-term management of post-operative pain, and in eye drops to relieve the ocular itching associated with seasonal allergic conjunctivitis. It was withdrawn from the market in many countries in 1993 following association with haemorrhage and renal failure.. 5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid : A member of the class of pyrrolizines that is 2,3-dihydro-1H-pyrrolizine which is substituted at positions 1 and 5 by carboxy and benzoyl groups, respectively. | 2.02 | 1 | 0 | amino acid; aromatic ketone; monocarboxylic acid; pyrrolizines; racemate | analgesic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; non-steroidal anti-inflammatory drug |
| labetalol Labetalol: A salicylamide derivative that is a non-cardioselective blocker of BETA-ADRENERGIC RECEPTORS and ALPHA-1 ADRENERGIC RECEPTORS.. labetalol : A diastereoisomeric mixture of approximately equal amounts of all four possible stereoisomers ((R,S)-labetolol, (S,R)-labetolol, (S,S)-labetalol and (R,R)-labetalol). It is an adrenergic antagonist used to treat high blood pressure.. 2-hydroxy-5-{1-hydroxy-2-[(4-phenylbutan-2-yl)amino]ethyl}benzamide : A member of the class of benzamides that is benzamide substituted by a hydroxy group at position 2 and by a 1-hydroxy-2-[(4-phenylbutan-2-yl)amino]ethyl group at position 5. | 2.02 | 1 | 0 | benzamides; benzenes; phenols; primary carboxamide; salicylamides; secondary alcohol; secondary amino compound | |
| lamotrigine [no description available] | 2.02 | 1 | 0 | 1,2,4-triazines; dichlorobenzene; primary arylamine | anticonvulsant; antidepressant; antimanic drug; calcium channel blocker; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; environmental contaminant; excitatory amino acid antagonist; geroprotector; non-narcotic analgesic; xenobiotic |
| lansoprazole Lansoprazole: A 2,2,2-trifluoroethoxypyridyl derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS. Lansoprazole is a racemic mixture of (R)- and (S)-isomers. | 2.02 | 1 | 0 | benzimidazoles; pyridines; sulfoxide | anti-ulcer drug; EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor |
| letrozole [no description available] | 2.72 | 3 | 0 | nitrile; triazoles | antineoplastic agent; EC 1.14.14.14 (aromatase) inhibitor |
| lomefloxacin lomefloxacin: structure given in first source. lomefloxacin : A fluoroquinolone antibiotic, used (generally as the hydrochloride salt) to treat bacterial infections including bronchitis and urinary tract infections. It is also used to prevent urinary tract infections prior to surgery. | 2.02 | 1 | 0 | fluoroquinolone antibiotic; N-arylpiperazine; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone | antimicrobial agent; antitubercular agent; photosensitizing agent |
| loratadine Loratadine: A second-generation histamine H1 receptor antagonist used in the treatment of allergic rhinitis and urticaria. Unlike most classical antihistamines (HISTAMINE H1 ANTAGONISTS) it lacks central nervous system depressing effects such as drowsiness.. loratadine : A benzocycloheptapyridine that is 6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine substituted by a chloro group at position 8 and a 1-(ethoxycarbonyl)piperidin-4-ylidene group at position 11. It is a H1-receptor antagonist commonly employed in the treatment of allergic disorders. | 2.02 | 1 | 0 | benzocycloheptapyridine; ethyl ester; N-acylpiperidine; organochlorine compound; tertiary carboxamide | anti-allergic agent; cholinergic antagonist; geroprotector; H1-receptor antagonist |
| lorazepam Lorazepam: A benzodiazepine used as an anti-anxiety agent with few side effects. It also has hypnotic, anticonvulsant, and considerable sedative properties and has been proposed as a preanesthetic agent. | 2.11 | 1 | 0 | benzodiazepine | |
| lorglumide lorglumide: RN given refers to (+-)-isomer. lorglumide : A racemate comprising equal amounts of (R)- and (S)-lorglumide.. N(2)-(3,4-dichlorobenzoyl)-N,N-dipentyl-alpha-glutamine : A dicarboxylic acid monoamide obtained by formal condensation of the alpha-carboxy group of N-(3,4-dichlorobenzoyl)glutamic acid with the amino group of dipentylamine. | 2.01 | 1 | 0 | benzamides; dicarboxylic acid monoamide; dichlorobenzene; glutamic acid derivative | |
| losartan Losartan: An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.. losartan : A biphenylyltetrazole where a 1,1'-biphenyl group is attached at the 5-position and has an additional trisubstituted imidazol-1-ylmethyl group at the 4'-position | 2.43 | 2 | 0 | biphenylyltetrazole; imidazoles | angiotensin receptor antagonist; anti-arrhythmia drug; antihypertensive agent; endothelin receptor antagonist |
| loxapine Loxapine: An antipsychotic agent used in SCHIZOPHRENIA. | 2.02 | 1 | 0 | dibenzooxazepine | antipsychotic agent; dopaminergic antagonist |
| maprotiline Maprotiline: A bridged-ring tetracyclic antidepressant that is both mechanistically and functionally similar to the tricyclic antidepressants, including side effects associated with its use. | 2.02 | 1 | 0 | anthracenes | |
| mebendazole Mebendazole: A benzimidazole that acts by interfering with CARBOHYDRATE METABOLISM and inhibiting polymerization of MICROTUBULES.. mebendazole : A carbamate ester that is methyl 1H-benzimidazol-2-ylcarbamate substituted by a benzoyl group at position 5. | 2.02 | 1 | 0 | aromatic ketone; benzimidazoles; carbamate ester | antinematodal drug; microtubule-destabilising agent; tubulin modulator |
| meclofenamic acid Meclofenamic Acid: A non-steroidal anti-inflammatory agent with antipyretic and antigranulation activities. It also inhibits prostaglandin biosynthesis.. meclofenamic acid : An aminobenzoic acid that is anthranilic acid in which one of the hydrogens attached to the nitrogen is replaced by a 2,6-dichloro-3-methylphenyl group. A non-steroidal anti-inflammatory drug, it is used as the sodium salt for the treatment of dysmenorrhoea (painful periods), osteoarthritis and rheumatoid arthritis. | 2.02 | 1 | 0 | aminobenzoic acid; organochlorine compound; secondary amino compound | analgesic; anticonvulsant; antineoplastic agent; antipyretic; antirheumatic drug; EC 1.13.11.34 (arachidonate 5-lipoxygenase) inhibitor; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-steroidal anti-inflammatory drug |
| mefenamic acid Mefenamic Acid: A non-steroidal anti-inflammatory agent with analgesic, anti-inflammatory, and antipyretic properties. It is an inhibitor of cyclooxygenase.. mefenamic acid : An aminobenzoic acid that is anthranilic acid in which one of the hydrogens attached to the nitrogen is replaced by a 2,3-dimethylphenyl group. Although classed as a non-steroidal anti-inflammatory drug, its anti-inflammatory properties are considered to be minor. It is used to relieve mild to moderate pain, including headaches, dental pain, osteoarthritis and rheumatoid arthritis. | 2.02 | 1 | 0 | aminobenzoic acid; secondary amino compound | analgesic; antipyretic; antirheumatic drug; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; environmental contaminant; non-steroidal anti-inflammatory drug; xenobiotic |
| mefloquine hydrochloride [2,8-bis(trifluoromethyl)quinolin-4-yl]-(2-piperidyl)methanol : An organofluorine compound that consists of quinoline bearing trifluoromethyl substituents at positions 2 and 8 as well as a (2-piperidinyl)hydroxymethyl substituent at position 4. | 2.02 | 1 | 0 | organofluorine compound; piperidines; quinolines; secondary alcohol | |
| mesalamine Mesalamine: An anti-inflammatory agent, structurally related to the SALICYLATES, which is active in INFLAMMATORY BOWEL DISEASE. It is considered to be the active moiety of SULPHASALAZINE. (From Martindale, The Extra Pharmacopoeia, 30th ed). mesalamine : A monohydroxybenzoic acid that is salicylic acid substituted by an amino group at the 5-position. | 2.02 | 1 | 0 | amino acid; aromatic amine; monocarboxylic acid; monohydroxybenzoic acid; phenols | non-steroidal anti-inflammatory drug |
| metformin Metformin: A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289). metformin : A member of the class of guanidines that is biguanide the carrying two methyl substituents at position 1. | 2.02 | 1 | 0 | guanidines | environmental contaminant; geroprotector; hypoglycemic agent; xenobiotic |
| methoxychlor Methoxychlor: An insecticide. Methoxychlor has estrogenic effects in mammals, among other effects. | 7.95 | 4 | 0 | organochlorine insecticide | |
| metoclopramide Metoclopramide: A dopamine D2 antagonist that is used as an antiemetic.. metoclopramide : A member of the class of benzamides resulting from the formal condensation of 4-amino-5-chloro-2-methoxybenzoic acid with the primary amino group of N,N-diethylethane-1,2-diamine. | 2.02 | 1 | 0 | benzamides; monochlorobenzenes; substituted aniline; tertiary amino compound | antiemetic; dopaminergic antagonist; environmental contaminant; gastrointestinal drug; xenobiotic |
| metoprolol Metoprolol: A selective adrenergic beta-1 blocking agent that is commonly used to treat ANGINA PECTORIS; HYPERTENSION; and CARDIAC ARRHYTHMIAS.. metoprolol : A propanolamine that is 1-(propan-2-ylamino)propan-2-ol substituted by a 4-(2-methoxyethyl)phenoxy group at position 1. | 2.02 | 1 | 0 | aromatic ether; propanolamine; secondary alcohol; secondary amino compound | antihypertensive agent; beta-adrenergic antagonist; environmental contaminant; geroprotector; xenobiotic |
| metronidazole Metronidazole: A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS.. metronidazole : A member of the class of imidazoles substituted at C-1, -2 and -5 with 2-hydroxyethyl, nitro and methyl groups respectively. It has activity against anaerobic bacteria and protozoa, and has a radiosensitising effect on hypoxic tumour cells. It may be given by mouth in tablets, or as the benzoate in an oral suspension. The hydrochloride salt can be used in intravenous infusions. Metronidazole is a prodrug and is selective for anaerobic bacteria due to their ability to intracellularly reduce the nitro group of metronidazole to give nitroso-containing intermediates. These can covalently bind to DNA, disrupting its helical structure, inducing DNA strand breaks and inhibiting bacterial nucleic acid synthesis, ultimately resulting in bacterial cell death. | 2.47 | 2 | 0 | C-nitro compound; imidazoles; primary alcohol | antiamoebic agent; antibacterial drug; antimicrobial agent; antiparasitic agent; antitrichomonal drug; environmental contaminant; prodrug; radiosensitizing agent; xenobiotic |
| mexiletine Mexiletine: Antiarrhythmic agent pharmacologically similar to LIDOCAINE. It may have some anticonvulsant properties.. mexiletine : An aromatic ether which is 2,6-dimethylphenyl ether of 2-aminopropan-1-ol. | 2.02 | 1 | 0 | aromatic ether; primary amino compound | anti-arrhythmia drug |
| mianserin Mianserin: A tetracyclic compound with antidepressant effects. It may cause drowsiness and hematological problems. Its mechanism of therapeutic action is not well understood, although it apparently blocks alpha-adrenergic, histamine H1, and some types of serotonin receptors.. mianserin : A dibenzoazepine (specifically 1,2,3,4,10,14b-hexahydrodibenzo[c,f]pyrazino[1,2-a]azepine) methyl-substituted on N-2. Closely related to (and now mostly superseded by) the tetracyclic antidepressant mirtazapinean, it is an atypical antidepressant used in the treatment of depression throughout Europe and elsewhere. | 2.03 | 1 | 0 | dibenzoazepine | adrenergic uptake inhibitor; alpha-adrenergic antagonist; antidepressant; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; geroprotector; H1-receptor antagonist; histamine agonist; sedative; serotonergic antagonist |
| midazolam Midazolam: A short-acting hypnotic-sedative drug with anxiolytic and amnestic properties. It is used in dentistry, cardiac surgery, endoscopic procedures, as preanesthetic medication, and as an adjunct to local anesthesia. The short duration and cardiorespiratory stability makes it useful in poor-risk, elderly, and cardiac patients. It is water-soluble at pH less than 4 and lipid-soluble at physiological pH.. midazolam : An imidazobenzodiazepine that is 4H-imidazo[1,5-a][1,4]benzodiazepine which is substituted by a methyl, 2-fluorophenyl and chloro groups at positions 1, 6 and 8, respectively. | 2.02 | 1 | 0 | imidazobenzodiazepine; monofluorobenzenes; organochlorine compound | anticonvulsant; antineoplastic agent; anxiolytic drug; apoptosis inducer; central nervous system depressant; GABAA receptor agonist; general anaesthetic; muscle relaxant; sedative |
| midodrine Midodrine: An ethanolamine derivative that is an adrenergic alpha-1 agonist. It is used as a vasoconstrictor agent in the treatment of HYPOTENSION.. midodrine : An aromatic ether that is 1,4-dimethoxybenzene which is substituted at position 2 by a 2-(glycylamino)-1-hydroxyethyl group. A direct-acting sympathomimetic with selective alpha-adrenergic agonist activity, it is used (generally as its hydrochloride salt) as a peripheral vasoconstrictor in the treatment of certain hypotensive states. The main active moiety is its major metabolite, deglymidodrine. | 2.02 | 1 | 0 | amino acid amide; aromatic ether; secondary alcohol | alpha-adrenergic agonist; prodrug; sympathomimetic agent; vasoconstrictor agent |
| minoxidil Minoxidil: A potent direct-acting peripheral vasodilator (VASODILATOR AGENTS) that reduces peripheral resistance and produces a fall in BLOOD PRESSURE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p371). minoxidil : A pyrimidine N-oxide that is pyrimidine-2,4-diamine 3-oxide substituted by a piperidin-1-yl group at position 6. | 2.02 | 1 | 0 | dialkylarylamine; tertiary amino compound | |
| mirtazapine Mirtazapine: A piperazinoazepine tetracyclic compound that enhances the release of NOREPINEPHRINE and SEROTONIN through blockage of presynaptic ALPHA-2 ADRENERGIC RECEPTORS. It also blocks both 5-HT2 and 5-HT3 serotonin receptors and is a potent HISTAMINE H1 RECEPTOR antagonist. It is used for the treatment of depression, and may also be useful for the treatment of anxiety disorders. | 2.43 | 2 | 0 | benzazepine; tetracyclic antidepressant | alpha-adrenergic antagonist; anxiolytic drug; H1-receptor antagonist; histamine antagonist; oneirogen; serotonergic antagonist |
| mitoxantrone Mitoxantrone: An anthracenedione-derived antineoplastic agent.. mitoxantrone : A dihydroxyanthraquinone that is 1,4-dihydroxy-9,10-anthraquinone which is substituted by 6-hydroxy-1,4-diazahexyl groups at positions 5 and 8. | 2.02 | 1 | 0 | dihydroxyanthraquinone | analgesic; antineoplastic agent |
| muscimol Muscimol: A neurotoxic isoxazole isolated from species of AMANITA. It is obtained by decarboxylation of IBOTENIC ACID. Muscimol is a potent agonist of GABA-A RECEPTORS and is used mainly as an experimental tool in animal and tissue studies.. muscimol : A member of the class of isoxazoles that is 1,2-oxazol-3(2H)-one substituted by an aminomethyl group at position 5. It has been isolated from mushrooms of the genus Amanita. | 2.74 | 3 | 0 | alkaloid; isoxazoles; primary amino compound | fungal metabolite; GABA agonist; oneirogen; psychotropic drug |
| nabumetone Nabumetone: A butanone non-steroidal anti-inflammatory drug and cyclooxygenase-2 (COX2) inhibitor that is used in the management of pain associated with OSTEOARTHRITIS and RHEUMATOID ARTHRITIS.. nabumetone : A methyl ketone that is 2-butanone in which one of the methyl hydrogens at position 4 is replaced by a 6-methoxy-2-naphthyl group. A prodrug that is converted to the active metabolite, 6-methoxy-2-naphthylacetic acid, following oral administration. It is shown to have a slightly lower risk of gastrointestinal side effects than most other non-steroidal anti-inflammatory drugs. | 2.02 | 1 | 0 | methoxynaphthalene; methyl ketone | cyclooxygenase 2 inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug; prodrug |
| nefazodone nefazodone: may be useful as an opiate adjunct | 2.41 | 2 | 0 | aromatic ether; monochlorobenzenes; N-alkylpiperazine; N-arylpiperazine; triazoles | alpha-adrenergic antagonist; analgesic; antidepressant; serotonergic antagonist; serotonin uptake inhibitor |
| nevirapine Nevirapine: A potent, non-nucleoside reverse transcriptase inhibitor used in combination with nucleoside analogues for treatment of HIV INFECTIONS and AIDS.. nevirapine : A dipyridodiazepine that is 5,11-dihydro-6H-dipyrido[3,2-b:2',3'-e][1,4]diazepine which is substituted by methyl, oxo, and cyclopropyl groups at positions 4, 6, and 11, respectively. A non-nucleoside reverse transcriptase inhibitor with activity against HIV-1, it is used in combination with other antiretrovirals for the treatment of HIV infection. | 2.02 | 1 | 0 | cyclopropanes; dipyridodiazepine | antiviral drug; HIV-1 reverse transcriptase inhibitor |
| nicardipine Nicardipine: A potent calcium channel blockader with marked vasodilator action. It has antihypertensive properties and is effective in the treatment of angina and coronary spasms without showing cardiodepressant effects. It has also been used in the treatment of asthma and enhances the action of specific antineoplastic agents.. nicardipine : A racemate comprising equimolar amounts of (R)- and (S)-nicardipine. It is a calcium channel blocker which is used to treat hypertension.. 2-[benzyl(methyl)amino]ethyl methyl 2,6-dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate : A dihydropyridine that is 1,4-dihydropyridine substituted by a methyl, {2-[benzyl(methyl)amino]ethoxy}carbonyl, 3-nitrophenyl, methoxycarbonyl and methyl groups at positions 2, 3, 4, 5 and 6, respectively. | 2.02 | 1 | 0 | benzenes; C-nitro compound; diester; dihydropyridine; methyl ester; tertiary amino compound | |
| nifedipine Nifedipine: A potent vasodilator agent with calcium antagonistic action. It is a useful anti-anginal agent that also lowers blood pressure. | 2.02 | 1 | 0 | C-nitro compound; dihydropyridine; methyl ester | calcium channel blocker; human metabolite; tocolytic agent; vasodilator agent |
| nilutamide [no description available] | 2.02 | 1 | 0 | (trifluoromethyl)benzenes; C-nitro compound; imidazolidinone | androgen antagonist; antineoplastic agent |
| nimodipine Nimodipine: A calcium channel blockader with preferential cerebrovascular activity. It has marked cerebrovascular dilating effects and lowers blood pressure.. nimodipine : A dihydropyridine that is 1,4-dihydropyridine which is substituted by methyl groups at positions 2 and 6, a (2-methoxyethoxy)carbonyl group at position 3, a m-nitrophenyl group at position 4, and an isopropoxycarbonyl group at position 5. An L-type calcium channel blocker, it acts particularly on cerebral circulation, and is used both orally and intravenously for the prevention and treatment of subarachnoid hemorrhage from ruptured intracranial aneurysm. | 2.02 | 1 | 0 | 2-methoxyethyl ester; C-nitro compound; dicarboxylic acids and O-substituted derivatives; diester; dihydropyridine; isopropyl ester | antihypertensive agent; calcium channel blocker; cardiovascular drug; vasodilator agent |
| nisoldipine Nisoldipine: A dihydropyridine calcium channel antagonist that acts as a potent arterial vasodilator and antihypertensive agent. It is also effective in patients with cardiac failure and angina.. nisoldipine : A racemate consisting of equimolar amounts of (R)- and (S)-nisoldipine. A calcium channel blocker, it is used in the treatment of hypertension and angina pectoris.. methyl 2-methylpropyl 2,6-dimethyl-4-(2-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate : A dihydropyridine that is 1,4-dihydropyridine which is substituted by methyl groups at positions 2 and 6, a methoxycarbonyl group at position 3, an o-nitrophenyl group at position 4, and an isobutoxycarbonyl group at position 5. The racemate, a calcium channel blocker, is used in the treatment of hypertension and angina pectoris. | 2.02 | 1 | 0 | C-nitro compound; dicarboxylic acids and O-substituted derivatives; diester; dihydropyridine; methyl ester | |
| nitroglycerin Nitroglycerin: A volatile vasodilator which relieves ANGINA PECTORIS by stimulating GUANYLATE CYCLASE and lowering cytosolic calcium. It is also sometimes used for TOCOLYSIS and explosives.. nitroglycerol : A nitrate ester that is glycerol in which nitro group(s) replace the hydrogen(s) attached to one or more of the hydroxy groups.. nitroglycerin : A nitroglycerol that is glycerol in which the hydrogen atoms of all three hydroxy groups are replaced by nitro groups. It acts as a prodrug, releasing nitric oxide to open blood vessels and so alleviate heart pain. | 2.08 | 1 | 0 | nitroglycerol | explosive; muscle relaxant; nitric oxide donor; prodrug; tocolytic agent; vasodilator agent; xenobiotic |
| nizatidine [no description available] | 2.02 | 1 | 0 | 1,3-thiazoles; C-nitro compound; carboxamidine; organic sulfide; tertiary amino compound | anti-ulcer drug; cholinergic drug; H2-receptor antagonist |
| masoprocol nordihydroguaretic acid: antioxidant compound found in the creosote bush (Larrea tridentata) | 2.02 | 1 | 0 | catechols; lignan; tetrol | antioxidant; ferroptosis inhibitor; geroprotector; plant metabolite |
| norfloxacin Norfloxacin: A synthetic fluoroquinolone (FLUOROQUINOLONES) with broad-spectrum antibacterial activity against most gram-negative and gram-positive bacteria. Norfloxacin inhibits bacterial DNA GYRASE.. norfloxacin : A quinolinemonocarboxylic acid with broad-spectrum antibacterial activity against most gram-negative and gram-positive bacteria. Norfloxacin is bactericidal and its mode of action depends on blocking of bacterial DNA replication by binding itself to an enzyme called DNA gyrase. | 2.02 | 1 | 0 | fluoroquinolone antibiotic; N-arylpiperazine; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone | antibacterial drug; DNA synthesis inhibitor; environmental contaminant; xenobiotic |
| nortriptyline Nortriptyline: A metabolite of AMITRIPTYLINE that is also used as an antidepressive agent. Nortriptyline is used in major depression, dysthymia, and atypical depressions.. nortriptyline : An organic tricyclic compound that is 10,11-dihydro-5H-dibenzo[a,d][7]annulene substituted by a 3-(methylamino)propylidene group at position 5. It is an active metabolite of amitriptyline. | 2.02 | 1 | 0 | organic tricyclic compound; secondary amine | adrenergic uptake inhibitor; analgesic; antidepressant; antineoplastic agent; apoptosis inducer; drug metabolite |
| ofloxacin Ofloxacin: A synthetic fluoroquinolone antibacterial agent that inhibits the supercoiling activity of bacterial DNA GYRASE, halting DNA REPLICATION.. 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid : An oxazinoquinoline that is 2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinolin-7-one substituted by methyl, carboxy, fluoro, and 4-methylpiperazin-1-yl groups at positions 3, 6, 9, and 10, respectively.. ofloxacin : A racemate comprising equimolar amounts of levofloxacin and dextrofloxacin. It is a synthetic fluoroquinolone antibacterial agent which inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication. | 2.02 | 1 | 0 | 3-oxo monocarboxylic acid; N-arylpiperazine; N-methylpiperazine; organofluorine compound; oxazinoquinoline | |
| omeprazole Omeprazole: A 4-methoxy-3,5-dimethylpyridyl, 5-methoxybenzimidazole derivative of timoprazole that is used in the therapy of STOMACH ULCERS and ZOLLINGER-ELLISON SYNDROME. The drug inhibits an H(+)-K(+)-EXCHANGING ATPASE which is found in GASTRIC PARIETAL CELLS.. omeprazole : A racemate comprising equimolar amounts of (R)- and (S)-omeprazole.. 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole : A member of the class of benzimidazoles that is 1H-benzimidazole which is substituted by a [4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl group at position 2 and a methoxy group at position 5. | 2.02 | 1 | 0 | aromatic ether; benzimidazoles; pyridines; sulfoxide | |
| ondansetron Ondansetron: A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties. | 2.02 | 1 | 0 | carbazoles | |
| oxaprozin Oxaprozin: An oxazole-propionic acid derivative, cyclooxygenase inhibitor, and non-steroidal anti-inflammatory drug that is used in the treatment of pain and inflammation associated with of OSTEOARTHRITIS; RHEUMATOID ARTHRITIS; and ARTHRITIS, JUVENILE.. oxaprozin : A monocarboxylic acid that is a propionic acid derivative having a 4,5-diphenyl-1,3-oxazol-2-yl substituent at position 3. It is non-steroidal anti-inflammatory drug commonly used to relieve the pain and inflammatory responses associated with osteoarthritis and rheumatoid arthritis. | 2.02 | 1 | 0 | 1,3-oxazoles; monocarboxylic acid | analgesic; non-steroidal anti-inflammatory drug |
| oxidopamine Oxidopamine: A neurotransmitter analogue that depletes noradrenergic stores in nerve endings and induces a reduction of dopamine levels in the brain. Its mechanism of action is related to the production of cytolytic free-radicals.. oxidopamine : A benzenetriol that is phenethylamine in which the hydrogens at positions 2, 4, and 5 on the phenyl ring are replaced by hydroxy groups. It occurs naturally in human urine, but is also produced as a metabolite of the drug DOPA (used for the treatment of Parkinson's disease). | 2.72 | 3 | 0 | benzenetriol; catecholamine; primary amino compound | drug metabolite; human metabolite; neurotoxin |
| pamidronate [no description available] | 2.02 | 1 | 0 | phosphonoacetic acid | |
| pd 98059 2-(2-amino-3-methoxyphenyl)-4H-1-benzopyran-4-one: inhibits MAP kinase kinase (MEK) activity, p42 MAPK and p44 MAPK; structure in first source. 2-(2-amino-3-methoxyphenyl)chromen-4-one : A member of the class of monomethoxyflavones that is 3'-methoxyflavone bearing an additional amino substituent at position 2'. | 2.04 | 1 | 0 | aromatic amine; monomethoxyflavone | EC 2.7.11.24 (mitogen-activated protein kinase) inhibitor; geroprotector |
| pemoline Pemoline: A central nervous system stimulant used in fatigue and depressive states and to treat hyperkinetic disorders in children.. pemoline : A member of the class of 1,3-oxazoles that is 1,3-oxazol-4(5H)-one which is substituted by an amino group at position 2 and by a phenyl group at position 5. A central nervous system stimulant, it was used to treat hyperactivity disorders in children, but withdrawn from use following reports of serious hepatotoxicity. | 2.02 | 1 | 0 | 1,3-oxazoles | central nervous system stimulant |
| pentamidine Pentamidine: Antiprotozoal agent effective in trypanosomiasis, leishmaniasis, and some fungal infections; used in treatment of PNEUMOCYSTIS pneumonia in HIV-infected patients. It may cause diabetes mellitus, central nervous system damage, and other toxic effects.. pentamidine : A diether consisting of pentane-1,5-diol in which both hydroxyl hydrogens have been replaced by 4-amidinophenyl groups. A trypanocidal drug that is used for treatment of cutaneous leishmaniasis and Chagas disease. | 2.02 | 1 | 0 | aromatic ether; carboxamidine; diether | anti-inflammatory agent; antifungal agent; calmodulin antagonist; chemokine receptor 5 antagonist; EC 2.3.1.48 (histone acetyltransferase) inhibitor; NMDA receptor antagonist; S100 calcium-binding protein B inhibitor; trypanocidal drug; xenobiotic |
| pentobarbital Pentobarbital: A short-acting barbiturate that is effective as a sedative and hypnotic (but not as an anti-anxiety) agent and is usually given orally. It is prescribed more frequently for sleep induction than for sedation but, like similar agents, may lose its effectiveness by the second week of continued administration. (From AMA Drug Evaluations Annual, 1994, p236). pentobarbital : A member of the class of barbiturates, the structure of which is that of barbituric acid substituted at C-5 by ethyl and sec-pentyl groups. | 1.98 | 1 | 0 | barbiturates | GABAA receptor agonist |
| pentoxifylline [no description available] | 2.02 | 1 | 0 | oxopurine | |
| perphenazine Perphenazine: An antipsychotic phenothiazine derivative with actions and uses similar to those of CHLORPROMAZINE.. perphenazine : A phenothiazine derivative in which the phenothiazine tricycle carries a chloro substituent at the 2-position and a 3-[4-(2-hydroxyethyl)piperazin-1-yl]propyl group at N-10. | 2.02 | 1 | 0 | N-(2-hydroxyethyl)piperazine; N-alkylpiperazine; organochlorine compound; phenothiazines | antiemetic; dopaminergic antagonist; phenothiazine antipsychotic drug |
| phenolsulfonphthalein Phenolsulfonphthalein: Red dye, pH indicator, and diagnostic aid for determination of renal function. It is used also for studies of the gastrointestinal and other systems.. phenol red : 3H-2,1-Benzoxathiole 1,1-dioxide in which both of the hydrogens at position 3 have been substituted by 4-hydroxyphenyl groups. A pH indicator changing colour from yellow below pH 6.8 to bright pink above pH 8.2, it is commonly used as an indicator in cell cultures and in home swimming pool test kits. It is also used in the (now infrequently performed) phenolsulfonphthalein (PSP) test for estimation of overall blood flow through the kidney. | 1.99 | 1 | 0 | 2,1-benzoxathiole; arenesulfonate ester; phenols; sultone | acid-base indicator; diagnostic agent; two-colour indicator |
| phenylmethylsulfonyl fluoride Phenylmethylsulfonyl Fluoride: An enzyme inhibitor that inactivates IRC-50 arvin, subtilisin, and the fatty acid synthetase complex.. phenylmethanesulfonyl fluoride : An acyl fluoride with phenylmethanesulfonyl as the acyl group. | 2.02 | 1 | 0 | acyl fluoride | serine proteinase inhibitor |
| pindolol Pindolol: A moderately lipophilic beta blocker (ADRENERGIC BETA-ANTAGONISTS). It is non-cardioselective and has intrinsic sympathomimetic actions, but little membrane-stabilizing activity. (From Martindale, The Extra Pharmocopoeia, 30th ed, p638). pindolol : A member of the class of indols which is the 2-hydroxy-3-(isopropylamino)propyl ether derivative of 1H-indol-4-ol. | 2.02 | 1 | 0 | indoles; secondary amine | antiglaucoma drug; antihypertensive agent; beta-adrenergic antagonist; serotonergic antagonist; vasodilator agent |
| pirbuterol pirbuterol: structure | 2.02 | 1 | 0 | pyridines | |
| prazepam Prazepam: A benzodiazepine that is used in the treatment of ANXIETY DISORDERS. | 2.02 | 1 | 0 | benzodiazepine | |
| praziquantel azinox: Russian drug | 2.02 | 1 | 0 | isoquinolines | |
| prazosin Prazosin: A selective adrenergic alpha-1 antagonist used in the treatment of HEART FAILURE; HYPERTENSION; PHEOCHROMOCYTOMA; RAYNAUD DISEASE; PROSTATIC HYPERTROPHY; and URINARY RETENTION.. prazosin : A member of the class of piperazines that is piperazine substituted by a furan-2-ylcarbonyl group and a 4-amino-6,7-dimethoxyquinazolin-2-yl group at positions 1 and 4 respectively. | 2.02 | 1 | 0 | aromatic ether; furans; monocarboxylic acid amide; piperazines; quinazolines | alpha-adrenergic antagonist; antihypertensive agent; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor |
| primidone Primidone: A barbiturate derivative that acts as a GABA modulator and anti-epileptic agent. It is partly metabolized to PHENOBARBITAL in the body and owes some of its actions to this metabolite.. primidone : A pyrimidone that is dihydropyrimidine-4,6(1H,5H)-dione substituted by an ethyl and a phenyl group at position 5. It is used as an anticonvulsant for treatment of various types of seizures. | 2.02 | 1 | 0 | pyrimidone | anticonvulsant; environmental contaminant; xenobiotic |
| probenecid Probenecid: The prototypical uricosuric agent. It inhibits the renal excretion of organic anions and reduces tubular reabsorption of urate. Probenecid has also been used to treat patients with renal impairment, and, because it reduces the renal tubular excretion of other drugs, has been used as an adjunct to antibacterial therapy.. probenecid : A sulfonamide in which the nitrogen of 4-sulfamoylbenzoic acid is substituted with two propyl groups. | 2.02 | 1 | 0 | benzoic acids; sulfonamide | uricosuric drug |
| procainamide Procainamide: A class Ia antiarrhythmic drug that is structurally-related to PROCAINE.. procainamide : A benzamide that is 4-aminobenzamide substituted on the amide N by a 2-(diethylamino)ethyl group. It is a pharmaceutical antiarrhythmic agent used for the medical treatment of cardiac arrhythmias. | 2.02 | 1 | 0 | benzamides | anti-arrhythmia drug; platelet aggregation inhibitor; sodium channel blocker |
| procarbazine Procarbazine: An antineoplastic agent used primarily in combination with mechlorethamine, vincristine, and prednisone (the MOPP protocol) in the treatment of Hodgkin's disease.. procarbazine : A benzamide obtained by formal condensation of the carboxy group of 4-[(2-methylhydrazino)methyl]benzoic acid with the amino group of isopropylamine. An antineoplastic chemotherapy drug used for treatment of Hodgkin's lymphoma. Metabolism yields azo-procarbazine and hydrogen peroxide, which results in the breaking of DNA strands. | 2.02 | 1 | 0 | benzamides; hydrazines | antineoplastic agent |
| proglumide Proglumide: A drug that exerts an inhibitory effect on gastric secretion and reduces gastrointestinal motility. It is used clinically in the drug therapy of gastrointestinal ulcers.. proglumide : A racemate composed of equal amounts of (R)- and (S)-proglumide. A non-selective CCK antagonist that was used primarily for treatment of stomach ulcers, but has been replaced by newer drugs.. N(2)-benzoyl-N,N-dipropyl-alpha-glutamine : A dicarboxylic acid monoamide obtained by formal condensation of the alpha-carboxy group of N-benzoylglutamic acid with dippropylamine. | 2.01 | 1 | 0 | benzamides; dicarboxylic acid monoamide; glutamine derivative; racemate | anti-ulcer drug; cholecystokinin antagonist; cholinergic antagonist; delta-opioid receptor agonist; drug metabolite; gastrointestinal drug; opioid analgesic; xenobiotic metabolite |
| propafenone Propafenone: An antiarrhythmia agent that is particularly effective in ventricular arrhythmias. It also has weak beta-blocking activity.. propafenone : An aromatic ketone that is 3-(propylamino)propane-1,2-diol in which the hydrogen of the primary hydroxy group is replaced by a 2-(3-phenylpropanoyl)phenyl group. It is a class 1C antiarrhythmic drug with local anesthetic effects, and is used as the hydrochloride salt in the management of supraventricular and ventricular arrhythmias. | 2.02 | 1 | 0 | aromatic ketone; secondary alcohol; secondary amino compound | anti-arrhythmia drug |
| propofol Propofol: An intravenous anesthetic agent which has the advantage of a very rapid onset after infusion or bolus injection plus a very short recovery period of a couple of minutes. (From Smith and Reynard, Textbook of Pharmacology, 1992, 1st ed, p206). Propofol has been used as ANTICONVULSANTS and ANTIEMETICS.. propofol : A phenol resulting from the formal substitution of the hydrogen at the 2 position of 1,3-diisopropylbenzene by a hydroxy group. | 2.02 | 1 | 0 | phenols | anticonvulsant; antiemetic; intravenous anaesthetic; radical scavenger; sedative |
| propranolol Propranolol: A widely used non-cardioselective beta-adrenergic antagonist. Propranolol has been used for MYOCARDIAL INFARCTION; ARRHYTHMIA; ANGINA PECTORIS; HYPERTENSION; HYPERTHYROIDISM; MIGRAINE; PHEOCHROMOCYTOMA; and ANXIETY but adverse effects instigate replacement by newer drugs.. propranolol : A propanolamine that is propan-2-ol substituted by a propan-2-ylamino group at position 1 and a naphthalen-1-yloxy group at position 3. | 2.44 | 2 | 0 | naphthalenes; propanolamine; secondary amine | anti-arrhythmia drug; antihypertensive agent; anxiolytic drug; beta-adrenergic antagonist; environmental contaminant; human blood serum metabolite; vasodilator agent; xenobiotic |
| sch 16134 quazepam: structure given in first source | 2.02 | 1 | 0 | benzodiazepine | |
| ranitidine [no description available] | 2.02 | 1 | 0 | aralkylamine | |
| riluzole Riluzole: A glutamate antagonist (RECEPTORS, GLUTAMATE) used as an anticonvulsant (ANTICONVULSANTS) and to prolong the survival of patients with AMYOTROPHIC LATERAL SCLEROSIS. | 2.02 | 1 | 0 | benzothiazoles | |
| rimantadine Rimantadine: An RNA synthesis inhibitor that is used as an antiviral agent in the prophylaxis and treatment of influenza. | 2.02 | 1 | 0 | alkylamine | |
| risperidone Risperidone: A selective blocker of DOPAMINE D2 RECEPTORS and SEROTONIN 5-HT2 RECEPTORS that acts as an atypical antipsychotic agent. It has been shown to improve both positive and negative symptoms in the treatment of SCHIZOPHRENIA.. risperidone : A member of the class of pyridopyrimidines that is 2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one carrying an additional 2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl group at position 2. | 2.02 | 1 | 0 | 1,2-benzoxazoles; heteroarylpiperidine; organofluorine compound; pyridopyrimidine | alpha-adrenergic antagonist; dopaminergic antagonist; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; H1-receptor antagonist; psychotropic drug; second generation antipsychotic; serotonergic antagonist |
| ritanserin Ritanserin: A selective and potent serotonin-2 antagonist that is effective in the treatment of a variety of syndromes related to anxiety and depression. The drug also improves the subjective quality of sleep and decreases portal pressure.. ritanserin : A thiazolopyrimidine that is 5H-[1,3]thiazolo[3,2-a]pyrimidin-5-one which is substituted at position 7 by a methyl group and at position 6 by a 2-{4-[bis(4-fluorophenyl)methylidene]piperidin-1-yl}ethyl group. A potent and long-acting seratonin (5-hydroxytryptamine, 5-HT) antagonist of the subtype 5-HT2 (Ki = 0.39 nM), it is used in the treatment of a variety of disorders including anxiety, depression and schizophrenia. It has little sedative action. | 2 | 1 | 0 | organofluorine compound; piperidines; thiazolopyrimidine | antidepressant; antipsychotic agent; anxiolytic drug; dopaminergic antagonist; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; serotonergic antagonist |
| salmeterol xinafoate salmeterol : A racemate consisting of equal parts of (R)- and (S)-salmeterol. It is a potent and selective beta2-adrenoceptor agonist (EC50 = 5.3 nM). Unlike other beta2 agonists, it binds to the exo-site domain of beta2 receptors, producing a slow onset of action and prolonged activation.. 2-(hydroxymethyl)-4-(1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl)phenol : A phenol having a hydroxymethyl group at C-2 and a 1-hydroxy-2-{[6-(4-phenylbutoxy)hexyl]amino}ethyl group at C-4; derivative of phenylethanolamine. | 2.02 | 1 | 0 | ether; phenols; primary alcohol; secondary alcohol; secondary amino compound | |
| sb 206553 SB 206553: a high-affinity 5-HT(2C/2B) antagonist; structure given in first source | 2.41 | 2 | 0 | pyrroloindole | |
| sevoflurane Sevoflurane: A non-explosive inhalation anesthetic used in the induction and maintenance of general anesthesia. It does not cause respiratory irritation and may also prevent PLATELET AGGREGATION.. sevoflurane : An ether compound having fluoromethyl and 1,1,1,3,3,3-hexafluoroisopropyl as the two alkyl groups. | 2.02 | 1 | 0 | ether; organofluorine compound | central nervous system depressant; inhalation anaesthetic; platelet aggregation inhibitor |
| sulfadiazine Sulfadiazine: One of the short-acting SULFONAMIDES used in combination with PYRIMETHAMINE to treat toxoplasmosis in patients with acquired immunodeficiency syndrome and in newborns with congenital infections.. sulfadiazine : A sulfonamide consisting of pyrimidine with a 4-aminobenzenesulfonamido group at the 2-position.. diazine : The parent structure of the diazines. | 2.02 | 1 | 0 | pyrimidines; substituted aniline; sulfonamide antibiotic; sulfonamide | antiinfective agent; antimicrobial agent; antiprotozoal drug; coccidiostat; drug allergen; EC 1.1.1.153 [sepiapterin reductase (L-erythro-7,8-dihydrobiopterin forming)] inhibitor; EC 2.5.1.15 (dihydropteroate synthase) inhibitor; environmental contaminant; xenobiotic |
| sotalol Sotalol: An adrenergic beta-antagonist that is used in the treatment of life-threatening arrhythmias.. sotalol : A sulfonamide that is N-phenylmethanesulfonamide in which the phenyl group is substituted at position 4 by a 1-hydroxy-2-(isopropylamino)ethyl group. It has both beta-adrenoreceptor blocking (Vaughan Williams Class II) and cardiac action potential duration prolongation (Vaughan Williams Class III) antiarrhythmic properties. It is used (usually as the hydrochloride salt) for the management of ventricular and supraventricular arrhythmias. | 2.02 | 1 | 0 | ethanolamines; secondary alcohol; secondary amino compound; sulfonamide | anti-arrhythmia drug; beta-adrenergic antagonist; environmental contaminant; xenobiotic |
| sulconazole sulconazole: RN given refers to cpd with unspecified isomeric designation; structure given in first source. sulconazole : A racemate comprising equimolar amounts of (R)- and (S)-sulconazole. An antifungal agent with activity against Candida species, it is used (generally as the nitrate salt) for the topical treatment of fungal skin infections.. 1-{2-[(4-chlorobenzyl)sulfanyl]-2-(2,4-dichlorophenyl)ethyl}-1H-imidazole : A member of the class of imidazoles that is 1-ethyl-1H-imidazole in which one of the hydrogens of the methyl group is replaced by a (4-chlorobenzyl)sulfanediyl group while a second is replaced by a 2,4-dichlorophenyl group. | 2.02 | 1 | 0 | dichlorobenzene; imidazoles; monochlorobenzenes; organic sulfide | |
| sulfadimethoxine Sulfadimethoxine: A sulfanilamide that is used as an anti-infective agent.. sulfadimethoxine : A sulfonamide consisting of pyrimidine having methoxy substituents at the 2- and 6-positions and a 4-aminobenzenesulfonamido group at the 4-position. | 2.01 | 1 | 0 | aromatic ether; pyrimidines; substituted aniline; sulfonamide antibiotic; sulfonamide | antiinfective agent; antimicrobial agent; drug allergen; environmental contaminant; xenobiotic |
| sulfasalazine Sulfasalazine: A drug that is used in the management of inflammatory bowel diseases. Its activity is generally considered to lie in its metabolic breakdown product, 5-aminosalicylic acid (see MESALAMINE) released in the colon. (From Martindale, The Extra Pharmacopoeia, 30th ed, p907). sulfasalazine : An azobenzene consisting of diphenyldiazene having a carboxy substituent at the 4-position, a hydroxy substituent at the 3-position and a 2-pyridylaminosulphonyl substituent at the 4'-position. | 2.02 | 1 | 0 | ||
| sulpiride Sulpiride: A dopamine D2-receptor antagonist. It has been used therapeutically as an antidepressant, antipsychotic, and as a digestive aid. (From Merck Index, 11th ed). sulpiride : A member of the class of benzamides obtained from formal condensation between the carboxy group of 2-methoxy-5-sulfamoylbenzoic acid and the primary amino group of (1-ethylpyrrolidin-2-yl)methylamine. | 4.37 | 4 | 1 | benzamides; N-alkylpyrrolidine; sulfonamide | antidepressant; antiemetic; antipsychotic agent; dopaminergic antagonist |
| sumatriptan Sumatriptan: A serotonin agonist that acts selectively at 5HT1 receptors. It is used in the treatment of MIGRAINE DISORDERS.. sumatriptan : A sulfonamide that consists of N,N-dimethyltryptamine bearing an additional (N-methylsulfamoyl)methyl substituent at position 5. Selective agonist for a vascular 5-HT1 receptor subtype (probably a member of the 5-HT1D family). Used (in the form of its succinate salt) for the acute treatment of migraine with or without aura in adults. | 2.02 | 1 | 0 | sulfonamide; tryptamines | serotonergic agonist; vasoconstrictor agent |
| suprofen Suprofen: An IBUPROFEN-type anti-inflammatory analgesic and antipyretic. It inhibits prostaglandin synthesis and has been proposed as an anti-arthritic.. suprofen : An aromatic ketone that is thiophene substituted at C-2 by a 4-(1-carboxyethyl)benzoyl group. | 2.02 | 1 | 0 | aromatic ketone; monocarboxylic acid; thiophenes | antirheumatic drug; drug allergen; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug; peripheral nervous system drug |
| tazarotene tazarotene: a topical acetylenic retinoid; a topical kerytolytic. tazarotene : The ethyl ester of tazarotenic acid. A prodrug for tazarotenic acid, it is used for the treatment of psoriasis, acne, and sun-damaged skin. | 2.02 | 1 | 0 | acetylenic compound; ethyl ester; pyridines; retinoid; thiochromane | keratolytic drug; prodrug; teratogenic agent |
| temazepam Temazepam: A benzodiazepine that acts as a GAMMA-AMINOBUTYRIC ACID modulator and anti-anxiety agent. | 2.02 | 1 | 0 | benzodiazepine | |
| terazosin Terazosin: induces decreased blood pressure; used in the treatment of benign prostatic hyperplasia | 2.02 | 1 | 0 | furans; piperazines; primary amino compound; quinazolines | alpha-adrenergic antagonist; antihypertensive agent; antineoplastic agent |
| terfenadine Terfenadine: A selective histamine H1-receptor antagonist devoid of central nervous system depressant activity. The drug was used for ALLERGY but withdrawn due to causing LONG QT SYNDROME. | 2.02 | 1 | 0 | diarylmethane | |
| thioridazine Thioridazine: A phenothiazine antipsychotic used in the management of PHYCOSES, including SCHIZOPHRENIA.. thioridazine : A phenothiazine derivative having a methylsulfanyl subsitituent at the 2-position and a (1-methylpiperidin-2-yl)ethyl] group at the N-10 position. | 2.02 | 1 | 0 | phenothiazines; piperidines | alpha-adrenergic antagonist; dopaminergic antagonist; EC 1.8.1.12 (trypanothione-disulfide reductase) inhibitor; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; first generation antipsychotic; H1-receptor antagonist; serotonergic antagonist |
| thiotepa Thiotepa: A very toxic alkylating antineoplastic agent also used as an insect sterilant. It causes skin, gastrointestinal, CNS, and bone marrow damage. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), thiotepa may reasonably be anticipated to be a carcinogen (Merck Index, 11th ed). | 2.02 | 1 | 0 | aziridines | |
| ticlopidine Ticlopidine: An effective inhibitor of platelet aggregation commonly used in the placement of STENTS in CORONARY ARTERIES.. ticlopidine : A thienopyridine that is 4,5,6,7-tetrahydrothieno[3,2-c]pyridine in which the hydrogen attached to the nitrogen is replaced by an o-chlorobenzyl group. | 2.02 | 1 | 0 | monochlorobenzenes; thienopyridine | anticoagulant; fibrin modulating drug; hematologic agent; P2Y12 receptor antagonist; platelet aggregation inhibitor |
| tioconazole tioconazole : A racemate comprising equimolar amounts of (R)- and (S)-tioconazole.. 1-{2-[(2-chloro-3-thienyl)methoxy]-2-(2,4-dichlorophenyl)ethyl}imidazole : A member of the class of imidazoles that comprises 2-(2,4-dichlorophenyl)ethylimidazole carrying an additional (2-chloro-3-thienyl)methoxy substituent at position 2. | 2.02 | 1 | 0 | dichlorobenzene; ether; imidazoles; thiophenes | |
| tiopronin Tiopronin: Sulfhydryl acylated derivative of GLYCINE. | 2.02 | 1 | 0 | N-acyl-amino acid | |
| tizanidine tizanidine: RN given refers to parent cpd; structure. tizanidine : 2,1,3-Benzothiadiazole substituted at C-4 by a Delta(1)-imidazolin-2-ylamino group and at C-4 by a chloro group. It is an agonist at alpha2-adrenergic receptor sites. | 2.02 | 1 | 0 | benzothiadiazole; imidazoles | alpha-adrenergic agonist; muscle relaxant |
| ultram 2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol : A tertiary alcohol that is cyclohexanol substituted at positions 1 and 2 by 3-methoxyphenyl and dimethylaminomethyl groups respectively. | 2.02 | 1 | 0 | aromatic ether; tertiary alcohol; tertiary amino compound | |
| trazodone Trazodone: A serotonin uptake inhibitor that is used as an antidepressive agent. It has been shown to be effective in patients with major depressive disorders and other subsets of depressive disorders. It is generally more useful in depressive disorders associated with insomnia and anxiety. This drug does not aggravate psychotic symptoms in patients with schizophrenia or schizoaffective disorders. (From AMA Drug Evaluations Annual, 1994, p309). trazodone : An N-arylpiperazine in which one nitrogen is substituted by a 3-chlorophenyl group, while the other is substituted by a 3-(3-oxo[1,2,4]triazolo[4,3-a]pyridin-2(3H)-yl)propyl group. | 2.02 | 1 | 0 | monochlorobenzenes; N-alkylpiperazine; N-arylpiperazine; triazolopyridine | adrenergic antagonist; antidepressant; anxiolytic drug; H1-receptor antagonist; sedative; serotonin uptake inhibitor |
| triazolam Triazolam: A short-acting benzodiazepine used in the treatment of insomnia. Some countries temporarily withdrew triazolam from the market because of concerns about adverse reactions, mostly psychological, associated with higher dose ranges. Its use at lower doses with appropriate care and labeling has been reaffirmed by the FDA and most other countries. | 2.02 | 1 | 0 | triazolobenzodiazepine | sedative |
| trientine Trientine: An ethylenediamine derivative used as stabilizer for EPOXY RESINS, as ampholyte for ISOELECTRIC FOCUSING and as chelating agent for copper in HEPATOLENTICULAR DEGENERATION.. TETA : An azamacrocyle in which four nitrogen atoms at positions 1, 4, 8 and 11 of a fouteen-membered ring are each substituted with a carboxymethyl group.. 2,2,2-tetramine : A polyazaalkane that is decane in which the carbon atoms at positions 1, 4, 7 and 10 are replaced by nitrogens. | 2.02 | 1 | 0 | polyazaalkane; tetramine | copper chelator |
| trifluoperazine [no description available] | 2.02 | 1 | 0 | N-alkylpiperazine; N-methylpiperazine; organofluorine compound; phenothiazines | antiemetic; calmodulin antagonist; dopaminergic antagonist; EC 1.8.1.12 (trypanothione-disulfide reductase) inhibitor; EC 5.3.3.5 (cholestenol Delta-isomerase) inhibitor; phenothiazine antipsychotic drug |
| trimethadione Trimethadione: An anticonvulsant effective in absence seizures, but generally reserved for refractory cases because of its toxicity. (From AMA Drug Evaluations Annual, 1994, p378). trimethadione : An oxazolidinone that is 1,3-oxazolidine-2,4-dione substituted by methyl groups at positions 3, 5 and 5. It is an antiepileptic agent. | 2.02 | 1 | 0 | oxazolidinone | anticonvulsant; geroprotector |
| trimetrexate Trimetrexate: A nonclassical folic acid inhibitor through its inhibition of the enzyme dihydrofolate reductase. It is being tested for efficacy as an antineoplastic agent and as an antiparasitic agent against PNEUMOCYSTIS PNEUMONIA in AIDS patients. Myelosuppression is its dose-limiting toxic effect. | 2.02 | 1 | 0 | ||
| trimipramine Trimipramine: Tricyclic antidepressant similar to IMIPRAMINE, but with more antihistaminic and sedative properties.. trimipramine : A dibenzoazepine that is 10,11-dihydro-5H-dibenzo[b,f]azepine substituted by a 3-(dimethylamino)-2-methylpropyl group at the nitrogen atom. It is used as an antidepressant. | 2.02 | 1 | 0 | dibenzoazepine; tertiary amino compound | antidepressant; environmental contaminant; xenobiotic |
| venlafaxine venlafaxine : A tertiary amino compound that is N,N-dimethylethanamine substituted at position 1 by a 1-hydroxycyclohexyl and 4-methoxyphenyl group. | 2.02 | 1 | 0 | cyclohexanols; monomethoxybenzene; tertiary alcohol; tertiary amino compound | adrenergic uptake inhibitor; analgesic; antidepressant; dopamine uptake inhibitor; environmental contaminant; serotonin uptake inhibitor; xenobiotic |
| wb 4101 N-(2,3-dihydro-1,4-benzodioxin-2-ylmethyl)-2-(2,6-dimethoxyphenoxy)ethanamine : A benzodioxine that is 2,3-dihydro-1,4-benzodioxine bearing a [(2',6'-dimethoxyphenoxy)ethylamino]methyl group at position 2. An alpha1A-adrenergic selective antagonist. | 2.02 | 1 | 0 | aromatic ether; benzodioxine; secondary amino compound | alpha-adrenergic antagonist |
| ici 204,219 zafirlukast: a leukotriene D4 receptor antagonist | 2.02 | 1 | 0 | carbamate ester; indoles; N-sulfonylcarboxamide | anti-asthmatic agent; leukotriene antagonist |
| zolpidem Zolpidem: An imidazopyridine derivative and short-acting GABA-A receptor agonist that is used for the treatment of INSOMNIA.. zolpidem : An imidazo[1,2-a]pyridine compound having a 4-tolyl group at the 2-position, an N,N-dimethylcarbamoylmethyl group at the 3-position and a methyl substituent at the 6-position. | 2.02 | 1 | 0 | imidazopyridine | central nervous system depressant; GABA agonist; sedative |
| zomepirac zomepirac: RN given refers to parent cpd; structure | 2.02 | 1 | 0 | aromatic ketone; monocarboxylic acid; monochlorobenzenes; pyrroles | cardiovascular drug; non-steroidal anti-inflammatory drug |
| mitomycin Mitomycin: An antineoplastic antibiotic produced by Streptomyces caespitosus. It is one of the bi- or tri-functional ALKYLATING AGENTS causing cross-linking of DNA and inhibition of DNA synthesis.. mitomycin : A family of aziridine-containing natural products isolated from Streptomyces caespitosus or Streptomyces lavendulae. | 2.01 | 1 | 0 | mitomycin | alkylating agent; antineoplastic agent |
| corticosterone [no description available] | 4.29 | 18 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; C21-steroid; glucocorticoid; primary alpha-hydroxy ketone | human metabolite; mouse metabolite |
| prednisolone Prednisolone: A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.. prednisolone : A glucocorticoid that is prednisone in which the oxo group at position 11 has been reduced to the corresponding beta-hydroxy group. It is a drug metabolite of prednisone. | 2.44 | 2 | 0 | 11beta-hydroxy steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; C21-steroid; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | adrenergic agent; anti-inflammatory drug; antineoplastic agent; drug metabolite; environmental contaminant; immunosuppressive agent; xenobiotic |
| estriol hormonin: estrogen replacement; each tablet contains 600 ug micronized 17beta-estradiol, 270 ug estriol and 1.4 mg estrone. chlorapatite : A phosphate mineral with the formula Ca5(PO4)3Cl. | 2.9 | 4 | 0 | 16alpha-hydroxy steroid; 17beta-hydroxy steroid; 3-hydroxy steroid | estrogen; human metabolite; human xenobiotic metabolite; mouse metabolite |
| thymidine [no description available] | 2.03 | 1 | 0 | pyrimidine 2'-deoxyribonucleoside | Escherichia coli metabolite; human metabolite; metabolite; mouse metabolite |
| floxuridine Floxuridine: An antineoplastic antimetabolite that is metabolized to fluorouracil when administered by rapid injection; when administered by slow, continuous, intra-arterial infusion, it is converted to floxuridine monophosphate. It has been used to treat hepatic metastases of gastrointestinal adenocarcinomas and for palliation in malignant neoplasms of the liver and gastrointestinal tract.. floxuridine : A pyrimidine 2'-deoxyribonucleoside compound having 5-fluorouracil as the nucleobase; used to treat hepatic metastases of gastrointestinal adenocarcinomas and for palliation in malignant neoplasms of the liver and gastrointestinal tract. | 2.02 | 1 | 0 | nucleoside analogue; organofluorine compound; pyrimidine 2'-deoxyribonucleoside | antimetabolite; antineoplastic agent; antiviral drug; radiosensitizing agent |
| hydroxyproline Hydroxyproline: A hydroxylated form of the imino acid proline. A deficiency in ASCORBIC ACID can result in impaired hydroxyproline formation.. hydroxyproline : A proline derivative that is proline substituted by at least one hydroxy group. | 2.07 | 1 | 0 | 4-hydroxyproline; L-alpha-amino acid zwitterion | human metabolite; mouse metabolite; plant metabolite |
| thyroxine Thyroxine: The major hormone derived from the thyroid gland. Thyroxine is synthesized via the iodination of tyrosines (MONOIODOTYROSINE) and the coupling of iodotyrosines (DIIODOTYROSINE) in the THYROGLOBULIN. Thyroxine is released from thyroglobulin by proteolysis and secreted into the blood. Thyroxine is peripherally deiodinated to form TRIIODOTHYRONINE which exerts a broad spectrum of stimulatory effects on cell metabolism.. thyroxine : An iodothyronine compound having iodo substituents at the 3-, 3'-, 5- and 5'-positions. | 3.39 | 7 | 0 | 2-halophenol; iodophenol; L-phenylalanine derivative; non-proteinogenic L-alpha-amino acid; thyroxine zwitterion; thyroxine | antithyroid drug; human metabolite; mouse metabolite; thyroid hormone |
| carbachol Carbachol: A slowly hydrolyzed CHOLINERGIC AGONIST that acts at both MUSCARINIC RECEPTORS and NICOTINIC RECEPTORS. | 2 | 1 | 0 | ammonium salt; carbamate ester | cardiotonic drug; miotic; muscarinic agonist; nicotinic acetylcholine receptor agonist; non-narcotic analgesic |
| spironolactone Spironolactone: A potassium sparing diuretic that acts by antagonism of aldosterone in the distal renal tubules. It is used mainly in the treatment of refractory edema in patients with congestive heart failure, nephrotic syndrome, or hepatic cirrhosis. Its effects on the endocrine system are utilized in the treatments of hirsutism and acne but they can lead to adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p827). spironolactone : A steroid lactone that is 17alpha-pregn-4-ene-21,17-carbolactone substituted by an oxo group at position 3 and an alpha-acetylsulfanyl group at position 7. | 2.02 | 1 | 0 | 3-oxo-Delta(4) steroid; oxaspiro compound; steroid lactone; thioester | aldosterone antagonist; antihypertensive agent; diuretic; environmental contaminant; xenobiotic |
| prednisolone acetate prednisolone acetate: RN given refers to cpd with locant for acetate group in position 21 & (11 beta)-isomer | 2.11 | 1 | 0 | corticosteroid hormone | |
| aldosterone [no description available] | 2.04 | 1 | 0 | 11beta-hydroxy steroid; 18-oxo steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; C21-steroid hormone; mineralocorticoid; primary alpha-hydroxy ketone; steroid aldehyde | human metabolite; mouse metabolite |
| penicillamine Penicillamine: 3-Mercapto-D-valine. The most characteristic degradation product of the penicillin antibiotics. It is used as an antirheumatic and as a chelating agent in Wilson's disease.. penicillamine : An alpha-amino acid having the structure of valine substituted at the beta position with a sulfanyl group. | 2.02 | 1 | 0 | non-proteinogenic alpha-amino acid; penicillamine | antirheumatic drug; chelator; copper chelator; drug allergen |
| prednisone Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.. prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid. | 2.02 | 1 | 0 | 11-oxo steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; C21-steroid; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | adrenergic agent; anti-inflammatory drug; antineoplastic agent; immunosuppressive agent; prodrug |
| estrone Hydroxyestrones: Estrone derivatives substituted with one or more hydroxyl groups in any position. They are important metabolites of estrone and other estrogens. | 3.6 | 9 | 0 | 17-oxo steroid; 3-hydroxy steroid; phenolic steroid; phenols | antineoplastic agent; bone density conservation agent; estrogen; human metabolite; mouse metabolite |
| androsterone [no description available] | 2.43 | 2 | 0 | 17-oxo steroid; 3alpha-hydroxy steroid; androstanoid; C19-steroid | androgen; anticonvulsant; human blood serum metabolite; human metabolite; human urinary metabolite; mouse metabolite; pheromone |
| etiocholanolone Etiocholanolone: The 5-beta-reduced isomer of ANDROSTERONE. Etiocholanolone is a major metabolite of TESTOSTERONE and ANDROSTENEDIONE in many mammalian species including humans. It is excreted in the URINE.. 3alpha-hydroxy-5beta-androstan-17-one : An androstanoid that is 5beta-androstane substituted by an alpha-hydroxy group at position 3 and an oxo group at position 17. It is a metabolite of testosterone in mammals. | 2.04 | 1 | 0 | 17-oxo steroid; 3alpha-hydroxy steroid; androstanoid | human metabolite; mouse metabolite |
| dehydroepiandrosterone Dehydroepiandrosterone: A major C19 steroid produced by the ADRENAL CORTEX. It is also produced in small quantities in the TESTIS and the OVARY. Dehydroepiandrosterone (DHEA) can be converted to TESTOSTERONE; ANDROSTENEDIONE; ESTRADIOL; and ESTRONE. Most of DHEA is sulfated (DEHYDROEPIANDROSTERONE SULFATE) before secretion.. dehydroepiandrosterone : An androstanoid that is androst-5-ene substituted by a beta-hydroxy group at position 3 and an oxo group at position 17. It is a naturally occurring steroid hormone produced by the adrenal glands. | 2.95 | 4 | 0 | 17-oxo steroid; 3beta-hydroxy-Delta(5)-steroid; androstanoid | androgen; human metabolite; mouse metabolite |
| 17-desoxyestradiol estra-1,3,5(10)-trien-3-ol : A 3-hydroxy steroid resulting from deoxygenation at position 17 of estradiol or estrone. | 2.04 | 1 | 0 | 3-hydroxy steroid; phenolic steroid; phenols | estrogen |
| pilocarpine Pilocarpine: A slowly hydrolyzed muscarinic agonist with no nicotinic effects. Pilocarpine is used as a miotic and in the treatment of glaucoma.. (+)-pilocarpine : The (+)-enantiomer of pilocarpine. | 2.02 | 1 | 0 | pilocarpine | antiglaucoma drug |
| triiodothyronine Triiodothyronine: A T3 thyroid hormone normally synthesized and secreted by the thyroid gland in much smaller quantities than thyroxine (T4). Most T3 is derived from peripheral monodeiodination of T4 at the 5' position of the outer ring of the iodothyronine nucleus. The hormone finally delivered and used by the tissues is mainly T3.. 3,3',5-triiodo-L-thyronine : An iodothyronine compound having iodo substituents at the 3-, 3'- and 5-positions. Although some is produced in the thyroid, most of the 3,3',5-triiodo-L-thyronine in the body is generated by mono-deiodination of L-thyroxine in the peripheral tissues. Its metabolic activity is about 3 to 5 times that of L-thyroxine. The sodium salt is used in the treatment of hypothyroidism. | 4.71 | 9 | 0 | 2-halophenol; amino acid zwitterion; iodophenol; iodothyronine | human metabolite; mouse metabolite; thyroid hormone |
| diethylnitrosamine Diethylnitrosamine: A nitrosamine derivative with alkylating, carcinogenic, and mutagenic properties.. N-nitrosodiethylamine : A nitrosamine that is N-ethylethanamine substituted by a nitroso group at the N-atom. | 2.02 | 1 | 0 | nitrosamine | carcinogenic agent; hepatotoxic agent; mutagen |
| carbon tetrachloride Carbon Tetrachloride: A solvent for oils, fats, lacquers, varnishes, rubber waxes, and resins, and a starting material in the manufacturing of organic compounds. Poisoning by inhalation, ingestion or skin absorption is possible and may be fatal. (Merck Index, 11th ed). tetrachloromethane : A chlorocarbon that is methane in which all the hydrogens have been replaced by chloro groups. | 1.93 | 1 | 0 | chlorocarbon; chloromethanes | hepatotoxic agent; refrigerant |
| desoxycorticosterone acetate Desoxycorticosterone Acetate: The 21-acetate derivative of desoxycorticosterone. | 1.93 | 1 | 0 | corticosteroid hormone | |
| aspartic acid Aspartic Acid: One of the non-essential amino acids commonly occurring in the L-form. It is found in animals and plants, especially in sugar cane and sugar beets. It may be a neurotransmitter.. aspartic acid : An alpha-amino acid that consists of succinic acid bearing a single alpha-amino substituent. L-aspartic acid : The L-enantiomer of aspartic acid. | 1.98 | 1 | 0 | aspartate family amino acid; aspartic acid; L-alpha-amino acid; proteinogenic amino acid | Escherichia coli metabolite; mouse metabolite; neurotransmitter |
| glutamine Glutamine: A non-essential amino acid present abundantly throughout the body and is involved in many metabolic processes. It is synthesized from GLUTAMIC ACID and AMMONIA. It is the principal carrier of NITROGEN in the body and is an important energy source for many cells.. L-glutamine : An optically active form of glutamine having L-configuration.. glutamine : An alpha-amino acid that consists of butyric acid bearing an amino substituent at position 2 and a carbamoyl substituent at position 4. | 2.05 | 1 | 0 | amino acid zwitterion; glutamine family amino acid; glutamine; L-alpha-amino acid; polar amino acid zwitterion; proteinogenic amino acid | EC 1.14.13.39 (nitric oxide synthase) inhibitor; Escherichia coli metabolite; human metabolite; metabolite; micronutrient; mouse metabolite; nutraceutical; Saccharomyces cerevisiae metabolite |
| lysine Lysine: An essential amino acid. It is often added to animal feed.. lysine : A diamino acid that is caproic (hexanoic) acid bearing two amino substituents at positions 2 and 6.. L-lysine : An L-alpha-amino acid; the L-isomer of lysine. | 1.94 | 1 | 0 | aspartate family amino acid; L-alpha-amino acid zwitterion; L-alpha-amino acid; lysine; organic molecular entity; proteinogenic amino acid | algal metabolite; anticonvulsant; Escherichia coli metabolite; human metabolite; micronutrient; mouse metabolite; nutraceutical; plant metabolite; Saccharomyces cerevisiae metabolite |
| vincristine [no description available] | 2.02 | 1 | 0 | acetate ester; formamides; methyl ester; organic heteropentacyclic compound; organic heterotetracyclic compound; tertiary alcohol; tertiary amino compound; vinca alkaloid | antineoplastic agent; drug; microtubule-destabilising agent; plant metabolite; tubulin modulator |
| physostigmine Physostigmine: A cholinesterase inhibitor that is rapidly absorbed through membranes. It can be applied topically to the conjunctiva. It also can cross the blood-brain barrier and is used when central nervous system effects are desired, as in the treatment of severe anticholinergic toxicity. | 2 | 1 | 0 | carbamate ester; indole alkaloid | antidote to curare poisoning; EC 3.1.1.8 (cholinesterase) inhibitor; miotic |
| sucrose Saccharum: A plant genus of the family POACEAE widely cultivated in the tropics for the sweet cane that is processed into sugar. | 2.73 | 3 | 0 | glycosyl glycoside | algal metabolite; Escherichia coli metabolite; human metabolite; mouse metabolite; osmolyte; Saccharomyces cerevisiae metabolite; sweetening agent |
| ethinyl estradiol Ethinyl Estradiol: A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.. 17alpha-ethynylestradiol : A 3-hydroxy steroid that is estradiol substituted by a ethynyl group at position 17. It is a xenoestrogen synthesized from estradiol and has been shown to exhibit high estrogenic potency on oral administration. | 3.16 | 5 | 0 | 17-hydroxy steroid; 3-hydroxy steroid; terminal acetylenic compound | xenoestrogen |
| testosterone propionate Testosterone Propionate: An ester of TESTOSTERONE with a propionate substitution at the 17-beta position.. androgen : A sex hormone that stimulates or controls the development and maintenance of masculine characteristics in vertebrates by binding to androgen receptors. | 9.6 | 26 | 0 | steroid ester | |
| 9,10-dimethyl-1,2-benzanthracene 9,10-Dimethyl-1,2-benzanthracene: Polycyclic aromatic hydrocarbon found in tobacco smoke that is a potent carcinogen.. 7,12-dimethyltetraphene : A tetraphene having methyl substituents at the 7- and 12-positions. It is a potent carcinogen and is present in tobacco smoke. | 2.42 | 2 | 0 | ortho-fused polycyclic arene; tetraphenes | carcinogenic agent |
| apomorphine Apomorphine: A derivative of morphine that is a dopamine D2 agonist. It is a powerful emetic and has been used for that effect in acute poisoning. It has also been used in the diagnosis and treatment of parkinsonism, but its adverse effects limit its use. | 2.05 | 1 | 0 | aporphine alkaloid | alpha-adrenergic drug; antidyskinesia agent; antiparkinson drug; dopamine agonist; emetic; serotonergic drug |
| methyltestosterone Methyltestosterone: A synthetic hormone used for androgen replacement therapy and as an hormonal antineoplastic agent (ANTINEOPLASTIC AGENTS, HORMONAL).. methyltestosterone : A 17beta-hydroxy steroid that is testosterone bearing a methyl group at the 17alpha position. | 2.9 | 4 | 0 | 17beta-hydroxy steroid; 3-oxo-Delta(4) steroid; enone | anabolic agent; androgen; antineoplastic agent |
| bromodeoxyuridine Bromodeoxyuridine: A nucleoside that substitutes for thymidine in DNA and thus acts as an antimetabolite. It causes breaks in chromosomes and has been proposed as an antiviral and antineoplastic agent. It has been given orphan drug status for use in the treatment of primary brain tumors. | 3.86 | 4 | 0 | pyrimidine 2'-deoxyribonucleoside | antimetabolite; antineoplastic agent |
| carbostyril Quinolones: A group of derivatives of naphthyridine carboxylic acid, quinoline carboxylic acid, or NALIDIXIC ACID.. quinolin-2(1H)-one : A quinolone that is 1,2-dihydroquinoline substituted by an oxo group at position 2. | 2.05 | 1 | 0 | monohydroxyquinoline; quinolone | bacterial xenobiotic metabolite |
| p-dimethylaminoazobenzene p-Dimethylaminoazobenzene: A reagent used mainly to induce experimental liver cancer. According to the Fourth Annual Report on Carcinogens (NTP 85-002, p. 89) published in 1985, this compound may reasonably be anticipated to be a carcinogen. (Merck, 11th ed) | 1.99 | 1 | 0 | azobenzenes | |
| methylene blue Methylene Blue: A compound consisting of dark green crystals or crystalline powder, having a bronze-like luster. Solutions in water or alcohol have a deep blue color. Methylene blue is used as a bacteriologic stain and as an indicator. It inhibits GUANYLATE CYCLASE, and has been used to treat cyanide poisoning and to lower levels of METHEMOGLOBIN.. methylene blue : An organic chloride salt having 3,7-bis(dimethylamino)phenothiazin-5-ium as the counterion. A commonly used dye that also exhibits antioxidant, antimalarial, antidepressant and cardioprotective properties. | 3.79 | 3 | 0 | organic chloride salt | acid-base indicator; antidepressant; antimalarial; antimicrobial agent; antioxidant; cardioprotective agent; EC 1.4.3.4 (monoamine oxidase) inhibitor; EC 3.1.1.8 (cholinesterase) inhibitor; EC 4.6.1.2 (guanylate cyclase) inhibitor; fluorochrome; histological dye; neuroprotective agent; physical tracer |
| bretylium tosylate Bretylium Tosylate: An agent that blocks the release of adrenergic transmitters and may have other actions. It was formerly used as an antihypertensive agent, but is now proposed as an anti-arrhythmic.. bretylium tosylate : The tosylate salt of bretylium. It blocks noradrenaline release from the peripheral sympathetic nervous system, and is used in emergency medicine, cardiology, and other specialties for the acute management of ventricular tachycardia and ventricular fibrillation. | 2.02 | 1 | 0 | organosulfonate salt; quaternary ammonium salt | adrenergic antagonist; anti-arrhythmia drug; antihypertensive agent |
| leucine Leucine: An essential branched-chain amino acid important for hemoglobin formation.. leucine : A branched-chain amino acid that consists of glycine in which one of the hydrogens attached to the alpha-carbon is substituted by an isobutyl group. | 2.05 | 1 | 0 | amino acid zwitterion; L-alpha-amino acid; leucine; proteinogenic amino acid; pyruvate family amino acid | algal metabolite; Escherichia coli metabolite; human metabolite; mouse metabolite; plant metabolite; Saccharomyces cerevisiae metabolite |
| androstenedione Androstenedione: A delta-4 C19 steroid that is produced not only in the TESTIS, but also in the OVARY and the ADRENAL CORTEX. Depending on the tissue type, androstenedione can serve as a precursor to TESTOSTERONE as well as ESTRONE and ESTRADIOL.. androst-4-ene-3,17-dione : A 3-oxo Delta(4)-steroid that is androst-4-ene substituted by oxo groups at positions 3 and 17. It is a steroid hormone synthesized in the adrenal glands and gonads. | 3.12 | 5 | 0 | 17-oxo steroid; 3-oxo-Delta(4) steroid; androstanoid | androgen; Daphnia magna metabolite; human metabolite; mouse metabolite |
| phenylalanine Phenylalanine: An essential aromatic amino acid that is a precursor of MELANIN; DOPAMINE; noradrenalin (NOREPINEPHRINE), and THYROXINE.. L-phenylalanine : The L-enantiomer of phenylalanine.. phenylalanine : An aromatic amino acid that is alanine in which one of the methyl hydrogens is substituted by a phenyl group. | 2.11 | 1 | 0 | amino acid zwitterion; erythrose 4-phosphate/phosphoenolpyruvate family amino acid; L-alpha-amino acid; phenylalanine; proteinogenic amino acid | algal metabolite; EC 3.1.3.1 (alkaline phosphatase) inhibitor; Escherichia coli metabolite; human xenobiotic metabolite; micronutrient; mouse metabolite; nutraceutical; plant metabolite; Saccharomyces cerevisiae metabolite |
| desoxycorticosterone Desoxycorticosterone: A steroid metabolite that is the 11-deoxy derivative of CORTICOSTERONE and the 21-hydroxy derivative of PROGESTERONE | 2.36 | 2 | 0 | 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; mineralocorticoid; primary alpha-hydroxy ketone | human metabolite; mouse metabolite |
| colchicine (S)-colchicine : A colchicine that has (S)-configuration. It is a secondary metabolite, has anti-inflammatory properties and is used to treat gout, crystal-induced joint inflammation, familial Mediterranean fever, and many other conditions. | 2 | 1 | 0 | alkaloid; colchicine | anti-inflammatory agent; gout suppressant; mutagen |
| cycloheximide Cycloheximide: Antibiotic substance isolated from streptomycin-producing strains of Streptomyces griseus. It acts by inhibiting elongation during protein synthesis.. cycloheximide : A dicarboximide that is 4-(2-hydroxyethyl)piperidine-2,6-dione in which one of the hydrogens attached to the carbon bearing the hydroxy group is replaced by a 3,5-dimethyl-2-oxocyclohexyl group. It is an antibiotic produced by the bacterium Streptomyces griseus. | 2.02 | 1 | 0 | antibiotic fungicide; cyclic ketone; dicarboximide; piperidine antibiotic; piperidones; secondary alcohol | anticoronaviral agent; bacterial metabolite; ferroptosis inhibitor; neuroprotective agent; protein synthesis inhibitor |
| chloroform Chloroform: A commonly used laboratory solvent. It was previously used as an anesthetic, but was banned from use in the U.S. due to its suspected carcinogenicity.. chloroform : A one-carbon compound that is methane in which three of the hydrogens are replaced by chlorines. | 2.52 | 2 | 0 | chloromethanes; one-carbon compound | carcinogenic agent; central nervous system drug; inhalation anaesthetic; non-polar solvent; refrigerant |
| norethindrone Norethindrone: A synthetic progestational hormone with actions similar to those of PROGESTERONE but functioning as a more potent inhibitor of ovulation. It has weak estrogenic and androgenic properties. The hormone has been used in treating amenorrhea, functional uterine bleeding, endometriosis, and for CONTRACEPTION.. norethisterone : A 17beta-hydroxy steroid that is testosterone in which the hydrogen at position 17 is replaced by an ethynyl group and in which the methyl group attached to position 10 is replaced by hydrogen. | 2.95 | 4 | 0 | 17beta-hydroxy steroid; 3-oxo-Delta(4) steroid; terminal acetylenic compound; tertiary alcohol | progestin; synthetic oral contraceptive |
| 17-alpha-hydroxyprogesterone 17alpha-hydroxyprogesterone : A 17alpha-hydroxy steroid that is the 17alpha-hydroxy derivative of progesterone. | 2.04 | 1 | 0 | 17alpha-hydroxy-C21-steroid; 17alpha-hydroxy steroid; tertiary alpha-hydroxy ketone | human metabolite; metabolite; mouse metabolite; progestin |
| cytarabine [no description available] | 2.02 | 1 | 0 | beta-D-arabinoside; monosaccharide derivative; pyrimidine nucleoside | antimetabolite; antineoplastic agent; antiviral agent; immunosuppressive agent |
| trifluridine Trifluridine: An antiviral derivative of THYMIDINE used mainly in the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis due to HERPES SIMPLEX virus. (From Martindale, The Extra Pharmacopoeia, 30th ed, p557). trifluridine : A pyrimidine 2'-deoxyribonucleoside compound having 5-trifluoromethyluracil as the nucleobase. An antiviral drug used mainly in the treatment of primary keratoconjunctivitis and recurrent epithelial keratitis. | 2.02 | 1 | 0 | nucleoside analogue; organofluorine compound; pyrimidine 2'-deoxyribonucleoside | antimetabolite; antineoplastic agent; antiviral drug; EC 2.1.1.45 (thymidylate synthase) inhibitor |
| ornithine Ornithine: An amino acid produced in the urea cycle by the splitting off of urea from arginine.. ornithine : An alpha-amino acid that is pentanoic acid bearing two amino substituents at positions 2 and 5. | 2 | 1 | 0 | non-proteinogenic L-alpha-amino acid; ornithine | algal metabolite; hepatoprotective agent; mouse metabolite |
| medroxyprogesterone acetate [no description available] | 3.55 | 8 | 0 | 20-oxo steroid; 3-oxo-Delta(4) steroid; acetate ester; corticosteroid; steroid ester | adjuvant; androgen; antineoplastic agent; antioxidant; female contraceptive drug; inhibitor; progestin; synthetic oral contraceptive |
| mestranol [no description available] | 2.02 | 1 | 0 | 17beta-hydroxy steroid; aromatic ether; terminal acetylenic compound | prodrug; xenoestrogen |
| arginine Arginine: An essential amino acid that is physiologically active in the L-form.. arginine : An alpha-amino acid that is glycine in which the alpha-is substituted by a 3-guanidinopropyl group. | 2.43 | 2 | 0 | arginine; glutamine family amino acid; L-alpha-amino acid; proteinogenic amino acid | biomarker; Escherichia coli metabolite; micronutrient; mouse metabolite; nutraceutical |
| trifluoroacetic acid Trifluoroacetic Acid: A very strong halogenated derivative of acetic acid. It is used in acid catalyzed reactions, especially those where an ester is cleaved in peptide synthesis.. trifluoroacetic acid : A monocarboxylic acid that is the trifluoro derivative of acetic acid. | 2.03 | 1 | 0 | fluoroalkanoic acid | human xenobiotic metabolite; NMR chemical shift reference compound; reagent |
| bisphenol a 4,4'-isopropylidene diphenol: stimulates proliferative responses and cytokine productions of murine spleen cells and thymus cells in vitro. bisphenol : By usage, the methylenediphenols, HOC6H4CH2C6H4OH, commonly p,p-methylenediphenol, and their substitution products (generally derived from condensation of two equivalent amounts of a phenol with an aldehyde or ketone). The term also includes analogues in the the methylene (or substituted methylene) group has been replaced by a heteroatom.. bisphenol A : A bisphenol that is 4,4'-methanediyldiphenol in which the methylene hydrogens are replaced by two methyl groups. | 8.44 | 7 | 0 | bisphenol | endocrine disruptor; environmental contaminant; xenobiotic; xenoestrogen |
| methylprednisolone Methylprednisolone: A PREDNISOLONE derivative with similar anti-inflammatory action.. 6alpha-methylprednisolone : The 6alpha-stereoisomer of 6-methylprednisolone. | 2.02 | 1 | 0 | 6-methylprednisolone; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | adrenergic agent; anti-inflammatory drug; antiemetic; environmental contaminant; neuroprotective agent; xenobiotic |
| quinoxalines quinoxaline : A naphthyridine in which the nitrogens are at positions 1 and 4. | 2.48 | 2 | 0 | mancude organic heterobicyclic parent; naphthyridine; ortho-fused heteroarene | |
| quinuclidines Quinuclidines: A class of organic compounds which contain two rings that share a pair of bridgehead carbon atoms and contains an amine group. | 2.21 | 1 | 0 | quinuclidines; saturated organic heterobicyclic parent | |
| pyrroles 1H-pyrrole : A tautomer of pyrrole that has the double bonds at positions 2 and 4.. pyrrole : A five-membered monocyclic heteroarene comprising one NH and four CH units which forms the parent compound of the pyrrole group of compounds. Its five-membered ring structure has three tautomers. A 'closed class'.. azole : Any monocyclic heteroarene consisting of a five-membered ring containing nitrogen. Azoles can also contain one or more other non-carbon atoms, such as nitrogen, sulfur or oxygen. | 2.46 | 2 | 0 | pyrrole; secondary amine | |
| methyl palmitate [no description available] | 2.31 | 1 | 0 | fatty acid methyl ester | metabolite |
| estradiol dipropionate estradiol dipropionate: RN given refers to (17beta)-isomer; RN for cpd without isomeric designation not in Chemline 7/83 | 2.44 | 2 | 0 | steroid ester | |
| diethylhexyl phthalate Diethylhexyl Phthalate: An ester of phthalic acid. It appears as a light-colored, odorless liquid and is used as a plasticizer for many resins and elastomers.. bis(2-ethylhexyl) phthalate : A phthalate ester that is the bis(2-ethylhexyl) ester of benzene-1,2-dicarboxylic acid. | 3.41 | 1 | 1 | diester; phthalate ester | androstane receptor agonist; apoptosis inhibitor; plasticiser |
| 4-tert-octylphenol 4-tert-octylphenol: structure given in first source | 2.04 | 1 | 0 | alkylbenzene | |
| pregnenolone [no description available] | 2.42 | 2 | 0 | 20-oxo steroid; 3beta-hydroxy-Delta(5)-steroid; C21-steroid | human metabolite; mouse metabolite |
| yohimbine Yohimbine: A plant alkaloid with alpha-2-adrenergic blocking activity. Yohimbine has been used as a mydriatic and in the treatment of ERECTILE DYSFUNCTION.. yohimbine : An indole alkaloid with alpha2-adrenoceptor antagonist activity. It is produced by Corynanthe johimbe and Rauwolfia serpentina. | 2.44 | 2 | 0 | methyl 17-hydroxy-20xi-yohimban-16-carboxylate | alpha-adrenergic antagonist; dopamine receptor D2 antagonist; serotonergic antagonist |
| nafcillin Nafcillin: A semi-synthetic antibiotic related to penicillin.. nafcillin : A penicillin in which the substituent at position 6 of the penam ring is a (2-ethoxy-1-naphthoyl)amino group. | 2.02 | 1 | 0 | penicillin allergen; penicillin | antibacterial drug |
| methohexital Methohexital: An intravenous anesthetic with a short duration of action that may be used for induction of anesthesia.. methohexital : A barbiturate, the structure of which is that of barbituric acid substituted at N-1 by a methyl group and at C-5 by allyl and 1-methylpent-2-ynyl groups. | 2.02 | 1 | 0 | acetylenic compound; barbiturates | drug allergen; intravenous anaesthetic |
| dydrogesterone [no description available] | 2.52 | 2 | 0 | 20-oxo steroid; 3-oxo-Delta(4) steroid | progestin |
| benzoxazoles 1,3-benzoxazole : A benzoxazole in which the benzene ring is fused to a 1,3-oxazole ring across positions 4 and 5.. benzoxazole : Compounds based on a fused 1,2- or 1,3-oxazole and benzene bicyclic ring skeleton. | 2.01 | 1 | 0 | 1,3-benzoxazoles; mancude organic heterobicyclic parent | |
| adamantane Adamantane: A tricyclo bridged hydrocarbon. | 2.13 | 1 | 0 | adamantanes; polycyclic alkane | |
| cyclopentane Cyclopentanes: A group of alicyclic hydrocarbons with the general formula R-C5H9.. cyclopentanes : Cyclopentane and its derivatives formed by substitution. | 2.1 | 1 | 0 | cycloalkane; cyclopentanes; volatile organic compound | non-polar solvent |
| oxazoles Oxazoles: Five-membered heterocyclic ring structures containing an oxygen in the 1-position and a nitrogen in the 3-position, in distinction from ISOXAZOLES where they are at the 1,2 positions.. 1,3-oxazole : A five-membered monocyclic heteroarene that is an analogue of cyclopentadiene with O in place of CH2 at position 1 and N in place of CH at position 3.. oxazole : An azole based on a five-membered heterocyclic aromatic skeleton containing one N and one O atom. | 2.48 | 2 | 0 | 1,3-oxazoles; mancude organic heteromonocyclic parent; monocyclic heteroarene | |
| thiazoles [no description available] | 2.13 | 1 | 0 | 1,3-thiazoles; mancude organic heteromonocyclic parent; monocyclic heteroarene | |
| pyrazines Pyrazines: A heterocyclic aromatic organic compound with the chemical formula C4H4N2.. pyrazine : A diazine that is benzene in which the carbon atoms at positions 1 and 4 have been replaced by nitrogen atoms. | 2.02 | 1 | 0 | diazine; pyrazines | Daphnia magna metabolite |
| hydrazine diamine : Any polyamine that contains two amino groups. | 2 | 1 | 0 | azane; hydrazines | EC 4.3.1.10 (serine-sulfate ammonia-lyase) inhibitor |
| chlormadinone acetate Chlormadinone Acetate: An orally active synthetic progestational hormone used often in combinations as an oral contraceptive (CONTRACEPTIVES, ORAL). | 2.42 | 2 | 0 | corticosteroid hormone | |
| dexamethasone 21-phosphate dexamethasone 21-phosphate: has anti-inflammatory activity. dexamethasone phosphate : A steroid phosphate that is the 21-O-phospho derivative of dexamethasone. | 2.11 | 1 | 0 | 11beta-hydroxy steroid; 17-hydroxy steroid; 3-oxo-Delta(4) steroid; fluorinated steroid; steroid phosphate; tertiary alpha-hydroxy ketone | glucocorticoid receptor agonist |
| estradiol 17 beta-cypionate [no description available] | 2.02 | 1 | 0 | steroid ester | |
| testosterone enanthate [no description available] | 3.86 | 2 | 1 | heptanoate ester; sterol ester | androgen |
| nandrolone decanoate Nandrolone Decanoate: Decanoic acid ester of nandrolone that is used as an anabolic agent to prevent or treat WASTING SYNDROME associated with severe chronic illness or HIV infection (HIV WASTING SYNDROME). It may also be used in the treatment of POSTMENOPAUSAL OSTEOPOROSIS. | 2.45 | 2 | 0 | steroid ester | |
| aminoimidazole carboxamide Aminoimidazole Carboxamide: An imidazole derivative which is a metabolite of the antineoplastic agents BIC and DIC. By itself, or as the ribonucleotide, it is used as a condensation agent in the preparation of nucleosides and nucleotides. Compounded with orotic acid, it is used to treat liver diseases.. 5-aminoimidazole-4-carboxamide : An aminoimidazole in which the amino group is at C-5 with a carboxamido group at C-4. | 2.5 | 2 | 0 | aminoimidazole; monocarboxylic acid amide | mouse metabolite |
| betamethasone Betamethasone: A glucocorticoid given orally, parenterally, by local injection, by inhalation, or applied topically in the management of various disorders in which corticosteroids are indicated. Its lack of mineralocorticoid properties makes betamethasone particularly suitable for treating cerebral edema and congenital adrenal hyperplasia. (From Martindale, The Extra Pharmacopoeia, 30th ed, p724) | 2.46 | 2 | 0 | 11beta-hydroxy steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; fluorinated steroid; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | anti-asthmatic agent; anti-inflammatory drug; immunosuppressive agent |
| nandrolone Nandrolone: C18 steroid with androgenic and anabolic properties. It is generally prepared from alkyl ethers of ESTRADIOL to resemble TESTOSTERONE but less one carbon at the 19 position.. nandrolone : A 3-oxo Delta(4)-steroid that is estr-4-en-3-one substituted by a beta-hydroxy group at position 17. | 8.14 | 5 | 0 | 17beta-hydroxy steroid; 3-oxo-Delta(4) steroid; anabolic androgenic steroid | human metabolite |
| fluorobenzenes Fluorobenzenes: Derivatives of BENZENE that contain FLUORINE.. monofluorobenzene : The simplest member of the class of monofluorobenzenes that is benzene carrying a single fluoro substituent.. fluorobenzenes : Any fluoroarene that is a benzene or a substituted benzene carrying at least one fluoro group. | 2 | 1 | 0 | monofluorobenzenes | NMR chemical shift reference compound |
| chenodeoxycholic acid Chenodeoxycholic Acid: A bile acid, usually conjugated with either glycine or taurine. It acts as a detergent to solubilize fats for intestinal absorption and is reabsorbed by the small intestine. It is used as cholagogue, a choleretic laxative, and to prevent or dissolve gallstones.. chenodeoxycholic acid : A dihydroxy-5beta-cholanic acid that is (5beta)-cholan-24-oic acid substituted by hydroxy groups at positions 3 and 7 respectively.. chenodeoxycholate : Conjugate base of chenodeoxycholic acid; major species at pH 7.3. | 2.02 | 1 | 0 | bile acid; C24-steroid; dihydroxy-5beta-cholanic acid | human metabolite; mouse metabolite |
| reticulin Reticulin: A scleroprotein fibril consisting mostly of type III collagen. Reticulin fibrils are extremely thin, with a diameter of between 0.5 and 2 um. They are involved in maintaining the structural integrity in a variety of organs. | 2.03 | 1 | 0 | benzylisoquinoline alkaloid; benzyltetrahydroisoquinoline; isoquinolinol | plant metabolite |
| bicuculline Bicuculline: An isoquinoline alkaloid obtained from Dicentra cucullaria and other plants. It is a competitive antagonist for GABA-A receptors.. bicuculline : A benzylisoquinoline alkaloid that is 6-methyl-5,6,7,8-tetrahydro[1,3]dioxolo[4,5-g]isoquinoline which is substituted at the 5-pro-S position by a (6R)-8-oxo-6,8-dihydrofuro[3,4-e][1,3]benzodioxol-6-yl group. A light-sensitive competitive antagonist of GABAA receptors. It was originally identified in 1932 in plant alkaloid extracts and has been isolated from Dicentra cucullaria, Adlumia fungosa, Fumariaceae, and several Corydalis species. | 2.71 | 3 | 0 | benzylisoquinoline alkaloid; isoquinoline alkaloid; isoquinolines | agrochemical; central nervous system stimulant; GABA-gated chloride channel antagonist; GABAA receptor antagonist; neurotoxin |
| kainic acid Kainic Acid: (2S-(2 alpha,3 beta,4 beta))-2-Carboxy-4-(1-methylethenyl)-3-pyrrolidineacetic acid. Ascaricide obtained from the red alga Digenea simplex. It is a potent excitatory amino acid agonist at some types of excitatory amino acid receptors and has been used to discriminate among receptor types. Like many excitatory amino acid agonists it can cause neurotoxicity and has been used experimentally for that purpose. | 2.92 | 4 | 0 | dicarboxylic acid; L-proline derivative; non-proteinogenic L-alpha-amino acid; pyrrolidinecarboxylic acid | antinematodal drug; excitatory amino acid agonist |
| indophenol Indophenol: A deep blue dye (with the formula OC6H4NC6H4OH) used to detect AMMONIA in a common test called the Berthelot's reaction and to detect PARACETAMOL by spectrophotometry.. indophenol : A quinone imine obtained by formal condensation of one of the keto groups of benzoquinone with the amino group of 4-hydroxyaniline. | 2 | 1 | 0 | quinone imine | dye |
| podophyllotoxin Podophyllum: A genus of poisonous American herbs, family BERBERIDACEAE. The roots yield PODOPHYLLOTOXIN and other pharmacologically important agents. The plant was formerly used as a cholagogue and cathartic. It is different from the European mandrake, MANDRAGORA. | 2.02 | 1 | 0 | furonaphthodioxole; lignan; organic heterotetracyclic compound | antimitotic; antineoplastic agent; keratolytic drug; microtubule-destabilising agent; plant metabolite; tubulin modulator |
| medroxyprogesterone [no description available] | 5.6 | 6 | 3 | 17alpha-hydroxy steroid; 20-oxo steroid; 3-oxo-Delta(4) steroid; tertiary alpha-hydroxy ketone | contraceptive drug; progestin; synthetic oral contraceptive |
| mestanolone mestanolone: non-virilizing androgenic steroid; RN given refers to (5alpha,17beta)-isomer; structure | 2.04 | 1 | 0 | 3-oxo-5alpha-steroid | |
| androstenediol Androstenediol: An intermediate in TESTOSTERONE biosynthesis, found in the TESTIS or the ADRENAL GLANDS. Androstenediol, derived from DEHYDROEPIANDROSTERONE by the reduction of the 17-keto group (17-HYDROXYSTEROID DEHYDROGENASES), is converted to TESTOSTERONE by the oxidation of the 3-beta hydroxyl group to a 3-keto group (3-HYDROXYSTEROID DEHYDROGENASES).. androst-5-ene-3beta,17beta-diol : A 3beta-hydroxy-Delta(5)-steroid that is 3beta-hydroxyandrost-5-ene carrying an additional hydroxy group at position 17beta. | 2.04 | 1 | 0 | 17beta-hydroxy steroid; 3beta-hydroxy-Delta(5)-steroid | androgen; human metabolite; mouse metabolite; radiation protective agent |
| dihydrotestosterone Dihydrotestosterone: A potent androgenic metabolite of TESTOSTERONE. It is produced by the action of the enzyme 3-OXO-5-ALPHA-STEROID 4-DEHYDROGENASE.. 17beta-hydroxyandrostan-3-one : A 17beta-hydroxy steroid that is testosterone in which the 4-5 double bond has been reduced to a single bond with unspecified configuration at position 5.. 17beta-hydroxy-5alpha-androstan-3-one : A 17beta-hydroxy steroid that is testosterone in which the 4,5 double bond has been reduced to a single bond with alpha-configuration at position 5. | 4.74 | 29 | 0 | 17beta-hydroxy steroid; 17beta-hydroxyandrostan-3-one; 3-oxo-5alpha-steroid | androgen; Daphnia magna metabolite; human metabolite; mouse metabolite |
| methoxyhydroxyphenylglycol Methoxyhydroxyphenylglycol: Synthesized from endogenous epinephrine and norepinephrine in vivo. It is found in brain, blood, CSF, and urine, where its concentrations are used to measure catecholamine turnover. | 2 | 1 | 0 | methoxybenzenes; phenols | |
| methamphetamine Methamphetamine: A central nervous system stimulant and sympathomimetic with actions and uses similar to DEXTROAMPHETAMINE. The smokable form is a drug of abuse and is referred to as crank, crystal, crystal meth, ice, and speed.. methamphetamine : A member of the class of amphetamines in which the amino group of (S)-amphetamine carries a methyl substituent. | 2.74 | 3 | 0 | amphetamines; secondary amine | central nervous system stimulant; environmental contaminant; neurotoxin; psychotropic drug; xenobiotic |
| levocarnitine (R)-carnitine : The (R)-enantiomer of carnitine. | 2.02 | 1 | 0 | carnitine | antilipemic drug; nootropic agent; nutraceutical; Saccharomyces cerevisiae metabolite; water-soluble vitamin (role) |
| malondialdehyde Malondialdehyde: The dialdehyde of malonic acid.. malonaldehyde : A dialdehyde that is propane substituted by two oxo groups at the terminal carbon atoms respectively. A biomarker of oxidative damage to lipids caused by smoking, it exists in vivo mainly in the enol form. | 3.02 | 4 | 0 | dialdehyde | biomarker |
| trinitrobenzenesulfonic acid Trinitrobenzenesulfonic Acid: A reagent that is used to neutralize peptide terminal amino groups.. 2,4,6-trinitrobenzenesulfonic acid : The arenesulfonic acid that is benzenesulfonic acid with three nitro substituents in the 2-, 4- and 6-positions. | 2.03 | 1 | 0 | arenesulfonic acid; C-nitro compound | epitope; explosive; reagent |
| paeonol paeonol: structure | 2.25 | 1 | 0 | methoxybenzenes; phenols | metabolite |
| megestrol acetate [no description available] | 2.93 | 4 | 0 | 20-oxo steroid; 3-oxo-Delta(4) steroid; acetate ester; steroid ester | antineoplastic agent; appetite enhancer; contraceptive drug; progestin; synthetic oral contraceptive |
| acetylcysteine N-acetyl-L-cysteine : An N-acetyl-L-amino acid that is the N-acetylated derivative of the natural amino acid L-cysteine. | 2.02 | 1 | 0 | acetylcysteine; L-cysteine derivative; N-acetyl-L-amino acid | antidote to paracetamol poisoning; antiinfective agent; antioxidant; antiviral drug; ferroptosis inhibitor; geroprotector; human metabolite; mucolytic; radical scavenger; vulnerary |
| c.i. 42510 Rosaniline Dyes: Compounds that contain the triphenylmethane aniline structure found in rosaniline. Many of them have a characteristic magenta color and are used as COLORING AGENTS.. basic fuchsin : A four-component mixture of chemically related dyes comprising pararosanilin, rosanilin, magenta II and new fuchsin in varying amounts. rosanilin : A hydrochloride that is the monohydrochloride of 4-[(4-aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-2-methylaniline. One of the major constituents of Basic fuchsin, together with pararosanilin, magenta II and new fuchsin. | 1.93 | 1 | 0 | ||
| erythromycin Erythromycin: A bacteriostatic antibiotic macrolide produced by Streptomyces erythreus. Erythromycin A is considered its major active component. In sensitive organisms, it inhibits protein synthesis by binding to 50S ribosomal subunits. This binding process inhibits peptidyl transferase activity and interferes with translocation of amino acids during translation and assembly of proteins.. erythromycin : Any of several wide-spectrum macrolide antibiotics obtained from actinomycete Saccharopolyspora erythraea (formerly known as Streptomyces erythraeus).. erythromycin A : An erythromycin that consists of erythronolide A having 2,6-dideoxy-3-C-methyl-3-O-methyl-alpha-L-ribo-hexopyranosyl and 3,4,6-trideoxy-3-(dimethylamino)-beta-D-xylo-hexopyranosyl residues attahced at positions 4 and 6 respectively. | 2.02 | 1 | 0 | cyclic ketone; erythromycin | |
| methylnitrosourea Methylnitrosourea: A nitrosourea compound with alkylating, carcinogenic, and mutagenic properties.. N-methyl-N-nitrosourea : A member of the class of N-nitrosoureas that is urea in which one of the nitrogens is substituted by methyl and nitroso groups. | 2.02 | 1 | 0 | N-nitrosoureas | alkylating agent; carcinogenic agent; mutagen; teratogenic agent |
| levonorgestrel Levonorgestrel: A synthetic progestational hormone with actions similar to those of PROGESTERONE and about twice as potent as its racemic or (+-)-isomer (NORGESTREL). It is used for contraception, control of menstrual disorders, and treatment of endometriosis. | 2.43 | 2 | 0 | 17beta-hydroxy steroid; 3-oxo-Delta(4) steroid; terminal acetylenic compound | contraceptive drug; female contraceptive drug; progestin; synthetic oral contraceptive |
| dihydrotestosterone propionate dihydrotestosterone propionate: RN given refers to (5alpha,17beta)-isomer; structure | 3.3 | 6 | 0 | ||
| estradiol valerate [no description available] | 2.02 | 1 | 0 | steroid ester | |
| ethambutol Ethambutol: An antitubercular agent that inhibits the transfer of mycolic acids into the cell wall of the tubercle bacillus. It may also inhibit the synthesis of spermidine in mycobacteria. The action is usually bactericidal, and the drug can penetrate human cell membranes to exert its lethal effect. (From Smith and Reynard, Textbook of Pharmacology, 1992, p863). ethambutol : An ethylenediamine derivative that is ethane-1,2-diamine in which one hydrogen attached to each of the nitrogens is sutstituted by a 1-hydroxybutan-2-yl group (S,S-configuration). It is a bacteriostatic antimycobacterial drug, effective against Mycobacterium tuberculosis and some other mycobacteria. It is used (as the dihydrochloride salt) in combination with other antituberculous drugs in the treatment of pulmonary and extrapulmonary tuberculosis; resistant strains of M. tuberculosis are readily produced if ethambutol is used alone. | 2.02 | 1 | 0 | ethanolamines; ethylenediamine derivative | antitubercular agent; environmental contaminant; xenobiotic |
| d-alpha tocopherol Vitamin E: A generic descriptor for all TOCOPHEROLS and TOCOTRIENOLS that exhibit ALPHA-TOCOPHEROL activity. By virtue of the phenolic hydrogen on the 2H-1-benzopyran-6-ol nucleus, these compounds exhibit varying degree of antioxidant activity, depending on the site and number of methyl groups and the type of ISOPRENOIDS.. tocopherol : A collective name for a group of closely related lipids that contain a chroman-6-ol nucleus substituted at position 2 by a methyl group and by a saturated hydrocarbon chain consisting of three isoprenoid units. They are designated as alpha-, beta-, gamma-, and delta-tocopherol depending on the number and position of additional methyl substituents on the aromatic ring. Tocopherols occur in vegetable oils and vegetable oil products, almost exclusively with R,R,R configuration. Tocotrienols differ from tocopherols only in having three double bonds in the hydrocarbon chain.. vitamin E : Any member of a group of fat-soluble chromanols that exhibit biological activity against vitamin E deficiency. The vitamers in this class consists of a chroman-6-ol core which is substituted at position 2 by a methyl group and (also at position 2) either a saturated or a triply-unsaturated hydrocarbon chain consisting of three isoprenoid units. The major function of vitamin E is to act as a natural antioxidant by scavenging free radicals and molecular oxygen.. (R,R,R)-alpha-tocopherol : An alpha-tocopherol that has R,R,R configuration. The naturally occurring stereoisomer of alpha-tocopherol, it is found particularly in sunflower and olive oils. | 2.36 | 2 | 0 | alpha-tocopherol | algal metabolite; antiatherogenic agent; anticoagulant; antioxidant; antiviral agent; EC 2.7.11.13 (protein kinase C) inhibitor; immunomodulator; micronutrient; nutraceutical; plant metabolite |
| mesterolone Mesterolone: 17 beta-Hydroxy-1 alpha-methyl-5 alpha-androstan-3-one. A synthetic steroid with anabolic and androgenic activities. | 2.04 | 1 | 0 | 3-oxo-5alpha-steroid | |
| methyl tert-butyl ether methyl tert-butyl ether: used to dissolve gallstones; gasoline additive. methyl tert-butyl ether : An ether having methyl and tert-butyl as the two alkyl components. | 2.03 | 1 | 0 | ether | fuel additive; metabolite; non-polar solvent |
| digoxigenin Digoxigenin: 3 beta,12 beta,14-Trihydroxy-5 beta-card-20(22)-enolide. A cardenolide which is the aglycon of digoxin. Can be obtained by hydrolysis of digoxin or from Digitalis orientalis L. and Digitalis lanata Ehrh.. digoxigenin : A hydroxy steroid that consists of 5beta-cardanolide having a double bond at the 20(22)-position as well as hydroxy groups at the 3beta-, 12beta- and 14beta-positions. It has been isolated from the plant species of the genus Digitalis. | 2 | 1 | 0 | 12beta-hydroxy steroid; 14beta-hydroxy steroid; 3beta-hydroxy steroid; 3beta-sterol | hapten; plant metabolite |
| 4-octylphenol 4-octylphenol: xenoestrogen. 4-octylphenol : A member of the class of phenols that is phenol which is substituted at the para- position by an octyl group. | 2 | 1 | 0 | phenols | metabolite; surfactant; xenoestrogen |
| 5 alpha-androstane-3 alpha,17 beta-diol 5alpha-androstane-3alpha,17beta-diol : The 5alpha-stereoisomer of androstane-3alpha,17beta-diol. | 2.04 | 1 | 0 | androstane-3alpha,17beta-diol | Daphnia magna metabolite; human metabolite |
| dronabinol Dronabinol: A psychoactive compound extracted from the resin of Cannabis sativa (marihuana, hashish). The isomer delta-9-tetrahydrocannabinol (THC) is considered the most active form, producing characteristic mood and perceptual changes associated with this compound.. Delta(9)-tetrahydrocannabinol : A diterpenoid that is 6a,7,8,10a-tetrahydro-6H-benzo[c]chromene substituted at position 1 by a hydroxy group, positions 6, 6 and 9 by methyl groups and at position 3 by a pentyl group. The principal psychoactive constituent of the cannabis plant, it is used for treatment of anorexia associated with AIDS as well as nausea and vomiting associated with cancer chemotherapy. | 2.02 | 1 | 0 | benzochromene; diterpenoid; phytocannabinoid; polyketide | cannabinoid receptor agonist; epitope; hallucinogen; metabolite; non-narcotic analgesic |
| pimozide Pimozide: A diphenylbutylpiperidine that is effective as an antipsychotic agent and as an alternative to HALOPERIDOL for the suppression of vocal and motor tics in patients with Tourette syndrome. Although the precise mechanism of action is unknown, blockade of postsynaptic dopamine receptors has been postulated. (From AMA Drug Evaluations Annual, 1994, p403). pimozide : A member of the class of benzimidazoles that is 1,3-dihydro-2H-benzimidazol-2-one in which one of the nitrogens is substituted by a piperidin-4-yl group, which in turn is substituted on the nitrogen by a 4,4-bis(p-fluorophenyl)butyl group. | 2.02 | 1 | 0 | benzimidazoles; heteroarylpiperidine; organofluorine compound | antidyskinesia agent; dopaminergic antagonist; first generation antipsychotic; H1-receptor antagonist; serotonergic antagonist |
| betamethasone valerate Betamethasone Valerate: The 17-valerate derivative of BETAMETHASONE. It has substantial topical anti-inflammatory activity and relatively low systemic anti-inflammatory activity.. betamethasone valerate : A steroid ester that is betamethasone in which the hydroxy group at the 17alpha position has been converted to the corresponding pentanoate ester. | 2.02 | 1 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; fluorinated steroid; primary alpha-hydroxy ketone; steroid ester | anti-inflammatory drug |
| methylprednisolone hemisuccinate Methylprednisolone Hemisuccinate: A water-soluble ester of METHYLPREDNISOLONE used for cardiac, allergic, and hypoxic emergencies. | 2.02 | 1 | 0 | corticosteroid hormone; hemisuccinate | |
| 2,4,2',4'-tetrachlorobiphenyl 2,4,2',4'-tetrachlorobiphenyl: structure. 2,2',4,4'-tetrachlorobiphenyl : A tetrachlorobiphenyl that is biphenyl in which each of the phenyl groups is substituted at positions 2 and 4 by chlorines. | 2.01 | 1 | 0 | dichlorobenzene; tetrachlorobiphenyl | |
| acadesine [no description available] | 2.08 | 1 | 0 | 1-ribosylimidazolecarboxamide; aminoimidazole; nucleoside analogue | antineoplastic agent; platelet aggregation inhibitor |
| stavudine Stavudine: A dideoxynucleoside analog that inhibits reverse transcriptase and has in vitro activity against HIV.. stavudine : A nucleoside analogue obtained by formal dehydration across positions 2 and 3 of thymidine. An inhibitor of HIV-1 reverse transcriptase | 2.02 | 1 | 0 | dihydrofuran; nucleoside analogue; organic molecular entity | antimetabolite; antiviral agent; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor |
| cyclacillin Cyclacillin: A cyclohexylamido analog of PENICILLANIC ACID. | 2.02 | 1 | 0 | penicillin | antibacterial drug |
| tranylcypromine Tranylcypromine: A propylamine formed from the cyclization of the side chain of amphetamine. This monoamine oxidase inhibitor is effective in the treatment of major depression, dysthymic disorder, and atypical depression. It also is useful in panic and phobic disorders. (From AMA Drug Evaluations Annual, 1994, p311). tranylcypromine : A racemate comprising equal amounts of (1R,2S)- and (1S,2R)-2-phenylcyclopropan-1-amine. An irreversible monoamine oxidase inhibitor that is used as an antidepressant (INN tranylcypromine).. (1R,2S)-tranylcypromine : A 2-phenylcyclopropan-1-amine that is the (1R,2S)-enantiomer of tranylcypromine. | 2.02 | 1 | 0 | 2-phenylcyclopropan-1-amine | |
| cladribine [no description available] | 2.02 | 1 | 0 | organochlorine compound; purine 2'-deoxyribonucleoside | antineoplastic agent; immunosuppressive agent |
| beclomethasone [no description available] | 2.02 | 1 | 0 | 11beta-hydroxy steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; chlorinated steroid; corticosteroid; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | anti-asthmatic drug; anti-inflammatory drug |
| ethylene dimethanesulfonate ethylene dimethanesulfonate: antispermatogenic agent; structure | 2.4 | 2 | 0 | ||
| estradiol enanthate [no description available] | 2.02 | 1 | 0 | steroid ester | |
| betamethasone-17,21-dipropionate [no description available] | 2.02 | 1 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 3-oxo-Delta(1),Delta(4)-steroid; fluorinated steroid; propanoate ester; steroid ester | antipsoriatic |
| olsalazine olsalazine: cpd with 2 salicylate molecules linked together by an azo bond. olsalazine : An azobenzene that consists of two molecules of 4-aminosalicylic acid joined by an azo linkage. A prodrug for mesalazine, an anti-inflammatory drug, it is used (as the disodium salt) in the treatment of inflammatory bowel disease. | 2.02 | 1 | 0 | azobenzenes; dicarboxylic acid | non-steroidal anti-inflammatory drug; prodrug |
| n-methylaspartate N-Methylaspartate: An amino acid that, as the D-isomer, is the defining agonist for the NMDA receptor subtype of glutamate receptors (RECEPTORS, NMDA).. N-methyl-D-aspartic acid : An aspartic acid derivative having an N-methyl substituent and D-configuration. | 2.94 | 4 | 0 | amino dicarboxylic acid; D-alpha-amino acid; D-aspartic acid derivative; secondary amino compound | neurotransmitter agent |
| zalcitabine Zalcitabine: A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by a hydrogen. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication at low concentrations, acting as a chain-terminator of viral DNA by binding to reverse transcriptase. Its principal toxic side effect is axonal degeneration resulting in peripheral neuropathy.. zalcitabine : A pyrimidine 2',3'-dideoxyribonucleoside compound having cytosine as the nucleobase. | 2.02 | 1 | 0 | pyrimidine 2',3'-dideoxyribonucleoside | antimetabolite; antiviral drug; HIV-1 reverse transcriptase inhibitor |
| zinc sulfate Zinc Sulfate: A compound given in the treatment of conditions associated with zinc deficiency such as acrodermatitis enteropathica. Externally, zinc sulfate is used as an astringent in lotions and eye drops. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995). zinc sulfate : A metal sulfate compound having zinc(2+) as the counterion. | 2.03 | 1 | 0 | metal sulfate; zinc molecular entity | fertilizer |
| ethinyl estradiol-norgestrel combination Ethinyl Estradiol-Norgestrel Combination: ETHINYL ESTRADIOL and NORGESTREL given in fixed proportions. | 3.44 | 1 | 1 | ||
| vasotocin Vasotocin: A nonapeptide that contains the ring of OXYTOCIN and the side chain of ARG-VASOPRESSIN with the latter determining the specific recognition of hormone receptors. Vasotocin is the non-mammalian vasopressin-like hormone or antidiuretic hormone regulating water and salt metabolism.. vasotocin : A heterodetic cyclic peptide that is homologous to oxytocin and vasopressin. It is a pituitary hormone that acts as an endocrine regulator for water balance, osmotic homoeostasis and is involved in social and sexual behavior in non-mammalian vertebrates. | 3.55 | 8 | 0 | ||
| diacerein diacerein: chelates with bivalent metals; a quinone which possesses redox properties; metabolized to active rhein; proposed mechanisms include inhibiting IL1 and metalloproteinases; called a slow acting symptomatic drug in osteoarthritis; no effect of cyclooxygenase; | 2.55 | 2 | 0 | anthraquinone | |
| selegiline Selegiline: A selective, irreversible inhibitor of Type B monoamine oxidase that is used for the treatment of newly diagnosed patients with PARKINSON DISEASE, and for the treatment of depressive disorders. The compound without isomeric designation is Deprenyl. | 2.02 | 1 | 0 | selegiline; terminal acetylenic compound | geroprotector |
| levamisole Levamisole: An antihelminthic drug that has been tried experimentally in rheumatic disorders where it apparently restores the immune response by increasing macrophage chemotaxis and T-lymphocyte function. Paradoxically, this immune enhancement appears to be beneficial in rheumatoid arthritis where dermatitis, leukopenia, and thrombocytopenia, and nausea and vomiting have been reported as side effects. (From Smith and Reynard, Textbook of Pharmacology, 1991, p435-6). levamisole : A 6-phenyl-2,3,5,6-tetrahydroimidazo[2,1-b][1,3]thiazole that has S configuration. It is used (generally as the monohydrochloride salt) to treat parasitic worm infections in pigs, sheep and cattle and was formerly used in humans as an adjuvant to chemotherapy for the treatment of various cancers. It is also widely used as an adulterant to coccaine. | 2.02 | 1 | 0 | 6-phenyl-2,3,5,6-tetrahydroimidazo[2,1-b][1,3]thiazole | antinematodal drug; antirheumatic drug; EC 3.1.3.1 (alkaline phosphatase) inhibitor; immunological adjuvant; immunomodulator |
| cephalexin Cephalexin: A semisynthetic cephalosporin antibiotic with antimicrobial activity similar to that of CEPHALORIDINE or CEPHALOTHIN, but somewhat less potent. It is effective against both gram-positive and gram-negative organisms.. cephalexin : A semisynthetic first-generation cephalosporin antibiotic having methyl and beta-(2R)-2-amino-2-phenylacetamido groups at the 3- and 7- of the cephem skeleton, respectively. It is effective against both Gram-negative and Gram-positive organisms, and is used for treatment of infections of the skin, respiratory tract and urinary tract. | 2.02 | 1 | 0 | beta-lactam antibiotic allergen; cephalosporin; semisynthetic derivative | antibacterial drug |
| cromolyn sodium Cromolyn Sodium: A chromone complex that acts by inhibiting the release of chemical mediators from sensitized MAST CELLS. It is used in the prophylactic treatment of both allergic and exercise-induced asthma, but does not affect an established asthmatic attack.. disodium cromoglycate : An organic sodium salt that is the disodium salt of cromoglycic acid. | 2.01 | 1 | 0 | organic sodium salt | anti-asthmatic drug; drug allergen |
| isosorbide-5-mononitrate isosorbide-5-mononitrate: for prevention of angina pectoris; structure given in first source; a Russian drug | 2.02 | 1 | 0 | glucitol derivative; nitrate ester | nitric oxide donor; vasodilator agent |
| gestrinone Gestrinone: A non-estrogenic contraceptive which is a weak progestin with strong anti-progesterone properties. It is effective if used once a week orally or can also be used in intravaginal devices. | 2.04 | 1 | 0 | oxo steroid | |
| danazol Danazol: A synthetic steroid with antigonadotropic and anti-estrogenic activities that acts as an anterior pituitary suppressant by inhibiting the pituitary output of gonadotropins. It possesses some androgenic properties. Danazol has been used in the treatment of endometriosis and some benign breast disorders. | 2.43 | 2 | 0 | 17beta-hydroxy steroid; terminal acetylenic compound | anti-estrogen; estrogen antagonist; geroprotector |
| clonixin Clonixin: Anti-inflammatory analgesic.. clonixin : A pyridinemonocarboxylic acid that is nicotinic acid substituted at position 2 by a (2-methyl-3-chlorophenyl)amino group. Used (as its lysine salt) for treatment of renal colic, muscular pain and moderately severe migraine attacks. | 2.43 | 2 | 0 | aminopyridine; organochlorine compound; pyridinemonocarboxylic acid | antipyretic; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; lipoxygenase inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug; platelet aggregation inhibitor; vasodilator agent |
| daunorubicin Daunorubicin: A very toxic anthracycline aminoglycoside antineoplastic isolated from Streptomyces peucetius and others, used in treatment of LEUKEMIA and other NEOPLASMS.. anthracycline : Anthracyclines are polyketides that have a tetrahydronaphthacenedione ring structure attached by a glycosidic linkage to the amino sugar daunosamine.. daunorubicin : A natural product found in Actinomadura roseola. | 2.02 | 1 | 0 | aminoglycoside antibiotic; anthracycline; p-quinones; tetracenequinones | antineoplastic agent; bacterial metabolite |
| cephapirin Cephapirin: Cephalosporin antibiotic, partly plasma-bound, that is effective against gram-negative and gram-positive organisms.. cephapirin : A cephalosporin with acetoxymethyl and 2(pyridin-4-ylsulfanyl)acetamido substituents at positions 3 and 7, respectively, of the cephem skeleton. It is used (as its sodium salt) as an antibiotic, being effective against gram-negative and gram-positive organisms. | 2.02 | 1 | 0 | cephalosporin | antibacterial drug |
| bromocriptine Bromocriptine: A semisynthetic ergotamine alkaloid that is a dopamine D2 agonist. It suppresses prolactin secretion. | 2.75 | 3 | 0 | indole alkaloid | antidyskinesia agent; antiparkinson drug; dopamine agonist; hormone antagonist |
| phenyl acetate phenyl acetate: The ester formed between phenol and acetic acid. Don't confuse with phenylacetic acid derivatives listed under PHENYLACETATES.. phenyl acetate : An acetate ester obtained by the formal condensation of phenol with acetic acid. | 1.94 | 1 | 0 | benzenes; phenyl acetates | |
| paraldehyde Paraldehyde: A hypnotic and sedative with anticonvulsant effects. However, because of the hazards associated with its administration, its tendency to react with plastic, and the risks associated with its deterioration, it has largely been superseded by other agents. It is still occasionally used to control status epilepticus resistant to conventional treatment. (From Martindale, The Extra Pharmacopoeia, 30th ed, p608-9). paraldehyde : A trioxane that is 1,3,5-trioxane substituted by methyl groups at positions 2, 4 and 6. | 1.93 | 1 | 0 | trioxane | sedative |
| ursodeoxycholic acid Ursodeoxycholic Acid: An epimer of chenodeoxycholic acid. It is a mammalian bile acid found first in the bear and is apparently either a precursor or a product of chenodeoxycholate. Its administration changes the composition of bile and may dissolve gallstones. It is used as a cholagogue and choleretic.. ursodeoxycholic acid : A bile acid found in the bile of bears (Ursidae) as a conjugate with taurine. Used therapeutically, it prevents the synthesis and absorption of cholesterol and can lead to the dissolution of gallstones.. ursodeoxycholate : A bile acid anion that is the conjugate base of ursodeoxycholic acid, obtained by deprotonation of the carboxy group; major species at pH 7.3. | 2.02 | 1 | 0 | bile acid; C24-steroid; dihydroxy-5beta-cholanic acid | human metabolite; mouse metabolite |
| pregnanolone Pregnanolone: A pregnane found in the urine of pregnant women and sows. It has anesthetic, hypnotic, and sedative properties.. 3alpha-hydroxy-5beta-pregnan-20-one : The 3alpha-stereoisomer of 3-hydroxy-5beta-pregnan-20-one. | 3.44 | 7 | 0 | 3-hydroxy-5beta-pregnan-20-one; 3alpha-hydroxy steroid | human metabolite; intravenous anaesthetic; sedative |
| metipranolol Metipranolol: A beta-adrenergic antagonist effective for both beta-1 and beta-2 receptors. It is used as an antiarrhythmic, antihypertensive, and antiglaucoma agent.. metipranolol : 3-(Propan-2-ylamino)propane-1,2-diol in which the hydrogen of the primary hydroxy group is substituted by a 4-acetoxy-2,3,5-trimethylphenoxy group. A non-cardioselective beta-blocker, it is used to lower intra-ocular pressure in the management of open-angle glaucoma. | 2.02 | 1 | 0 | acetate ester; aromatic ether; propanolamine; secondary amino compound | anti-arrhythmia drug; antiglaucoma drug; antihypertensive agent; beta-adrenergic antagonist |
| halazepam halazepam: structure | 2.02 | 1 | 0 | organic molecular entity | |
| du-21220 Ritodrine: An adrenergic beta-2 agonist used to control PREMATURE LABOR.. 4-[2-[[1-hydroxy-1-(4-hydroxyphenyl)propan-2-yl]amino]ethyl]phenol : A secondary amino compound that is 4-(2-amino-1-hydroxypropyl)phenol in which one of the hydrogens attached to the nitrogen is replaced by a 2-(4-hydroxyphenyl)ethyl group. | 2.02 | 1 | 0 | benzyl alcohols; polyphenol; secondary alcohol; secondary amino compound | |
| 8-bromo cyclic adenosine monophosphate 8-Bromo Cyclic Adenosine Monophosphate: A long-acting derivative of cyclic AMP. It is an activator of cyclic AMP-dependent protein kinase, but resistant to degradation by cyclic AMP phosphodiesterase.. 8-Br-cAMP : A 3',5'-cyclic purine nucleotide that is 3',5'-cyclic AMP bearing an additional bromo substituent at position 8 on the adenine ring. An activator of cyclic AMP-dependent protein kinase, but resistant to degradation by cyclic AMP phosphodiesterase. | 2 | 1 | 0 | 3',5'-cyclic purine nucleotide; adenyl ribonucleotide; organobromine compound | antidepressant; protein kinase agonist |
| n-methyl-n-(trimethylsilyl)trifluoroacetamide N-methyl-N-(trimethylsilyl)trifluoroacetamide : An N-silyl compound that is N-methyltrifluoroacetamide in which the amide nitrogen is replaced by a trimethylsilyl group. N-methyl-N-(trimethylsilyl)trifluoroacetamide is a derivatisation agent used in gas chromatography/mass spectrometry applications. | 2.03 | 1 | 0 | monocarboxylic acid amide; N-silyl compound; trifluoroacetamide | chromatographic reagent |
| androstane-3,17-diol Androstane-3,17-diol: The unspecified form of the steroid, normally a major metabolite of TESTOSTERONE with androgenic activity. It has been implicated as a regulator of gonadotropin secretion. | 2.01 | 1 | 0 | 17-hydroxy steroid; 3-hydroxy steroid; androstanoid | |
| glutamic acid Glutamic Acid: A non-essential amino acid naturally occurring in the L-form. Glutamic acid is the most common excitatory neurotransmitter in the CENTRAL NERVOUS SYSTEM.. glutamic acid : An alpha-amino acid that is glutaric acid bearing a single amino substituent at position 2. | 2.96 | 4 | 0 | glutamic acid; glutamine family amino acid; L-alpha-amino acid; proteinogenic amino acid | Escherichia coli metabolite; ferroptosis inducer; micronutrient; mouse metabolite; neurotransmitter; nutraceutical |
| cefazolin Cefazolin: A semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis. It attains high serum levels and is excreted quickly via the urine.. cefazolin : A first-generation cephalosporin compound having [(5-methyl-1,3,4-thiadiazol-2-yl)sulfanyl]methyl and (1H-tetrazol-1-ylacetyl)amino side-groups at positions 3 and 7 respectively. | 2.02 | 1 | 0 | beta-lactam antibiotic allergen; cephalosporin; tetrazoles; thiadiazoles | antibacterial drug |
| amoxicillin Amoxicillin: A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.. amoxicillin : A penicillin in which the substituent at position 6 of the penam ring is a 2-amino-2-(4-hydroxyphenyl)acetamido group. | 2.02 | 1 | 0 | penicillin allergen; penicillin | antibacterial drug |
| timolol (S)-timolol (anhydrous) : The (S)-(-) (more active) enantiomer of timolol. A beta-adrenergic antagonist, both the hemihydrate and the maleate salt are used in the mangement of glaucoma, hypertension, angina pectoris and myocardial infarction, and for the prevention of migraine. | 2.02 | 1 | 0 | timolol | anti-arrhythmia drug; antiglaucoma drug; antihypertensive agent; beta-adrenergic antagonist |
| moricizine Moricizine: An antiarrhythmia agent used primarily for ventricular rhythm disturbances.. moricizine : A phenothiazine substituted on the nitrogen by a 3-(morpholin-4-yl)propanoyl group, and at position 2 by an (ethoxycarbonyl)amino group. | 2.02 | 1 | 0 | carbamate ester; morpholines; phenothiazines | anti-arrhythmia drug |
| s-adenosylmethionine acylcarnitine: structure in first source. S-adenosyl-L-methioninate : A sulfonium betaine that is a conjugate base of S-adenosyl-L-methionine obtained by the deprotonation of the carboxy group. | 2.25 | 1 | 0 | sulfonium betaine | human metabolite |
| bitolterol bitolterol: RN given refers to parent cpd; structure. bitolterol : The di-4-toluate ester of (+-)-N-tert-butylnoradrenaline (colterol). A pro-drug for colterol, a beta2-adrenergic receptor agonist, bitolterol is used as its methanesulfonate salt for relief of bronchospasm in conditions such as asthma, chronic bronchitis and emphysema. | 2.02 | 1 | 0 | carboxylic ester; diester; ethanolamines; secondary alcohol; secondary amino compound | anti-asthmatic drug; beta-adrenergic agonist; bronchodilator agent; prodrug |
| zidovudine Zidovudine: A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by an azido group. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA during reverse transcription. It improves immunologic function, partially reverses the HIV-induced neurological dysfunction, and improves certain other clinical abnormalities associated with AIDS. Its principal toxic effect is dose-dependent suppression of bone marrow, resulting in anemia and leukopenia.. zidovudine : A pyrimidine 2',3'-dideoxyribonucleoside compound having a 3'-azido substituent and thymine as the nucleobase. | 2.02 | 1 | 0 | azide; pyrimidine 2',3'-dideoxyribonucleoside | antimetabolite; antiviral drug; HIV-1 reverse transcriptase inhibitor |
| 3,4,3',4'-tetrachlorobiphenyl 3,4,3',4'-tetrachlorobiphenyl: RN given refers to parent cpd. 3,3',4,4'-tetrachlorobiphenyl : A tetrachlorobiphenyl that is biphenyl in which the hydrogens at position 3 and 4 on each phenyl group are replaced by chlorines. | 2.01 | 1 | 0 | dichlorobenzene; tetrachlorobiphenyl | |
| tobramycin Tobramycin: An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the PSEUDOMONAS species. It is a 10% component of the antibiotic complex, NEBRAMYCIN, produced by the same species.. tobramycin : A amino cyclitol glycoside that is kanamycin B lacking the 3-hydroxy substituent from the 2,6-diaminoglucose ring. | 2.02 | 1 | 0 | amino cyclitol glycoside | antibacterial agent; antimicrobial agent; toxin |
| paclitaxel Taxus: Genus of coniferous yew trees or shrubs, several species of which have medicinal uses. Notable is the Pacific yew, Taxus brevifolia, which is used to make the anti-neoplastic drug taxol (PACLITAXEL). | 2.02 | 1 | 0 | taxane diterpenoid; tetracyclic diterpenoid | antineoplastic agent; human metabolite; metabolite; microtubule-stabilising agent |
| etoposide [no description available] | 2.02 | 1 | 0 | beta-D-glucoside; furonaphthodioxole; organic heterotetracyclic compound | antineoplastic agent; DNA synthesis inhibitor |
| substance p [no description available] | 2.41 | 2 | 0 | peptide | neurokinin-1 receptor agonist; neurotransmitter; vasodilator agent |
| dobutamine Dobutamine: A catecholamine derivative with specificity for BETA-1 ADRENERGIC RECEPTORS. It is commonly used as a cardiotonic agent after CARDIAC SURGERY and during DOBUTAMINE STRESS ECHOCARDIOGRAPHY.. dobutamine : A catecholamine that is 4-(3-aminobutyl)phenol in which one of the hydrogens attached to the nitrogen is substituted by a 2-(3,4-dihydroxyphenyl)ethyl group. A beta1-adrenergic receptor agonist that has cardiac stimulant action without evoking vasoconstriction or tachycardia, it is used as the hydrochloride to increase the contractility of the heart in the management of acute heart failure. | 2.02 | 1 | 0 | catecholamine; secondary amine | beta-adrenergic agonist; cardiotonic drug; sympathomimetic agent |
| penbutolol Penbutolol: A nonselective beta-blocker used as an antihypertensive and an antianginal agent. | 2.02 | 1 | 0 | ethanolamines | |
| ribavirin Rebetron: Rebetron is tradename | 2.46 | 2 | 0 | 1-ribosyltriazole; aromatic amide; monocarboxylic acid amide; primary carboxamide | anticoronaviral agent; antiinfective agent; antimetabolite; antiviral agent; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor |
| flunixin flunixin : A pyridinemonocarboxylic acid that is nicotinic acid substituted at position 2 by a 2-methyl-3-(trifluoromethyl)phenylamino group. A relatively potent non-narcotic, nonsteroidal analgesic with anti-inflammatory, anti-endotoxic and anti-pyretic properties; used in veterinary medicine (usually as the meglumine salt) for treatment of horses, cattle and pigs. | 2.05 | 1 | 0 | aminopyridine; organofluorine compound; pyridinemonocarboxylic acid | antipyretic; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| guanadrel guanadrel: RN given refers to parent cpd; structure. guanadrel : A spiroketal resulting from the formal condensation of the keto group of cyclohexanone with the hydroxy groups of 1-(2,3-dihydroxypropyl)guanidine. A postganglionic adrenergic blocking agent formerly used (generally as the sulfate salt) for the management of hypertension, it has been largely superseded by other drugs less likely to cause orthostatic hypotension (dizzy spells on standing up or stretching). | 2.02 | 1 | 0 | guanidines; spiroketal | adrenergic antagonist; antihypertensive agent |
| methyldopa Methyldopa: An alpha-2 adrenergic agonist that has both central and peripheral nervous system effects. Its primary clinical use is as an antihypertensive agent.. alpha-methyl-L-dopa : A derivative of L-tyrosine having a methyl group at the alpha-position and an additional hydroxy group at the 3-position on the phenyl ring. | 2.02 | 1 | 0 | L-tyrosine derivative; non-proteinogenic L-alpha-amino acid | alpha-adrenergic agonist; antihypertensive agent; hapten; peripheral nervous system drug; sympatholytic agent |
| tocainide Tocainide: An antiarrhythmic agent which exerts a potential- and frequency-dependent block of SODIUM CHANNELS.. tocainide : A monocarboxylic acid amide in which 2,6-dimethylphenylaniline and isobutyric acid have combined to form the amide bond; used as a local anaesthetic. | 2.02 | 1 | 0 | monocarboxylic acid amide | anti-arrhythmia drug; local anaesthetic; sodium channel blocker |
| sq-11725 Nadolol: A non-selective beta-adrenergic antagonist with a long half-life, used in cardiovascular disease to treat arrhythmias, angina pectoris, and hypertension. Nadolol is also used for MIGRAINE DISORDERS and for tremor.. nadolol : Nadolol is a diastereoisomeric mixture consisting of equimolar amounts of the four possible 2,3-cis-isomers of 5-[3-(tert-butylamino)-2-hydroxypropoxy]-1,2,3,4-tetrahydronaphthalene-2,3-diol. | 2.02 | 1 | 0 | ||
| diltiazem Diltiazem: A benzothiazepine derivative with vasodilating action due to its antagonism of the actions of CALCIUM ion on membrane functions.. diltiazem : A 5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate in which both stereocentres have S configuration. A calcium-channel blocker and vasodilator, it is used as the hydrochloride in the management of angina pectoris and hypertension. | 2.02 | 1 | 0 | 5-[2-(dimethylamino)ethyl]-2-(4-methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl acetate | antihypertensive agent; calcium channel blocker; vasodilator agent |
| flunixin meglumine flunixin meglumine : An organoammonium salt obtained by combining flunixin with one molar equivalent of 1-deoxy-1-(methylamino)-D-glucitol. A relatively potent non-narcotic, nonsteroidal analgesic with anti-inflammatory, anti-endotoxic and anti-pyretic properties; used in veterinary medicine for treatment of horses, cattle and pigs. | 2 | 1 | 0 | organoammonium salt | antipyretic; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug |
| levobunolol Levobunolol: The L-Isomer of bunolol.. levobunolol : A cyclic ketone that is 3,4-dihydronaphthalen-1-one substituted at position 5 by a 3-(tert-butylamino)-2-hydroxypropoxy group (the S-enantiomer). A non-selective beta-adrenergic antagonist used (as its hydrochloride salt) for treatment of glaucoma. | 2.02 | 1 | 0 | aromatic ether; cyclic ketone; propanolamine | antiglaucoma drug; beta-adrenergic antagonist |
| 1-methyl-4-phenylpyridinium 1-Methyl-4-phenylpyridinium: An active neurotoxic metabolite of 1-METHYL-4-PHENYL-1,2,3,6-TETRAHYDROPYRIDINE. The compound reduces dopamine levels, inhibits the biosynthesis of catecholamines, depletes cardiac norepinephrine and inactivates tyrosine hydroxylase. These and other toxic effects lead to cessation of oxidative phosphorylation, ATP depletion, and cell death. The compound, which is related to PARAQUAT, has also been used as an herbicide.. N-methyl-4-phenylpyridinium : A pyridinium ion that is N-methylpyridinium having a phenyl substituent at the 4-position. | 2.15 | 1 | 0 | pyridinium ion | apoptosis inducer; herbicide; human xenobiotic metabolite; neurotoxin |
| vecuronium bromide Vecuronium Bromide: Monoquaternary homolog of PANCURONIUM. A non-depolarizing neuromuscular blocking agent with shorter duration of action than pancuronium. Its lack of significant cardiovascular effects and lack of dependence on good kidney function for elimination as well as its short duration of action and easy reversibility provide advantages over, or alternatives to, other established neuromuscular blocking agents.. vecuronium bromide : The organic bromide salt of a 5alpha-androstane compound having 3alpha-acetoxy-, 17beta-acetoxy-, 2beta-piperidinino- and 16beta-N-methylpiperidinium substituents. | 2.02 | 1 | 0 | organic bromide salt; quaternary ammonium salt | muscle relaxant; neuromuscular agent; nicotinic antagonist |
| ng-nitroarginine methyl ester NG-Nitroarginine Methyl Ester: A non-selective inhibitor of nitric oxide synthase. It has been used experimentally to induce hypertension. | 2.03 | 1 | 0 | alpha-amino acid ester; L-arginine derivative; methyl ester; N-nitro compound | EC 1.14.13.39 (nitric oxide synthase) inhibitor |
| permethrin hemoglobin Atlanta-Coventry: Leu replaced by Pro at beta75 and Leu deleted at beta141 | 2.02 | 1 | 0 | cyclopropanecarboxylate ester; cyclopropanes | agrochemical; ectoparasiticide; pyrethroid ester acaricide; pyrethroid ester insecticide; scabicide |
| diisopropanolnitrosamine diisopropanolnitrosamine: experimental carcinogen. N,N-bis(2-hydroxypropyl)nitrosamine : A nitrosamine that is dipropylamine in which the hydrogen attached to the nitrogen has been replaced by a nitroso group. It is a genotoxic carcinogen, targeting the lung, liver, thyroid, and kidney. | 2.42 | 2 | 0 | diol; nitrosamine; secondary alcohol | carcinogenic agent |
| desogestrel Desogestrel: A synthetic progestational hormone used often as the progestogenic component of combined oral contraceptive agents (ORAL CONTRACEPTIVES, COMBINED). | 2.04 | 1 | 0 | 17beta-hydroxy steroid; terminal acetylenic compound | contraceptive drug; progestin; synthetic oral contraceptive |
| sufentanil Sufentanil: An opioid analgesic that is used as an adjunct in anesthesia, in balanced anesthesia, and as a primary anesthetic agent.. sufentanil : An anilide resulting from the formal condensation of the aryl amino group of 4-(methoxymethyl)-N-phenyl-1-[2-(2-thienyl)ethyl]piperidin-4-amine with propanoic acid. | 2.02 | 1 | 0 | anilide; ether; piperidines; thiophenes | anaesthesia adjuvant; intravenous anaesthetic; mu-opioid receptor agonist; opioid analgesic |
| torsemide Torsemide: A pyridine and sulfonamide derivative that acts as a sodium-potassium chloride symporter inhibitor (loop diuretic). It is used for the treatment of EDEMA associated with CONGESTIVE HEART FAILURE; CHRONIC RENAL INSUFFICIENCY; and LIVER DISEASES. It is also used for the management of HYPERTENSION.. torasemide : An N-sulfonylurea obtained by formal condensation of [(3-methylphenyl)amino]pyridine-3-sulfonic acid with the free amino group of N-isopropylurea. It is a potent loop diuretic used for the treatment of hypertension and edema in patients with congestive heart failure. | 2.02 | 1 | 0 | aminopyridine; N-sulfonylurea; secondary amino compound | antihypertensive agent; loop diuretic |
| cefmetazole Cefmetazole: A semisynthetic cephamycin antibiotic with a broad spectrum of activity against both gram-positive and gram-negative microorganisms. It has a high rate of efficacy in many types of infection and to date no severe side effects have been noted.. cefmetazole : A second-generation cephalosporin antibiotic having N(1)-methyltetrazol-5-ylthiomethyl, {[(cyanomethyl)sulfanyl]acetyl}amino and methoxy side-groups at positions 3, 7beta and 7alpha respectively of the parent cephem bicyclic structure. | 2.02 | 1 | 0 | cephalosporin | antibacterial drug |
| desflurane Desflurane: A fluorinated ether that is used as a volatile anesthetic for maintenance of general anesthesia. | 2.02 | 1 | 0 | organofluorine compound | inhalation anaesthetic |
| idarubicin Idarubicin: An orally administered anthracycline antineoplastic. The compound has shown activity against BREAST NEOPLASMS; LYMPHOMA; and LEUKEMIA. | 2.02 | 1 | 0 | anthracycline antibiotic; deoxy hexoside; monosaccharide derivative | |
| cefonicid Cefonicid: A second-generation cephalosporin administered intravenously or intramuscularly. Its bactericidal action results from inhibition of cell wall synthesis. It is used for urinary tract infections, lower respiratory tract infections, and soft tissue and bone infections.. cefonicid : A cephalosporin bearing {[1-(sulfomethyl)-1H-tetrazol-5-yl]sulfanyl}methyl and (R)-2-hydroxy-2-phenylacetamido groups at positions 3 and 7, respectively, of the cephem skeleton. | 2.02 | 1 | 0 | cephalosporin | antibacterial drug |
| piperacillin Piperacillin: Semisynthetic, broad-spectrum, AMPICILLIN derived ureidopenicillin antibiotic proposed for PSEUDOMONAS infections. It is also used in combination with other antibiotics.. piperacillin : A penicillin in which the substituent at position 6 of the penam ring is a 2-[(4-ethyl-2,3-dioxopiperazin-1-yl)carboxamido]-2-phenylacetamido group. | 2.02 | 1 | 0 | penicillin allergen; penicillin | antibacterial drug |
| paroxetine Paroxetine: A serotonin uptake inhibitor that is effective in the treatment of depression.. paroxetine : A benzodioxole that consists of piperidine bearing 1,3-benzodioxol-5-yloxy)methyl and 4-fluorophenyl substituents at positions 3 and 4 respectively; the (3S,4R)-diastereomer. Highly potent and selective 5-HT uptake inhibitor that binds with high affinity to the serotonin transporter (Ki = 0.05 nM). Ki values are 1.1, 350 and 1100 nM for inhibition of [3H]-5-HT, [3H]-l-NA and [3H]-DA uptake respectively. Displays minimal affinity for alpha1-, alpha2- or beta-adrenoceptors, 5-HT2A, 5-HT1A, D2 or H1 receptors at concentrations below 1000 nM, however displays weak affinity for muscarinic ACh receptors (Ki = 42 nM). Antidepressant and anxiolytic in vivo. | 2.4 | 2 | 0 | aromatic ether; benzodioxoles; organofluorine compound; piperidines | antidepressant; anxiolytic drug; hepatotoxic agent; P450 inhibitor; serotonin uptake inhibitor |
| captopril Captopril: A potent and specific inhibitor of PEPTIDYL-DIPEPTIDASE A. It blocks the conversion of ANGIOTENSIN I to ANGIOTENSIN II, a vasoconstrictor and important regulator of arterial blood pressure. Captopril acts to suppress the RENIN-ANGIOTENSIN SYSTEM and inhibits pressure responses to exogenous angiotensin.. captopril : A L-proline derivative in which L-proline is substituted on nitrogen with a (2S)-2-methyl-3-sulfanylpropanoyl group. It is used as an anti-hypertensive ACE inhibitor drug. | 2.43 | 2 | 0 | alkanethiol; L-proline derivative; N-acylpyrrolidine; pyrrolidinemonocarboxylic acid | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor |
| cefoperazone Cefoperazone: Semisynthetic broad-spectrum cephalosporin with a tetrazolyl moiety that is resistant to beta-lactamase. It may be used to treat Pseudomonas infections.. cefoperazone : A semi-synthetic parenteral cephalosporin with a tetrazolyl moiety that confers beta-lactamase resistance. | 2.02 | 1 | 0 | cephalosporin | antibacterial drug |
| lodoxamide [no description available] | 2.02 | 1 | 0 | organonitrogen compound; organooxygen compound | |
| atracurium Atracurium: A non-depolarizing neuromuscular blocking agent with short duration of action. Its lack of significant cardiovascular effects and its lack of dependence on good kidney function for elimination provide clinical advantage over alternate non-depolarizing neuromuscular blocking agents.. atracurium : A diester compound consisting of pentane-1,5-diol with both hydroxyls bearing 3-[1-(3,4-dimethoxybenzyl)-6,7-dimethoxy-2-methyl-3,4-dihydroisoquinolinium-2(1H)-yl]propanoyl groups. | 2.02 | 1 | 0 | diester; quaternary ammonium ion | muscle relaxant; nicotinic antagonist |
| butoconazole butoconazole: RN given refers to parent cpd; structure. butoconazole : A member of the class of imidazoles that is 1H-imidazole in which the hydrogen attached to the nitrogen is substituted by a 4-(4-chlorophenyl)-2-[(2,6-dichlorophenyl)sulfanyl]butyl group. An antifungal agent, it is used as its nitrate salt in gynaecology for treatment of vulvovaginal infections caused by Candida species, particularly Candida albicans. | 2.02 | 1 | 0 | aryl sulfide; conazole antifungal drug; dichlorobenzene; imidazole antifungal drug; imidazoles; monochlorobenzenes | |
| naftifine naftifine: allylamine der; RN given refers to unlabeled parent cpd. naftifine : A tertiary amine in which the nitrogen is substituted by methyl, alpha-naphthylmethyl, and (1E)-cinnamyl groups. It is used (usually as its hydrochloride salt) for the treatment of fungal skin infections. | 2.02 | 1 | 0 | allylamine antifungal drug; naphthalenes; tertiary amine | EC 1.14.13.132 (squalene monooxygenase) inhibitor; sterol biosynthesis inhibitor |
| pergolide Pergolide: A long-acting dopamine agonist which has been used to treat PARKINSON DISEASE and HYPERPROLACTINEMIA but withdrawn from some markets due to potential for HEART VALVE DISEASES.. pergolide : A diamine that is ergoline in which the beta-hydrogen at position 8 is replaced by a (methylthio)methyl group and the hydrogen attached to the piperidine nitrogen (position 6) is replaced by a propyl group. A dopamine D2 receptor agonist which also has D1 and D2 agonist properties, it is used as the mesylate salt in the management of Parkinson's disease, although it was withdrawn from the U.S. and Canadian markets in 2007 due to an increased risk of cardiac valve dysfunction. | 2.02 | 1 | 0 | diamine; methyl sulfide; organic heterotetracyclic compound | antiparkinson drug; dopamine agonist |
| colforsin Colforsin: Potent activator of the adenylate cyclase system and the biosynthesis of cyclic AMP. From the plant COLEUS FORSKOHLII. Has antihypertensive, positive inotropic, platelet aggregation inhibitory, and smooth muscle relaxant activities; also lowers intraocular pressure and promotes release of hormones from the pituitary gland. | 2.69 | 3 | 0 | acetate ester; cyclic ketone; labdane diterpenoid; organic heterotricyclic compound; tertiary alpha-hydroxy ketone; triol | adenylate cyclase agonist; anti-HIV agent; antihypertensive agent; plant metabolite; platelet aggregation inhibitor; protein kinase A agonist |
| cefadroxil anhydrous Cefadroxil: Long-acting, broad-spectrum, water-soluble, CEPHALEXIN derivative.. cefadroxil : A cephalosporin bearing methyl and (2R)-2-amino-2-(4-hydroxyphenyl)acetamido groups at positions 3 and 7, respectively, of the cephem skeleton. | 2.02 | 1 | 0 | cephalosporin | antibacterial drug |
| encainide Encainide: One of the ANTI-ARRHYTHMIA AGENTS, it blocks VOLTAGE-GATED SODIUM CHANNELS and slows conduction within the His-Purkinje system and MYOCARDIUM.. encainide : 4-Methoxy-N-phenylbenzamide in which the hydrogen at the 2 position of the phenyl group is substituted by a 2-(1-methylpiperidin-2-yl)ethyl group. A class Ic antiarrhythmic, the hydrochloride was used for the treatment of severe or life-threatening ventricular arrhythmias, but it was associated with increased death rates in patients who had asymptomatic heart rhythm abnormalities after a recent heart attack and was withdrawn from the market. | 2.02 | 1 | 0 | benzamides; piperidines | anti-arrhythmia drug; sodium channel blocker |
| buserelin Buserelin: A potent synthetic analog of GONADOTROPIN-RELEASING HORMONE with D-serine substitution at residue 6, glycine10 deletion, and other modifications. | 6.13 | 8 | 4 | oligopeptide | |
| nedocromil Nedocromil: A pyranoquinolone derivative that inhibits activation of inflammatory cells which are associated with ASTHMA, including EOSINOPHILS; NEUTROPHILS; MACROPHAGES; MAST CELLS; MONOCYTES; AND PLATELETS. | 2.02 | 1 | 0 | dicarboxylic acid; organic heterotricyclic compound | anti-allergic agent; anti-asthmatic drug; non-steroidal anti-inflammatory drug |
| cefaclor anhydrous Cefaclor: Semisynthetic, broad-spectrum antibiotic derivative of CEPHALEXIN.. cefaclor : A cephalosporin bearing chloro and (R)-2-amino-2-phenylacetamido groups at positions 3 and 7, respectively, of the cephem skeleton. | 2.02 | 1 | 0 | cephalosporin | antibacterial drug; drug allergen |
| alfentanil Alfentanil: A short-acting opioid anesthetic and analgesic derivative of FENTANYL. It produces an early peak analgesic effect and fast recovery of consciousness. Alfentanil is effective as an anesthetic during surgery, for supplementation of analgesia during surgical procedures, and as an analgesic for critically ill patients.. alfentanil : A member of the class of piperidines that is piperidine having a 2-(4-ethyl-5-oxo-4,5-dihydro-1H-tetrazol-1-yl)ethyl group at the 1-position as well as N-phenylpropanamido- and methoxymethyl groups at the 4-position. | 2.02 | 1 | 0 | monocarboxylic acid amide; piperidines | central nervous system depressant; intravenous anaesthetic; mu-opioid receptor agonist; opioid analgesic; peripheral nervous system drug |
| cefotetan Cefotetan: A semisynthetic cephamycin antibiotic that is administered intravenously or intramuscularly. The drug is highly resistant to a broad spectrum of beta-lactamases and is active against a wide range of both aerobic and anaerobic gram-positive and gram-negative microorganisms.. cefotetan : A semi-synthetic second-generation cephamycin antibiotic with [(1-methyl-1H-tetrazol-5-yl)sulfanyl]methyl, methoxy and {[4-(2-amino-1-carboxy-2-oxoethylidene)-1,3-dithietan-2-yl]carbonyl}amino groups at the 3, 7alpha, and 7beta positions, respectively, of the cephem skeleton. It is resistant to a wide range of beta-lactamases and is active against a broad spectrum of aerobic and anaerobic Gram-positive and Gram-negative microorganisms. | 2.02 | 1 | 0 | ||
| lovastatin Lovastatin: A fungal metabolite isolated from cultures of Aspergillus terreus. The compound is a potent anticholesteremic agent. It inhibits 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It also stimulates the production of low-density lipoprotein receptors in the liver.. lovastatin : A fatty acid ester that is mevastatin carrying an additional methyl group on the carbobicyclic skeleton. It is used in as an anticholesteremic drug and has been found in fungal species such as Aspergillus terreus and Pleurotus ostreatus (oyster mushroom). | 2.02 | 1 | 0 | delta-lactone; fatty acid ester; hexahydronaphthalenes; polyketide; statin (naturally occurring) | anticholesteremic drug; antineoplastic agent; Aspergillus metabolite; prodrug |
| levocabastine levocabastine: for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis | 2.02 | 1 | 0 | piperidines | |
| simvastatin Simvastatin: A derivative of LOVASTATIN and potent competitive inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES), which is the rate-limiting enzyme in cholesterol biosynthesis. It may also interfere with steroid hormone production. Due to the induction of hepatic LDL RECEPTORS, it increases breakdown of LDL CHOLESTEROL.. simvastatin : A member of the class of hexahydronaphthalenes that is lovastatin in which the 2-methylbutyrate ester moiety has been replaced by a 2,2-dimethylbutyrate ester group. It is used as a cholesterol-lowering and anti-cardiovascular disease drug. | 2.02 | 1 | 0 | delta-lactone; fatty acid ester; hexahydronaphthalenes; statin (semi-synthetic) | EC 1.1.1.34/EC 1.1.1.88 (hydroxymethylglutaryl-CoA reductase) inhibitor; EC 3.4.24.83 (anthrax lethal factor endopeptidase) inhibitor; ferroptosis inducer; geroprotector; prodrug |
| quinpirole Quinpirole: A dopamine D2/D3 receptor agonist.. quinpirole : A pyrazoloquinoline that is (4aR,8aR)-4,4a,5,6,7,8,8a,9-octahydro-1H-pyrazolo[3,4-g]quinoline substituted by a propyl group at position 5. It acts as a dopamine agonist. | 2.44 | 2 | 0 | pyrazoloquinoline | dopamine agonist |
| pravastatin Pravastatin: An antilipemic fungal metabolite isolated from cultures of Nocardia autotrophica. It acts as a competitive inhibitor of HMG CoA reductase (HYDROXYMETHYLGLUTARYL COA REDUCTASES).. pravastatin : A carboxylic ester resulting from the formal condensation of (S)-2-methylbutyric acid with the hydroxy group adjacent to the ring junction of (3R,5R)-7-[(1S,2S,6S,8S,8aR)-6,8-dihydroxy-2-methyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic acid. Derived from microbial transformation of mevastatin, pravastatin is a reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA). The sodium salt is used for lowering cholesterol and preventing cardiovascular disease. It is one of the lower potency statins, but has the advantage of fewer side effects compared with lovastatin and simvastatin. | 2.02 | 1 | 0 | 3-hydroxy carboxylic acid; carbobicyclic compound; carboxylic ester; hydroxy monocarboxylic acid; secondary alcohol; statin (semi-synthetic) | anticholesteremic drug; environmental contaminant; metabolite; xenobiotic |
| cabergoline Cabergoline: An ergoline derivative and dopamine D2-agonist that inhibits PROLACTIN secretion. It is used in the management of HYPERPROLACTINEMIA, and to suppress lactation following childbirth for medical reasons. Cabergoline is also used in the management of PARKINSON DISEASE.. cabergoline : An N-acylurea that is (8R)-ergoline-8-carboxamide in which the hydrogen attached to the piperidine nitrogen (position 6) is substituted by an allyl group and the hydrogens attached to the carboxamide nitrogen are substituted by a 3-(dimethylamino)propyl group and an N-ethylcarbamoyl group. A dopamine D2 receptor agonist, cabergoline is used in the management of Parkinson's disease and of disorders associated with hyperprolactinaemia. | 2.46 | 2 | 0 | N-acylurea | antineoplastic agent; antiparkinson drug; dopamine agonist |
| quinapril Quinapril: A tetrahydroisoquinoline derivative and ANGIOTENSIN CONVERTING ENZYME inhibitor that is used in the treatment of HYPERTENSION and HEART FAILURE.. quinapril : A member of the class of isoquinolines that is (3S)-2-L-alanyl-1,2,3,4-tetrahydroisoquinoline-3-carboxylic acid in which the alpha-amino group of the alanyl residue has been substituted by a 1-ethoxycarbonyl-4-phenylbutan-2-yl group (the all-S isomer). A prodrug for quinaprilat (by hydrolysis of the ethyl ester to the corresponding carboxylic acid), it is used as an angiotensin-converting enzyme inhibitor (ACE inhibitor) used (generally as the hydrochloride salt) for the treatment of hypertension and congestive heart failure. | 2.02 | 1 | 0 | dicarboxylic acid monoester; ethyl ester; isoquinolines; tertiary carboxamide | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; prodrug |
| raloxifene hydrochloride Raloxifene Hydrochloride: A second generation selective estrogen receptor modulator (SERM) used to prevent osteoporosis in postmenopausal women. It has estrogen agonist effects on bone and cholesterol metabolism but behaves as a complete estrogen antagonist on mammary gland and uterine tissue.. raloxifene hydrochloride : A hydrochloride salt resulting from the reaction of equimolar amounts of raloxifene and hydrogen chloride. | 3.55 | 8 | 0 | hydrochloride | bone density conservation agent; estrogen antagonist; estrogen receptor modulator |
| mifepristone Mifepristone: A progestational and glucocorticoid hormone antagonist. Its inhibition of progesterone induces bleeding during the luteal phase and in early pregnancy by releasing endogenous prostaglandins from the endometrium or decidua. As a glucocorticoid receptor antagonist, the drug has been used to treat hypercortisolism in patients with nonpituitary CUSHING SYNDROME. | 3.86 | 11 | 0 | 3-oxo-Delta(4) steroid; acetylenic compound; tertiary amino compound | abortifacient; contraceptive drug; hormone antagonist; synthetic oral contraceptive |
| ractopamine ractopamine: veterinary growth stimulant. ractopamine : A diastereoisomeric mixture of approximately equal amounts of all four possible diastereoisomers of 4-(1-hydroxy-2-{[4-(4-hydroxyphenyl)butan-2-yl]amino}ethyl)phenol. A beta-adrenergic agonist, it is used (generally as the hydrochloride salt) as a feed additive for use in pigs and other livestock to promote protein deposition, resulting in leaner meat. The R,R diastereoisomer, butopamine, is responsible for most of the leanness-enhancing effects. While use of ractopamine has been banned in over 120 countries including throughout the EU, in the US it used in an estimated 80% of all beef, pork and turkey production.. 4-(1-hydroxy-2-{[4-(4-hydroxyphenyl)butan-2-yl]amino}ethyl)phenol : A secondary amino compound that is 4-(2-amino-1-hydroxyethyl)phenol in which one of the hydrogens attached to the nitrogen is replaced by a 4-(p-hydroxyphenyl)butan-2-yl group. | 2.5 | 2 | 0 | benzyl alcohols; polyphenol; secondary alcohol; secondary amino compound | |
| fosphenytoin fosphenytoin: structure given in first & second source | 2.02 | 1 | 0 | imidazolidine-2,4-dione | |
| finasteride Finasteride: An orally active 3-OXO-5-ALPHA-STEROID 4-DEHYDROGENASE inhibitor. It is used as a surgical alternative for treatment of benign PROSTATIC HYPERPLASIA.. finasteride : An aza-steroid that is a synthetic drug for the treatment of benign prostatic hyperplasia. | 2.41 | 2 | 0 | 3-oxo steroid; aza-steroid; delta-lactam | androgen antagonist; antihyperplasia drug; EC 1.3.1.22 [3-oxo-5alpha-steroid 4-dehydrogenase (NADP(+))] inhibitor |
| esmolol methyl 3-{4-[2-hydroxy-3-(propan-2-ylamino)propoxy]phenyl}propanoate : A methyl ester that is methyl 3-(4-hydroxyphenyl)propanoate in which the hydrogen attached to the phenolic hydroxy group is substituted by a 2-hydroxy-3-(isopropylamino)propyl group.. esmolol : A racemate comprising equimolar amounts of (R)- and (S)-esmolol. A cardioselective and short-acting beta1 receptor blocker with rapid onset but lacking intrinsic sympathomimetic and membrane-stabilising properties, it is used as the hydrochloride salt in the management of supraventricular arrhythmias, and for the control of hypertension and tachycardia during surgery. While the S enantiomer possesses all of the heart rate control, both enantiomers contribute to lowering blood pressure. | 2.02 | 1 | 0 | aromatic ether; ethanolamines; methyl ester; secondary alcohol; secondary amino compound | |
| adapalene Adapalene: A naphthalene derivative that has specificity for RETINOIC ACID RECEPTORS. It is used as a DERMATOLOGIC AGENT for the treatment of ACNE.. adapalene : A naphthoic acid that is CD437 in which the phenolic hydroxy group has been converted to its methyl ether. | 2.02 | 1 | 0 | adamantanes; monocarboxylic acid; naphthoic acid | dermatologic drug; EC 2.7.11.22 (cyclin-dependent kinase) inhibitor; non-steroidal anti-inflammatory drug |
| sparfloxacin [no description available] | 2.02 | 1 | 0 | fluoroquinolone antibiotic; N-arylpiperazine; quinolinemonocarboxylic acid; quinolone antibiotic; quinolone | |
| zileuton [no description available] | 2.02 | 1 | 0 | 1-benzothiophenes; ureas | anti-asthmatic drug; EC 1.13.11.34 (arachidonate 5-lipoxygenase) inhibitor; ferroptosis inhibitor; leukotriene antagonist; non-steroidal anti-inflammatory drug |
| cidofovir anhydrous Cidofovir: An acyclic nucleoside phosphonate that acts as a competitive inhibitor of viral DNA polymerases. It is used in the treatment of RETINITIS caused by CYTOMEGALOVIRUS INFECTIONS and may also be useful for treating HERPESVIRUS INFECTIONS.. cidofovir anhydrous : Cytosine substituted at the 1 position by a 3-hydroxy-2-(phosphonomethoxy)propyl group (S configuration). A nucleoside analogue, it is an injectable antiviral used for the treatment of cytomegalovirus (CMV) retinitis in AIDS patients. | 2.02 | 1 | 0 | phosphonic acids; pyrimidone | anti-HIV agent; antineoplastic agent; antiviral drug; photosensitizing agent |
| topotecan Topotecan: An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.. topotecan : A pyranoindolizinoquinoline used as an antineoplastic agent. It is a derivative of camptothecin and works by binding to the topoisomerase I-DNA complex and preventing religation of these 328 single strand breaks. | 2.02 | 1 | 0 | pyranoindolizinoquinoline | antineoplastic agent; EC 5.99.1.2 (DNA topoisomerase) inhibitor |
| gemcitabine gemcitabine : A 2'-deoxycytidine having geminal fluoro substituents in the 2'-position. An inhibitor of ribonucleotide reductase, gemcitabine is used in the treatment of various carcinomas, particularly non-small cell lung cancer, pancreatic cancer, bladder cancer and breast cancer. | 2.02 | 1 | 0 | organofluorine compound; pyrimidine 2'-deoxyribonucleoside | antimetabolite; antineoplastic agent; antiviral drug; DNA synthesis inhibitor; EC 1.17.4.1 (ribonucleoside-diphosphate reductase) inhibitor; environmental contaminant; immunosuppressive agent; photosensitizing agent; prodrug; radiosensitizing agent; xenobiotic |
| ibutilide ibutilide: RN & structure in first source; RN refers to the fumarate salt | 2.02 | 1 | 0 | benzenes; organic amino compound | |
| remifentanil Remifentanil: A piperidine-propionate derivative and opioid analgesic structurally related to FENTANYL. It functions as a short-acting MU OPIOID RECEPTOR agonist, and is used as an analgesic during induction or maintenance of general anesthesia, following surgery, during childbirth, and in mechanically ventilated patients under intensive care.. remifentanil : A piperidinecarboxylate ester that is methyl piperidine-4-carboxylate in which the hydrogen attached to the nitrogen is substituted by a 3-methoxy-3-oxopropyl group and the hydrogen at position 4 is substituted the nitrogen of N-propanoylaniline. | 2.02 | 1 | 0 | alpha-amino acid ester; anilide; monocarboxylic acid amide; piperidinecarboxylate ester | intravenous anaesthetic; mu-opioid receptor agonist; opioid analgesic; sedative |
| atorvastatin [no description available] | 2.02 | 1 | 0 | aromatic amide; dihydroxy monocarboxylic acid; monofluorobenzenes; pyrroles; statin (synthetic) | environmental contaminant; xenobiotic |
| lamivudine [no description available] | 2.02 | 1 | 0 | monothioacetal; nucleoside analogue; oxacycle; primary alcohol | allergen; anti-HBV agent; antiviral drug; EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor; HIV-1 reverse transcriptase inhibitor; prodrug |
| irinotecan [no description available] | 2.02 | 1 | 0 | carbamate ester; delta-lactone; N-acylpiperidine; pyranoindolizinoquinoline; ring assembly; tertiary alcohol; tertiary amino compound | antineoplastic agent; apoptosis inducer; EC 5.99.1.2 (DNA topoisomerase) inhibitor; prodrug |
| valsartan Valsartan: A tetrazole derivative and ANGIOTENSIN II TYPE 1 RECEPTOR BLOCKER that is used to treat HYPERTENSION.. valsartan : A monocarboxylic acid amide consisting of L-valine in which the amino hydrogens have been replaced by a pentanoyl and a [2'-(1H-tetrazol-5-yl)biphenyl]-4-yl]methyl group. It exhibits antihypertensive activity. | 2.02 | 1 | 0 | biphenylyltetrazole; monocarboxylic acid amide; monocarboxylic acid | angiotensin receptor antagonist; antihypertensive agent; environmental contaminant; xenobiotic |
| adenosine quinquefolan B: isolated from roots of Panax quinquefolium L.; RN not in Chemline 10/87; RN from Toxlit | 2.02 | 1 | 0 | adenosines; purines D-ribonucleoside | analgesic; anti-arrhythmia drug; fundamental metabolite; human metabolite; vasodilator agent |
| cefprozil [no description available] | 2.02 | 1 | 0 | cephalosporin; semisynthetic derivative | antibacterial drug |
| methylprednisolone aceponate methylprednisolone aceponate: RN given for (6alpha,11beta)-isomer | 2.02 | 1 | 0 | corticosteroid hormone | |
| dexamethasone 17-valerate dexamethasone 17-valerate: RN given refers to (11beta,16alpha)-isomer; structure | 2.02 | 1 | 0 | 21-hydroxy steroid | |
| dexamethasone dipropionate [no description available] | 2.02 | 1 | 0 | corticosteroid hormone | |
| 4-[1-[4-[2-(dimethylamino)ethoxy]phenyl]-2-phenylbut-1-enyl]phenol [no description available] | 2.37 | 2 | 0 | stilbenoid | |
| aica ribonucleotide AICA ribonucleotide: purine precursor that has antineoplastic activity. AICA ribonucleotide : A 1-(phosphoribosyl)imidazolecarboxamide that is acadesine in which the hydroxy group at the 5' position has been converted to its monophosphate derivative. | 2.11 | 1 | 0 | 1-(phosphoribosyl)imidazolecarboxamide; aminoimidazole | cardiovascular drug; Escherichia coli metabolite; human metabolite; mouse metabolite; plant metabolite; Saccharomyces cerevisiae metabolite |
| iopamidol Iopamidol: A non-ionic, water-soluble contrast agent which is used in myelography, arthrography, nephroangiography, arteriography, and other radiological procedures.. iopamidol : A benzenedicarboxamide compound having N-substituted carbamoyl groups at the 1- and 3-positions, iodo substituents at the 2-, 4- and 6-positions and a (2S)-2-hydroxypropanamido group at the 5-position. | 2.02 | 1 | 0 | benzenedicarboxamide; organoiodine compound; pentol | environmental contaminant; radioopaque medium; xenobiotic |
| 16-hydroxytestosterone 16-hydroxytestosterone: RN given refers to (16alpha,17beta)-isomer. 16alpha-hydroxytestosterone : A C19-steroid that is testosterone in which the hydrogen at the 16alpha position has been replaced by a hydroxy group. | 2.04 | 1 | 0 | 16alpha-hydroxy steroid; 17beta-hydroxy steroid; 3-oxo-Delta(4) steroid; androstanoid; C19-steroid; diol; secondary alcohol | androgen |
| dexfenfluramine Dexfenfluramine: The S-isomer of FENFLURAMINE. It is a serotonin agonist and is used as an anorectic. Unlike fenfluramine, it does not possess any catecholamine agonist activity.. (S)-fenfluramine : The S-enantiomer of fenfluramine. It stimulates the release of serotonin and selectively inhibits its reuptake, but unlike fenfluramine it does not possess catecholamine agonist activity. It was formerly given by mouth as the hydrochloride in the treatment of obesity, but, like fenfluramine, was withdrawn wolrdwide following reports of valvular heart defects. | 2.02 | 1 | 0 | fenfluramine | appetite depressant; serotonergic agonist; serotonin uptake inhibitor |
| trenbolone acetate Trenbolone Acetate: An anabolic steroid used mainly as an anabolic agent in veterinary practice. | 7.43 | 22 | 6 | steroid ester | |
| 2-methoxyestradiol 2-methoxy-17beta-estradiol : A 17beta-hydroxy steroid, being 17beta-estradiol methoxylated at C-2. | 2.04 | 1 | 0 | 17beta-hydroxy steroid; 3-hydroxy steroid | angiogenesis modulating agent; antimitotic; antineoplastic agent; human metabolite; metabolite; mouse metabolite |
| triazoles Triazoles: Heterocyclic compounds containing a five-membered ring with two carbon atoms and three nitrogen atoms with the molecular formula C2H3N3.. triazoles : An azole in which the five-membered heterocyclic aromatic skeleton contains three N atoms and two C atoms. | 3.11 | 5 | 0 | 1,2,3-triazole | |
| 2-iodoestradiol 2-iodoestradiol: RN given refers to unlabeled cpd | 2.04 | 1 | 0 | ||
| methyl 2-tetradecylglycidate methyl 2-tetradecylglycidate: structure | 2.02 | 1 | 0 | ||
| sertraline Sertraline: A selective serotonin uptake inhibitor that is used in the treatment of depression.. sertraline : A member of the class of tetralins that is tetralin which is substituted at positions 1 and 4 by a methylamino and a 3,4-dichlorophenyl group, respectively (the S,S diastereoisomer). A selective serotonin-reuptake inhibitor (SSRI), it is administered orally as the hydrochloride salt as an antidepressant for the treatment of depression, obsessive-compulsive disorder, panic disorder and post-traumatic stress disorder. | 2.02 | 1 | 0 | dichlorobenzene; secondary amino compound; tetralins | antidepressant; serotonin uptake inhibitor |
| erythromycin propionate erythromycin propionate: form in which erythromycin estolate is principally absorbed | 2.02 | 1 | 0 | erythromycin derivative | |
| dexrazoxane Dexrazoxane: The (+)-enantiomorph of razoxane. | 2.02 | 1 | 0 | razoxane | antineoplastic agent; cardiovascular drug; chelator; immunosuppressive agent |
| antebate betamethasone butyrate propionate: a topical corticosteroid | 2.02 | 1 | 0 | corticosteroid hormone | |
| xanthomicrol xanthomicrol: structure in first source. xanthomicrol : A trimethoxyflavone that is flavone substituted by methoxy groups at positions 6, 7 and 8 and hydroxy groups at positions 5 and 4'. | 2.03 | 1 | 0 | dihydroxyflavone; trimethoxyflavone | antineoplastic agent; plant metabolite |
| atovaquone Atovaquone: A hydroxynaphthoquinone that has antimicrobial activity and is being used in antimalarial protocols.. atovaquone : A naphthoquinone compound having a 4-(4-chlorophenyl)cyclohexyl group at the 2-position and a hydroxy substituent at the 3-position. | 2.47 | 2 | 0 | hydroxy-1,2-naphthoquinone | |
| flunisolide flunisolide: flunisolide HFA is a formulation of flunisolide using hydrofluoroalkane (HFA) as propellant in place of chlorofluorocarbon (CFC) ones | 2.02 | 1 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; cyclic ketal; fluorinated steroid; primary alpha-hydroxy ketone | anti-asthmatic drug; anti-inflammatory drug; immunosuppressive agent |
| clarithromycin Clarithromycin: A semisynthetic macrolide antibiotic derived from ERYTHROMYCIN that is active against a variety of microorganisms. It can inhibit PROTEIN SYNTHESIS in BACTERIA by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation.. clarithromycin : The 6-O-methyl ether of erythromycin A, clarithromycin is a macrolide antibiotic used in the treatment of respiratory-tract, skin and soft-tissue infections. It is also used to eradicate Helicobacter pylori in the treatment of peptic ulcer disease. It prevents bacteria from growing by interfering with their protein synthesis. | 2.02 | 1 | 0 | macrolide antibiotic | antibacterial drug; environmental contaminant; protein synthesis inhibitor; xenobiotic |
| trimethylsilyl iodide trimethylsilyl iodide: structure in first source | 2.03 | 1 | 0 | ||
| nicotine (S)-nicotine : A 3-(1-methylpyrrolidin-2-yl)pyridine in which the chiral centre has S-configuration. The naturally occurring and most active enantiomer of nicotine, isolated from Nicotiana tabacum. | 2.44 | 2 | 0 | 3-(1-methylpyrrolidin-2-yl)pyridine | anxiolytic drug; biomarker; immunomodulator; mitogen; neurotoxin; nicotinic acetylcholine receptor agonist; peripheral nervous system drug; phytogenic insecticide; plant metabolite; psychotropic drug; teratogenic agent; xenobiotic |
| moexipril [no description available] | 2.02 | 1 | 0 | peptide | |
| 17-alpha-hydroxypregnenolone 17-alpha-Hydroxypregnenolone: A 21-carbon steroid that is converted from PREGNENOLONE by STEROID 17-ALPHA-HYDROXYLASE. It is an intermediate in the delta-5 pathway of biosynthesis of GONADAL STEROID HORMONES and the adrenal CORTICOSTEROIDS.. 17alpha-hydroxypregnenolone : A hydroxypregnenolone carrying an alpha-hydroxy group at position 17. | 2.04 | 1 | 0 | 17alpha-hydroxy-C21-steroid; 17alpha-hydroxy steroid; 3beta-hydroxy-Delta(5)-steroid; hydroxypregnenolone; tertiary alpha-hydroxy ketone | human metabolite; mouse metabolite |
| equol Equol: A non-steroidal ESTROGEN generated when soybean products are metabolized by certain bacteria in the intestines. | 2.03 | 1 | 0 | hydroxyisoflavans | |
| hydroxyflutamide [no description available] | 2.03 | 1 | 0 | ||
| 19-norandrostenedione 19-norandrostenedione: structure | 2.04 | 1 | 0 | 3-oxo steroid | |
| indole-3-lactic acid indole-3-lactic acid: RN given refers to cpd without isomeric designation. 3-(indol-3-yl)lactic acid : A hydroxy monocarboxylic acid that is lactic acid substituted by a 1H-indol-3-yl group at position 3. It is a metabolite of tryptophan. | 2.01 | 1 | 0 | hydroxy monocarboxylic acid; indol-3-yl carboxylic acid | human metabolite |
| bolasterone bolasterone: 7alpha, 17alpha-dimethyl-testosterone; anabolic (Merck Index, 13th ed) | 2.04 | 1 | 0 | 3-hydroxy steroid | androgen |
| 2,3-bis(4-hydroxyphenyl)-propionitrile 2,3-bis(4-hydroxyphenyl)-propionitrile: a selective estrogen receptor beta agonist or modulator. also called DPN compound. 2,3-bis(4-hydroxyphenyl)propionitrile : A nitrile that is acetonitrile in which one of the hydrogens is replaced by a 4-hydroxyphenyl group while a second hydrogen is replaced by a 4-hydroxybenzyl group. It is a specific agonist for estrogen receptor beta (ERbeta). | 5.29 | 19 | 0 | nitrile; phenols | estrogen receptor agonist |
| fulvestrant Fulvestrant: An estradiol derivative and estrogen receptor antagonist that is used for the treatment of estrogen receptor-positive, locally advanced or metastatic breast cancer.. fulvestrant : A 3-hydroxy steroid that is 17beta-estradiol in which the 7alpha hydrogen has been replaced by a nonyl group in which one of the hydrogens of the terminal methyl has been replaced by a (4,4,5,5,5-pentafluoropentyl)sulfinyl group. An estrogen receptor antagonist, it is used in the treatment of breast cancer. | 3.74 | 10 | 0 | 17beta-hydroxy steroid; 3-hydroxy steroid; organofluorine compound; sulfoxide | antineoplastic agent; estrogen antagonist; estrogen receptor antagonist |
| sr141716 [no description available] | 2.02 | 1 | 0 | amidopiperidine; carbohydrazide; dichlorobenzene; monochlorobenzenes; pyrazoles | anti-obesity agent; appetite depressant; CB1 receptor antagonist |
| pregnenolone sulfate pregnenolone sulfate: RN given refers to (3 beta)-isomer | 2 | 1 | 0 | steroid sulfate | EC 2.7.1.33 (pantothenate kinase) inhibitor; human metabolite |
| gr 127935 GR 127935: a 5-HT 1D receptor antagonist. GR 127935 : A member of the class of benzamides obtained by formal condensation of the carboxy group of 2'-methyl-4'-(5-methyl-1,2,4-oxadiazol-3-yl)biphenyl-4-carboxylic acid and the anilino group of 4-methoxy-3-(4-methylpiperazin-1-yl)aniline. Potent and selective 5-HT1B/1D receptor antagonist (pKi values are 8.5 for both guinea pig 5-HT1D and rat 5-HT1B receptors). Displays > 100-fold selectivity over 5HT1A, 5-HT2A, 5-HT2C receptors and other receptor types. Centrally active following oral administration. | 2.05 | 1 | 0 | 1,2,4-oxadiazole; benzamides; N-alkylpiperazine; N-arylpiperazine | |
| sr 95531 [no description available] | 2.47 | 2 | 0 | methoxybenzenes | |
| n(g)-iminoethylornithine [no description available] | 2 | 1 | 0 | L-alpha-amino acid | |
| 6-chloro-2-(1-piperazinyl)pyrazine [no description available] | 2.02 | 1 | 0 | N-arylpiperazine | |
| deoxyglucose Deoxyglucose: 2-Deoxy-D-arabino-hexose. An antimetabolite of glucose with antiviral activity.. deoxyglucose : A deoxyhexose comprising glucose having at least one hydroxy group replaced by hydrogen. | 2.7 | 3 | 0 | ||
| tadalafil [no description available] | 3.59 | 1 | 1 | benzodioxoles; pyrazinopyridoindole | EC 3.1.4.35 (3',5'-cyclic-GMP phosphodiesterase) inhibitor; vasodilator agent |
| way 100135 WAY 100135: a selective antagonist at presynaptic & postsynaptic 5-HT(1A) receptors; structure given in first source | 2.42 | 2 | 0 | piperazines | |
| hrp 102 estradiol, norethindrone drug combination: combination of estradiol & norethindrone acetate; | 2.52 | 2 | 0 | ||
| matairesinol matairesinol: lignan that is a central precursor in plants in the biosynthesis of numerous lignans (coordinate with specific); RN refers to (3R-trans)-isomer. (-)-matairesinol : A lignan that is gamma-butyrolactone in which the 3 and 4 positions are substituted by 4-hydroxy-3-methoxybenzyl groups (the 3R,4R-diastereomer). | 2.04 | 1 | 0 | gamma-lactone; lignan; polyphenol | angiogenesis inhibitor; anti-asthmatic agent; phytoestrogen; plant metabolite |
| rti 121 RTI 121: structure given in first source; selectively binds to dopamine transporters | 2.02 | 1 | 0 | ||
| cp 93129 3-(1,2,5,6-tetrahydropyrid-4-yl)pyrrolo(3,2-b)pyrid-5-one: serotonin agonist; structure given in first source | 2.05 | 1 | 0 | pyrrolopyridine | |
| methotrexate [no description available] | 2.02 | 1 | 0 | dicarboxylic acid; monocarboxylic acid amide; pteridines | abortifacient; antimetabolite; antineoplastic agent; antirheumatic drug; dermatologic drug; DNA synthesis inhibitor; EC 1.5.1.3 (dihydrofolate reductase) inhibitor; immunosuppressive agent |
| n,n-di-n-hexyl-2-(4-fluorophenyl)indole-3-acetamide N,N-di-n-hexyl-2-(4-fluorophenyl)indole-3-acetamide: binds with high affinity to glial mitochondrial diazepam binding inhibitor receptors & increases mitochondrial steroidogenesis | 2.42 | 2 | 0 | phenylindole | |
| bibn 99 BIBN 99: structure given in first source; a highly selective M2 antagonist | 2 | 1 | 0 | ||
| 4-androstene-3,17-diol 4-androstene-3,17-diol: RN given refers to (3alpha,17beta)-isomer | 2.04 | 1 | 0 | 3-hydroxy steroid | androgen |
| m 8218 M 8218: structure given in first source | 2.21 | 1 | 0 | ||
| docetaxel [no description available] | 2.02 | 1 | 0 | hydrate; secondary alpha-hydroxy ketone | antineoplastic agent |
| levofloxacin Levofloxacin: The L-isomer of Ofloxacin.. levofloxacin : An optically active form of ofloxacin having (S)-configuration; an inhibitor of bacterial topoisomerase IV and DNA gyrase. | 2.02 | 1 | 0 | 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid; fluoroquinolone antibiotic; quinolone antibiotic | antibacterial drug; DNA synthesis inhibitor; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor; topoisomerase IV inhibitor |
| testosterone decanoate testosterone decanoate: ester of testosterone | 2.05 | 1 | 0 | steroid ester | |
| naproxen Naproxen: An anti-inflammatory agent with analgesic and antipyretic properties. Both the acid and its sodium salt are used in the treatment of rheumatoid arthritis and other rheumatic or musculoskeletal disorders, dysmenorrhea, and acute gout.. naproxen : A methoxynaphthalene that is 2-methoxynaphthalene substituted by a carboxy ethyl group at position 6. Naproxen is a non-steroidal anti-inflammatory drug commonly used for the reduction of pain, fever, inflammation and stiffness caused by conditions such as osteoarthritis, kidney stones, rheumatoid arthritis, psoriatic arthritis, gout, ankylosing spondylitis, menstrual cramps, tendinitis, bursitis, and for the treatment of primary dysmenorrhea. It works by inhibiting both the COX-1 and COX-2 enzymes. | 2.02 | 1 | 0 | methoxynaphthalene; monocarboxylic acid | antipyretic; cyclooxygenase 1 inhibitor; cyclooxygenase 2 inhibitor; drug allergen; environmental contaminant; gout suppressant; non-narcotic analgesic; non-steroidal anti-inflammatory drug; xenobiotic |
| ketanserinol ketanserinol: major ketanserin metabolite; structure given in first source | 2.02 | 1 | 0 | ||
| trendione trendione: structure given in first source | 2.15 | 1 | 0 | ||
| 17 alpha-hydroxyprogesterone caproate 17 alpha-Hydroxyprogesterone Caproate: Hydroxyprogesterone derivative that acts as a PROGESTIN and is used to reduce the risk of recurrent MISCARRIAGE and of PREMATURE BIRTH. It is also used in combination with ESTROGEN in the management of MENSTRUATION DISORDERS. | 3.37 | 1 | 1 | corticosteroid hormone | |
| revalor Revalor: trenbolone acetate & estradiol | 2.43 | 2 | 0 | ||
| angiotensin ii Giapreza: injectable form of angiotensin II used to increase blood pressure in adult patients with septic or other distributive shock. Ile(5)-angiotensin II : An angiotensin II that acts on the central nervous system (PDB entry: 1N9V). | 2.41 | 2 | 0 | amino acid zwitterion; angiotensin II | human metabolite |
| atropine tropan-3alpha-yl 3-hydroxy-2-phenylpropanoate : A tropane alkaloid that is (1R,5)-8-methyl-8-azabicyclo[3.2.1]octane substituted by a (3-hydroxy-2-phenylpropanoyl)oxy group at position 3. | 2.13 | 1 | 0 | ||
| ropivacaine Ropivacaine: An anilide used as a long-acting local anesthetic. It has a differential blocking effect on sensory and motor neurons.. ropivacaine : The piperidinecarboxamide obtained by the formal condensation of N-propylpipecolic acid and 2,6-dimethylaniline.. (S)-ropivacaine : A piperidinecarboxamide-based amide-type local anaesthetic (amide caine) in which (S)-N-propylpipecolic acid and 2,6-dimethylaniline are combined to form the amide bond. | 2.02 | 1 | 0 | piperidinecarboxamide; ropivacaine | local anaesthetic |
| 3,4-divanillyltetrahydrofuran 3,4-divanillyltetrahydrofuran: lignan with the highest binding affinity; structure in first source | 2.04 | 1 | 0 | ||
| fertirelin fertirelin: analog of luteinizing hormone releasing factor; more potent than LHFSHRH; RN given is for releasing factor from pig; RN given refers to parent cpd | 2.47 | 2 | 0 | oligopeptide | |
| cortisone [no description available] | 2.37 | 2 | 0 | 11-oxo steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(4) steroid; C21-steroid; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | human metabolite; mouse metabolite |
| equilin Equilin: An estrogenic steroid produced by HORSES. It has a total of four double bonds in the A- and B-ring. High concentration of euilin is found in the URINE of pregnant mares. | 2.04 | 1 | 0 | 17-oxo steroid; 3-hydroxy steroid | |
| melengestrol acetate Melengestrol Acetate: A 6-methyl PROGESTERONE acetate with reported glucocorticoid activity and effect on ESTRUS. | 2.41 | 2 | 0 | corticosteroid hormone | |
| estramustine Estramustine: A nitrogen mustard linked to estradiol, usually as phosphate; used to treat prostatic neoplasms; also has radiation protective properties.. estramustine : A carbamate ester obtained by the formal condensation of the hydroxy group of 17beta-estradiol with the carboxy group of bis(2-chloroethyl)carbamic acid. | 2.02 | 1 | 0 | 17beta-hydroxy steroid; carbamate ester; organochlorine compound | alkylating agent; antineoplastic agent; radiation protective agent |
| 4-oxy-6-(4-oxybezoyloxy)dauc-8,9-en 4-oxy-6-(4-oxybezoyloxy)dauc-8,9-en: RN given for (3R-(3alpha,3abeta,4beta,8aalpha))-isomer; a natural benzyl ester of a carotyl type azulene sesquiterpenoid; structure in first source | 2.44 | 2 | 0 | ||
| ritonavir Ritonavir: An HIV protease inhibitor that works by interfering with the reproductive cycle of HIV. It also inhibits CYTOCHROME P-450 CYP3A.. ritonavir : An L-valine derivative that is L-valinamide in which alpha-amino group has been acylated by a [(2-isopropyl-1,3-thiazol-4-yl)methyl]methylcarbamoyl group and in which a hydrogen of the carboxamide amino group has been replaced by a (2R,4S,5S)-4-hydroxy-1,6-diphenyl-5-{[(1,3-thiazol-5-ylmethoxy)carbonyl]amino}hexan-2-yl group. A CYP3A inhibitor and antiretroviral drug from the protease inhibitor class used to treat HIV infection and AIDS, it is often used as a fixed-dose combination with another protease inhibitor, lopinavir. Also used in combination with dasabuvir sodium hydrate, ombitasvir and paritaprevir (under the trade name Viekira Pak) for treatment of chronic hepatitis C virus genotype 1 infection as well as cirrhosis of the liver. | 2.02 | 1 | 0 | 1,3-thiazoles; carbamate ester; carboxamide; L-valine derivative; ureas | antiviral drug; environmental contaminant; HIV protease inhibitor; xenobiotic |
| lithium chloride Lithium Chloride: A salt of lithium that has been used experimentally as an immunomodulator.. lithium chloride : A metal chloride salt with a Li(+) counterion. | 2.11 | 1 | 0 | inorganic chloride; lithium salt | antimanic drug; geroprotector |
| glycogen glycogen : A polydisperse, highly branched glucan composed of chains of D-glucopyranose residues in alpha(1->4) glycosidic linkage, joined together by alpha(1->6) glycosidic linkages. A small number of alpha(1->3) glycosidic linkages and some cumulative alpha(1->6) links also may occur. The branches in glycogen typically contain 8 to 12 glucose residues. | 3.74 | 2 | 1 | ||
| naringenin (S)-naringenin : The (S)-enantiomer of naringenin. | 2.04 | 1 | 0 | (2S)-flavan-4-one; naringenin | expectorant; plant metabolite |
| oxytocin Oxytocin: A nonapeptide hormone released from the neurohypophysis (PITUITARY GLAND, POSTERIOR). It differs from VASOPRESSIN by two amino acids at residues 3 and 8. Oxytocin acts on SMOOTH MUSCLE CELLS, such as causing UTERINE CONTRACTIONS and MILK EJECTION.. oxytocin : A cyclic nonapeptide hormone with amino acid sequence CYIQNCPLG that also acts as a neurotransmitter in the brain; the principal uterine-contracting and milk-ejecting hormone of the posterior pituitary. Together with the neuropeptide vasopressin, it is believed to influence social cognition and behaviour. | 4.54 | 23 | 0 | heterodetic cyclic peptide; peptide hormone | oxytocic; vasodilator agent |
| inositol 1,4,5-trisphosphate Inositol 1,4,5-Trisphosphate: Intracellular messenger formed by the action of phospholipase C on phosphatidylinositol 4,5-bisphosphate, which is one of the phospholipids that make up the cell membrane. Inositol 1,4,5-trisphosphate is released into the cytoplasm where it releases calcium ions from internal stores within the cell's endoplasmic reticulum. These calcium ions stimulate the activity of B kinase or calmodulin. | 2 | 1 | 0 | myo-inositol trisphosphate | mouse metabolite |
| pentostatin Pentostatin: A potent inhibitor of ADENOSINE DEAMINASE. The drug induces APOPTOSIS of LYMPHOCYTES, and is used in the treatment of many lymphoproliferative malignancies, particularly HAIRY CELL LEUKEMIA. It is also synergistic with some other antineoplastic agents and has immunosuppressive activity.. pentostatin : A member of the class of coformycins that is coformycin in which the hydroxy group at position 2' is replaced with a hydrogen. It is a drug used for the treatment of hairy cell leukaemia. | 2.02 | 1 | 0 | coformycins | antimetabolite; antineoplastic agent; Aspergillus metabolite; bacterial metabolite; EC 3.5.4.4 (adenosine deaminase) inhibitor |
| cortodoxone Cortodoxone: 17,21-Dihydroxypregn-4-ene-3,20-dione. A 17-hydroxycorticosteroid with glucocorticoid and anti-inflammatory activities.. 11-deoxycortisol : A deoxycortisol that is cortisol in which the hydroxy group at position 11 has been replaced by a hydrogen. | 2.04 | 1 | 0 | deoxycortisol; glucocorticoid; primary alpha-hydroxy ketone; tertiary alpha-hydroxy ketone | human metabolite; mouse metabolite |
| quinidine Quinidine: An optical isomer of quinine, extracted from the bark of the CHINCHONA tree and similar plant species. This alkaloid dampens the excitability of cardiac and skeletal muscles by blocking sodium and potassium currents across cellular membranes. It prolongs cellular ACTION POTENTIALS, and decreases automaticity. Quinidine also blocks muscarinic and alpha-adrenergic neurotransmission.. quinidine : A cinchona alkaloid consisting of cinchonine with the hydrogen at the 6-position of the quinoline ring substituted by methoxy. | 2.02 | 1 | 0 | cinchona alkaloid | alpha-adrenergic antagonist; anti-arrhythmia drug; antimalarial; drug allergen; EC 1.14.13.181 (13-deoxydaunorubicin hydroxylase) inhibitor; EC 3.6.3.44 (xenobiotic-transporting ATPase) inhibitor; muscarinic antagonist; P450 inhibitor; potassium channel blocker; sodium channel blocker |
| meropenem Meropenem: A thienamycin derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of bacterial infections, including infections in immunocompromised patients.. meropenem : A carbapenemcarboxylic acid in which the azetidine and pyrroline rings carry 1-hydroxymethyl and in which the azetidine and pyrroline rings carry 1-hydroxymethyl and 5-(dimethylcarbamoyl)pyrrolidin-3-ylthio substituents respectively. | 2.02 | 1 | 0 | alpha,beta-unsaturated monocarboxylic acid; carbapenemcarboxylic acid; organic sulfide; pyrrolidinecarboxamide | antibacterial agent; antibacterial drug; drug allergen |
| griseofulvin Griseofulvin: An antifungal agent used in the treatment of TINEA infections.. griseofulvin : An oxaspiro compound produced by Penicillium griseofulvum. It is used by mouth as an antifungal drug for infections involving the scalp, hair, nails and skin that do not respond to topical treatment. | 2.02 | 1 | 0 | 1-benzofurans; antibiotic antifungal drug; benzofuran antifungal drug; organochlorine compound; oxaspiro compound | antibacterial agent; Penicillium metabolite |
| monensin Monensin: An antiprotozoal agent produced by Streptomyces cinnamonensis. It exerts its effect during the development of first-generation trophozoites into first-generation schizonts within the intestinal epithelial cells. It does not interfere with hosts' development of acquired immunity to the majority of coccidial species. Monensin is a sodium and proton selective ionophore and is widely used as such in biochemical studies.. monensin A : A spiroketal, monensin A is the major component of monensin, a mixture of antibiotic substances produced by Streptomyces cinnamonensis. An antiprotozoal, it is used as the sodium salt as a feed additive for the prevention of coccidiosis in poultry and as a growth promoter in cattle. | 2.03 | 1 | 0 | cyclic hemiketal; monocarboxylic acid; polyether antibiotic; spiroketal | antifungal agent; coccidiostat; ionophore |
| cefoxitin Cefoxitin: A semisynthetic cephamycin antibiotic resistant to beta-lactamase.. cefoxitin : A semisynthetic cephamycin antibiotic which, in addition to the methoxy group at the 7alpha position, has 2-thienylacetamido and carbamoyloxymethyl side-groups. It is resistant to beta-lactamase. | 2.02 | 1 | 0 | beta-lactam antibiotic allergen; cephalosporin; cephamycin; semisynthetic derivative | antibacterial drug |
| saquinavir Saquinavir: An HIV protease inhibitor which acts as an analog of an HIV protease cleavage site. It is a highly specific inhibitor of HIV-1 and HIV-2 proteases, and also inhibits CYTOCHROME P-450 CYP3A.. saquinavir : An aspartic acid derivative obtained by formal condensation of the primary amino group of (2S,3R)-4-[(3S,4aS,8aS)-3-(tert-butylcarbamoyl)octahydroisoquinolin-2(1H)-yl]-3-hydroxy-1-phenylbutan-2-ylamine with the carboxy group of N(2)(-quinolin-2-ylcarbonyl)-L-asparagine. An inhibitor of HIV-1 protease. | 2.02 | 1 | 0 | L-asparagine derivative; quinolines | antiviral drug; HIV protease inhibitor |
| netilmicin Netilmicin: Semisynthetic 1-N-ethyl derivative of SISOMYCIN, an aminoglycoside antibiotic with action similar to gentamicin, but less ear and kidney toxicity. | 2.02 | 1 | 0 | ||
| metyrosine alpha-methyl-L-tyrosine : An L-tyrosine derivative that consists of L-tyrosine bearing an additional methyl substituent at position 2. An inhibitor of the enzyme tyrosine 3-monooxygenase, and consequently of the synthesis of catecholamines. It is used to control the symptoms of excessive sympathetic stimulation in patients with pheochromocytoma. | 2.02 | 1 | 0 | L-tyrosine derivative; non-proteinogenic L-alpha-amino acid | antihypertensive agent; EC 1.14.16.2 (tyrosine 3-monooxygenase) inhibitor |
| rocuronium bromide rocuronium bromide : The organic bromide salt of a 5alpha androstane compound having 3alpha-hydroxy-, 17beta-acetoxy-, 2beta-morpholino- and 16beta-N-allyllyrrolidinium substituents. | 2.02 | 1 | 0 | organic bromide salt; quaternary ammonium salt | muscle relaxant; neuromuscular agent |
| terconazole terconazole: structure & RN for (cis)-isomer from first source. terconazole : A racemate consisting of equimolar amounts of (2R,4S)- and (2S,4R)-terconazole. It has broad-spectrum antifungal activitiy and is used for the treatment of vaginal yeast infections (Candida).. (2R,4S)-terconazole : A 1-(4-{[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)-4-isopropylpiperazine in which positions 2 and 4 of the 1,3-dioxolane moiety have R and S configuration, respectively. | 2.02 | 1 | 0 | 1-(4-{[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)-4-isopropylpiperazine | |
| bacampicillin bacampicillin: ester prodrug that is hydrolyzed to ampicillin after its absorption from the gastrointestinal tract; RN given refers to parent cpd; structure. bacampicillin : A penicillanic acid ester that is the 1-ethoxycarbonyloxyethyl ester of ampicillin. It is a semi-synthetic, microbiologically inactive prodrug of ampicillin. | 2.02 | 1 | 0 | penicillanic acid ester | prodrug |
| devazepide Devazepide: A derivative of benzodiazepine that acts on the cholecystokinin A (CCKA) receptor to antagonize CCK-8's (SINCALIDE) physiological and behavioral effects, such as pancreatic stimulation and inhibition of feeding.. devazepide : An indolecarboxamide obtained by formal condensation of the carboxy group of indole-2-carboxylic acid with the exocyclic amino group of (3S)-3-amino-1-methyl-5-phenyl-1,3-dihydro-1,4-benzodiazepin-2-one. A cholecystokinin antagonist used for treatment of gastrointestinal disorders. | 2.01 | 1 | 0 | 1,4-benzodiazepinone; indolecarboxamide | antineoplastic agent; apoptosis inducer; cholecystokinin antagonist; gastrointestinal drug |
| erythromycin ethylsuccinate Erythromycin Ethylsuccinate: A macrolide antibiotic, produced by Streptomyces erythreus. This compound is an ester of erythromycin base and succinic acid. It acts primarily as a bacteriostatic agent. In sensitive organisms, it inhibits protein synthesis by binding to 50S ribosomal subunits. This binding process inhibits peptidyl transferase activity and interferes with translocation of amino acids during translation and assembly of proteins.. erythromycin ethylsuccinate : A erythromycin derivative that is erythromycin A in which the hydroxy group at position 3R is substituted by a (4-ethoxy-4-oxobutanoyl)oxy group. It is used for the treatment of a wide variety of bacterial infections. | 2.02 | 1 | 0 | cyclic ketone; erythromycin derivative; ethyl ester; succinate ester | |
| amcinonide amcinonide: structure | 2.02 | 1 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 3-oxo-Delta(1),Delta(4)-steroid; acetate ester; corticosteroid; fluorinated steroid; spiroketal | anti-inflammatory drug |
| betamethasone acetate [no description available] | 2.02 | 1 | 0 | 11beta-hydroxy steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 3-oxo-Delta(1),Delta(4)-steroid; acetate ester; fluorinated steroid; steroid ester; tertiary alpha-hydroxy ketone | |
| tibolone tibolone: used in prevention of postmenopausal osteoporosis. tibolone : Estran-3-one with a double bond between positions 5 and 10, and bearing both an ethynyl group and a hydroxy group at position 17 (R-configuration). A synthetic steroid hormone drug which acts as an agonist at all five type I steroid hormone receptors, it is used in the prevention of postmenopausal osteoporosis and for treatment of endometriosis. | 3.27 | 5 | 0 | 17beta-hydroxy steroid; terminal acetylenic compound | bone density conservation agent; hormone agonist |
| acarbose [no description available] | 2.02 | 1 | 0 | amino cyclitol; glycoside | |
| tretinoin Tretinoin: An important regulator of GENE EXPRESSION during growth and development, and in NEOPLASMS. Tretinoin, also known as retinoic acid and derived from maternal VITAMIN A, is essential for normal GROWTH; and EMBRYONIC DEVELOPMENT. An excess of tretinoin can be teratogenic. It is used in the treatment of PSORIASIS; ACNE VULGARIS; and several other SKIN DISEASES. It has also been approved for use in promyelocytic leukemia (LEUKEMIA, PROMYELOCYTIC, ACUTE).. retinoic acid : A retinoid consisting of 3,7-dimethylnona-2,4,6,8-tetraenoic acid substituted at position 9 by a 2,6,6-trimethylcyclohex-1-en-1-yl group (geometry of the four exocyclic double bonds is not specified).. all-trans-retinoic acid : A retinoic acid in which all four exocyclic double bonds have E- (trans-) geometry. | 2.43 | 2 | 0 | retinoic acid; vitamin A | anti-inflammatory agent; antineoplastic agent; antioxidant; AP-1 antagonist; human metabolite; keratolytic drug; retinoic acid receptor agonist; retinoid X receptor agonist; signalling molecule |
| equilenin Equilenin: An estrogenic steroid produced by HORSES. It has a total of five double bonds in the A- and B-ring. High concentration of equilenin is found in the URINE of pregnant mares.. equilenin : A 3-hydroxy steroid that is estrone which carries two double bonds at positions 6 and 8. It is found in the urine of pregnant mare's and extensively used for estrogen replacement therapy in postmenopausal women. | 2.04 | 1 | 0 | 17-oxo steroid; 3-hydroxy steroid | antioxidant; mammalian metabolite |
| retinol Vitamin A: Retinol and derivatives of retinol that play an essential role in metabolic functioning of the retina, the growth of and differentiation of epithelial tissue, the growth of bone, reproduction, and the immune response. Dietary vitamin A is derived from a variety of CAROTENOIDS found in plants. It is enriched in the liver, egg yolks, and the fat component of dairy products.. vitamin A : Any member of a group of fat-soluble retinoids produced via metabolism of provitamin A carotenoids that exhibit biological activity against vitamin A deficiency. Vitamin A is involved in immune function, vision, reproduction, and cellular communication.. all-trans-retinol : A retinol in which all four exocyclic double bonds have E- (trans-) geometry.. retinol : A retinoid consisting of 3,7-dimethylnona-2,4,6,8-tetraen-1-ol substituted at position 9 by a 2,6,6-trimethylcyclohex-1-en-1-yl group (geometry of the four exocyclic double bonds is not specified). | 2.04 | 1 | 0 | retinol; vitamin A | human metabolite; mouse metabolite; plant metabolite |
| cocaine Cocaine: An alkaloid ester extracted from the leaves of plants including coca. It is a local anesthetic and vasoconstrictor and is clinically used for that purpose, particularly in the eye, ear, nose, and throat. It also has powerful central nervous system effects similar to the amphetamines and is a drug of abuse. Cocaine, like amphetamines, acts by multiple mechanisms on brain catecholaminergic neurons; the mechanism of its reinforcing effects is thought to involve inhibition of dopamine uptake.. cocaine : A tropane alkaloid obtained from leaves of the South American shrub Erythroxylon coca. | 3.97 | 13 | 0 | benzoate ester; methyl ester; tertiary amino compound; tropane alkaloid | adrenergic uptake inhibitor; central nervous system stimulant; dopamine uptake inhibitor; environmental contaminant; local anaesthetic; mouse metabolite; plant metabolite; serotonin uptake inhibitor; sodium channel blocker; sympathomimetic agent; vasoconstrictor agent; xenobiotic |
| eicosapentaenoic acid icosapentaenoic acid : Any straight-chain, C20 polyunsaturated fatty acid having five C=C double bonds.. all-cis-5,8,11,14,17-icosapentaenoic acid : An icosapentaenoic acid having five cis-double bonds at positions 5, 8, 11, 14 and 17. | 2.15 | 1 | 0 | icosapentaenoic acid; omega-3 fatty acid | anticholesteremic drug; antidepressant; antineoplastic agent; Daphnia galeata metabolite; fungal metabolite; micronutrient; mouse metabolite; nutraceutical |
| mycophenolic acid Mycophenolic Acid: Compound derived from Penicillium stoloniferum and related species. It blocks de novo biosynthesis of purine nucleotides by inhibition of the enzyme inosine monophosphate dehydrogenase (IMP DEHYDROGENASE). Mycophenolic acid exerts selective effects on the immune system in which it prevents the proliferation of T-CELLS, LYMPHOCYTES, and the formation of antibodies from B-CELLS. It may also inhibit recruitment of LEUKOCYTES to sites of INFLAMMATION.. mycophenolate : A monocarboxylic acid anion resulting from the removal of a proton from the carboxy group of mycophenolic acid.. mycophenolic acid : A member of the class of 2-benzofurans that is 2-benzofuran-1(3H)-one which is substituted at positions 4, 5, 6, and 7 by methyl, methoxy, (2E)-5-carboxy-3-methylpent-2-en-1-yl, and hydroxy groups, respectively. It is an antibiotic produced by Penicillium brevi-compactum, P. stoloniferum, P. echinulatum and related species. An immunosuppressant, it is widely used (partiularly as its sodium salt and as the 2-(morpholin-4-yl)ethyl ester prodrug, mycophenolate mofetil) to prevent tissue rejection following organ transplants and for the treatment of certain autoimmune diseases. | 2.02 | 1 | 0 | 2-benzofurans; gamma-lactone; monocarboxylic acid; phenols | anticoronaviral agent; antimicrobial agent; antineoplastic agent; EC 1.1.1.205 (IMP dehydrogenase) inhibitor; environmental contaminant; immunosuppressive agent; mycotoxin; Penicillium metabolite; xenobiotic |
| mupirocin Mupirocin: A topically used antibiotic from a strain of Pseudomonas fluorescens. It has shown excellent activity against gram-positive staphylococci and streptococci. The antibiotic is used primarily for the treatment of primary and secondary skin disorders, nasal infections, and wound healing.. mupirocin : An alpha,beta-unsaturated ester resulting from the formal condensation of the alcoholic hydroxy group of 9-hydroxynonanoic acid with the carboxy group of (2E)-4-[(2S)-tetrahydro-2H-pyran-2-yl]-3-methylbut-2-enoic acid in which the tetrahydropyranyl ring is substituted at positions 3 and 4 by hydroxy groups and at position 5 by a {(2S,3S)-3-[(2S,3S)-3-hydroxybutan-2-yl]oxiran-2-yl}methyl group. Originally isolated from the Gram-negative bacterium Pseudomonas fluorescens, it is used as a topical antibiotic for the treatment of Gram-positive bacterial infections. | 2.02 | 1 | 0 | alpha,beta-unsaturated carboxylic ester; epoxide; monocarboxylic acid; oxanes; secondary alcohol; triol | antibacterial drug; bacterial metabolite; protein synthesis inhibitor |
| fosfomycin Fosfomycin: An antibiotic produced by Streptomyces fradiae.. fosfomycin : A phosphonic acid having an (R,S)-1,2-epoxypropyl group attached to phosphorus. | 2.02 | 1 | 0 | epoxide; phosphonic acids | antimicrobial agent; EC 2.5.1.7 (UDP-N-acetylglucosamine 1-carboxyvinyltransferase) inhibitor |
| zithromax Azithromycin: A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.. azithromycin : A macrolide antibiotic useful for the treatment of bacterial infections. | 2.02 | 1 | 0 | macrolide antibiotic | antibacterial drug; environmental contaminant; xenobiotic |
| diethylstilbestrol Diethylstilbestrol: A synthetic nonsteroidal estrogen used in the treatment of menopausal and postmenopausal disorders. It was also used formerly as a growth promoter in animals. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), diethylstilbestrol has been listed as a known carcinogen. (Merck, 11th ed). diethylstilbestrol : An olefinic compound that is trans-hex-3-ene in which the hydrogens at positions 3 and 4 have been replaced by p-hydroxyphenyl groups. | 4.47 | 5 | 0 | olefinic compound; polyphenol | antifungal agent; antineoplastic agent; autophagy inducer; calcium channel blocker; carcinogenic agent; EC 1.1.1.146 (11beta-hydroxysteroid dehydrogenase) inhibitor; EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor; endocrine disruptor; xenoestrogen |
| afimoxifene afimoxifene : A tertiary amino compound that is tamoxifen in which the phenyl group which is in a Z- relationship to the ethyl substituent is hydroxylated at the para- position. It is the active metabolite of tamoxifen. | 2.42 | 2 | 0 | phenols; tertiary amino compound | antineoplastic agent; estrogen receptor antagonist; metabolite |
| teniposide [no description available] | 2.02 | 1 | 0 | aromatic ether; beta-D-glucoside; cyclic acetal; furonaphthodioxole; gamma-lactone; monosaccharide derivative; phenols; thiophenes | antineoplastic agent; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor |
| cefamandole Cefamandole: Semisynthetic wide-spectrum cephalosporin with prolonged action, probably due to beta-lactamase resistance. It is used also as the nafate.. cefamandole : A cephalosporin compound having (R)-mandelamido and N-methylthiotetrazole side-groups. | 2.02 | 1 | 0 | cephalosporin; semisynthetic derivative | antibacterial drug |
| dactinomycin Dactinomycin: A compound composed of a two CYCLIC PEPTIDES attached to a phenoxazine that is derived from STREPTOMYCES parvullus. It binds to DNA and inhibits RNA synthesis (transcription), with chain elongation more sensitive than initiation, termination, or release. As a result of impaired mRNA production, protein synthesis also declines after dactinomycin therapy. (From AMA Drug Evaluations Annual, 1993, p2015) | 2.02 | 1 | 0 | actinomycin | mutagen |
| melphalan Melphalan: An alkylating nitrogen mustard that is used as an antineoplastic in the form of the levo isomer - MELPHALAN, the racemic mixture - MERPHALAN, and the dextro isomer - MEDPHALAN; toxic to bone marrow, but little vesicant action; potential carcinogen.. melphalan : A phenylalanine derivative comprising L-phenylalanine having [bis(2-chloroethyl)amino group at the 4-position on the phenyl ring. | 2.02 | 1 | 0 | L-phenylalanine derivative; nitrogen mustard; non-proteinogenic L-alpha-amino acid; organochlorine compound | alkylating agent; antineoplastic agent; carcinogenic agent; drug allergen; immunosuppressive agent |
| enkephalin, leucine Enkephalin, Leucine: One of the endogenous pentapeptides with morphine-like activity. It differs from MET-ENKEPHALIN in the LEUCINE at position 5. Its first four amino acid sequence is identical to the tetrapeptide sequence at the N-terminal of BETA-ENDORPHIN.. Leu-enkephalin : A pentapeptide comprising L-tyrosine, glycine, glycine, L-phenylalanine and L-leucine residues joined in sequence by peptide linkages. It is an endogenous opioid peptide produced in vertebrate species, including rodents, primates and humans that results from decomposition of proenkephalin or dynorphin and exhibits antinociceptive properties. | 3.63 | 3 | 0 | pentapeptide; peptide zwitterion | analgesic; delta-opioid receptor agonist; human metabolite; mu-opioid receptor agonist; neurotransmitter; rat metabolite |
| bromochloroacetic acid Keratins: A class of fibrous proteins or scleroproteins that represents the principal constituent of EPIDERMIS; HAIR; NAILS; horny tissues, and the organic matrix of tooth ENAMEL. Two major conformational groups have been characterized, alpha-keratin, whose peptide backbone forms a coiled-coil alpha helical structure consisting of TYPE I KERATIN and a TYPE II KERATIN, and beta-keratin, whose backbone forms a zigzag or pleated sheet structure. alpha-Keratins have been classified into at least 20 subtypes. In addition multiple isoforms of subtypes have been found which may be due to GENE DUPLICATION.. bromochloroacetic acid : A monocarboxylic acid that is acetic acid in which one of the methyl hydrogens is replaced by bromine while a second is replaced by chlorine. A low-melting (27.5-31.5degreeC), hygroscopic crystalline solid, it can be formed during the disinfection (by chlorination) of water that contains bromide ions and organic matter, so can occur in drinking water as a byproduct of the disinfection process. | 2.01 | 1 | 0 | 2-bromocarboxylic acid; monocarboxylic acid; organochlorine compound | |
| sch 22219 alclometasone dipropionate : A prednisolone compound having an alpha-chloro substituent at the 7-position, an alpha-methyl substituent at the 16-position and O-propanoyl groups at the 17- and 21-positions. | 2.02 | 1 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 3-oxo-Delta(1),Delta(4)-steroid; chlorinated steroid; glucocorticoid; propanoate ester; steroid ester | anti-inflammatory drug |
| arginine vasopressin Arginine Vasopressin: The predominant form of mammalian antidiuretic hormone. It is a nonapeptide containing an ARGININE at residue 8 and two disulfide-linked cysteines at residues of 1 and 6. Arg-vasopressin is used to treat DIABETES INSIPIDUS or to improve vasomotor tone and BLOOD PRESSURE.. argipressin : The predominant form of mammalian vasopressin (antidiuretic hormone). It is a nonapeptide containing an arginine at residue 8 and two disulfide-linked cysteines at residues of 1 and 6. | 2.02 | 1 | 0 | vasopressin | cardiovascular drug; hematologic agent; mitogen |
| mezlocillin Mezlocillin: Semisynthetic ampicillin-derived acylureido penicillin. It has been proposed for infections with certain anaerobes and may be useful in inner ear, bile, and CNS infections.. mezlocillin : A penicillin in which the substituent at position 6 of the penam ring is a (2R)-2-[3-(methanesulfonyl)-2-oxoimidazolidine-1-carboxamido]-2-phenylacetamido group. | 2.02 | 1 | 0 | penicillin allergen; penicillin | antibacterial drug |
| trilostane trilostane: inhibits conversion of pregnenolone to progesterone; adrenal blocking agent used in treatment of Cushing's syndrome. trilostane : An epoxy steroid that is 3,17beta-dihydroxy-5alpha-androst-2-ene-2-carbonitrile in which the oxygen of the epoxy group is joined to the 4alpha and 5 alpha positions. | 2.43 | 2 | 0 | 17beta-hydroxy steroid; 3-hydroxy steroid; androstanoid; epoxy steroid; nitrile | abortifacient; antineoplastic agent; EC 1.1.1.210 [3beta(or 20alpha)-hydroxysteroid dehydrogenase] inhibitor |
| cholinophyllin [no description available] | 2.02 | 1 | 0 | ||
| tropisetron Tropisetron: An indole derivative and 5-HT3 RECEPTOR antagonist that is used for the prevention of nausea and vomiting.. tropisetron : An indolyl carboxylate ester obtained by formal condensation of the carboxy group of indole-3-carboxylic acid with the hydroxy group of tropine. | 2.06 | 1 | 0 | indolyl carboxylic acid | |
| fludarabine [no description available] | 2.02 | 1 | 0 | purine nucleoside | |
| propylthiouracil Propylthiouracil: A thiourea antithyroid agent. Propythiouracil inhibits the synthesis of thyroxine and inhibits the peripheral conversion of throxine to tri-iodothyronine. It is used in the treatment of hyperthyroidism. (From Martindale, The Extra Pharmacopeoia, 30th ed, p534). 6-propyl-2-thiouracil : A pyrimidinethione consisting of uracil in which the 2-oxo group is substituted by a thio group and the hydrogen at position 6 is substituted by a propyl group. | 2.02 | 1 | 0 | pyrimidinethione | antidote to paracetamol poisoning; antimetabolite; antioxidant; antithyroid drug; carcinogenic agent; EC 1.14.13.39 (nitric oxide synthase) inhibitor; hormone antagonist |
| ipratropium bromide anhydrous [no description available] | 2.02 | 1 | 0 | ||
| sesquiterpenes [no description available] | 2.44 | 2 | 0 | ||
| etomidate Etomidate: Imidazole derivative anesthetic and hypnotic with little effect on blood gases, ventilation, or the cardiovascular system. It has been proposed as an induction anesthetic.. etomidate : The ethyl ester of 1-[(1R)-1-phenylethyl]-1H-imidazole-5-carboxylic acid. It is an intravenous general anaesthetic with no analgesic activity. | 2.02 | 1 | 0 | ethyl ester; imidazoles | intravenous anaesthetic; sedative |
| mercaptopurine Mercaptopurine: An antimetabolite antineoplastic agent with immunosuppressant properties. It interferes with nucleic acid synthesis by inhibiting purine metabolism and is used, usually in combination with other drugs, in the treatment of or in remission maintenance programs for leukemia.. purine-6-thiol : A thiol that is the tautomer of mercaptopurine.. mercaptopurine : A member of the class of purines that is 6,7-dihydro-1H-purine carrying a thione group at position 6. An adenine analogue, it is used in the treatment of acute lymphocytic leukemia (ALL), chronic myeloid leukemia (CML), Crohn's disease, and ulcerative colitis. | 2.02 | 1 | 0 | aryl thiol; purines; thiocarbonyl compound | anticoronaviral agent; antimetabolite; antineoplastic agent |
| thiothixene [no description available] | 2.02 | 1 | 0 | N-methylpiperazine | anticoronaviral agent |
| benztropine Benztropine: A centrally active muscarinic antagonist that has been used in the symptomatic treatment of PARKINSON DISEASE. Benztropine also inhibits the uptake of dopamine.. benzatropine : Tropane in which a hydrogen at position 3 is substituted by a diphenylmethoxy group (endo-isomer). An acetylcholine receptor antagonist, it is used (particularly as its methanesulphonate salt) in the treatment of Parkinson's disease, and to reduce parkinsonism and akathisia side effects of antipsychotic treatments. | 2.02 | 1 | 0 | diarylmethane | |
| thiouracil Thiouracil: Occurs in seeds of Brassica and Crucifera species. Thiouracil has been used as antithyroid, coronary vasodilator, and in congestive heart failure although its use has been largely supplanted by other drugs. It is known to cause blood dyscrasias and suspected of terato- and carcinogenesis.. thiouracil : A nucleobase analogue that is uracil in which the oxo group at C-2 is replaced by a thioxo group. | 1.92 | 1 | 0 | nucleobase analogue; thiocarbonyl compound | antithyroid drug; metabolite |
| sulindac Sulindac: A sulfinylindene derivative prodrug whose sulfinyl moiety is converted in vivo to an active NSAID analgesic. Specifically, the prodrug is converted by liver enzymes to a sulfide which is excreted in the bile and then reabsorbed from the intestine. This helps to maintain constant blood levels with reduced gastrointestinal side effects.. sulindac : A monocarboxylic acid that is 1-benzylidene-1H-indene which is substituted at positions 2, 3, and 5 by methyl, carboxymethyl, and fluorine respectively, and in which the phenyl group of the benzylidene moiety is substituted at the para position by a methylsulfinyl group. It is a prodrug for the corresponding sulfide, a non-steroidal anti-inflammatory drug, used particularly in the treatment of acute and chronic inflammatory conditions. | 2.02 | 1 | 0 | monocarboxylic acid; organofluorine compound; sulfoxide | analgesic; antineoplastic agent; antipyretic; apoptosis inducer; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-narcotic analgesic; non-steroidal anti-inflammatory drug; prodrug; tocolytic agent |
| capsaicin ALGRX-4975: an injectable capsaicin (TRPV1 receptor agonist) formulation for longlasting pain relief. capsaicinoid : A family of aromatic fatty amides produced as secondary metabolites by chilli peppers. | 2.02 | 1 | 0 | capsaicinoid | non-narcotic analgesic; TRPV1 agonist; voltage-gated sodium channel blocker |
| enclomiphene Enclomiphene: The trans or (E)-isomer of clomiphene. | 4.09 | 3 | 1 | ||
| terbinafine [no description available] | 2.02 | 1 | 0 | acetylenic compound; allylamine antifungal drug; enyne; naphthalenes; tertiary amine | EC 1.14.13.132 (squalene monooxygenase) inhibitor; P450 inhibitor; sterol biosynthesis inhibitor |
| thioguanine anhydrous Thioguanine: An antineoplastic compound which also has antimetabolite action. The drug is used in the therapy of acute leukemia.. tioguanine : A 2-aminopurine that is the 6-thiono derivative of 2-amino-1,9-dihydro-6H-purine. Incorporates into DNA and inhibits synthesis. Used in the treatment of leukaemia. | 2.02 | 1 | 0 | 2-aminopurines | anticoronaviral agent; antimetabolite; antineoplastic agent |
| thiourea Thiourea: A photographic fixative used also in the manufacture of resins. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), this substance may reasonably be anticipated to be a carcinogen (Merck Index, 9th ed). Many of its derivatives are ANTITHYROID AGENTS and/or FREE RADICAL SCAVENGERS.. thiourea : The simplest member of the thiourea class, consisting of urea with the oxygen atom substituted by sulfur. | 1.92 | 1 | 0 | one-carbon compound; thioureas; ureas | antioxidant; chromophore |
| D-fructopyranose [no description available] | 2.39 | 2 | 0 | cyclic hemiketal; D-fructose; fructopyranose | sweetening agent |
| thioacetamide Thioacetamide: A crystalline compound used as a laboratory reagent in place of HYDROGEN SULFIDE. It is a potent hepatocarcinogen.. thioacetamide : A thiocarboxamide consiting of acetamide having the oxygen replaced by sulfur. | 7.02 | 1 | 0 | thiocarboxamide | hepatotoxic agent |
| succimer Succimer: A mercaptodicarboxylic acid used as an antidote to heavy metal poisoning because it forms strong chelates with them.. succimer : A sulfur-containing carboxylic acid that is succinic acid bearing two mercapto substituents at positions 2 and 3. A lead chelator used as an antedote to lead poisoning. | 2.02 | 1 | 0 | dicarboxylic acid; dithiol; sulfur-containing carboxylic acid | chelator |
| streptozocin [no description available] | 2.02 | 1 | 0 | ||
| capsazepine capsazepine: modified capsaicin molecule; a capsaicin receptor antagonist. capsazepine : A benzazepine that is 2,3,4,5-tetrahydro-1H-2-benzazepine which is substituted by hydroxy groups at positions 7 and 8 and on the nitrogen atom by a 2-(p-chlorophenyl)ethylaminothiocarbonyl group. A synthetic analogue of capsaicin, it was the first reported capsaicin receptor antagonist. | 2.02 | 1 | 0 | benzazepine; catechols; monochlorobenzenes; thioureas | capsaicin receptor antagonist |
| tamoxifen [no description available] | 9.76 | 30 | 0 | stilbenoid; tertiary amino compound | angiogenesis inhibitor; antineoplastic agent; bone density conservation agent; EC 1.2.3.1 (aldehyde oxidase) inhibitor; EC 2.7.11.13 (protein kinase C) inhibitor; estrogen antagonist; estrogen receptor antagonist; estrogen receptor modulator |
| ethionamide Ethionamide: A second-line antitubercular agent that inhibits mycolic acid synthesis.. ethionamide : A thiocarboxamide that is pyridine-4-carbothioamide substituted by an ethyl group at position 2. A prodrug that undergoes metabolic activation by conversion to the corresponding S-oxide. | 2.02 | 1 | 0 | pyridines; thiocarboxamide | antilipemic drug; antitubercular agent; fatty acid synthesis inhibitor; leprostatic drug; prodrug |
| zeranol Zeranol: A non-steroidal estrogen analog. | 2.05 | 1 | 0 | macrolide | |
| estrone sulfate estrone sulfate: sulfoconjugated estrone; RN given refers to parent cpd | 2 | 1 | 0 | 17-oxo steroid; steroid sulfate | human metabolite; mouse metabolite |
| nitromifene Nitromifene: A non-steroidal estrogen antagonist (as the 1:1 citrate) most commonly used as a research tool in animal studies. | 2.01 | 1 | 0 | ||
| dezocine dezocine: potent analgesic; RN given refers to ((5R-(5alpha,11alpha,13S*)))-isomer (dezocin); structure. dezocine : (7S,8S)-7-Amino-8-methyl-5,6,7,8-tetrahydronaphthalen-2-ol in which the hydrogen at position 8 and one of the hydrogens at position 6 are substituted by each end of a tetramethylene bridge. A synthetic opioid analgesic, it has mixed opiod agonist and antagonist properties. Although it is used for pain management, it can produce opioid withdrawal syndrome in patients already dependent on other opioids, and its clinical application is limited by side effects such as dizziness. | 2.02 | 1 | 0 | phenols; primary amino compound | opioid analgesic |
| dapiprazole [no description available] | 2.02 | 1 | 0 | N-alkylpiperazine; N-arylpiperazine; pyridines | alpha-adrenergic antagonist; antipsychotic agent; miotic; ophthalmology drug |
| droloxifene [no description available] | 1.96 | 1 | 0 | stilbenoid | |
| orlistat Orlistat: A lactone derivative of LEUCINE that acts as a pancreatic lipase inhibitor to limit the absorption of dietary fat; it is used in the management of obesity.. orlistat : A carboxylic ester resulting from the formal condensation of the carboxy group of N-formyl-L-leucine with the hydroxy group of (3S,4S)-3-hexyl-4-[(2S)-2-hydroxytridecyl]oxetan-2-one. A pancreatic lipase inhibitor, it is used as an anti-obesity drug. | 2.15 | 1 | 0 | beta-lactone; carboxylic ester; formamides; L-leucine derivative | anti-obesity agent; bacterial metabolite; EC 2.3.1.85 (fatty acid synthase) inhibitor; EC 3.1.1.3 (triacylglycerol lipase) inhibitor |
| u-50488 3,4-Dichloro-N-methyl-N-(2-(1-pyrrolidinyl)-cyclohexyl)-benzeneacetamide, (trans)-Isomer: A non-peptide, kappa-opioid receptor agonist which has also been found to stimulate the release of adrenocorticotropin (ADRENOCORTICOTROPIC HORMONE) via the release of hypothalamic arginine vasopressin (ARGININE VASOPRESSIN) and CORTICOTROPIN-RELEASING HORMONE. (From J Pharmacol Exp Ther 1997;280(1):416-21). U50488 : A monocarboxylic acid amide obtained by formal condensation between the carboxy group of 3,4-dichlorophenylacetic acid and the secondary amino group of (1R,2R)-N-methyl-2-(pyrrolidin-1-yl)cyclohexanamine | 2 | 1 | 0 | dichlorobenzene; monocarboxylic acid amide; N-alkylpyrrolidine | analgesic; antitussive; calcium channel blocker; diuretic; kappa-opioid receptor agonist |
| sch 23390 SCH 23390: a selective D1-receptor antagonist. SCH 23390 : A benzazepine that is 2,3,4,5-tetrahydro-3-benzazepine bearing a phenyl substituent at position 1, a methyl substituent at position 3, a chloro substituent at position 7 and a hydroxy substituent at position 8. | 2.11 | 1 | 0 | benzazepine | |
| ginsenosides ginsenoside : Triterpenoid saponins with a dammarane-like skeleton originally isolated from ginseng (Panax) species. Use of the term has been extended to include semi-synthetic derivatives. | 2.49 | 2 | 0 | ||
| ru 42173 RU 42173: structure given in first source | 2.5 | 2 | 0 | benzazepine | |
| fg 9041 FG 9041: structure given in first source | 2.48 | 2 | 0 | quinoxaline derivative | |
| 17-ketosteroids 17-Ketosteroids: Steroids that contain a ketone group at position 17.. 17-oxo steroid : Any oxo steroid carrying the oxo group at position 17. | 1.93 | 1 | 0 | ||
| osteoprotegerin Osteoprotegerin: A secreted member of the TNF receptor superfamily that negatively regulates osteoclastogenesis. It is a soluble decoy receptor of RANK LIGAND that inhibits both CELL DIFFERENTIATION and function of OSTEOCLASTS by inhibiting the interaction between RANK LIGAND and RECEPTOR ACTIVATOR OF NUCLEAR FACTOR-KAPPA B. | 2.15 | 1 | 0 | long-chain fatty acid | |
| flosequinan [no description available] | 2.02 | 1 | 0 | quinolines | |
| quercetin [no description available] | 2.47 | 2 | 0 | 7-hydroxyflavonol; pentahydroxyflavone | antibacterial agent; antineoplastic agent; antioxidant; Aurora kinase inhibitor; chelator; EC 1.10.99.2 [ribosyldihydronicotinamide dehydrogenase (quinone)] inhibitor; geroprotector; phytoestrogen; plant metabolite; protein kinase inhibitor; radical scavenger |
| bilirubin [no description available] | 1.94 | 1 | 0 | biladienes; dicarboxylic acid | antioxidant; human metabolite; mouse metabolite |
| dinoprostone prostaglandin E2 : Prostaglandin F2alpha in which the hydroxy group at position 9 has been oxidised to the corresponding ketone. Prostaglandin E2 is the most common and most biologically potent of mammalian prostaglandins. | 2.25 | 1 | 0 | prostaglandins E | human metabolite; mouse metabolite; oxytocic |
| dinoprost Dinoprost: A naturally occurring prostaglandin that has oxytocic, luteolytic, and abortifacient activities. Due to its vasocontractile properties, the compound has a variety of other biological actions.. prostaglandin F2alpha : A prostaglandins Falpha that is prosta-5,13-dien-1-oic acid substituted by hydroxy groups at positions 9, 11 and 15. It is a naturally occurring prostaglandin used to induce labor. | 9.97 | 48 | 12 | monocarboxylic acid; prostaglandins Falpha | human metabolite; mouse metabolite |
| biochanin a [no description available] | 2.05 | 1 | 0 | 4'-methoxyisoflavones; 7-hydroxyisoflavones | antineoplastic agent; EC 3.5.1.99 (fatty acid amide hydrolase) inhibitor; phytoestrogen; plant metabolite; tyrosine kinase inhibitor |
| linoleic acid Linoleic Acid: A doubly unsaturated fatty acid, occurring widely in plant glycosides. It is an essential fatty acid in mammalian nutrition and is used in the biosynthesis of prostaglandins and cell membranes. (From Stedman, 26th ed). linoleic acid : An octadecadienoic acid in which the two double bonds are at positions 9 and 12 and have Z (cis) stereochemistry. | 2.6 | 1 | 0 | octadecadienoic acid; omega-6 fatty acid | algal metabolite; Daphnia galeata metabolite; plant metabolite |
| calcitriol dihydroxy-vitamin D3: as a major in vitro metabolite of 1alpha,25-dihydroxyvitamin D3, produced in primary cultures of neonatal human keratinocytes | 2.91 | 4 | 0 | D3 vitamins; hydroxycalciol; triol | antineoplastic agent; antipsoriatic; bone density conservation agent; calcium channel agonist; calcium channel modulator; hormone; human metabolite; immunomodulator; metabolite; mouse metabolite; nutraceutical |
| alprostadil [no description available] | 2.02 | 1 | 0 | prostaglandins E | anticoagulant; human metabolite; platelet aggregation inhibitor; vasodilator agent |
| alpha-linolenic acid linolenic acid : A two-membered subclass of octadecatrienoic acid comprising the (9Z,12Z,15Z)- and (6Z,9Z,12Z)-isomers. Linolenic acids are nutrients essential to the formation of prostaglandins and are also used in making paints and synthetic resins.. linolenate : A polyunsaturated fatty acid anion obtained by deprotonation of the carboxy group of either alpha- or gamma-linolenic acid. | 2.15 | 1 | 0 | linolenic acid; omega-3 fatty acid | micronutrient; mouse metabolite; nutraceutical |
| genistein [no description available] | 3.63 | 9 | 0 | 7-hydroxyisoflavones | antineoplastic agent; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor; geroprotector; human urinary metabolite; phytoestrogen; plant metabolite; tyrosine kinase inhibitor |
| amphotericin b Amphotericin B: Macrolide antifungal antibiotic produced by Streptomyces nodosus obtained from soil of the Orinoco river region of Venezuela.. amphotericin B : A macrolide antibiotic used to treat potentially life-threatening fungal infections. | 2.02 | 1 | 0 | antibiotic antifungal drug; macrolide antibiotic; polyene antibiotic | antiamoebic agent; antiprotozoal drug; bacterial metabolite |
| pulmicort Budesonide: A glucocorticoid used in the management of ASTHMA, the treatment of various skin disorders, and allergic RHINITIS.. budesonide : A glucocorticoid steroid having a highly oxygenated pregna-1,4-diene structure. It is used mainly in the treatment of asthma and non-infectious rhinitis and for treatment and prevention of nasal polyposis. | 2.02 | 1 | 0 | 11beta-hydroxy steroid; 20-oxo steroid; 21-hydroxy steroid; 3-oxo-Delta(1),Delta(4)-steroid; cyclic acetal; glucocorticoid; primary alpha-hydroxy ketone | anti-inflammatory drug; bronchodilator agent; drug allergen |
| olopatadine [no description available] | 2.02 | 1 | 0 | ||
| bw b1090u [no description available] | 2.02 | 1 | 0 | isoquinolines | |
| zearalenone Zearalenone: (S-(E))-3,4,5,6,8,10-Hexahydro-14,16-dihydroxy-3-methyl-1H-2-benzoxacyclotetradecin-1,7(8H)-dione. One of a group of compounds known under the general designation of resorcylic acid lactones. Cis, trans, dextro and levo forms have been isolated from the fungus Gibberella zeae (formerly Fusarium graminearum). They have estrogenic activity, cause toxicity in livestock as feed contaminant, and have been used as anabolic or estrogen substitutes.. zearalenone : A macrolide comprising a fourteen-membered lactone fused to 1,3-dihydroxybenzene; a potent estrogenic metabolite produced by some Giberella species. | 2.21 | 1 | 0 | macrolide; resorcinols | fungal metabolite; mycoestrogen |
| coumestrol Coumestrol: A daidzein derivative occurring naturally in forage crops which has some estrogenic activity.. coumestrol : A member of the class of coumestans that is coumestan with hydroxy substituents at positions 3 and 9. | 2 | 1 | 0 | coumestans; delta-lactone; polyphenol | anti-inflammatory agent; antioxidant; plant metabolite |
| daidzein [no description available] | 2 | 1 | 0 | 7-hydroxyisoflavones | antineoplastic agent; EC 2.7.7.7 (DNA-directed DNA polymerase) inhibitor; EC 3.2.1.20 (alpha-glucosidase) inhibitor; phytoestrogen; plant metabolite |
| anandamide anandamide : An N-acylethanolamine 20:4 resulting from the formal condensation of carboxy group of arachidonic acid with the amino group of ethanolamine. | 2.02 | 1 | 0 | endocannabinoid; N-acylethanolamine 20:4 | human blood serum metabolite; neurotransmitter; vasodilator agent |
| 7432 s Ceftibuten: A cephalosporin antibacterial agent that is used in the treatment of infections, including urinary-tract and respiratory-tract infections.. ceftibuten : A third-generation cephalosporin antibiotic with a [(2Z)-2-(2-amino-1,3-thiazol-4-yl)-4-carboxybut-2-enoyl]amino substituent at the 7 position of the cephem skeleton. An orally-administered agent, ceftibuten is used as the dihydrate to treat urinary-tract and respiratory-tract infections. | 2.02 | 1 | 0 | cephalosporin; dicarboxylic acid | antibacterial drug |
| etretinate retinoid : Oxygenated derivatives of 3,7-dimethyl-1-(2,6,6-trimethylcyclohex-1-enyl)nona-1,3,5,7-tetraene and derivatives thereof. | 2.02 | 1 | 0 | enoate ester; ethyl ester; retinoid | keratolytic drug |
| isotretinoin Isotretinoin: A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.. isotretinoin : A retinoic acid that is all-trans-retinoic acid in which the double bond which is alpha,beta- to the carboxy group is isomerised to Z configuration. A synthetic retinoid, it is used for the treatment of severe cases of acne and other skin diseases. | 2.02 | 1 | 0 | retinoic acid | antineoplastic agent; keratolytic drug; teratogenic agent |
| misoprostol Misoprostol: A synthetic analog of natural prostaglandin E1. It produces a dose-related inhibition of gastric acid and pepsin secretion, and enhances mucosal resistance to injury. It is an effective anti-ulcer agent and also has oxytocic properties.. misoprostol : A diastereoisomeric mixture composed of approximately equal amounts of a double racemate of four of the sixteen possible diastereoisomers of methyl (13E)-11,16-dihydroxy-16-methyl-9-oxoprost-13-en-1-oate that is racemic prostaglandin E1 which is lacking the hydroxy group at position 15, but which has an additional hydroxy group at position 16. It is a synthetic prostaglandin E1 analogue, used in the treatment of gastric and duodenal ulcers. A weak abortifacient, it is also used for cervical ripening prior to surgical termination of pregnancy. The (11R,16S)-diastereoisomer is the pharmacologically active form. | 2.02 | 1 | 0 | ||
| epoprostenol [no description available] | 2.02 | 1 | 0 | prostaglandins I | mouse metabolite |
| dinoprost tromethamine [no description available] | 5.24 | 5 | 2 | organic molecular entity | |
| betamethasone benzoate [no description available] | 2.02 | 1 | 0 | 21-hydroxy steroid | |
| 15-keto-13,14-dihydroprostaglandin f2alpha 15-keto-13,14-dihydroprostaglandin F2alpha: main metabolite of PGF2alpha in plasma after allergen provoked asthma; RN given refers to (5Z,9alpha,11alpha)-isomer; structure. 13,14-dihydro-15-keto-PGF2alpha : A prostaglandin Falpha obtained by formal oxidation of the 15-hydroxy group and hydrogenation of the 13,14-double bond of prostaglandin F2alpha. | 2 | 1 | 0 | ketone; prostaglandins Falpha | metabolite |
| dorzolamide dorzolamide: topically effective ocular hypotensive carbonic anhydrase inhibitor; RN refers to mono-HCl (4S-trans)-isomer. dorzolamide : 5,6-Dihydro-4H-thieno[2,3-b]thiopyran-2-sulfonamide 7,7-dioxide in which hydrogens at the 4 and 6 positions are substituted by ethylamino and methyl groups, respectively (4S, trans-configuration). A carbonic anhydrase inhibitor, it is used as the hydrochloride in ophthalmic solutions to lower increased intraocular pressure in the treatment of open-angle glaucoma and ocular hypertension. | 2.02 | 1 | 0 | sulfonamide; thiophenes | antiglaucoma drug; antihypertensive agent; EC 4.2.1.1 (carbonic anhydrase) inhibitor |
| ethisterone Ethisterone: 17 alpha-Hydroxypregn-4-en-20-yn-3-one. A synthetic steroid hormone with progestational effects.. ethisterone : A 17beta-hydroxy steroid that is testosterone in which the 17beta hydrogen is replaced by an ethynyl group. Ethisterone was the first orally active progestin and is a metabolite of danazol. | 2.04 | 1 | 0 | 17beta-hydroxy steroid; 3-oxo-Delta(4) steroid; terminal acetylenic compound; tertiary alcohol | drug metabolite; progestin |
| hydromorphone Hydromorphone: An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine.. hydromorphone : A morphinane alkaloid that is a hydrogenated ketone derivative of morphine. A semi-synthetic drug, it is a centrally acting pain medication of the opioid class. | 2.02 | 1 | 0 | morphinane alkaloid; organic heteropentacyclic compound | mu-opioid receptor agonist; opioid analgesic |
| ly 163892 loracarbef: 1-carbacephem antibiotic; has a broad spectrum of antimicrobial activity; structure given in first source; carbacephems differ from cephalosporins in the substitution of a sulfur atom in the dihydrothiazine ring with a methylene group to form a tetrahydropyridine ring. loracarbef : A synthetic "carba" analogue of cefaclor, with carbon replacing sulfur at position 1. Used to treat a wide range of infections caused by both gram-positive and gram-negative bacteria. | 2.02 | 1 | 0 | carbacephem; zwitterion | antibacterial drug; antimicrobial agent |
| nalmefene nalmefene: RN given refers to 5-alpha isomer | 2.02 | 1 | 0 | morphinane alkaloid | |
| naloxone Naloxone: A specific opiate antagonist that has no agonist activity. It is a competitive antagonist at mu, delta, and kappa opioid receptors.. naloxone : A synthetic morphinane alkaloid that is morphinone in which the enone double bond has been reduced to a single bond, the hydrogen at position 14 has been replaced by a hydroxy group, and the methyl group attached to the nitrogen has been replaced by an allyl group. A specific opioid antagonist, it is used (commonly as its hydrochloride salt) to reverse the effects of opioids, both following their use of opioids during surgery and in cases of known or suspected opioid overdose. | 4.49 | 5 | 1 | morphinane alkaloid; organic heteropentacyclic compound; tertiary alcohol | antidote to opioid poisoning; central nervous system depressant; mu-opioid receptor antagonist |
| topiramate Topiramate: A sulfamate-substituted fructose analog that was originally identified as a hypoglycemic agent. It is used for the treatment of EPILEPSY and MIGRAINE DISORDERS, and may also promote weight loss.. topiramate : A hexose derivative that is 2,3:4,5-di-O-isopropylidene-beta-D-fructopyranose in which the hydroxy group has been converted to the corresponding sulfamate ester. It blocks voltage-dependent sodium channels and is used as an antiepileptic and for the prevention of migraine. | 2.02 | 1 | 0 | cyclic ketal; ketohexose derivative; sulfamate ester | anticonvulsant; sodium channel blocker |
| afimoxifene [no description available] | 1.96 | 1 | 0 | ||
| calcipotriene [no description available] | 2.02 | 1 | 0 | cyclopropanes; hydroxy seco-steroid; seco-cholestane; secondary alcohol; triol | antipsoriatic; drug allergen |
| morphine Meconium: The thick green-to-black mucilaginous material found in the intestines of a full-term fetus. It consists of secretions of the INTESTINAL GLANDS; BILE PIGMENTS; FATTY ACIDS; AMNIOTIC FLUID; and intrauterine debris. It constitutes the first stools passed by a newborn. | 3.11 | 5 | 0 | morphinane alkaloid; organic heteropentacyclic compound; tertiary amino compound | anaesthetic; drug allergen; environmental contaminant; geroprotector; mu-opioid receptor agonist; opioid analgesic; plant metabolite; vasodilator agent; xenobiotic |
| atosiban [no description available] | 2.21 | 1 | 0 | oligopeptide | |
| bibo 3457 BIBO 3304: BIBO-3457 is the inactive enantiomer | 2.01 | 1 | 0 | ||
| clobetasol Clobetasol: A derivative of PREDNISOLONE with high glucocorticoid activity and low mineralocorticoid activity. Absorbed through the skin faster than FLUOCINONIDE, it is used topically in treatment of PSORIASIS but may cause marked adrenocortical suppression.. clobetasol : A 3-oxo-Delta(1),Delta(4)-steroid that is 16beta-methylpregna-1,4-diene-3,20-dione bearing hydroxy groups at the 11beta and 17alpha positions, fluorine at position 9, and a chlorine substituent at position 21. It is used as its 17alpha-propionate ester to treat various skin disorders, including exzema and psoriasis. | 2.02 | 1 | 0 | 11beta-hydroxy steroid; 17alpha-hydroxy steroid; 20-oxo steroid; 3-oxo-Delta(1),Delta(4)-steroid; chlorinated steroid; fluorinated steroid; glucocorticoid; tertiary alpha-hydroxy ketone | anti-inflammatory drug; SMO receptor agonist |
| cloprostenol Cloprostenol: A synthetic prostaglandin F2alpha analog. The compound has luteolytic effects and is used for the synchronization of estrus in cattle. | 8.13 | 30 | 9 | prostanoid | |
| endomorphin 1 endomorphin 1: isolated from bovine brain | 3.82 | 2 | 1 | oligopeptide | |
| fluticasone Fluticasone: A STEROID with GLUCOCORTICOID RECEPTOR activity that is used to manage the symptoms of ASTHMA; ALLERGIC RHINITIS, and ATOPIC DERMATITIS.. fluticasone : A trifluorinated corticosteroid used in the form of its propionate ester for treatment of allergic rhinitis. | 2.02 | 1 | 0 | 11beta-hydroxy steroid; 17alpha-hydroxy steroid; 3-oxo-Delta(4) steroid; corticosteroid; fluorinated steroid; thioester | anti-allergic agent; anti-asthmatic drug |
| halobetasol halobetasol: used in ointment to treat psoriasis; Ulobetasol cream contains 0.05% 6-fluoroclobetasol 17-propionate | 2.02 | 1 | 0 | corticosteroid hormone | |
| l 365260 L 365260: a CCK-B antagonist; structure given in first source; potent & selective CCK-B & gastrin receptor ligand; L 365260 and L 365346 are (R)- and (S)-stereoisomers, respectively | 2.01 | 1 | 0 | benzodiazepine | |
| latanoprost Latanoprost: A prostaglandin F analog used to treat OCULAR HYPERTENSION in patients with GLAUCOMA.. latanoprost : A prostaglandin Falpha that is the isopropyl ester prodrug of latanoprost free acid. Used in the treatment of open-angle glaucoma and ocular hypertension. | 2.02 | 1 | 0 | isopropyl ester; prostaglandins Falpha; triol | antiglaucoma drug; antihypertensive agent; EC 4.2.1.1 (carbonic anhydrase) inhibitor; prodrug |
| mdl 100907 Serotonin 5-HT2 Receptor Antagonists: Drugs that bind to but do not activate SEROTONIN 5-HT2 RECEPTORS, thereby blocking the actions of SEROTONIN or SEROTONIN 5-HT2 RECEPTOR AGONISTS. Included under this heading are antagonists for one or more specific 5-HT2 receptor subtypes. | 2 | 1 | 0 | ||
| nalbuphine Nalbuphine: A narcotic used as a pain medication. It appears to be an agonist at KAPPA RECEPTORS and an antagonist or partial agonist at MU RECEPTORS. | 2.02 | 1 | 0 | organic heteropentacyclic compound | mu-opioid receptor antagonist; opioid analgesic |
| neurokinin b Neurokinin B: A mammalian neuropeptide of 10 amino acids that belongs to the tachykinin family. It is similar in structure and action to SUBSTANCE P and NEUROKININ A with the ability to excite neurons, dilate blood vessels, and contract smooth muscles, such as those in the URINARY BLADDER and UTERUS. | 2.47 | 2 | 0 | polypeptide | |
| rimexolone [no description available] | 2.02 | 1 | 0 | 20-oxo steroid | |
| vinorelbine [no description available] | 2.02 | 1 | 0 | acetate ester; methyl ester; organic heteropentacyclic compound; organic heterotetracyclic compound; ring assembly; vinca alkaloid | antineoplastic agent; photosensitizing agent |
| kn 93 KN 93: reduces dopamine content in PC12h cells. KN-93 : A sulfonamide resulting from the formal condensation of p-methoxybenzenesulfonic acid with the anilino nitrogen of 2-(aminomethyl)-N-(2-hydroxyethyl)aniline in which the hydrogens of the primary amino group have been replaced by methyl and p-chlorocinnamyl groups. KN-93 is a selective inhibitor of Ca(2+)/calmodulin-dependent protein kinase II. | 2.04 | 1 | 0 | monochlorobenzenes; monomethoxybenzene; primary alcohol; sulfonamide; tertiary amino compound | EC 2.7.11.17 (Ca(2+)/calmodulin-dependent protein kinase) inhibitor; geroprotector |
| 1-(4-(6-bromobenzo(1,3)dioxol-5-yl)-3a,4,5,9b-tetrahydro-3h-cyclopenta(c)quinolin-8-yl)ethanone 1-(4-(6-bromobenzo(1,3)dioxol-5-yl)-3a,4,5,9b-tetrahydro-3H-cyclopenta(c)quinolin-8-yl)ethanone: G-1 was able to induce both c-fos expression and proliferation in the ERalpha-negative/GPR30-positive SKBR3 breast cancer cells, the requirement for ERalpha expression in GPR30/EGFR signaling may depend on the specific cellular context of different tumor types | 2.1 | 1 | 0 | agonist | |
| fluvoxamine Fluvoxamine: A selective serotonin reuptake inhibitor that is used in the treatment of DEPRESSION and a variety of ANXIETY DISORDERS.. fluvoxamine : An oxime O-ether that is benzene substituted by a (1E)-N-(2-aminoethoxy)-5-methoxypentanimidoyl group at position 1 and a trifluoromethyl group at position 4. It is a selective serotonin reuptake inhibitor that is used for the treatment of obsessive-compulsive disorder. | 2.44 | 2 | 0 | (trifluoromethyl)benzenes; 5-methoxyvalerophenone O-(2-aminoethyl)oxime | antidepressant; anxiolytic drug; serotonin uptake inhibitor |
| afimoxifene [no description available] | 1.97 | 1 | 0 | ||
| (6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid (6E)-7-[3-(4-fluorophenyl)-1-(propan-2-yl)-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid : A dihydroxy monocarboxylic acid that is N-isopropylindole which is substituted at position 3 by a p-fluorophenyl group and at position 2 by a 6-carboxy-3,5-dihydroxyhex-1-en-1-yl group. It has four possible diastereoisomers. | 2.02 | 1 | 0 | dihydroxy monocarboxylic acid; indoles; organofluorine compound | |
| oxiconazole oxiconazole: RN given refers to parent cpd(Z)-isomer; structure given in first source. oxiconazole : An oxime O-ether that is the 2,4-dichlorobenzyl ether of the oxime obtained by formal condensation of hydroxylamine with the carbonyl group of acetopnenone in which the phenyl group is substituted by chlorines at positions 2 and 4, and in which one of the hydrogens of the methyl group is replaced by a 1H-imidazol-1-yl group. An antifungal agent, it is used (generally as the nitrate salt) in creams and powders for the topical treatment of fungal skin infections. | 2.02 | 1 | 0 | conazole antifungal drug; dichlorobenzene; imidazole antifungal drug; imidazoles; oxime O-ether | antiinfective agent |
| naltrexone Naltrexone: Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.. naltrexone : An organic heteropentacyclic compound that is naloxone substituted in which the allyl group attached to the nitrogen is replaced by a cyclopropylmethyl group. A mu-opioid receptor antagonist, it is used to treat alcohol dependence. | 2.42 | 2 | 0 | cyclopropanes; morphinane-like compound; organic heteropentacyclic compound | antidote to opioid poisoning; central nervous system depressant; environmental contaminant; mu-opioid receptor antagonist; xenobiotic |
| butorphanol Butorphanol: A synthetic morphinan analgesic with narcotic antagonist action. It is used in the management of severe pain.. butorphanol : Levorphanol in which a hydrogen at position 14 of the morphinan skeleton is substituted by hydroxy and one of the hydrogens of the N-methyl group is substituted by cyclopropyl. A semi-synthetic opioid agonist-antagonist analgesic, it is used as its (S,S)-tartaric acid salt for relief or moderate to severe pain. | 2.02 | 1 | 0 | morphinane alkaloid | antitussive; kappa-opioid receptor agonist; mu-opioid receptor agonist; opioid analgesic |
| cefixime [no description available] | 2.02 | 1 | 0 | cephalosporin | antibacterial drug; drug allergen |
| lisinopril Lisinopril: One of the ANGIOTENSIN-CONVERTING ENZYME INHIBITORS (ACE inhibitors), orally active, that has been used in the treatment of hypertension and congestive heart failure. | 2.02 | 1 | 0 | dipeptide | EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor |
| benazepril benazepril: structure given in first source. benazepril : A benzazepine that is benazeprilat in which the carboxy group of the 2-amino-4-phenylbutanoic acid moiety has been converted to the corresponding ethyl ester. It is used (generally as its hydrochloride salt) as a prodrug for the angiotensin-converting enzyme inhibitor benazeprilat in the treatment of hypertension and heart failure. | 2.02 | 1 | 0 | benzazepine; dicarboxylic acid monoester; ethyl ester; lactam | EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; prodrug |
| ramipril Ramipril: A long-acting angiotensin-converting enzyme inhibitor. It is a prodrug that is transformed in the liver to its active metabolite ramiprilat.. ramipril : A dipeptide that is the prodrug for ramiprilat, the active metabolite obtained by hydrolysis of the ethyl ester group. An angiotensin-converting enzyme (ACE) inhibitor, used to treat high blood pressure and congestive heart failure.. quark : Quarks comprise one of two classes of the fundamental particles. Quarks possess fractional electric charges and are not observed in free state. The word "quark" first appears in James Joyce's Finnegans Wake and has been chosen by Murray Gell-Mann as a name for fundamental building blocks of particles. | 2.02 | 1 | 0 | azabicycloalkane; cyclopentapyrrole; dicarboxylic acid monoester; dipeptide; ethyl ester | bradykinin receptor B2 agonist; cardioprotective agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; matrix metalloproteinase inhibitor; prodrug |
| indinavir sulfate Indinavir: A potent and specific HIV protease inhibitor that appears to have good oral bioavailability. | 2.02 | 1 | 0 | dicarboxylic acid diamide; N-(2-hydroxyethyl)piperazine; piperazinecarboxamide | HIV protease inhibitor |
| enalapril Enalapril: An angiotensin-converting enzyme inhibitor that is used to treat HYPERTENSION and HEART FAILURE.. enalapril : A dicarboxylic acid monoester that is ethyl 4-phenylbutanoate in which a hydrogen alpha to the carboxy group is substituted by the amino group of L-alanyl-L-proline (S-configuration). | 2.02 | 1 | 0 | dicarboxylic acid monoester; dipeptide | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; geroprotector; prodrug |
| cysteine Cysteine: A thiol-containing non-essential amino acid that is oxidized to form CYSTINE.. L-cysteinium : The L-enantiomer of cysteinium.. cysteine : A sulfur-containing amino acid that is propanoic acid with an amino group at position 2 and a sulfanyl group at position 3. | 1.93 | 1 | 0 | cysteinium | fundamental metabolite |
| phosphorus Phosphorus: A non-metal element that has the atomic symbol P, atomic number 15, and atomic weight 31. It is an essential element that takes part in a broad variety of biochemical reactions. | 2.65 | 3 | 0 | monoatomic phosphorus; nonmetal atom; pnictogen | macronutrient |
| cefuroxime [no description available] | 2.02 | 1 | 0 | 3-(carbamoyloxymethyl)cephalosporin; furans; oxime O-ether | drug allergen |
| ceftriaxone [no description available] | 2.02 | 1 | 0 | 1,2,4-triazines; 1,3-thiazoles; cephalosporin; oxime O-ether | antibacterial drug; drug allergen; EC 3.5.2.6 (beta-lactamase) inhibitor |
| cefepime Cefepime: A fourth-generation cephalosporin antibacterial agent that is used in the treatment of infections, including those of the abdomen, urinary tract, respiratory tract, and skin. It is effective against PSEUDOMONAS AERUGINOSA and may also be used in the empiric treatment of FEBRILE NEUTROPENIA.. cefepime : A cephalosporin bearing (1-methylpyrrolidinium-1-yl)methyl and (2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido groups at positions 3 and 7, respectively, of the cephem skeleton. | 2.02 | 1 | 0 | cephalosporin; oxime O-ether | antibacterial drug |
| ceftazidime [no description available] | 2.02 | 1 | 0 | cephalosporin; oxime O-ether | antibacterial drug; drug allergen; EC 2.4.1.129 (peptidoglycan glycosyltransferase) inhibitor |
| trandolapril trandolapril : A heterobicylic compound that is (2S,3aR,7aS)-1-[(2S)-2-aminopropanoyl]octahydro-1H-indole-2-carboxylic acid in which the hydrogen of the amino group is substituted by a (2R)-1-ethoxy-1-oxo-4-phenylbutan-2-yl group. It is a angiotensin-converting enzyme inhibitor and a prodrug used for the treatment of hypertension. | 2.02 | 1 | 0 | dicarboxylic acid monoester; dipeptide; ethyl ester; organic heterobicyclic compound; secondary amino compound; tertiary carboxamide | antihypertensive agent; EC 3.4.15.1 (peptidyl-dipeptidase A) inhibitor; prodrug |
| enkephalin, ala(2)-mephe(4)-gly(5)- Enkephalin, Ala(2)-MePhe(4)-Gly(5)-: An enkephalin analog that selectively binds to the MU OPIOID RECEPTOR. It is used as a model for drug permeability experiments. | 2.4 | 2 | 0 | ||
| guanabenz Guanabenz: An alpha-2 selective adrenergic agonist used as an antihypertensive agent. | 2.02 | 1 | 0 | dichlorobenzene | |
| famotidine [no description available] | 2.02 | 1 | 0 | 1,3-thiazoles; guanidines; sulfonamide | anti-ulcer drug; H2-receptor antagonist; P450 inhibitor |
| cefotaxime Cefotaxime: Semisynthetic broad-spectrum cephalosporin.. cefotaxime : A cephalosporin compound having acetoxymethyl and [2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino side groups. | 2.02 | 1 | 0 | 1,3-thiazoles; cephalosporin; oxime O-ether | antibacterial drug; drug allergen |
| aztreonam [no description available] | 2.02 | 1 | 0 | beta-lactam antibiotic allergen; monobactam | antibacterial drug; drug allergen; EC 2.4.1.129 (peptidoglycan glycosyltransferase) inhibitor |
| cci 15641 [no description available] | 2.02 | 1 | 0 | cephalosporin | |
| tetrodotoxin Tetrodotoxin: An aminoperhydroquinazoline poison found mainly in the liver and ovaries of fishes in the order TETRAODONTIFORMES, which are eaten. The toxin causes paresthesia and paralysis through interference with neuromuscular conduction.. tetrodotoxin : A quinazoline alkaloid that is a marine toxin isolated from fish such as puffer fish. It has been shown to exhibit potential neutotoxicity due to its ability to block voltage-gated sodium channels. | 2.41 | 2 | 0 | azatetracycloalkane; oxatetracycloalkane; quinazoline alkaloid | animal metabolite; bacterial metabolite; marine metabolite; neurotoxin; voltage-gated sodium channel blocker |
| cefpodoxime [no description available] | 2.02 | 1 | 0 | carboxylic acid; cephalosporin | antibacterial drug |
| dizocilpine maleate Dizocilpine Maleate: A potent noncompetitive antagonist of the NMDA receptor (RECEPTORS, N-METHYL-D-ASPARTATE) used mainly as a research tool. The drug has been considered for the wide variety of neurodegenerative conditions or disorders in which NMDA receptors may play an important role. Its use has been primarily limited to animal and tissue experiments because of its psychotropic effects.. dizocilpine maleate : A maleate salt obtained by reaction of dizocilpine with one equivalent of maleic acid. | 2.44 | 2 | 0 | maleate salt; tetracyclic antidepressant | anaesthetic; anticonvulsant; neuroprotective agent; nicotinic antagonist; NMDA receptor antagonist |
| luprostenol luprostenol: RN given refers to 1S-(1alpha(Z),2beta(*R),3alpha,5alpha)-isomer | 2.41 | 2 | 0 | ||
| oxepins Oxepins: Compounds based on a 7-membered heterocyclic ring including an oxygen. They can be considered a medium ring ether. A natural source is the MONTANOA plant genus. Some dibenzo-dioxepins, called depsidones, are found in GARCINIA plants. | 2.02 | 1 | 0 | ||
| dirithromycin [no description available] | 2.02 | 1 | 0 | macrolide antibiotic | prodrug |
| cefpodoxime proxetil cefpodoxime proxetil: structure given in first source; prodrug for cefpodoxime. cefpodoxime proxetil : The 1-[(isopropoxycarbonyl)oxy]ethyl (proxetil) ester prodrug of cefpodoxime. After swallowing, hydrolysis of the ester group occurs in the intestinal epithelium, to release active cefpodoxime in the bloodstream. It is used to treat acute otitis media, pharyngitis, and sinusitis. | 2.02 | 1 | 0 | carboxylic acid; carboxylic ester; cephalosporin | antibacterial drug; prodrug |
| ceftizoxime [no description available] | 2.02 | 1 | 0 | cephalosporin | antibacterial drug |
| nitrofurantoin Nitrofurantoin: A urinary anti-infective agent effective against most gram-positive and gram-negative organisms. Although sulfonamides and antibiotics are usually the agents of choice for urinary tract infections, nitrofurantoin is widely used for prophylaxis and long-term suppression.. nitrofurantoin : An imidazolidine-2,4-dione that is hydantoin substituted at position 1 by a [(5-nitro-2-furyl)methylene]amino group. An antibiotic that damages bacterial DNA. | 2.02 | 1 | 0 | imidazolidine-2,4-dione; nitrofuran antibiotic; organonitrogen heterocyclic antibiotic; organooxygen heterocyclic antibiotic | antibacterial drug; antiinfective agent; hepatotoxic agent |
| sb 269970 SB 269970: a 5-HT(7) antagonist; structure in first source | 2.03 | 1 | 0 | sulfonamide | |
| sb 334867-a 1-(2-methylbenzoxazol-6-yl)-3-(1,5)naphthyridin-4-yl urea: selective OX1 receptor antagonist | 2.01 | 1 | 0 | naphthyridine derivative | |
| ergoline Ergolines: A series of structurally-related alkaloids that contain the ergoline backbone structure.. ergoline : An indole alkaloid whose structural skeleton is found in many naturally occurring and synthetic ergolines which are known to bind to neurotransmitter receptors, such as dopamine, noradrenaline and serotonin receptors and function as unselective agonists or antagonists at these receptors. | 2.15 | 1 | 0 | diamine; ergoline alkaloid; indole alkaloid fundamental parent; indole alkaloid; organic heterotetracyclic compound | |
| adenosine-3',5'-cyclic phosphorothioate adenosine-3',5'-cyclic phosphorothioate: RP-cAMP-S is a protein kinase A inhibitor; SP-cAMP-S is a protein kinase A agonist. (Sp)-cAMPS : A nucleoside 3',5'-cyclic phosphorothioate having adenine as the nucleobase (the Sp-stereoisomer).. (Rp)-cAMPS : A nucleoside 3',5'-cyclic phosphorothioate having adenine as the nucleobase (the Rp-stereoisomer). | 2.04 | 1 | 0 | nucleoside 3',5'-cyclic phosphorothioate | |
| dantrolene [no description available] | 2.02 | 1 | 0 | ||
| epostane [no description available] | 1.99 | 1 | 0 | ||
| etonogestrel [no description available] | 2.04 | 1 | 0 | 17beta-hydroxy steroid; 3-oxo-Delta(4) steroid; terminal acetylenic compound | contraceptive drug; female contraceptive drug; progestin |
| vorozole vorozole: structure given in first source; vorozole/R 83842 is ((+)/dextro-isomer), RN 129731-10-8; R 83839 ((-)/levo-isomer) | 1.99 | 1 | 0 | benzotriazoles | |
| ru 58668 RU 58668: a steroidal antiestrogen; induces a long-term regression of human mammary MCF-7 tumors implanted in nude mice; structure given in first source. RU 58668 : A 17beta-hydroxy steroid that is 17beta-estradiol in the the hydrogen at the 11beta position has been replaced by a p-({5-[(4,4,5,5,5-pentafluoropentyl)sulfonyl]pentyl}oxy)phenyl group. RU 58668 is a pure anti-estrogen that downregulates estrogen receptor expression (IC50 = 0.04 nM). | 2.02 | 1 | 0 | 17beta-hydroxy steroid; 3-hydroxy steroid; aromatic ether; organofluorine compound; sulfone | anti-estrogen; antineoplastic agent; estrogen receptor antagonist |
| 19-norandrosterone 19-norandrosterone: major metabolite of 19-nortestosterone; RN given refers to cpd without isomeric designation | 2.04 | 1 | 0 | 17-oxo steroid | metabolite |
| chlorhexidine Chlorhexidine: A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.. chlorhexidine : A bisbiguanide compound with a structure consisting of two (p-chlorophenyl)guanide units linked by a hexamethylene bridge. | 3.38 | 1 | 1 | biguanides; monochlorobenzenes | antibacterial agent; antiinfective agent |
| fosinopril [no description available] | 2.02 | 1 | 0 | ||
| telapristone acetate telapristone acetate: structure in first source | 2.49 | 2 | 0 | steroid ester | |
| norgestomet norgestomet: synthetic 19-norprogesterone that synchronizes estrus in cattle without reducing fertility; affects pituitary gonadotropins & the menstrual cycle in humans; minor descriptor (79-86), on-line & INDEX MEDICUS search PREGNENEDIONES (79-86); RN given refers to (11beta)-isomer | 5.61 | 6 | 3 | ||
| sincalide Sincalide: An octapeptide hormone present in the intestine and brain. When secreted from the gastric mucosa, it stimulates the release of bile from the gallbladder and digestive enzymes from the pancreas. | 1.98 | 1 | 0 | oligopeptide | |
| mocetinostat mocetinostat: undergoing phase II clinical trials for treatment of cancer. mocetinostat : A benzamide obtained by formal condensation of the carboxy group of 4-({[4-(pyridin-3-yl)pyrimidin-2-yl]amino}methyl)benzoic acid with one of the amino groups of benzene-1,2-diamine. It is an orally active and isotype-selective HDAC inhibitor which exhibits antitumour activity (IC50 = 0.15, 0.29, 1.66 and 0.59 muM for HDAC1, HDAC2, HDAC3 and HDAC11). | 2.42 | 2 | 0 | aminopyrimidine; benzamides; pyridines; secondary amino compound; secondary carboxamide; substituted aniline | antineoplastic agent; apoptosis inducer; autophagy inducer; cardioprotective agent; EC 3.5.1.98 (histone deacetylase) inhibitor; hepatotoxic agent |
| altrenogest altrenogest: a synthetic PROGESTERONE agonist; used in estrus synchronization | 2.73 | 3 | 0 | 3-hydroxy steroid | |
| oxadiazoles Oxadiazoles: Compounds containing five-membered heteroaromatic rings containing two carbons, two nitrogens, and one oxygen atom which exist in various regioisomeric forms. | 2.05 | 1 | 0 | ||
| 4-(2-phenyl-5,7-bis(trifluoromethyl)pyrazolo(1,5-a)pyrimidin-3-yl)phenol 4-(2-phenyl-5,7-bis(trifluoromethyl)pyrazolo(1,5-a)pyrimidin-3-yl)phenol: a selective estrogen receptor modulator | 2.11 | 1 | 0 | pyrazoles; ring assembly | |
| nystatin a1 Nystatin: Macrolide antifungal antibiotic complex produced by Streptomyces noursei, S. aureus, and other Streptomyces species. The biologically active components of the complex are nystatin A1, A2, and A3.. nystatin : A heterogeneous mixture of polyene compounds produced by cultures of Streptomyces noursei. It mainly consists of three biologically active components designated nystatin A1, nystatin A2, and nystatin A3. It is used to treat oral and dermal fungal infections.. nystatin A1 : A polyene macrolide antibiotic; part of the nystatin complex produced by several Streptomyces species. It is an antifungal antibiotic used for the treatment of topical fungal infections caused by a broad spectrum of fungal pathogens comprising yeast-like and filamentous species. | 2.02 | 1 | 0 | nystatins | |
| calcimycin Calcimycin: An ionophorous, polyether antibiotic from Streptomyces chartreusensis. It binds and transports CALCIUM and other divalent cations across membranes and uncouples oxidative phosphorylation while inhibiting ATPase of rat liver mitochondria. The substance is used mostly as a biochemical tool to study the role of divalent cations in various biological systems. | 2 | 1 | 0 | benzoxazole | |
| scopolamine hydrobromide [no description available] | 1.99 | 1 | 0 | ||
| pituitrin Pituitrin: A substance or extract from the neurohypophysis (PITUITARY GLAND, POSTERIOR). | 2.41 | 2 | 0 | ||
| tenuigenin tenuigenin: decreases secretion of the Alzheimer's disease amyloid beta-protein in cultured cells | 2.08 | 1 | 0 | 12alpha-hydroxy steroid | |
| acid phosphatase Acid Phosphatase: An enzyme that catalyzes the conversion of an orthophosphoric monoester and water to an alcohol and orthophosphate. EC 3.1.3.2. | 3.31 | 2 | 0 | ||
| ferrous citrate ferrous citrate: iron fortificant | 2.05 | 1 | 0 | ||
| nad NAD(1-) : An anionic form of nicotinamide adenine dinucleotide arising from deprotonation of the two OH groups of the diphosphate moiety. | 2.04 | 1 | 0 | organophosphate oxoanion | cofactor; human metabolite; hydrogen acceptor; Saccharomyces cerevisiae metabolite |
| cytochrome c-t Cytochromes c: Cytochromes of the c type that are found in eukaryotic MITOCHONDRIA. They serve as redox intermediates that accept electrons from MITOCHONDRIAL ELECTRON TRANSPORT COMPLEX III and transfer them to MITOCHONDRIAL ELECTRON TRANSPORT COMPLEX IV. | 2.82 | 2 | 0 | ||
| cholecystokinin Cholecystokinin: A peptide, of about 33 amino acids, secreted by the upper INTESTINAL MUCOSA and also found in the central nervous system. It causes gallbladder contraction, release of pancreatic exocrine (or digestive) enzymes, and affects other gastrointestinal functions. Cholecystokinin may be the mediator of satiety. | 2.72 | 3 | 0 | ||
| dynorphins Dynorphins: A class of opioid peptides including dynorphin A, dynorphin B, and smaller fragments of these peptides. Dynorphins prefer kappa-opioid receptors (RECEPTORS, OPIOID, KAPPA) and have been shown to play a role as central nervous system transmitters. | 3.45 | 2 | 0 | ||
| atrial natriuretic factor Atrial Natriuretic Factor: A potent natriuretic and vasodilatory peptide or mixture of different-sized low molecular weight PEPTIDES derived from a common precursor and secreted mainly by the HEART ATRIUM. All these peptides share a sequence of about 20 AMINO ACIDS. | 2.45 | 2 | 0 | polypeptide | |
| iturelix iturelix: a gonadotropin-releasing hormone antagonist | 2.25 | 1 | 0 | ||
| beta-endorphin beta-Endorphin: A 31-amino acid peptide that is the C-terminal fragment of BETA-LIPOTROPIN. It acts on OPIOID RECEPTORS and is an analgesic. Its first four amino acids at the N-terminal are identical to the tetrapeptide sequence of METHIONINE ENKEPHALIN and LEUCINE ENKEPHALIN.. beta-endorphin : A polypeptide consisting of 31 amino acid residues in the sequence Tyr-Gly-Gly-Phe-Met-Thr-Ser-Glu-Lys-Ser-Gln-Thr-Pro-Leu-Val-Thr-Leu-Phe-Lys-Asn-Ala-Ile-Ile-Lys-Asn-Ala-Tyr-Lys-Lys-Gly-Glu. It is an endogenous opioid peptide neurotransmitter found in the neurons of both the central and peripheral nervous system and results from processing of the precursor protein proopiomelanocortin (POMC). | 2.43 | 2 | 0 | ||
| neuropeptide y Neuropeptide Y: A 36-amino acid peptide present in many organs and in many sympathetic noradrenergic neurons. It has vasoconstrictor and natriuretic activity and regulates local blood flow, glandular secretion, and smooth muscle activity. The peptide also stimulates feeding and drinking behavior and influences secretion of pituitary hormones. | 3.53 | 8 | 0 | ||
| angiotensinogen Angiotensinogen: An alpha-globulin of about 453 amino acids, depending on the species. It is produced by the liver in response to lowered blood pressure and secreted into blood circulation. Angiotensinogen is the inactive precursor of the ANGIOTENSINS produced in the body by successive enzyme cleavages. Cleavage of angiotensinogen by RENIN yields the decapeptide ANGIOTENSIN I. Further cleavage of angiotensin I (by ANGIOTENSIN CONVERTING ENZYME) yields the potent vasoconstrictor octapeptide ANGIOTENSIN II; and then, via other enzymes, other angiotensins also involved in the hemodynamic-regulating RENIN-ANGIOTENSIN SYSTEM. | 2.02 | 1 | 0 | ||
| glucagon-like peptide 1 Glucagon-Like Peptide 1: A peptide of 36 or 37 amino acids that is derived from PROGLUCAGON and mainly produced by the INTESTINAL L CELLS. GLP-1(1-37 or 1-36) is further N-terminally truncated resulting in GLP-1(7-37) or GLP-1-(7-36) which can be amidated. These GLP-1 peptides are known to enhance glucose-dependent INSULIN release, suppress GLUCAGON release and gastric emptying, lower BLOOD GLUCOSE, and reduce food intake. | 2.15 | 1 | 0 | ||
| lhrh, n-ac-2-nal(1)-4-cl-phe(2)-trp(3)-hci(6)-alanh2(10)- LHRH, N-Ac-2-Nal(1)-4-Cl-Phe(2)-Trp(3)-Hci(6)-AlaNH2(10)-: RN given refers to (D-Ala-D-Phe-D-Trp-L-Ser-L-Tyr-D-Lys-L-Leu-L-Arg-L-Pro-D-Ala)-isomer; RN for cpd without isomeric designation not avail 10/90; LHRH antagonist | 1.98 | 1 | 0 | ||
| endothelin-1 Endothelin-1: A 21-amino acid peptide produced in a variety of tissues including endothelial and vascular smooth-muscle cells, neurons and astrocytes in the central nervous system, and endometrial cells. It acts as a modulator of vasomotor tone, cell proliferation, and hormone production. (N Eng J Med 1995;333(6):356-63) | 2.07 | 1 | 0 | ||
| sapogenins Sapogenins: The aglucon moiety of a saponin molecule. It may be triterpenoid or steroid, usually spirostan, in nature. | 2.49 | 2 | 0 | ||
| mesna Mesna: A sulfhydryl compound used to prevent urothelial toxicity by inactivating metabolites from ANTINEOPLASTIC AGENTS, such as IFOSFAMIDE or CYCLOPHOSPHAMIDE. | 2.02 | 1 | 0 | organosulfonic acid | |
| bucladesine Bucladesine: A cyclic nucleotide derivative that mimics the action of endogenous CYCLIC AMP and is capable of permeating the cell membrane. It has vasodilator properties and is used as a cardiac stimulant. (From Merck Index, 11th ed). bucladesine : A 3',5'-cyclic purine nucleotide that is the 2'-butanoate ester and 6-N-butanoyl derivative of 3',5'-cyclic AMP. | 2 | 1 | 0 | 3',5'-cyclic purine nucleotide | |
| cefamandole nafate [no description available] | 2.02 | 1 | 0 | organic sodium salt | antibacterial drug; prodrug |
| sodium glutamate Sodium Glutamate: One of the FLAVORING AGENTS used to impart a meat-like flavor.. monosodium glutamate : An organic sodium salt that is the monosodium salt of glutamic acid. | 2.31 | 1 | 0 | monosodium glutamate | flavouring agent |
| picrotoxin Picrotoxin: A noncompetitive antagonist at GABA-A receptors and thus a convulsant. Picrotoxin blocks the GAMMA-AMINOBUTYRIC ACID-activated chloride ionophore. Although it is most often used as a research tool, it has been used as a CNS stimulant and an antidote in poisoning by CNS depressants, especially the barbiturates.. picrotoxin : A mixture consisting of equimolar amounts of picrotoxinin and picrotin found in the climbing plant Anamirta cocculus. | 2.02 | 1 | 0 | ||
| insulin, isophane Insulin, Isophane: An intermediate-acting INSULIN preparation with onset time of 2 hours and duration of 24 hours. It is produced by crystallizing ZINC-insulin-PROTAMINES at neutral pH 7. Thus it is called neutral protamine Hagedorn for inventor Hans Christian Hagedorn. | 2.05 | 1 | 0 | ||
| 1229u91 1229U91: a selective neuropeptide Y-Y1 receptor antagonist; structure given in first source | 2 | 1 | 0 | ||
| neurotensin neurotensin, Tyr(11)-: RN given refers to parent cpd & (D)-isomer; RN for cpd without isomeric designation not avail 5/91 | 2 | 1 | 0 | peptide hormone | human metabolite; mitogen; neurotransmitter; vulnerary |
| lgd 3303 9-chloro-2-ethyl-1-methyl-3-(2,2,2-trifluoroethyl)-3H-pyrrolo(3,2-f)quinolin-7(6H)-one: an androgen receptor modulator; structure in first source | 2.05 | 1 | 0 | ||
| glycolipids [no description available] | 2.25 | 1 | 0 | ||
| piperidines Piperidines: A family of hexahydropyridines. | 2.41 | 2 | 0 | ||
| tylosin [no description available] | 2.05 | 1 | 0 | ||
| vasoactive intestinal peptide Vasoactive Intestinal Peptide: A highly basic, 28 amino acid neuropeptide released from intestinal mucosa. It has a wide range of biological actions affecting the cardiovascular, gastrointestinal, and respiratory systems and is neuroprotective. It binds special receptors (RECEPTORS, VASOACTIVE INTESTINAL PEPTIDE). | 2 | 1 | 0 | ||
| natriuretic peptide, brain Natriuretic Peptide, Brain: A PEPTIDE that is secreted by the BRAIN and the HEART ATRIA, stored mainly in cardiac ventricular MYOCARDIUM. It can cause NATRIURESIS; DIURESIS; VASODILATION; and inhibits secretion of RENIN and ALDOSTERONE. It improves heart function. It contains 32 AMINO ACIDS. | 2.02 | 1 | 0 | polypeptide | |
| neuromedin b neuromedin B: decapeptide isolated from porcine spinal cord | 2.01 | 1 | 0 | ||
| ascorbic acid Ascorbic Acid: A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.. L-ascorbic acid : The L-enantiomer of ascorbic acid and conjugate acid of L-ascorbate.. L-ascorbate : The L-enantiomer of ascorbate and conjugate base of L-ascorbic acid, arising from selective deprotonation of the 3-hydroxy group. Required for a range of essential metabolic reactions in all animals and plants.. vitamin C : Any member of a group of vitamers that belong to the chemical structural class called butenolides that exhibit biological activity against vitamin C deficiency in animals. The vitamers include L-ascorbic acid and its salt, ionized and oxidized forms. | 2.08 | 1 | 0 | ascorbic acid; vitamin C | coenzyme; cofactor; flour treatment agent; food antioxidant; food colour retention agent; geroprotector; plant metabolite; skin lightening agent |
| tetracycline Tetracycline: A naphthacene antibiotic that inhibits AMINO ACYL TRNA binding during protein synthesis.. tetracycline : A broad-spectrum polyketide antibiotic produced by the Streptomyces genus of actinobacteria. | 2.02 | 1 | 0 | ||
| oxytetracycline, anhydrous Oxytetracycline: A TETRACYCLINE analog isolated from the actinomycete STREPTOMYCES RIMOSUS and used in a wide variety of clinical conditions.. oxytetracycline : A tetracycline used for treatment of infections caused by a variety of Gram positive and Gram negative microorganisms including Mycoplasma pneumoniae, Pasteurella pestis, Escherichia coli, Haemophilus influenzae (respiratory infections), and Diplococcus pneumoniae. | 2.41 | 2 | 0 | ||
| minocycline Minocycline: A TETRACYCLINE analog, having a 7-dimethylamino and lacking the 5 methyl and hydroxyl groups, which is effective against tetracycline-resistant STAPHYLOCOCCUS infections.. minocycline : A tetracycline analogue having a dimethylamino group at position 7 and lacking the methyl and hydroxy groups at position 5. | 2.02 | 1 | 0 | ||
| piroxicam [no description available] | 2.42 | 2 | 0 | benzothiazine; monocarboxylic acid amide; pyridines | analgesic; antirheumatic drug; cyclooxygenase 1 inhibitor; EC 1.14.99.1 (prostaglandin-endoperoxide synthase) inhibitor; non-steroidal anti-inflammatory drug |
| meclocycline [no description available] | 2.02 | 1 | 0 | ||
| mobic Meloxicam: A benzothiazine and thiazole derivative that acts as a NSAID and cyclooxygenase-2 (COX-2) inhibitor. It is used in the treatment of RHEUMATOID ARTHRITIS; OSTEOARTHRITIS; and ANKYLOSING SPONDYLITIS.. meloxicam : A benzothiazine that is piroxicam in which the pyridin-2-yl group is replaced by a 5-methyl-1,3-thiazol-2-yl group. A non-steroidal anti-inflammatory drug and selective inhibitor of COX-2, it is used particularly for the management of rheumatoid arthritis. | 2.13 | 1 | 0 | 1,3-thiazoles; benzothiazine; monocarboxylic acid amide | analgesic; antirheumatic drug; cyclooxygenase 2 inhibitor; non-steroidal anti-inflammatory drug |
| warfarin Warfarin: An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.. warfarin : A racemate comprising equal amounts of (R)- and (S)-warfarin. Extensively used as both an anticoagulant drug and as a pesticide against rats and mice.. 4-hydroxy-3-(3-oxo-1-phenylbutyl)-1-benzopyran-2-one : A member of the class of coumarins that is 4-hydroxycoumarin which is substituted at position 3 by a 1-phenyl-3-oxo-1-butyl group. | 2.02 | 1 | 0 | benzenes; hydroxycoumarin; methyl ketone | |
| estradiol benzoate, progesterone drug combination estradiol benzoate, progesterone drug combination: contains estradiol benzoate & progesterone | 2.52 | 2 | 0 | ||
| epidermal growth factor Epidermal Growth Factor: A 6-kDa polypeptide growth factor initially discovered in mouse submaxillary glands. Human epidermal growth factor was originally isolated from urine based on its ability to inhibit gastric secretion and called urogastrone. Epidermal growth factor exerts a wide variety of biological effects including the promotion of proliferation and differentiation of mesenchymal and EPITHELIAL CELLS. It is synthesized as a transmembrane protein which can be cleaved to release a soluble active form. | 4.23 | 5 | 0 | ||
| transforming growth factor beta Transforming Growth Factor beta: A factor synthesized in a wide variety of tissues. It acts synergistically with TGF-alpha in inducing phenotypic transformation and can also act as a negative autocrine growth factor. TGF-beta has a potential role in embryonal development, cellular differentiation, hormone secretion, and immune function. TGF-beta is found mostly as homodimer forms of separate gene products TGF-beta1, TGF-beta2 or TGF-beta3. Heterodimers composed of TGF-beta1 and 2 (TGF-beta1.2) or of TGF-beta2 and 3 (TGF-beta2.3) have been isolated. The TGF-beta proteins are synthesized as precursor proteins. | 2.15 | 1 | 0 | ||
| phytoestrogens Phytoestrogens: Compounds derived from plants, primarily ISOFLAVONES that mimic or modulate endogenous estrogens, usually by binding to ESTROGEN RECEPTORS. | 3.64 | 9 | 0 | ||
| lecirelin [no description available] | 3.46 | 1 | 1 | ||
| kiss1 protein, human Kisspeptins: Intercellular signaling peptides that were originally characterized by their ability to suppress NEOPLASM METASTASIS. Kisspeptins have since been found to play an important role in the neuroendocrine regulation of REPRODUCTION. | 5.44 | 13 | 1 | ||
| angiotensin i Angiotensin I: A decapeptide that is cleaved from precursor angiotensinogen by RENIN. Angiotensin I has limited biological activity. It is converted to angiotensin II, a potent vasoconstrictor, after the removal of two amino acids at the C-terminal by ANGIOTENSIN CONVERTING ENZYME.. angiotensin I : A ten amino acid peptide formed by renin cleavage of angiotensinogen. Angiotensin I has no direct biological function except that high levels can stimulate catecholamine production. It is metabolized to its biologically active byproduct angiotensin II, a potent vasoconstrictor, by angiotensin converting enzyme (ACE) through cleavage of the two terminal amino acids.. angiotensin I dizwitterion : A peptide zwitterion that is the dizwitterionic form of angiotensin I having both carboxy groups deprotonated and the aspartyl amino group and arginine side-chain protonated. It is the major species at pH 7.3. | 2.01 | 1 | 0 | angiotensin; peptide zwitterion | human metabolite; neurotransmitter agent |
| lactoferrin Lactoferrin: An iron-binding protein that was originally characterized as a milk protein. It is widely distributed in secretory fluids and is found in the neutrophilic granules of LEUKOCYTES. The N-terminal part of lactoferrin possesses a serine protease which functions to inactivate the TYPE III SECRETION SYSTEM used by bacteria to export virulence proteins for host cell invasion. | 2.15 | 1 | 0 | ||
| apyrase Apyrase: A calcium-activated enzyme that catalyzes the hydrolysis of ATP to yield AMP and orthophosphate. It can also act on ADP and other nucleoside triphosphates and diphosphates. EC 3.6.1.5. | 2.21 | 1 | 0 | ||
| chondroitin sulfates Chondroitin Sulfates: Derivatives of chondroitin which have a sulfate moiety esterified to the galactosamine moiety of chondroitin. Chondroitin sulfate A, or chondroitin 4-sulfate, and chondroitin sulfate C, or chondroitin 6-sulfate, have the sulfate esterified in the 4- and 6-positions, respectively. Chondroitin sulfate B (beta heparin; DERMATAN SULFATE) is a misnomer and this compound is not a true chondroitin sulfate. | 1.93 | 1 | 0 | ||
| acyclovir Acyclovir: A GUANOSINE analog that acts as an antimetabolite. Viruses are especially susceptible. Used especially against herpes.. acyclovir : An oxopurine that is guanine substituted by a (2-hydroxyethoxy)methyl substituent at position 9. Used in the treatment of viral infections. | 2.02 | 1 | 0 | 2-aminopurines; oxopurine | antimetabolite; antiviral drug |
| cyclic gmp Cyclic GMP: Guanosine cyclic 3',5'-(hydrogen phosphate). A guanine nucleotide containing one phosphate group which is esterified to the sugar moiety in both the 3'- and 5'-positions. It is a cellular regulatory agent and has been described as a second messenger. Its levels increase in response to a variety of hormones, including acetylcholine, insulin, and oxytocin and it has been found to activate specific protein kinases. (From Merck Index, 11th ed). 3',5'-cyclic GMP : A 3',5'-cyclic purine nucleotide in which the purine nucleobase is specified as guanidine. | 1.99 | 1 | 0 | 3',5'-cyclic purine nucleotide; guanyl ribonucleotide | Escherichia coli metabolite; human metabolite; mouse metabolite; plant metabolite; Saccharomyces cerevisiae metabolite |
| sapropterin sapropterin: RN given refers to parent cpd; co-factor required for catalytic activity of nitric oxide synthases. (6R)-5,6,7,8-tetrahydrobiopterin : A 5,6,7,8-tetrahydrobiopterin in which the stereocentre at position 6 has R-configuration.. sapropterin : A tetrahydropterin that is 2-amino-5,6,7,8-tetrahydropteridin-4(3H)-one in which a hydrogen at position 6 is substituted by a 1,2-dihydroxypropyl group (6R,1'R,2'S-enantiomer). | 2.02 | 1 | 0 | 5,6,7,8-tetrahydrobiopterin | coenzyme; cofactor; diagnostic agent; human metabolite |
| guanosine 5'-o-(3-thiotriphosphate) Guanosine 5'-O-(3-Thiotriphosphate): Guanosine 5'-(trihydrogen diphosphate), monoanhydride with phosphorothioic acid. A stable GTP analog which enjoys a variety of physiological actions such as stimulation of guanine nucleotide-binding proteins, phosphoinositide hydrolysis, cyclic AMP accumulation, and activation of specific proto-oncogenes. | 2.01 | 1 | 0 | nucleoside triphosphate analogue | |
| rifampin Rifampin: A semisynthetic antibiotic produced from Streptomyces mediterranei. It has a broad antibacterial spectrum, including activity against several forms of Mycobacterium. In susceptible organisms it inhibits DNA-dependent RNA polymerase activity by forming a stable complex with the enzyme. It thus suppresses the initiation of RNA synthesis. Rifampin is bactericidal, and acts on both intracellular and extracellular organisms. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p1160) | 2.02 | 1 | 0 | cyclic ketal; hydrazone; N-iminopiperazine; N-methylpiperazine; rifamycins; semisynthetic derivative; zwitterion | angiogenesis inhibitor; antiamoebic agent; antineoplastic agent; antitubercular agent; DNA synthesis inhibitor; EC 2.7.7.6 (RNA polymerase) inhibitor; Escherichia coli metabolite; geroprotector; leprostatic drug; neuroprotective agent; pregnane X receptor agonist; protein synthesis inhibitor |
| clozapine Clozapine: A tricylic dibenzodiazepine, classified as an atypical antipsychotic agent. It binds several types of central nervous system receptors, and displays a unique pharmacological profile. Clozapine is a serotonin antagonist, with strong binding to 5-HT 2A/2C receptor subtype. It also displays strong affinity to several dopaminergic receptors, but shows only weak antagonism at the dopamine D2 receptor, a receptor commonly thought to modulate neuroleptic activity. Agranulocytosis is a major adverse effect associated with administration of this agent.. clozapine : A benzodiazepine that is 5H-dibenzo[b,e][1,4]diazepine substituted by a chloro group at position 8 and a 4-methylpiperazin-1-yl group at position 11. It is a second generation antipsychotic used in the treatment of psychiatric disorders like schizophrenia. | 2.02 | 1 | 0 | benzodiazepine; N-arylpiperazine; N-methylpiperazine; organochlorine compound | adrenergic antagonist; dopaminergic antagonist; EC 3.4.21.26 (prolyl oligopeptidase) inhibitor; environmental contaminant; GABA antagonist; histamine antagonist; muscarinic antagonist; second generation antipsychotic; serotonergic antagonist; xenobiotic |
| didanosine Didanosine: A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by a hydrogen. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. Didanosine is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA by binding to reverse transcriptase; ddI is then metabolized to dideoxyadenosine triphosphate, its putative active metabolite.. didanosine : A purine 2',3'-dideoxyribonucleoside that is inosine in which the hydroxy groups at both the 2' and the 3' positions on the sugar moiety have been replaced by hydrogen. An antiviral drug, it is used as a medication to treat HIV/AIDS. | 2.02 | 1 | 0 | purine 2',3'-dideoxyribonucleoside | antimetabolite; antiviral drug; EC 2.4.2.1 (purine-nucleoside phosphorylase) inhibitor; geroprotector; HIV-1 reverse transcriptase inhibitor |
| ganciclovir [no description available] | 2.02 | 1 | 0 | 2-aminopurines; oxopurine | antiinfective agent; antiviral drug |
| valacyclovir Valacyclovir: A prodrug of acyclovir that is used in the treatment of HERPES ZOSTER and HERPES SIMPLEX VIRUS INFECTION of the skin and mucous membranes, including GENITAL HERPES. | 2.02 | 1 | 0 | L-valyl ester | antiviral drug |
| olanzapine Olanzapine: A benzodiazepine derivative that binds SEROTONIN RECEPTORS; MUSCARINIC RECEPTORS; HISTAMINE H1 RECEPTORS; ADRENERGIC ALPHA-1 RECEPTORS; and DOPAMINE RECEPTORS. It is an antipsychotic agent used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER; and MAJOR DEPRESSIVE DISORDER; it may also reduce nausea and vomiting in patients undergoing chemotherapy.. olanzapine : A benzodiazepine that is 10H-thieno[2,3-b][1,5]benzodiazepine substituted by a methyl group at position 2 and a 4-methylpiperazin-1-yl group at position 4. | 2.02 | 1 | 0 | benzodiazepine; N-arylpiperazine; N-methylpiperazine | antiemetic; dopaminergic antagonist; histamine antagonist; muscarinic antagonist; second generation antipsychotic; serotonergic antagonist; serotonin uptake inhibitor |
| penciclovir penciclovir : A member of the class of 2-aminopurines that is guanine in which the hydrogen at position 9 is substituted by a 4-hydroxy-3-(hydroxymethyl)but-1-yl group. An antiviral drug, it is administered topically for treatment of herpes labialis. A prodrug, famciclovir, is used for oral administration. | 2.02 | 1 | 0 | 2-aminopurines; propane-1,3-diols | antiviral drug |
| allopurinol Allopurinol: A XANTHINE OXIDASE inhibitor that decreases URIC ACID production. It also acts as an antimetabolite on some simpler organisms.. allopurinol : A bicyclic structure comprising a pyrazole ring fused to a hydroxy-substituted pyrimidine ring. | 2.02 | 1 | 0 | nucleobase analogue; organic heterobicyclic compound | antimetabolite; EC 1.17.3.2 (xanthine oxidase) inhibitor; gout suppressant; radical scavenger |
| rifabutin [no description available] | 2.02 | 1 | 0 | ||
| way 200070 WAY 200070: a neuroprotective agent; structure in first source | 2.48 | 2 | 0 | ||
| trypan blue Trypan Blue: A diazo-naphthalene sulfonate that is widely used as a stain.. trypan blue : An organosulfonate salt that is the tetrasodium salt of 3,3'-[(3,3'-dimethylbiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis(5-amino-4-hydroxynaphthalene-2,7-disulfonic acid). | 1.93 | 1 | 0 | ||
| alcian blue Alcian Blue: A copper-containing dye used as a gelling agent for lubricants, for staining of bacteria and for the dyeing of histiocytes and fibroblasts in vivo. | 2.08 | 1 | 0 | ||
| leptin Leptin: A 16-kDa peptide hormone secreted from WHITE ADIPOCYTES. Leptin serves as a feedback signal from fat cells to the CENTRAL NERVOUS SYSTEM in regulation of food intake, energy balance, and fat storage. | 3.41 | 7 | 0 |
| Condition | Indicated | Relationship Strength | Studies | Trials |
|---|---|---|---|---|
| Breast Cancer [description not available] | 0 | 2.35 | 2 | 0 |
| Breast Neoplasms Tumors or cancer of the human BREAST. | 0 | 2.35 | 2 | 0 |
| Adverse Drug Event [description not available] | 0 | 2.02 | 1 | 0 |
| Drug-Related Side Effects and Adverse Reactions Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals. | 0 | 2.02 | 1 | 0 |
| Innate Inflammatory Response [description not available] | 0 | 5.69 | 10 | 2 |
| Inflammation A pathological process characterized by injury or destruction of tissues caused by a variety of cytologic and chemical reactions. It is usually manifested by typical signs of pain, heat, redness, swelling, and loss of function. | 0 | 5.69 | 10 | 2 |
| Congenital Zika Syndrome [description not available] | 0 | 2.25 | 1 | 0 |
| Disease Models, Animal Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases. | 0 | 5.2 | 45 | 0 |
| Zika Virus Infection A viral disease transmitted by the bite of AEDES mosquitoes infected with ZIKA VIRUS. Its mild DENGUE-like symptoms include fever, rash, headaches and ARTHRALGIA. The viral infection during pregnancy, in rare cases, is associated with congenital brain and ocular abnormalities, called Congenital Zika Syndrome, including MICROCEPHALY and may also lead to GUILLAIN-BARRE SYNDROME. | 0 | 2.25 | 1 | 0 |
| Cancer of Pituitary [description not available] | 0 | 2.72 | 3 | 0 |
| Adenoma, Prolactin-Secreting, Pituitary [description not available] | 0 | 2.49 | 2 | 0 |
| Pituitary Neoplasms Neoplasms which arise from or metastasize to the PITUITARY GLAND. The majority of pituitary neoplasms are adenomas, which are divided into non-secreting and secreting forms. Hormone producing forms are further classified by the type of hormone they secrete. Pituitary adenomas may also be characterized by their staining properties (see ADENOMA, BASOPHIL; ADENOMA, ACIDOPHIL; and ADENOMA, CHROMOPHOBE). Pituitary tumors may compress adjacent structures, including the HYPOTHALAMUS, several CRANIAL NERVES, and the OPTIC CHIASM. Chiasmal compression may result in bitemporal HEMIANOPSIA. | 0 | 2.72 | 3 | 0 |
| Sex Disorders [description not available] | 0 | 2.79 | 3 | 0 |
| Sexual Dysfunction, Physiological Physiological disturbances in normal sexual performance in either the male or the female. | 0 | 2.79 | 3 | 0 |
| Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. | 0 | 12.79 | 177 | 43 |
| Lordosis The anterior concavity in the curvature of the lumbar and cervical spine as viewed from the side. The term usually refers to abnormally increased curvature (hollow back, saddle back, swayback). It does not include lordosis as normal mating posture in certain animals ( = POSTURE + SEX BEHAVIOR, ANIMAL). | 0 | 3.06 | 4 | 0 |
| Equine Diseases [description not available] | 0 | 3.8 | 1 | 1 |
| Anovulation Suspension or cessation of OVULATION in animals or humans with follicle-containing ovaries (OVARIAN FOLLICLE). Depending on the etiology, OVULATION may be induced with appropriate therapy. | 0 | 4.72 | 3 | 2 |
| Liver Steatosis [description not available] | 0 | 3.99 | 1 | 1 |
| Bleeding [description not available] | 0 | 3.99 | 1 | 1 |
| Fatty Liver Lipid infiltration of the hepatic parenchymal cells resulting in a yellow-colored liver. The abnormal lipid accumulation is usually in the form of TRIGLYCERIDES, either as a single large droplet or multiple small droplets. Fatty liver is caused by an imbalance in the metabolism of FATTY ACIDS. | 0 | 3.99 | 1 | 1 |
| Hemorrhage Bleeding or escape of blood from a vessel. | 0 | 3.99 | 1 | 1 |
| Atypical Endometrial Hyperplasia A benign form of endometrial hyperplasia with increased number of cells with atypia. The atypical cells are large and irregular and have an increased nuclear/cytoplasmic ratio. The risk of progression to endometrial carcinoma rises with the increasing degree of cell atypia. | 0 | 3.23 | 5 | 0 |
| Endometrial Hyperplasia Benign proliferation of the ENDOMETRIUM in the UTERUS. Endometrial hyperplasia is classified by its cytology and glandular tissue. There are simple, complex (adenomatous without atypia), and atypical hyperplasia representing also the ascending risk of becoming malignant. | 0 | 3.23 | 5 | 0 |
| Impaired Glucose Tolerance [description not available] | 0 | 2.6 | 1 | 0 |
| Glucose Intolerance A pathological state in which BLOOD GLUCOSE level is less than approximately 140 mg/100 ml of PLASMA at fasting, and above approximately 200 mg/100 ml plasma at 30-, 60-, or 90-minute during a GLUCOSE TOLERANCE TEST. This condition is seen frequently in DIABETES MELLITUS, but also occurs with other diseases and MALNUTRITION. | 0 | 2.6 | 1 | 0 |
| Disease Exacerbation [description not available] | 0 | 2.76 | 3 | 0 |
| Bone Loss, Perimenopausal [description not available] | 0 | 2.21 | 1 | 0 |
| Osteoporosis, Postmenopausal Metabolic disorder associated with fractures of the femoral neck, vertebrae, and distal forearm. It occurs commonly in women within 15-20 years after menopause, and is caused by factors associated with menopause including estrogen deficiency. | 0 | 2.21 | 1 | 0 |
| Canine Diseases [description not available] | 0 | 4.14 | 3 | 1 |
| Adenoma, Prostatic [description not available] | 0 | 4.34 | 4 | 1 |
| Prostatic Hyperplasia Increase in constituent cells in the PROSTATE, leading to enlargement of the organ (hypertrophy) and adverse impact on the lower urinary tract function. This can be caused by increased rate of cell proliferation, reduced rate of cell death, or both. | 0 | 4.34 | 4 | 1 |
| Body Weight The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms. | 0 | 6.75 | 55 | 1 |
| Calcification, Pathologic [description not available] | 0 | 2.21 | 1 | 0 |
| Calcinosis Pathologic deposition of calcium salts in tissues. | 0 | 2.21 | 1 | 0 |
| Menstruation, Painful [description not available] | 0 | 3.4 | 6 | 0 |
| Dysmenorrhea Painful menstruation. | 0 | 3.4 | 6 | 0 |
| Cancer of Prostate [description not available] | 0 | 3.69 | 3 | 0 |
| Acute Bacterial Prostatitis [description not available] | 0 | 2.63 | 2 | 0 |
| Prostatic Neoplasms Tumors or cancer of the PROSTATE. | 0 | 3.69 | 3 | 0 |
| Prostatitis Infiltration of inflammatory cells into the parenchyma of PROSTATE. The subtypes are classified by their varied laboratory analysis, clinical presentation and response to treatment. | 0 | 2.63 | 2 | 0 |
| Gestational Hypertension [description not available] | 0 | 2.31 | 1 | 0 |
| Pulmonary Arterial Remodeling [description not available] | 0 | 2.31 | 1 | 0 |
| Hypertension, Pregnancy-Induced A condition in pregnant women with elevated systolic ( | 0 | 2.31 | 1 | 0 |
| Fibroid [description not available] | 0 | 2.31 | 1 | 0 |
| Leiomyoma A benign tumor derived from smooth muscle tissue, also known as a fibroid tumor. They rarely occur outside of the UTERUS and the GASTROINTESTINAL TRACT but can occur in the SKIN and SUBCUTANEOUS TISSUE, probably arising from the smooth muscle of small blood vessels in these tissues. | 0 | 2.31 | 1 | 0 |
| Aging The gradual irreversible changes in structure and function of an organism that occur as a result of the passage of time. | 0 | 6.38 | 21 | 2 |
| Abortion, Veterinary Premature expulsion of the FETUS in animals. | 0 | 2.52 | 2 | 0 |
| Anorexia The lack or loss of APPETITE accompanied by an aversion to food and the inability to eat. It is the defining characteristic of the disorder ANOREXIA NERVOSA. | 0 | 2.76 | 3 | 0 |
| Drug Withdrawal Symptoms [description not available] | 0 | 2.95 | 4 | 0 |
| Substance Withdrawal Syndrome Physiological and psychological symptoms associated with withdrawal from the use of a drug after prolonged administration or habituation. The concept includes withdrawal from smoking or drinking, as well as withdrawal from an administered drug. | 0 | 2.95 | 4 | 0 |
| Hypernutrition [description not available] | 0 | 2.21 | 1 | 0 |
| Idiopathic Parkinson Disease [description not available] | 0 | 2.47 | 2 | 0 |
| Parkinson Disease A progressive, degenerative neurologic disease characterized by a TREMOR that is maximal at rest, retropulsion (i.e. a tendency to fall backwards), rigidity, stooped posture, slowness of voluntary movements, and a masklike facial expression. Pathologic features include loss of melanin containing neurons in the substantia nigra and other pigmented nuclei of the brainstem. LEWY BODIES are present in the substantia nigra and locus coeruleus but may also be found in a related condition (LEWY BODY DISEASE, DIFFUSE) characterized by dementia in combination with varying degrees of parkinsonism. (Adams et al., Principles of Neurology, 6th ed, p1059, pp1067-75) | 0 | 2.47 | 2 | 0 |
| Keratoderma Blennorrhagicum [description not available] | 0 | 2.15 | 1 | 0 |
| Keratosis Any horny growth such as a wart or callus. | 0 | 2.15 | 1 | 0 |
| Depression Depressive states usually of moderate intensity in contrast with MAJOR DEPRESSIVE DISORDER present in neurotic and psychotic disorders. | 0 | 2.81 | 3 | 0 |
| Fatty Liver, Nonalcoholic [description not available] | 0 | 2.15 | 1 | 0 |
| Polycystic Ovarian Syndrome [description not available] | 0 | 2.15 | 1 | 0 |
| Polycystic Ovary Syndrome A complex disorder characterized by infertility, HIRSUTISM; OBESITY; and various menstrual disturbances such as OLIGOMENORRHEA; AMENORRHEA; ANOVULATION. Polycystic ovary syndrome is usually associated with bilateral enlarged ovaries studded with atretic follicles, not with cysts. The term, polycystic ovary, is misleading. | 0 | 2.15 | 1 | 0 |
| Non-alcoholic Fatty Liver Disease Fatty liver finding without excessive ALCOHOL CONSUMPTION. | 0 | 2.15 | 1 | 0 |
| Binge Alcohol Consumption [description not available] | 0 | 2.17 | 1 | 0 |
| Alcohol Drinking Behaviors associated with the ingesting of ALCOHOLIC BEVERAGES, including social drinking. | 0 | 2.17 | 1 | 0 |
| Alloxan Diabetes [description not available] | 0 | 2.59 | 2 | 0 |
| Aggression Behavior which may be manifested by destructive and attacking action which is verbal or physical, by covert attitudes of hostility or by obstructionism. | 0 | 3.3 | 6 | 0 |
| Cirrhosis [description not available] | 0 | 2.21 | 1 | 0 |
| Cardiac Diseases [description not available] | 0 | 2.21 | 1 | 0 |
| Fibrosis Any pathological condition where fibrous connective tissue invades any organ, usually as a consequence of inflammation or other injury. | 0 | 2.21 | 1 | 0 |
| Heart Diseases Pathological conditions involving the HEART including its structural and functional abnormalities. | 0 | 2.21 | 1 | 0 |
| Atrophy Decrease in the size of a cell, tissue, organ, or multiple organs, associated with a variety of pathological conditions such as abnormal cellular changes, ischemia, malnutrition, or hormonal changes. | 0 | 3.08 | 5 | 0 |
| Ache [description not available] | 0 | 3.13 | 5 | 0 |
| Pain An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS. | 0 | 3.13 | 5 | 0 |
| Chronic Illness [description not available] | 0 | 3.3 | 6 | 0 |
| Chronic Disease Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2). | 0 | 3.3 | 6 | 0 |
| Sterility, Male [description not available] | 0 | 3.26 | 6 | 0 |
| Infertility, Male The inability of the male to effect FERTILIZATION of an OVUM after a specified period of unprotected intercourse. Male sterility is permanent infertility. | 0 | 3.26 | 6 | 0 |
| Azoospermia A condition of having no sperm present in the ejaculate (SEMEN). | 0 | 2.21 | 1 | 0 |
| Toxoplasmosis, Animal Acquired infection of non-human animals by organisms of the genus TOXOPLASMA. | 0 | 2.21 | 1 | 0 |
| Diabetes Mellitus, Adult-Onset [description not available] | 0 | 2.21 | 1 | 0 |
| Hyperglycemia, Postprandial Abnormally high BLOOD GLUCOSE level after a meal. | 0 | 2.21 | 1 | 0 |
| Diabetes Mellitus, Type 2 A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY. | 0 | 2.21 | 1 | 0 |
| Hyperglycemia Abnormally high BLOOD GLUCOSE level. | 0 | 2.21 | 1 | 0 |
| Delayed Effects, Prenatal Exposure [description not available] | 0 | 4.24 | 17 | 0 |
| Cognition Disorders Disorders characterized by disturbances in mental processes related to learning, thinking, reasoning, and judgment. | 0 | 2.08 | 1 | 0 |
| Academic Disorder, Developmental [description not available] | 0 | 2.5 | 2 | 0 |
| Age-Related Memory Disorders [description not available] | 0 | 2.46 | 2 | 0 |
| Learning Disabilities Conditions characterized by a significant discrepancy between an individual's perceived level of intellect and their ability to acquire new language and other cognitive skills. These may result from organic or psychological conditions. Relatively common subtypes include DYSLEXIA, DYSCALCULIA, and DYSGRAPHIA. | 0 | 2.5 | 2 | 0 |
| Memory Disorders Disturbances in registering an impression, in the retention of an acquired impression, or in the recall of an impression. Memory impairments are associated with DEMENTIA; CRANIOCEREBRAL TRAUMA; ENCEPHALITIS; ALCOHOLISM (see also ALCOHOL AMNESTIC DISORDER); SCHIZOPHRENIA; and other conditions. | 0 | 2.46 | 2 | 0 |
| Necrosis The death of cells in an organ or tissue due to disease, injury or failure of the blood supply. | 0 | 2.49 | 2 | 0 |
| Candidiasis, Genital [description not available] | 0 | 2.08 | 1 | 0 |
| Candidiasis, Vulvovaginal Infection of the VULVA and VAGINA with a fungus of the genus CANDIDA. | 0 | 2.08 | 1 | 0 |
| Blastocyst Disintegration [description not available] | 0 | 3 | 1 | 0 |
| Sterility, Female [description not available] | 0 | 3.37 | 2 | 0 |
| Infertility, Female Diminished or absent ability of a female to achieve conception. | 0 | 3.37 | 2 | 0 |
| Symptom Cluster [description not available] | 0 | 2.1 | 1 | 0 |
| Syndrome A characteristic symptom complex. | 0 | 2.1 | 1 | 0 |
| Stunted Growth [description not available] | 0 | 2.1 | 1 | 0 |
| Delayed Puberty [description not available] | 0 | 2.49 | 2 | 0 |
| Growth Disorders Deviations from the average values for a specific age and sex in any or all of the following: height, weight, skeletal proportions, osseous development, or maturation of features. Included here are both acceleration and retardation of growth. | 0 | 2.1 | 1 | 0 |
| Overweight A status with BODY WEIGHT that is above certain standards. In the scale of BODY MASS INDEX, overweight is defined as having a BMI of 25.0-29.9 kg/m2. Overweight may or may not be due to increases in body fat (ADIPOSE TISSUE), hence overweight does not equal over fat. | 0 | 2.1 | 1 | 0 |
| Weight Gain Increase in BODY WEIGHT over existing weight. | 0 | 6.6 | 14 | 4 |
| Age-Related Osteoporosis [description not available] | 0 | 3.26 | 6 | 0 |
| Osteoporosis Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis. | 0 | 3.26 | 6 | 0 |
| Insulin Sensitivity [description not available] | 0 | 2.1 | 1 | 0 |
| Insulin Resistance Diminished effectiveness of INSULIN in lowering blood sugar levels: requiring the use of 200 units or more of insulin per day to prevent HYPERGLYCEMIA or KETOSIS. | 0 | 2.1 | 1 | 0 |
| Obesity A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY). | 0 | 2.44 | 2 | 0 |
| Infections, Coronavirus [description not available] | 0 | 2.11 | 1 | 0 |
| Poultry Diseases Diseases of birds which are raised as a source of meat or eggs for human consumption and are usually found in barnyards, hatcheries, etc. The concept is differentiated from BIRD DISEASES which is for diseases of birds not considered poultry and usually found in zoos, parks, and the wild. | 0 | 2.11 | 1 | 0 |
| Coronavirus Infections Virus diseases caused by the CORONAVIRUS genus. Some specifics include transmissible enteritis of turkeys (ENTERITIS, TRANSMISSIBLE, OF TURKEYS); FELINE INFECTIOUS PERITONITIS; and transmissible gastroenteritis of swine (GASTROENTERITIS, TRANSMISSIBLE, OF SWINE). | 0 | 2.11 | 1 | 0 |
| Diathesis [description not available] | 0 | 2.46 | 2 | 0 |
| Malnourishment [description not available] | 0 | 2.13 | 1 | 0 |
| Fetal Growth Restriction [description not available] | 0 | 2.13 | 1 | 0 |
| Deficiency, Protein [description not available] | 0 | 2.13 | 1 | 0 |
| Fetal Growth Retardation Failure of a FETUS to attain expected GROWTH. | 0 | 2.13 | 1 | 0 |
| Malnutrition An imbalanced nutritional status resulting from insufficient intake of nutrients to meet normal physiological requirement. | 0 | 2.13 | 1 | 0 |
| Anxiety Feelings or emotions of dread, apprehension, and impending disaster but not disabling as with ANXIETY DISORDERS. | 0 | 3.66 | 9 | 0 |
| Fasting Hypoglycemia HYPOGLYCEMIA expressed in the postabsorptive state, after prolonged FASTING, or an overnight fast. | 0 | 2.97 | 4 | 0 |
| Hypoglycemia A syndrome of abnormally low BLOOD GLUCOSE level. Clinical hypoglycemia has diverse etiologies. Severe hypoglycemia eventually lead to glucose deprivation of the CENTRAL NERVOUS SYSTEM resulting in HUNGER; SWEATING; PARESTHESIA; impaired mental function; SEIZURES; COMA; and even DEATH. | 0 | 2.97 | 4 | 0 |
| Androgenization [description not available] | 0 | 2.47 | 2 | 0 |
| Elevated Cholesterol [description not available] | 0 | 2.11 | 1 | 0 |
| Hypercholesterolemia A condition with abnormally high levels of CHOLESTEROL in the blood. It is defined as a cholesterol value exceeding the 95th percentile for the population. | 0 | 2.11 | 1 | 0 |
| Bovine Diseases [description not available] | 0 | 5.06 | 5 | 2 |
| Hypospadias A birth defect due to malformation of the URETHRA in which the urethral opening is below its normal location. In the male, the malformed urethra generally opens on the ventral surface of the PENIS or on the PERINEUM. In the female, the malformed urethral opening is in the VAGINA. | 0 | 2.68 | 3 | 0 |
| Cryptogenic Infantile Spasms [description not available] | 0 | 2.13 | 1 | 0 |
| Spasms, Infantile An epileptic syndrome characterized by the triad of infantile spasms, hypsarrhythmia, and arrest of psychomotor development at seizure onset. The majority present between 3-12 months of age, with spasms consisting of combinations of brief flexor or extensor movements of the head, trunk, and limbs. The condition is divided into two forms: cryptogenic (idiopathic) and symptomatic (secondary to a known disease process such as intrauterine infections; nervous system abnormalities; BRAIN DISEASES, METABOLIC, INBORN; prematurity; perinatal asphyxia; TUBEROUS SCLEROSIS; etc.). (From Menkes, Textbook of Child Neurology, 5th ed, pp744-8) | 0 | 2.13 | 1 | 0 |
| Child Development Deviations [description not available] | 0 | 2.13 | 1 | 0 |
| Diseases of Endocrine System [description not available] | 0 | 2.13 | 1 | 0 |
| Developmental Disabilities Disorders in which there is a delay in development based on that expected for a given age level or stage of development. These impairments or disabilities originate before age 18, may be expected to continue indefinitely, and constitute a substantial impairment. Biological and nonbiological factors are involved in these disorders. (From American Psychiatric Glossary, 6th ed) | 0 | 2.13 | 1 | 0 |
| Endocrine System Diseases Pathological processes of the ENDOCRINE GLANDS, and diseases resulting from abnormal level of available HORMONES. | 0 | 2.13 | 1 | 0 |
| Infections, Orthomyxoviridae [description not available] | 0 | 2.13 | 1 | 0 |
| Edema, Pulmonary [description not available] | 0 | 2.13 | 1 | 0 |
| Deficiency, Yang [description not available] | 0 | 2.13 | 1 | 0 |
| Kidney Diseases Pathological processes of the KIDNEY or its component tissues. | 0 | 2.46 | 2 | 0 |
| Orthomyxoviridae Infections Virus diseases caused by the ORTHOMYXOVIRIDAE. | 0 | 2.13 | 1 | 0 |
| Pulmonary Edema Excessive accumulation of extravascular fluid in the lung, an indication of a serious underlying disease or disorder. Pulmonary edema prevents efficient PULMONARY GAS EXCHANGE in the PULMONARY ALVEOLI, and can be life-threatening. | 0 | 2.13 | 1 | 0 |
| Low Bone Density [description not available] | 0 | 2.71 | 3 | 0 |
| Bone Loss, Osteoclastic [description not available] | 0 | 2.74 | 3 | 0 |
| Bone Diseases, Metabolic Diseases that affect the METABOLIC PROCESSES of BONE TISSUE. | 0 | 2.71 | 3 | 0 |
| Infections, Staphylococcal [description not available] | 0 | 2.15 | 1 | 0 |
| Caprine Diseases [description not available] | 0 | 2.15 | 1 | 0 |
| Mastitis INFLAMMATION of the BREAST, or MAMMARY GLAND. | 0 | 2.15 | 1 | 0 |
| Staphylococcal Infections Infections with bacteria of the genus STAPHYLOCOCCUS. | 0 | 2.15 | 1 | 0 |
| Endometrioma An enlarged area of ENDOMETRIOSIS that resembles a tumor. It is usually found in the OVARY. When it is filled with old blood, it is known as a chocolate cyst. | 0 | 2.04 | 1 | 0 |
| Endometriosis A condition in which functional endometrial tissue is present outside the UTERUS. It is often confined to the PELVIS involving the OVARY, the ligaments, cul-de-sac, and the uterovesical peritoneum. | 0 | 2.04 | 1 | 0 |
| Nerve Degeneration Loss of functional activity and trophic degeneration of nerve axons and their terminal arborizations following the destruction of their cells of origin or interruption of their continuity with these cells. The pathology is characteristic of neurodegenerative diseases. Often the process of nerve degeneration is studied in research on neuroanatomical localization and correlation of the neurophysiology of neural pathways. | 0 | 2.94 | 4 | 0 |
| Bile Duct Obstruction, Intrahepatic [description not available] | 0 | 2.04 | 1 | 0 |
| Complications, Pregnancy [description not available] | 0 | 2.43 | 2 | 0 |
| Cholestasis, Intrahepatic Impairment of bile flow due to injury to the HEPATOCYTES; BILE CANALICULI; or the intrahepatic bile ducts (BILE DUCTS, INTRAHEPATIC). | 0 | 2.04 | 1 | 0 |
| Binge Eating [description not available] | 0 | 2.04 | 1 | 0 |
| Bulimia Eating an excess amount of food in a short period of time, as seen in the disorder of BULIMIA NERVOSA. It is caused by an abnormal craving for food, or insatiable hunger also known as ox hunger. | 0 | 2.04 | 1 | 0 |
| Central Hypothyroidism [description not available] | 0 | 1.92 | 1 | 0 |
| Hypothyroidism A syndrome that results from abnormally low secretion of THYROID HORMONES from the THYROID GLAND, leading to a decrease in BASAL METABOLIC RATE. In its most severe form, there is accumulation of MUCOPOLYSACCHARIDES in the SKIN and EDEMA, known as MYXEDEMA. It may be primary or secondary due to other pituitary disease, or hypothalamic dysfunction. | 0 | 1.92 | 1 | 0 |
| Segond Fracture [description not available] | 0 | 2.05 | 1 | 0 |
| Tibial Fractures Fractures of the TIBIA. | 0 | 2.05 | 1 | 0 |
| Sensitivity and Specificity Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed) | 0 | 2.05 | 1 | 0 |
| Post-Natal Depression [description not available] | 0 | 2.44 | 2 | 0 |
| Depression, Postpartum Depression in POSTPARTUM WOMEN, usually within four weeks after giving birth (PARTURITION). The degree of depression ranges from mild transient depression to neurotic or psychotic depressive disorders. (From DSM-IV, p386) | 0 | 2.44 | 2 | 0 |
| Acute-Phase Reaction An early local inflammatory reaction to insult or injury that consists of fever, an increase in inflammatory humoral factors, and an increased synthesis by hepatocytes of a number of proteins or glycoproteins usually found in the plasma. | 0 | 2.05 | 1 | 0 |
| Acute Brain Injuries [description not available] | 0 | 2.05 | 1 | 0 |
| Brain Injuries Acute and chronic (see also BRAIN INJURIES, CHRONIC) injuries to the brain, including the cerebral hemispheres, CEREBELLUM, and BRAIN STEM. Clinical manifestations depend on the nature of injury. Diffuse trauma to the brain is frequently associated with DIFFUSE AXONAL INJURY or COMA, POST-TRAUMATIC. Localized injuries may be associated with NEUROBEHAVIORAL MANIFESTATIONS; HEMIPARESIS, or other focal neurologic deficits. | 0 | 2.05 | 1 | 0 |
| Colitis Inflammation of the COLON section of the large intestine (INTESTINE, LARGE), usually with symptoms such as DIARRHEA (often with blood and mucus), ABDOMINAL PAIN, and FEVER. | 0 | 2.72 | 3 | 0 |
| Bacterial Disease [description not available] | 0 | 2.05 | 1 | 0 |
| Bacterial Infections Infections by bacteria, general or unspecified. | 0 | 2.05 | 1 | 0 |
| Avian Diseases [description not available] | 0 | 2.05 | 1 | 0 |
| Hyperphagia Ingestion of a greater than optimal quantity of food. | 0 | 2.06 | 1 | 0 |
| Disease A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown. | 0 | 2.07 | 1 | 0 |
| Atherogenesis [description not available] | 0 | 3.2 | 6 | 0 |
| Atherosclerosis A thickening and loss of elasticity of the walls of ARTERIES that occurs with formation of ATHEROSCLEROTIC PLAQUES within the ARTERIAL INTIMA. | 0 | 3.2 | 6 | 0 |
| Blood Pressure, High [description not available] | 0 | 1.94 | 1 | 0 |
| Hypertension Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more. | 0 | 1.94 | 1 | 0 |
| Menopause The last menstrual period. Permanent cessation of menses (MENSTRUATION) is usually defined after 6 to 12 months of AMENORRHEA in a woman over 45 years of age. In the United States, menopause generally occurs in women between 48 and 55 years of age. | 0 | 2.72 | 3 | 0 |
| Menopause, Premature The premature cessation of menses (MENSTRUATION) when the last menstrual period occurs in a woman under the age of 40. It is due to the depletion of OVARIAN FOLLICLES. Premature MENOPAUSE can be caused by diseases; OVARIECTOMY; RADIATION; chemicals; and chromosomal abnormalities. | 0 | 2.06 | 1 | 0 |
| Coronary Artery Stenosis [description not available] | 0 | 2.07 | 1 | 0 |
| Coronary Stenosis Narrowing or constriction of a coronary artery. | 0 | 2.07 | 1 | 0 |
| Double Nuchal Cord [description not available] | 0 | 3.46 | 1 | 1 |
| Abdominal Migraine [description not available] | 0 | 2.08 | 1 | 0 |
| Migraine Disorders A class of disabling primary headache disorders, characterized by recurrent unilateral pulsatile headaches. The two major subtypes are common migraine (without aura) and classic migraine (with aura or neurological symptoms). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1) | 0 | 2.08 | 1 | 0 |
| Body Weight, Fetal [description not available] | 0 | 2.08 | 1 | 0 |
| Fetal Death Death of the developing young in utero. BIRTH of a dead FETUS is STILLBIRTH. | 0 | 2.72 | 3 | 0 |
| Animal Mammary Carcinoma [description not available] | 0 | 2.01 | 1 | 0 |
| Leukemia P388 An experimental lymphocytic leukemia originally induced in DBA/2 mice by painting with methylcholanthrene. | 0 | 2.01 | 1 | 0 |
| Sarcoma 180 An experimental sarcoma of mice. | 0 | 2.01 | 1 | 0 |
| Female Genital Diseases [description not available] | 0 | 2.01 | 1 | 0 |
| Infections, Ureaplasma [description not available] | 0 | 2.01 | 1 | 0 |
| Genital Diseases, Female Pathological processes involving the female reproductive tract (GENITALIA, FEMALE). | 0 | 2.01 | 1 | 0 |
| Cancer of the Thyroid [description not available] | 0 | 2.71 | 3 | 0 |
| Thyroid Neoplasms Tumors or cancer of the THYROID GLAND. | 0 | 2.71 | 3 | 0 |
| Absence Seizure [description not available] | 0 | 3.1 | 5 | 0 |
| Seizures Clinical or subclinical disturbances of cortical function due to a sudden, abnormal, excessive, and disorganized discharge of brain cells. Clinical manifestations include abnormal motor, sensory and psychic phenomena. Recurrent seizures are usually referred to as EPILEPSY or seizure disorder. | 0 | 3.1 | 5 | 0 |
| Apoplexy [description not available] | 0 | 2.01 | 1 | 0 |
| Angiogenesis, Pathologic [description not available] | 0 | 2.01 | 1 | 0 |
| Stroke A group of pathological conditions characterized by sudden, non-convulsive loss of neurological function due to BRAIN ISCHEMIA or INTRACRANIAL HEMORRHAGES. Stroke is classified by the type of tissue NECROSIS, such as the anatomic location, vasculature involved, etiology, age of the affected individual, and hemorrhagic vs. non-hemorrhagic nature. (From Adams et al., Principles of Neurology, 6th ed, pp777-810) | 0 | 2.01 | 1 | 0 |
| Abnormality, Torsion [description not available] | 0 | 2.01 | 1 | 0 |
| Autoimmune Diabetes [description not available] | 0 | 2.01 | 1 | 0 |
| Diabetes Mellitus, Type 1 A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence. | 0 | 2.01 | 1 | 0 |
| Deficiency, Ascorbic Acid [description not available] | 0 | 1.93 | 1 | 0 |
| Carbon Tetrachloride Poisoning Poisoning that results from ingestion, injection, inhalation, or skin absorption of CARBON TETRACHLORIDE. | 0 | 1.93 | 1 | 0 |
| Hypoascorbemia [description not available] | 0 | 1.93 | 1 | 0 |
| Ascorbic Acid Deficiency A condition due to a dietary deficiency of ascorbic acid (vitamin C), characterized by malaise, lethargy, and weakness. As the disease progresses, joints, muscles, and subcutaneous tissues may become the sites of hemorrhage. Ascorbic acid deficiency frequently develops into SCURVY in young children fed unsupplemented cow's milk exclusively during their first year. It develops also commonly in chronic alcoholism. (Cecil Textbook of Medicine, 19th ed, p1177) | 0 | 1.93 | 1 | 0 |
| Hepatitis INFLAMMATION of the LIVER. | 0 | 1.93 | 1 | 0 |
| Scurvy An acquired blood vessel disorder caused by severe deficiency of vitamin C (ASCORBIC ACID) in the diet leading to defective collagen formation in small blood vessels. Scurvy is characterized by bleeding in any tissue, weakness, ANEMIA, spongy gums, and a brawny induration of the muscles of the calves and legs. | 0 | 1.93 | 1 | 0 |
| Cancer of the Uterus [description not available] | 0 | 1.93 | 1 | 0 |
| Uterine Neoplasms Tumors or cancer of the UTERUS. | 0 | 1.93 | 1 | 0 |
| Electrolytes Substances that dissociate into two or more ions, to some extent, in water. Solutions of electrolytes thus conduct an electric current and can be decomposed by it (ELECTROLYSIS). (Grant & Hackh's Chemical Dictionary, 5th ed) | 0 | 2.62 | 3 | 0 |
| Diabetes Mellitus A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE. | 0 | 1.93 | 1 | 0 |
| Rachitis [description not available] | 0 | 1.93 | 1 | 0 |
| Deficiency, Vitamin D [description not available] | 0 | 1.93 | 1 | 0 |
| Vitamin D Deficiency A nutritional condition produced by a deficiency of VITAMIN D in the diet, insufficient production of vitamin D in the skin, inadequate absorption of vitamin D from the diet, or abnormal conversion of vitamin D to its bioactive metabolites. It is manifested clinically as RICKETS in children and OSTEOMALACIA in adults. (From Cecil Textbook of Medicine, 19th ed, p1406) | 0 | 1.93 | 1 | 0 |
| Agranulocytosis A decrease in the number of GRANULOCYTES; (BASOPHILS; EOSINOPHILS; and NEUTROPHILS). | 0 | 1.93 | 1 | 0 |
| Hyperthyroid [description not available] | 0 | 2.36 | 2 | 0 |
| Hyperthyroidism Hypersecretion of THYROID HORMONES from the THYROID GLAND. Elevated levels of thyroid hormones increase BASAL METABOLIC RATE. | 0 | 2.36 | 2 | 0 |
| Encephalitis, Polio [description not available] | 0 | 1.93 | 1 | 0 |
| Poliomyelitis An acute infectious disease of humans, particularly children, caused by any of three serotypes of human poliovirus (POLIOVIRUS). Usually the infection is limited to the gastrointestinal tract and nasopharynx, and is often asymptomatic. The central nervous system, primarily the spinal cord, may be affected, leading to rapidly progressive paralysis, coarse FASCICULATION and hyporeflexia. Motor neurons are primarily affected. Encephalitis may also occur. The virus replicates in the nervous system, and may cause significant neuronal loss, most notably in the spinal cord. A rare related condition, nonpoliovirus poliomyelitis, may result from infections with nonpoliovirus enteroviruses. (From Adams et al., Principles of Neurology, 6th ed, pp764-5) | 0 | 1.93 | 1 | 0 |
| Arteriosclerosis Thickening and loss of elasticity of the walls of ARTERIES of all sizes. There are many forms classified by the types of lesions and arteries involved, such as ATHEROSCLEROSIS with fatty lesions in the ARTERIAL INTIMA of medium and large muscular arteries. | 0 | 2.62 | 3 | 0 |
| Aortic Diseases Pathological processes involving any part of the AORTA. | 0 | 1.93 | 1 | 0 |
| Heavy Menstrual Bleeding [description not available] | 0 | 1.93 | 1 | 0 |
| Bleeding Between Periods [description not available] | 0 | 1.93 | 1 | 0 |
| Menorrhagia Excessive uterine bleeding during MENSTRUATION. | 0 | 1.93 | 1 | 0 |
| Metrorrhagia Abnormal uterine bleeding that is not related to MENSTRUATION, usually in females without regular MENSTRUAL CYCLE. The irregular and unpredictable bleeding usually comes from a dysfunctional ENDOMETRIUM. | 0 | 1.93 | 1 | 0 |
| Ambiguous Genitalia [description not available] | 0 | 2.36 | 2 | 0 |
| Feminization Development of female secondary SEX CHARACTERISTICS in the MALE. It is due to the effects of estrogenic metabolites of precursors from endogenous or exogenous sources, such as ADRENAL GLANDS or therapeutic drugs. | 0 | 2.64 | 3 | 0 |
| Disorders of Sex Development In gonochoristic organisms, congenital conditions in which development of chromosomal, gonadal, or anatomical sex is atypical. Effects from exposure to abnormal levels of GONADAL HORMONES in the maternal environment, or disruption of the function of those hormones by ENDOCRINE DISRUPTORS are included. | 0 | 2.36 | 2 | 0 |
| Liver Dysfunction [description not available] | 0 | 2.34 | 2 | 0 |
| Liver Diseases Pathological processes of the LIVER. | 0 | 2.34 | 2 | 0 |
| Muscular Dystrophy [description not available] | 0 | 1.93 | 1 | 0 |
| Muscular Dystrophies A heterogeneous group of inherited MYOPATHIES, characterized by wasting and weakness of the SKELETAL MUSCLE. They are categorized by the sites of MUSCLE WEAKNESS; AGE OF ONSET; and INHERITANCE PATTERNS. | 0 | 1.93 | 1 | 0 |
| Adenohypophyseal Diseases [description not available] | 0 | 2.33 | 2 | 0 |
| Pituitary Diseases Disorders involving either the ADENOHYPOPHYSIS or the NEUROHYPOPHYSIS. These diseases usually manifest as hypersecretion or hyposecretion of PITUITARY HORMONES. Neoplastic pituitary masses can also cause compression of the OPTIC CHIASM and other adjacent structures. | 0 | 2.33 | 2 | 0 |
| Choriocarcinoma A malignant metastatic form of trophoblastic tumors. Unlike the HYDATIDIFORM MOLE, choriocarcinoma contains no CHORIONIC VILLI but rather sheets of undifferentiated cytotrophoblasts and syncytiotrophoblasts (TROPHOBLASTS). It is characterized by the large amounts of CHORIONIC GONADOTROPIN produced. Tissue origins can be determined by DNA analyses: placental (fetal) origin or non-placental origin (CHORIOCARCINOMA, NON-GESTATIONAL). | 0 | 1.93 | 1 | 0 |
| Reproductive Sterility [description not available] | 0 | 1.93 | 1 | 0 |
| Infertility A reduced or absent capacity to reproduce. | 0 | 1.93 | 1 | 0 |
| Icterus [description not available] | 0 | 1.94 | 1 | 0 |
| Cirrhosis, Liver [description not available] | 0 | 1.94 | 1 | 0 |
| Dubin-Johnson Syndrome [description not available] | 0 | 1.94 | 1 | 0 |
| Jaundice A clinical manifestation of HYPERBILIRUBINEMIA, characterized by the yellowish staining of the SKIN; MUCOUS MEMBRANE; and SCLERA. Clinical jaundice usually is a sign of LIVER dysfunction. | 0 | 1.94 | 1 | 0 |
| Liver Cirrhosis Liver disease in which the normal microcirculation, the gross vascular anatomy, and the hepatic architecture have been variably destroyed and altered with fibrous septa surrounding regenerated or regenerating parenchymal nodules. | 0 | 1.94 | 1 | 0 |
| Abnormalities, Drug-Induced Congenital abnormalities caused by medicinal substances or drugs of abuse given to or taken by the mother, or to which she is inadvertently exposed during the manufacture of such substances. The concept excludes abnormalities resulting from exposure to non-medicinal chemicals in the environment. | 0 | 1.94 | 1 | 0 |
| Hypertrophy General increase in bulk of a part or organ due to CELL ENLARGEMENT and accumulation of FLUIDS AND SECRETIONS, not due to tumor formation, nor to an increase in the number of cells (HYPERPLASIA). | 0 | 1.94 | 1 | 0 |
| Abdominal Cryptorchidism [description not available] | 0 | 1.94 | 1 | 0 |
| Gastric Ulcer [description not available] | 0 | 2.01 | 1 | 0 |
| Stomach Ulcer Ulceration of the GASTRIC MUCOSA due to contact with GASTRIC JUICE. It is often associated with HELICOBACTER PYLORI infection or consumption of nonsteroidal anti-inflammatory drugs (NSAIDS). | 0 | 2.01 | 1 | 0 |
| Infectious Diseases [description not available] | 0 | 1.92 | 1 | 0 |
| Paratyphoid Fever A prolonged febrile illness commonly caused by several Paratyphi serotypes of SALMONELLA ENTERICA. It is similar to TYPHOID FEVER but less severe. | 0 | 1.92 | 1 | 0 |
| Communicable Diseases An illness caused by an infectious agent or its toxins that occurs through the direct or indirect transmission of the infectious agent or its products from an infected individual or via an animal, vector or the inanimate environment to a susceptible animal or human host. | 0 | 1.92 | 1 | 0 |
| Remission, Spontaneous A spontaneous diminution or abatement of a disease over time, without formal treatment. | 0 | 2.02 | 1 | 0 |
| Gingival Hyperplasia Non-inflammatory enlargement of the gingivae produced by factors other than local irritation. It is characteristically due to an increase in the number of cells. (From Jablonski's Dictionary of Dentistry, 1992, p400) | 0 | 2.02 | 1 | 0 |
| Hemorrhage, Gingival [description not available] | 0 | 2.02 | 1 | 0 |
| Gingival Hemorrhage The flowing of blood from the marginal gingival area, particularly the sulcus, seen in such conditions as GINGIVITIS, marginal PERIODONTITIS, injury, and ASCORBIC ACID DEFICIENCY. | 0 | 2.02 | 1 | 0 |
| Gingival Overgrowth Excessive growth of the gingiva either by an increase in the size of the constituent cells (GINGIVAL HYPERTROPHY) or by an increase in their number (GINGIVAL HYPERPLASIA). (From Jablonski's Dictionary of Dentistry, 1992, p574) | 0 | 2.02 | 1 | 0 |
| Follicular Cyst Cyst due to the occlusion of the duct of a follicle or small gland. | 0 | 3.82 | 2 | 1 |
| Ovarian Diseases Pathological processes of the OVARY. | 0 | 2.02 | 1 | 0 |
| Nervous System Disorders [description not available] | 0 | 2.02 | 1 | 0 |
| Nervous System Diseases Diseases of the central and peripheral nervous system. This includes disorders of the brain, spinal cord, cranial nerves, peripheral nerves, nerve roots, autonomic nervous system, neuromuscular junction, and muscle. | 0 | 2.02 | 1 | 0 |
| Autosomal Dominant Juvenile Parkinson Disease [description not available] | 0 | 2.02 | 1 | 0 |
| Parkinsonian Disorders A group of disorders which feature impaired motor control characterized by bradykinesia, MUSCLE RIGIDITY; TREMOR; and postural instability. Parkinsonian diseases are generally divided into primary parkinsonism (see PARKINSON DISEASE), secondary parkinsonism (see PARKINSON DISEASE, SECONDARY) and inherited forms. These conditions are associated with dysfunction of dopaminergic or closely related motor integration neuronal pathways in the BASAL GANGLIA. | 0 | 2.02 | 1 | 0 |
| Experimental Mammary Neoplasms [description not available] | 0 | 2.02 | 1 | 0 |
| Gingivitis Inflammation of gum tissue (GINGIVA) without loss of connective tissue. | 0 | 1.92 | 1 | 0 |
| Cirrhoses, Experimental Liver [description not available] | 0 | 2.02 | 1 | 0 |
| Experimental Hepatoma [description not available] | 0 | 2.02 | 1 | 0 |
| Hyperandrogenism A condition caused by the excessive secretion of ANDROGENS from the ADRENAL CORTEX; the OVARIES; or the TESTES. The clinical significance in males is negligible. In women, the common manifestations are HIRSUTISM and VIRILISM as seen in patients with POLYCYSTIC OVARY SYNDROME and ADRENOCORTICAL HYPERFUNCTION. | 0 | 2.02 | 1 | 0 |
| Affective Disorders [description not available] | 0 | 3.41 | 1 | 1 |
| Premenstrual Tension A term used to describe the psychological aspects of PREMENSTRUAL SYNDROME, such as the indescribable tension, depression, hostility, and increased seizure activity in women with seizure disorder. | 0 | 3.41 | 1 | 1 |
| Premenstrual Syndrome A combination of distressing physical, psychologic, or behavioral changes that occur during the luteal phase of the menstrual cycle. Symptoms of PMS are diverse (such as pain, water-retention, anxiety, cravings, and depression) and they diminish markedly 2 or 3 days after the initiation of menses. | 0 | 3.41 | 1 | 1 |
| Mood Disorders Those disorders that have a disturbance in mood as their predominant feature. | 0 | 3.41 | 1 | 1 |
| Cell Transformation, Neoplastic Cell changes manifested by escape from control mechanisms, increased growth potential, alterations in the cell surface, karyotypic abnormalities, morphological and biochemical deviations from the norm, and other attributes conferring the ability to invade, metastasize, and kill. | 0 | 2.03 | 1 | 0 |
| Alveolar Bone Atrophy [description not available] | 0 | 2.03 | 1 | 0 |
| Delayed Postpartum Hemorrhage [description not available] | 0 | 3.41 | 1 | 1 |
| Uterine Atony [description not available] | 0 | 3.41 | 1 | 1 |
| Postpartum Hemorrhage Excess blood loss from uterine bleeding associated with OBSTETRIC LABOR or CHILDBIRTH. It is defined as blood loss greater than 500 ml or of the amount that adversely affects the maternal physiology, such as BLOOD PRESSURE and HEMATOCRIT. Postpartum hemorrhage is divided into two categories, immediate (within first 24 hours after birth) or delayed (after 24 hours postpartum). | 0 | 3.41 | 1 | 1 |
| Uterine Inertia Failure of the UTERUS to contract with normal strength, duration, and intervals during childbirth (LABOR, OBSTETRIC). It is also called uterine atony. | 0 | 3.41 | 1 | 1 |
| Anankastic Personality [description not available] | 0 | 2.03 | 1 | 0 |
| Obsessive-Compulsive Disorder An anxiety disorder characterized by recurrent, persistent obsessions or compulsions. Obsessions are the intrusive ideas, thoughts, or images that are experienced as senseless or repugnant. Compulsions are repetitive and seemingly purposeful behavior which the individual generally recognizes as senseless and from which the individual does not derive pleasure although it may provide a release from tension. | 0 | 2.03 | 1 | 0 |
| Libman-Sacks Disease [description not available] | 0 | 2.03 | 1 | 0 |
| Albuminuria The presence of albumin in the urine, an indicator of KIDNEY DISEASES. | 0 | 2.03 | 1 | 0 |
| Lupus Erythematosus, Systemic A chronic, relapsing, inflammatory, and often febrile multisystemic disorder of connective tissue, characterized principally by involvement of the skin, joints, kidneys, and serosal membranes. It is of unknown etiology, but is thought to represent a failure of the regulatory mechanisms of the autoimmune system. The disease is marked by a wide range of system dysfunctions, an elevated erythrocyte sedimentation rate, and the formation of LE cells in the blood or bone marrow. | 0 | 2.03 | 1 | 0 |
| Cocaine Abuse [description not available] | 0 | 2.44 | 2 | 0 |
| Cocaine-Related Disorders Disorders related or resulting from use of cocaine. | 0 | 2.44 | 2 | 0 |
| Recrudescence [description not available] | 0 | 2.03 | 1 | 0 |
| Uterine Prolapse Downward displacement of the UTERUS. It is classified in various degrees: in the first degree the UTERINE CERVIX is within the vaginal orifice; in the second degree the cervix is outside the orifice; in the third degree the entire uterus is outside the orifice. | 0 | 2.04 | 1 | 0 |
| Hyponatremia Deficiency of sodium in the blood; salt depletion. (Dorland, 27th ed) | 0 | 2.04 | 1 | 0 |
| Deficiency, Magnesium [description not available] | 0 | 2.68 | 3 | 0 |
| Magnesium Deficiency A nutritional condition produced by a deficiency of magnesium in the diet, characterized by anorexia, nausea, vomiting, lethargy, and weakness. Symptoms are paresthesias, muscle cramps, irritability, decreased attention span, and mental confusion, possibly requiring months to appear. Deficiency of body magnesium can exist even when serum values are normal. In addition, magnesium deficiency may be organ-selective, since certain tissues become deficient before others. (Harrison's Principles of Internal Medicine, 12th ed, p1936) | 0 | 2.68 | 3 | 0 |
| Adenoma, Basal Cell [description not available] | 0 | 2.4 | 2 | 0 |
| Adenoma A benign epithelial tumor with a glandular organization. | 0 | 2.4 | 2 | 0 |
| Adenocarcinoma, Basal Cell [description not available] | 0 | 3.37 | 1 | 1 |
| Cancer of Endometrium [description not available] | 0 | 3.37 | 1 | 1 |
| Hormone-Dependent Neoplasms [description not available] | 0 | 3.37 | 1 | 1 |
| Adenocarcinoma A malignant epithelial tumor with a glandular organization. | 0 | 3.37 | 1 | 1 |
| Endometrial Neoplasms Tumors or cancer of ENDOMETRIUM, the mucous lining of the UTERUS. These neoplasms can be benign or malignant. Their classification and grading are based on the various cell types and the percent of undifferentiated cells. | 0 | 3.37 | 1 | 1 |
| Adjuvant Arthritis [description not available] | 0 | 1.99 | 1 | 0 |
| Endomyometritis Inflammation of both the ENDOMETRIUM and the MYOMETRIUM, usually caused by infections after a CESAREAN SECTION. | 0 | 1.99 | 1 | 0 |
| Endometritis Inflammation of the ENDOMETRIUM, usually caused by intrauterine infections. Endometritis is the most common cause of postpartum fever. | 0 | 1.99 | 1 | 0 |
| Autotomy Human [description not available] | 0 | 2 | 1 | 0 |
| External Ear Inflammation [description not available] | 0 | 3.38 | 1 | 1 |
| Otitis Externa Inflammation of the OUTER EAR including the external EAR CANAL, cartilages of the auricle (EAR CARTILAGE), and the TYMPANIC MEMBRANE. | 0 | 3.38 | 1 | 1 |
| Acute Confusional Senile Dementia [description not available] | 0 | 2 | 1 | 0 |
| Alzheimer Disease A degenerative disease of the BRAIN characterized by the insidious onset of DEMENTIA. Impairment of MEMORY, judgment, attention span, and problem solving skills are followed by severe APRAXIAS and a global loss of cognitive abilities. The condition primarily occurs after age 60, and is marked pathologically by severe cortical atrophy and the triad of SENILE PLAQUES; NEUROFIBRILLARY TANGLES; and NEUROPIL THREADS. (From Adams et al., Principles of Neurology, 6th ed, pp1049-57) | 0 | 2 | 1 | 0 |
| Absence Status [description not available] | 0 | 2 | 1 | 0 |
| Status Epilepticus A prolonged seizure or seizures repeated frequently enough to prevent recovery between episodes occurring over a period of 20-30 minutes. The most common subtype is generalized tonic-clonic status epilepticus, a potentially fatal condition associated with neuronal injury and respiratory and metabolic dysfunction. Nonconvulsive forms include petit mal status and complex partial status, which may manifest as behavioral disturbances. Simple partial status epilepticus consists of persistent motor, sensory, or autonomic seizures that do not impair cognition (see also EPILEPSIA PARTIALIS CONTINUA). Subclinical status epilepticus generally refers to seizures occurring in an unresponsive or comatose individual in the absence of overt signs of seizure activity. (From N Engl J Med 1998 Apr 2;338(14):970-6; Neurologia 1997 Dec;12 Suppl 6:25-30) | 0 | 2 | 1 | 0 |
| Hyperplasia An increase in the number of cells in a tissue or organ without tumor formation. It differs from HYPERTROPHY, which is an increase in bulk without an increase in the number of cells. | 0 | 3.32 | 2 | 0 |
| Anesthesia A state characterized by loss of feeling or sensation. This depression of nerve function is usually the result of pharmacologic action and is induced to allow performance of surgery or other painful procedures. | 0 | 2 | 1 | 0 |
| Aura [description not available] | 0 | 2 | 1 | 0 |
| Epilepsy A disorder characterized by recurrent episodes of paroxysmal brain dysfunction due to a sudden, disorderly, and excessive neuronal discharge. Epilepsy classification systems are generally based upon: (1) clinical features of the seizure episodes (e.g., motor seizure), (2) etiology (e.g., post-traumatic), (3) anatomic site of seizure origin (e.g., frontal lobe seizure), (4) tendency to spread to other structures in the brain, and (5) temporal patterns (e.g., nocturnal epilepsy). (From Adams et al., Principles of Neurology, 6th ed, p313) | 0 | 2 | 1 | 0 |
| Alopecia Cicatrisata [description not available] | 0 | 2 | 1 | 0 |
| Alopecia Absence of hair from areas where it is normally present. | 0 | 2 | 1 | 0 |
| Allodynia [description not available] | 0 | 2.01 | 1 | 0 |
| Corpus Luteum Cyst [description not available] | 0 | 2.01 | 1 | 0 |
| Ovarian Cysts General term for CYSTS and cystic diseases of the OVARY. | 0 | 2.01 | 1 | 0 |
| Bone Cancer [description not available] | 0 | 2.92 | 1 | 0 |
| Bone Neoplasms Tumors or cancer located in bone tissue or specific BONES. | 0 | 2.92 | 1 | 0 |