ID Source | ID |
---|---|
PubMed CID | 9403 |
CHEMBL ID | 1200973 |
CHEBI ID | 34745 |
SCHEMBL ID | 41551 |
MeSH ID | M0050935 |
Synonym |
---|
17.beta.-estradiol 17-cyclopentylpropionate |
depofemin |
e. ionate p.a. |
depo-estradiol |
depo-estradiol cyclopentylpropionate |
estra-1,5(10)-triene-3,17-diol, (17.beta.)-, 17-cyclopentanepropanoate |
17.beta.-estradiol cyclopentylpropionate |
estradep |
estradiol cypionate , |
17.beta.-estradiol cypionate |
nsc3354 , |
estradiol 17.beta.-cyclopentylpropionate |
313-06-4 |
estradiol 17-cypionate |
depoestradiol |
cyclopentanepropionic acid, 17-ester with estradiol |
estradiol 17.beta.-cylopentylpropionate |
estra-1,5(10)-triene-3,17-diol (17.beta.)-, 17-cyclopentanepropanoate |
estrapo |
dep-estro |
depestro |
estro-depo |
estradiol 17-cyclopentylpropionate |
femogen cyp |
estradiol 17.beta.-cyclopentanepropionate |
estradiol, 17-cyclopentanepropionate |
estradiol 17.beta.-cypionate |
depoestra |
estradiol cyclopentylpropionate |
17.beta.-estradiol cyclopentanepropionate |
nsc-3354 |
smr000058700 |
MLS000069763 |
NCI60_002938 |
(17beta)-3-hydroxyestra-1(10),2,4-trien-17-yl 3-cyclopentylpropanoate |
estradiol 17beta-cyclopentanepropionate |
17beta-estradiol 17-cyclopentylpropionate |
estra-1,3,5(10)-triene-3,17-diol, (17beta)-, 17-cyclopentanepropanoate |
depoestradiol cypionate |
estra-1,3,5(10)-triene-3,17-diol (17beta)-, 17-cyclopentanepropanoate |
cyclopentanepropionic acid, 3-hydroxyestra-1,3,5(10)-trien-17beta-yl ester |
estradiol 17beta-cylopentylpropionate |
estradiol 17-cyclopentanepropionate |
pertradiol |
estra-1,3,5(10)-triene-3,17beta-diol 17-(cyclopentanepropionate) |
einecs 206-237-8 |
ecp (van) |
brn 3171075 |
neoginon depositum |
estradiol 17beta-cypionate |
nsc 3354 |
depgynogen |
D04063 |
depo-estradiol (tn) |
estradiol cypionate (usp) |
estradiol 17beta-cyclopentylpropionate |
beta-estradiol 17-cypionate |
MLS001074891 |
NCGC00166134-01 |
estradiol 17.beta.-cyclopentanepropanoate |
chebi:34745 , |
estradiol cipionate |
CHEMBL1200973 |
beta-estradiol 17-cyclopentylpropionate |
E0875 |
dtxcid302999 |
cas-313-06-4 |
tox21_301818 |
NCGC00255333-01 |
dtxsid4022999 , |
(1s,11s,14s,15s,10r)-5-hydroxy-15-methyltetracyclo[8.7.0.0<2,7>.0<11,15>]hepta deca-2,4,6-trien-14-yl 3-cyclopentylpropanoate |
tox21_112331 |
NCGC00013034-01 |
tox21_110003 |
HMS2234K11 |
S4046 |
unii-7e1dv054lo |
estradiol cypionate [usp] |
4-09-00-00047 (beilstein handbook reference) |
7e1dv054lo , |
estra-1,3,5(10)-triene-3,17-diol(17b)-, 17-cyclopentanepropanoate |
depo-testadiol component estradiol cypionate |
estra-1,3,5(10)-triene-3,17-diol, (17.beta.)-, 17-cyclopentanepropanoate |
estradiol cypionate [vandf] |
estradiol cypionate [usp monograph] |
estradiol cypionate component of lunelle |
.beta.-estradiol 17-cypionate |
lunelle component estradiol cypionate |
estradiol cypionate component of depo-testadiol |
estradiol cipionate [who-dd] |
estradiol cipionate [mart.] |
estradiol cypionate [usp-rs] |
estradiol cypionate [orange book] |
estradioli cypionas [who-ip] |
estradiol-17-cyclopentanepropionate |
estradiol 17.beta.-cyclopentanepropanoate [mi] |
AKOS015895730 |
SCHEMBL41551 |
NCGC00166134-02 |
tox21_112331_1 |
KS-5296 |
CS-4691 |
W-106910 |
17beta-estradiol 17-cypionate |
(17?)-3-hydroxyestra-1,3,5(10)-trien-17-yl 3-cyclopentylpropanoate |
17.beta.-[(3-cyclopentylpropanoyl)oxy]estra-1,3,5(10)-trien-3-ol |
(17.beta.)-estra-1,3,5(10)-triene-3,17-diol 17.beta.-cyclopentanepropanoate |
cyclopentanepropionic acid, 3-hydroxyestra-1,3,5(10)-trien-17.beta.-yl ester |
HY-B1100 |
estradiol (cypionate) , |
mfcd00056558 |
(8r,9s,13s,14s,17s)-3-hydroxy-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6h-cyclopenta[a]phenanthren-17-yl 3-cyclopentylpropanoate |
estradiol cypionate, united states pharmacopeia (usp) reference standard |
NCGC00166134-03 |
Q5401760 |
DB13954 |
BCP11930 |
estradiol-cypionate |
CCG-268613 |
estradiol cypionate salt |
EN300-19734590 |
(1s,3as,3br,9bs,11as)-7-hydroxy-11a-methyl-1h,2h,3h,3ah,3bh,4h,5h,9bh,10h,11h,11ah-cyclopenta[a]phenanthren-1-yl 3-cyclopentylpropanoate |
estradiol cypionate (usp monograph) |
estradiol cypionate (usp-rs) |
estradioli cypionas |
estradiol 17beta-cyclopentanepropanoate |
estradiol cipionate (mart.) |
Excerpt | Reference | Relevance |
---|---|---|
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects." | ( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004) | 0.32 |
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 |
Class | Description |
---|---|
steroid ester | |
[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) |
---|---|---|---|---|---|---|---|
hypoxia-inducible factor 1 alpha subunit | Homo sapiens (human) | Potency | 58.2929 | 3.1890 | 29.8841 | 59.4836 | AID1224846; AID1224894 |
RAR-related orphan receptor gamma | Mus musculus (house mouse) | Potency | 32.6757 | 0.0060 | 38.0041 | 19,952.5996 | AID1159521; AID1159523 |
GLI family zinc finger 3 | Homo sapiens (human) | Potency | 13.1300 | 0.0007 | 14.5928 | 83.7951 | AID1259369; AID1259392 |
AR protein | Homo sapiens (human) | Potency | 10.8813 | 0.0002 | 21.2231 | 8,912.5098 | AID1259243; AID1259247; AID1259381; AID743035; AID743036; AID743040; AID743053; AID743063 |
caspase 7, apoptosis-related cysteine protease | Homo sapiens (human) | Potency | 47.3111 | 0.0133 | 26.9810 | 70.7614 | AID1346978 |
estrogen receptor 2 (ER beta) | Homo sapiens (human) | Potency | 1.1167 | 0.0006 | 57.9133 | 22,387.1992 | AID1259377; AID1259378; AID1259394 |
nuclear receptor subfamily 1, group I, member 3 | Homo sapiens (human) | Potency | 20.9793 | 0.0010 | 22.6508 | 76.6163 | AID1224839 |
progesterone receptor | Homo sapiens (human) | Potency | 6.0577 | 0.0004 | 17.9460 | 75.1148 | AID1346784; AID1346795; AID1347036 |
cytochrome P450 family 3 subfamily A polypeptide 4 | Homo sapiens (human) | Potency | 1.8131 | 0.0123 | 7.9835 | 43.2770 | AID1346984; AID1645841 |
glucocorticoid receptor [Homo sapiens] | Homo sapiens (human) | Potency | 36.1732 | 0.0002 | 14.3764 | 60.0339 | AID720691; AID720692; AID720719 |
retinoic acid nuclear receptor alpha variant 1 | Homo sapiens (human) | Potency | 42.5741 | 0.0030 | 41.6115 | 22,387.1992 | AID1159552; AID1159553; AID1159555 |
retinoid X nuclear receptor alpha | Homo sapiens (human) | Potency | 45.1939 | 0.0008 | 17.5051 | 59.3239 | AID1159527; AID1159531 |
estrogen-related nuclear receptor alpha | Homo sapiens (human) | Potency | 41.3364 | 0.0015 | 30.6073 | 15,848.9004 | AID1224841; AID1224848; AID1224849; AID1259401; AID1259403 |
farnesoid X nuclear receptor | Homo sapiens (human) | Potency | 24.5412 | 0.3758 | 27.4851 | 61.6524 | AID743217 |
pregnane X nuclear receptor | Homo sapiens (human) | Potency | 21.2010 | 0.0054 | 28.0263 | 1,258.9301 | AID1346982; AID1346985 |
estrogen nuclear receptor alpha | Homo sapiens (human) | Potency | 21.6593 | 0.0002 | 29.3054 | 16,493.5996 | AID1259244; AID1259248; AID1259383; AID743069; AID743075; AID743077; AID743080; AID743091 |
G | Vesicular stomatitis virus | Potency | 23.2697 | 0.0123 | 8.9648 | 39.8107 | AID1645842 |
peroxisome proliferator-activated receptor delta | Homo sapiens (human) | Potency | 61.6448 | 0.0010 | 24.5048 | 61.6448 | AID743215 |
peroxisome proliferator activated receptor gamma | Homo sapiens (human) | Potency | 48.1551 | 0.0010 | 19.4141 | 70.9645 | AID743094; AID743191 |
caspase-3 | Homo sapiens (human) | Potency | 47.3111 | 0.0133 | 26.9810 | 70.7614 | AID1346978 |
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_a | Homo sapiens (human) | Potency | 61.1306 | 0.0017 | 23.8393 | 78.1014 | AID743083 |
thyroid stimulating hormone receptor | Homo sapiens (human) | Potency | 20.8733 | 0.0016 | 28.0151 | 77.1139 | AID1224895 |
nuclear factor of kappa light polypeptide gene enhancer in B-cells 1 (p105), isoform CRA_a | Homo sapiens (human) | Potency | 54.9410 | 19.7391 | 45.9784 | 64.9432 | AID1159509 |
v-jun sarcoma virus 17 oncogene homolog (avian) | Homo sapiens (human) | Potency | 35.0064 | 0.0578 | 21.1097 | 61.2679 | AID1159526; AID1159528 |
Histone H2A.x | Cricetulus griseus (Chinese hamster) | Potency | 49.2793 | 0.0391 | 47.5451 | 146.8240 | AID1224845; AID1224896 |
Caspase-7 | Cricetulus griseus (Chinese hamster) | Potency | 38.3843 | 0.0067 | 23.4960 | 68.5896 | AID1346980 |
vitamin D3 receptor isoform VDRA | Homo sapiens (human) | Potency | 89.1251 | 0.3548 | 28.0659 | 89.1251 | AID504847 |
potassium voltage-gated channel subfamily H member 2 isoform d | Homo sapiens (human) | Potency | 25.1189 | 0.0178 | 9.6374 | 44.6684 | AID588834 |
transcriptional regulator ERG isoform 3 | Homo sapiens (human) | Potency | 3.9811 | 0.7943 | 21.2757 | 50.1187 | AID624246 |
caspase-3 | Cricetulus griseus (Chinese hamster) | Potency | 38.3843 | 0.0067 | 23.4960 | 68.5896 | AID1346980 |
thyroid hormone receptor beta isoform 2 | Rattus norvegicus (Norway rat) | Potency | 42.3466 | 0.0003 | 23.4451 | 159.6830 | AID743065; AID743067 |
heat shock protein beta-1 | Homo sapiens (human) | Potency | 47.7903 | 0.0420 | 27.3789 | 61.6448 | AID743210; AID743228 |
Voltage-dependent calcium channel gamma-2 subunit | Mus musculus (house mouse) | Potency | 68.5896 | 0.0015 | 57.7890 | 15,848.9004 | AID1259244 |
Interferon beta | Homo sapiens (human) | Potency | 23.2697 | 0.0033 | 9.1582 | 39.8107 | AID1645842 |
HLA class I histocompatibility antigen, B alpha chain | Homo sapiens (human) | Potency | 23.2697 | 0.0123 | 8.9648 | 39.8107 | AID1645842 |
Cellular tumor antigen p53 | Homo sapiens (human) | Potency | 51.7114 | 0.0023 | 19.5956 | 74.0614 | AID651631; AID720552 |
Glutamate receptor 2 | Rattus norvegicus (Norway rat) | Potency | 68.5896 | 0.0015 | 51.7393 | 15,848.9004 | AID1259244 |
Inositol hexakisphosphate kinase 1 | Homo sapiens (human) | Potency | 23.2697 | 0.0123 | 8.9648 | 39.8107 | AID1645842 |
cytochrome P450 2C9, partial | Homo sapiens (human) | Potency | 23.2697 | 0.0123 | 8.9648 | 39.8107 | AID1645842 |
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023] |
Assay ID | Title | Year | Journal | Article |
---|---|---|---|---|
AID1224817 | Assays to identify small molecules inhibitory for eIF4E expression | 2015 | Chemistry & biology, Jul-23, Volume: 22, Issue:7 | Internal Ribosome Entry Site-Based Bicistronic In Situ Reporter Assays for Discovery of Transcription-Targeted Lead Compounds. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
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. |
AID977599 | Inhibition of sodium fluorescein uptake in OATP1B1-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM | 2013 | Molecular pharmacology, Jun, Volume: 83, Issue:6 | Structure-based identification of OATP1B1/3 inhibitors. |
AID675314 | Binding affinity to human synthetic proadrenomedullin N-terminal 20 peptide assessed as reduction in absorbance at 1 uM after 1 hr by monoclonal antibody method | 2012 | European journal of medicinal chemistry, Sep, Volume: 55 | Identification of first proadrenomedullin N-terminal 20 peptide (PAMP) modulator by means of virtual screening and NMR interaction experiments. |
AID977602 | Inhibition of sodium fluorescein uptake in OATP1B3-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM | 2013 | Molecular pharmacology, Jun, Volume: 83, Issue:6 | Structure-based identification of OATP1B1/3 inhibitors. |
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. |
AID651635 | Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression | |||
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 | |||
AID1347101 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347104 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347097 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347083 | qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen | 2020 | Antiviral research, 01, Volume: 173 | A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity. |
AID1347092 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347098 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347094 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347095 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347091 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347108 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347090 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347099 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347096 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347107 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347102 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347407 | qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection | 2020 | ACS chemical biology, 07-17, Volume: 15, Issue:7 | High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle. |
AID1347105 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347106 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347425 | Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1) | 2019 | The Journal of biological chemistry, 11-15, Volume: 294, Issue:46 | Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens. |
AID1347093 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347100 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347089 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347154 | Primary screen GU AMC 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. |
AID1347086 | qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal | 2020 | Antiviral research, 01, Volume: 173 | A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity. |
AID1347103 | qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells | 2018 | Oncotarget, Jan-12, Volume: 9, Issue:4 | Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing. |
AID1347424 | RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1) | 2019 | The Journal of biological chemistry, 11-15, Volume: 294, Issue:46 | Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens. |
AID1508630 | Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay | 2021 | Cell reports, 04-27, Volume: 35, Issue:4 | A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome. |
AID1347082 | qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal | 2020 | Antiviral research, 01, Volume: 173 | A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity. |
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. |
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. |
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023] |
Timeframe | Studies, This Drug (%) | All Drugs % |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 2 (12.50) | 29.6817 |
2010's | 8 (50.00) | 24.3611 |
2020's | 6 (37.50) | 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 weak demand-to-supply ratio for research on this compound.
| This Compound (12.02) All Compounds (24.57) |
Publication Type | This drug (%) | All Drugs (%) |
---|---|---|
Trials | 0 (0.00%) | 5.53% |
Reviews | 0 (0.00%) | 6.00% |
Case Studies | 0 (0.00%) | 4.05% |
Observational | 0 (0.00%) | 0.25% |
Other | 16 (100.00%) | 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 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 | ||
HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC [NCT02038335] | 451 participants (Actual) | Observational | 2014-02-28 | 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 DuraGenâ„¢ [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 | ||
A Study of Prevention and Treatment of Postmenopausal Osteoporosis in Chinese Women [NCT00860964] | Phase 4 | 221 participants (Actual) | Interventional | 1998-02-28 | 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 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 | ||
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 | |||
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 | ||
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 | ||
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 | ||
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 | ||
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 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 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 | ||
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) | ||
Study of Vasomotor Symptoms in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen [NCT00332553] | Phase 2 | 150 participants | Interventional | 2002-02-28 | Completed | ||
The Efficacy of 17Beta-Estradiol in Postpartum-Related Depressive Illness [NCT00059228] | Phase 2 | 12 participants (Actual) | Interventional | 2003-04-17 | Terminated | ||
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 | ||
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 Randomized Controlled Study:the Different Outcomes Between Natural Cycle and Hormon Replacement Cycle in FET [NCT01780558] | 600 participants (Anticipated) | Interventional | 2010-01-31 | Recruiting | |||
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 | ||
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 | ||
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 | ||
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 | ||
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 | ||
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 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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 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 |
"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 |
"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 |
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 |
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 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 |
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 |
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 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 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 |
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 |
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 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 |
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 |
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 |
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-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 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 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 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-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 |
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 |
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 |
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 |
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 |
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 |
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 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 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 |
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 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 |
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 |
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 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 |
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 |
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 |
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 |
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 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 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-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 |
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 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 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-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 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 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 |
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 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 |
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 | ngï½¥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 |
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 | mIUï½¥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 |
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 | pgï½¥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 |
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 | mIUï½¥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 |
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 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 |
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 |
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 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-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 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 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 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-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 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 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 |
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 |
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 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 |
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 |
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 |
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 |
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 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 |
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 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 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 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 |
"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 |
"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 |
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). 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 |
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) 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 |
"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 |
"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 |
"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 |
"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 |
(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 |
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 |
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 | 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 |
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 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 |
"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 |
"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 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 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 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 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 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 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 |
"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 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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 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 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 |
(NCT01546454)
Timeframe: Entire Study
Intervention | Total to HDL Cholesterol Ratio (Mean) |
---|---|
Non-steroidal Effects | 0.146 |
Contraceptive Effects | 0.148 |
Steroid Effects | -0.89 |
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 |
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. 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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 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 |
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 |
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 |
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 |
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 |
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 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 |
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 |
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 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 |
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 |
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 |
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 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 |
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 |
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 |
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 |
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 |
"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 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 |
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 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 |
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: 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 |
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 |
"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 |
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 |
"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 |
"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 |
"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 |
"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 |
"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 |
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 |
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 |
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 |
"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 |
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 |
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 |
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 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 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 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 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 |
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 |
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 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 |
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 |
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 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 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 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 |
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 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 |
"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 |
(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 |
(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 |
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 |
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 |
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 |
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 |
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 Superficial Cells (Least Squares Mean) |
---|---|
TX-12-004-HR 10μg | 35.2 |
Placebo | 8.8 |
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 |
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 |
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 |
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 |
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 |
"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 |
(NCT02654054)
Timeframe: Month 0 (Baseline), Month 6
Intervention | percentage of participants (Number) |
---|---|
Placebo | 16.1 |
Elagolix | 65.9 |
Elagolix + E2/NETA | 61.5 |
"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 |
"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 |
(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 |
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 |
"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 |
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. (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 1
Intervention | mL (Least Squares Mean) |
---|---|
Placebo | -2.1 |
Elagolix | -196.6 |
Elagolix + E2/NETA | -127.0 |
"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 |
"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 |
(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 |
"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 |
"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) | -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 |
"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 |
"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 |
"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 |
"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 |
"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 |
"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 |
"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 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 |
"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 |
"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 |
"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 |
"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 |
"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 |
"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 |
"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 |
"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 |
"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 |
"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 |
"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 |
"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 |
"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 |
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 |
"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 |
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 |
"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 |
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 |
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 |
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 |
"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 |
"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 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 |
"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 |
"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 |
"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 |
"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 |
"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 |
"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). 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 |
"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 |
"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 |
"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 |
"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 |
"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 |
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 |
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 |
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 |
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 |
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 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 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 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 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 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 |
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 |
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 |
Substance | Relationship Strength | Studies | Trials | Classes | Roles |
---|---|---|---|---|---|
2-(3-pyridine)acetic acid 3-pyridylacetic acid : A monocarboxylic acid that is acetic acid substituted by a (pyridin-3-yl) group. It is a metabolite of nicotine and other tobacco alkaloids. | 2.11 | 1 | 0 | monocarboxylic acid; pyridines | human xenobiotic metabolite |
ureidosuccinic acid ureidosuccinic acid: RN given refers to (DL)-isomer. N-carbamoylaspartic acid : An N-carbamoylamino acid that is aspartic acid with one of its amino hydrogens replaced by a carbamoyl group. | 2.11 | 1 | 0 | aspartic acid derivative; C4-dicarboxylic acid; N-carbamoyl-amino acid | Escherichia coli metabolite; human metabolite; Saccharomyces cerevisiae metabolite |
arabinofuranosylcytosine triphosphate [no description available] | 2.11 | 1 | 0 | pyrimidine ribonucleoside monophosphate | |
aminoethylphosphonic acid Aminoethylphosphonic Acid: An organophosphorus compound isolated from human and animal tissues.. (2-aminoethyl)phosphonic acid : A phosphonic acid in which the hydrogen attached to the phosphorus of phosphonic acid is substituted by a 2-aminoethyl group. | 2.11 | 1 | 0 | phosphonic acids; primary amino compound; zwitterion | human metabolite; metabolite; mouse 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 |
gamma-guanidinobutyric acid gamma-guanidinobutyric acid: RN given refers to parent cpd. 4-guanidinobutyric acid : A monocarboxylic acid that is butanoic acid substituted by a guanidino group at position 4.. 4-guanidinobutanoate : A monocarboxylic acid anion that is the conjugate base of 4-guanidinobutanoic acid.. 4-guanidinobutanoic acid : The 4-guanidino derivative of butanoic acid. | 2.11 | 1 | 0 | guanidines; monocarboxylic acid; zwitterion | fungal metabolite; mouse metabolite; Saccharomyces cerevisiae 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 |
inositol Inositol: An isomer of glucose that has traditionally been considered to be a B vitamin although it has an uncertain status as a vitamin and a deficiency syndrome has not been identified in man. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1379) Inositol phospholipids are important in signal transduction.. inositol : Any cyclohexane-1,2,3,4,5,6-hexol.. 1D-chiro-inositol : Belonging to the inositol family of compounds, D-chiro-inositol (DCI) is an isomer of glucose. It is an important secondary messenger in insulin signal transduction.. muco-inositol : An inositol that is cyclohexane-1,2,3,4,5,6-hexol having a (1R,2R,3r,4R,5S,6r)-configuration. | 2.11 | 1 | 0 | cyclitol; hexol | |
pentachlorophenol PENTA: structure given in first source | 2.11 | 1 | 0 | aromatic fungicide; chlorophenol; organochlorine pesticide; pentachlorobenzenes | human xenobiotic metabolite |
phenylalanine [no description available] | 2.11 | 1 | 0 | alpha-amino acid; aromatic amino acid | Daphnia magna metabolite |
nsc-267703 [no description available] | 2.11 | 1 | 0 | anthracycline | |
phenytoin [no description available] | 2.02 | 1 | 0 | imidazolidine-2,4-dione | anticonvulsant; drug allergen; sodium channel blocker; teratogenic agent |
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 |
n-acetyltryptophan N-acetyltryptophan : An N-acetylamino acid that is the N-acetyl derivative of tryptophan. | 2.11 | 1 | 0 | N-acetyl-amino acid; tryptophan derivative | metabolite |
tyrphostin ag957 tyrphostin AG957: tyrosine kinase blocker; structure given in first source | 2.11 | 1 | 0 | aromatic amine | |
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 |
2-amino-4-phosphonobutyric acid 2-amino-4-phosphonobutyric acid: glutamate antagonist in locust muscle; structure; do not confuse with L-AP4, which is the propionic acid version | 2.11 | 1 | 0 | ||
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 |
aristolochic acid i aristolochic acid I: phospholipase A inhibitor. aristolochic acid A : An aristolochic acid that is phenanthrene-1-carboxylic acid that is substituted by a methylenedioxy group at the 3,4 positions, by a methoxy group at position 8, and by a nitro group at position 10. It is the most abundant of the aristolochic acids and is found in almost all Aristolochia (birthworts or pipevines) species. It has been tried in a number of treatments for inflammatory disorders, mainly in Chinese and folk medicine. However, there is concern over their use as aristolochic acid is both carcinogenic and nephrotoxic. | 2.11 | 1 | 0 | aristolochic acids; aromatic ether; C-nitro compound; cyclic acetal; monocarboxylic acid; organic heterotetracyclic compound | carcinogenic agent; metabolite; mutagen; nephrotoxin; toxin |
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. | 2.02 | 1 | 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. | 2.02 | 1 | 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 |
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 |
benzbromarone Benzbromarone: Uricosuric that acts by increasing uric acid clearance. It is used in the treatment of gout.. benzbromarone : 1-Benzofuran substituted at C-2 and C-3 by an ethyl group and a 3,5-dibromo-4-hydroxybenzoyl group respectively. An inhibitor of CYP2C9, it is used as an anti-gout medication. | 2.11 | 1 | 0 | 1-benzofurans; aromatic ketone | uricosuric drug |
benzylhydrochlorothiazide [no description available] | 2.11 | 1 | 0 | benzenes; benzothiadiazine; organochlorine compound; secondary amino compound; sulfonamide | |
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 |
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 | |
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 |
eucalyptol [no description available] | 2.11 | 1 | 0 | ||
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. | 2.02 | 1 | 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 |
amberlite cg 400 [no description available] | 2.11 | 1 | 0 | methyl ester; organic heteropentacyclic compound; yohimban alkaloid | |
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 |
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. | 2.02 | 1 | 0 | 1,4-benzodiazepinone; organochlorine compound | anticonvulsant; anxiolytic drug; environmental contaminant; sedative; xenobiotic |
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 |
stallimycin [no description available] | 2.11 | 1 | 0 | ||
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 |
domperidone Domperidone: A specific blocker of dopamine receptors. It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic and tool in the study of dopaminergic mechanisms.. domperidone : 1-[3-(Piperidin-1-yl)propyl]-1,3-dihydro-2H-benzimidazol-2-one in which the 4-position of the piperidine ring is substituted by a 5-chloro-1,3-dihydro-2H-benzimidazol-2-on-1-yl group. A dopamine antagonist, it is used as an antiemetic for the short-term treatment of nausea and vomiting, and to control gastrointestinal effects of dopaminergic drugs given in the management of parkinsonism. The free base is used in oral suspensions, while the maleate salt is used in tablet preparations. | 2.49 | 2 | 0 | benzimidazoles; heteroarylpiperidine | antiemetic; dopaminergic antagonist |
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. | 2.02 | 1 | 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 | |
ellipticine ellipticine : A organic heterotetracyclic compound that is pyrido[4,3-b]carbazole carrying two methyl substituents at positions 5 and 11. | 2.11 | 1 | 0 | indole alkaloid; organic heterotetracyclic compound; organonitrogen heterocyclic compound; polycyclic heteroarene | antineoplastic agent; plant metabolite |
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. | 2.02 | 1 | 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. | 2.02 | 1 | 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. | 2.02 | 1 | 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. | 2.02 | 1 | 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 |
glyphosate glyphosate: active cpd in herbicidal formulation Roundup; inhibits EC 2.5.1.19, 5-enolpyruvylshikimate-3-phosphate synthase; structure. glyphosate : A phosphonic acid resulting from the formal oxidative coupling of the methyl group of methylphosphonic acid with the amino group of glycine. It is one of the most commonly used herbicides worldwide, and the only one to target the enzyme 5-enolpyruvyl-3-shikimate phosphate synthase (EPSPS). | 2.11 | 1 | 0 | glycine derivative; phosphonic acid | agrochemical; EC 2.5.1.19 (3-phosphoshikimate 1-carboxyvinyltransferase) inhibitor; herbicide |
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 |
miltefosine miltefosine: hexadecyl phosphocholine derivative of cisplatin; did not substantially activate HIV long terminal repeat; less toxic than cisplatin. miltefosine : A phospholipid that is the hexadecyl monoester of phosphocholine. | 2.11 | 1 | 0 | phosphocholines; phospholipid | anti-inflammatory agent; anticoronaviral agent; antifungal agent; antineoplastic agent; antiprotozoal drug; apoptosis inducer; immunomodulator; protein kinase inhibitor |
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 |
hypericin [no description available] | 2.11 | 1 | 0 | ||
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 | |
batyl alcohol batyl alcohol: RN given refers to cpd without isomeric designation. batilol : An alkylglycerol that is glycerol in which one of the primary hydroxy groups has been converted into the corresponding octadecyl ether. It is used in cosmetics as a stabilising ingredient and skin-conditioning agent. | 2.11 | 1 | 0 | alkylglycerol | |
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. | 2.11 | 1 | 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. | 2.02 | 1 | 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 | |
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 |
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 | |
nsc 664704 kenpaullone: inhibits CDK1/cyclin B; structure in first source. kenpaullone : An indolobenzazepine that is paullone in which the hydrogen at position 9 is replaced by a bromo substituent. It is an ATP-competitive inhibitor of cyclin-dependent kinases (CDKs) and glycogen synthase kinase 3beta (GSK3beta). | 2.11 | 1 | 0 | indolobenzazepine; lactam; organobromine compound | cardioprotective agent; EC 2.7.11.22 (cyclin-dependent kinase) inhibitor; EC 2.7.11.26 (tau-protein kinase) inhibitor; geroprotector |
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. | 2.46 | 2 | 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 |
khellin Khellin: A vasodilator that also has bronchodilatory action. It has been employed in the treatment of angina pectoris, in the treatment of asthma, and in conjunction with ultraviolet light A, has been tried in the treatment of vitiligo. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1024). khellin : A furanochrome in which the basic tricyclic skeleton is substituted at positions 4 and 9 with methoxy groups and at position 7 with a methyl group. A major constituent of the plant Ammi visnaga it is a herbal folk medicine used for various illnesses, its main effect being as a vasodilator. | 2.11 | 1 | 0 | furanochromone; organic heterotricyclic compound; oxacycle | anti-asthmatic agent; bronchodilator agent; cardiovascular drug; vasodilator agent |
2-amino-3-phosphonopropionic acid 2-amino-3-phosphonopropionic acid: metabotropic glutamate receptor antagonist; do not confuse AP-3 used as an abbreviation for this with enhancer-binding protein AP-3 (a trans-activator) or clathrin assembly protein AP-3. 2-amino-3-phosphonopropanoic acid : A non-proteinogenc alpha-amino acid that is alanine in which one of the hydrogens of the terminal methyl group has been replaced by a dihydroxy(oxido)-lambda(5)-phosphanyl group. | 2.11 | 1 | 0 | alanine derivative; non-proteinogenic alpha-amino acid; phosphonic acids | human metabolite; metabotropic glutamate receptor antagonist |
benzylsuccinic acid benzylsuccinic acid: inhibitor of carboxypeptidase A. 2-benzylsuccinic acid : A dicarboxylic acid consisting of succinic acid carrying a 2-benzyl substituent. | 2.11 | 1 | 0 | dicarboxylic acid | bacterial xenobiotic metabolite |
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 |
beta-lapachone beta-lapachone: antineoplastic inhibitor of reverse transcriptase, DNA topoisomerase, and DNA polymerase. beta-lapachone : A benzochromenone that is 3,4-dihydro-2H-benzo[h]chromene-5,6-dione substituted by geminal methyl groups at position 2. Isolated from Tabebuia avellanedae, it exhibits antineoplastic and anti-inflammatory activities. | 2.11 | 1 | 0 | benzochromenone; orthoquinones | anti-inflammatory agent; antineoplastic agent; plant metabolite |
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 |
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 | 2.02 | 1 | 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 |
mesoridazine Mesoridazine: A phenothiazine antipsychotic with effects similar to CHLORPROMAZINE.. mesoridazine : A phenothiazine substituted at position 2 (para to the S atom) by a methylsulfinyl group, and on the nitrogen by a 2-(1-methylpiperidin-2-yl)ethyl group. | 2.11 | 1 | 0 | phenothiazines; sulfoxide; tertiary amino compound | dopaminergic antagonist; first generation antipsychotic |
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 |
methoxsalen Methoxsalen: A naturally occurring furocoumarin compound found in several species of plants, including Psoralea corylifolia. It is a photoactive substance that forms DNA ADDUCTS in the presence of ultraviolet A irradiation.. methoxsalen : A member of the class of psoralens that is 7H-furo[3,2-g]chromen-7-one in which the 9 position is substituted by a methoxy group. It is a constituent of the fruits of Ammi majus. Like other psoralens, trioxsalen causes photosensitization of the skin. It is administered topically or orally in conjunction with UV-A for phototherapy treatment of vitiligo and severe psoriasis. | 2.11 | 1 | 0 | aromatic ether; psoralens | antineoplastic agent; cross-linking reagent; dermatologic drug; photosensitizing agent; plant metabolite |
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. | 2.02 | 1 | 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 |
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. | 2.02 | 1 | 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 |
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 | 2.02 | 1 | 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 | |
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. | 2.46 | 2 | 0 | 1,3-oxazoles; monocarboxylic acid | analgesic; non-steroidal anti-inflammatory drug |
pamidronate [no description available] | 2.02 | 1 | 0 | phosphonoacetic acid | |
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 |
penicillamine [no description available] | 2.11 | 1 | 0 | non-proteinogenic alpha-amino acid; thiol | |
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 |
pentoxifylline [no description available] | 2.46 | 2 | 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. | 2.11 | 1 | 0 | 2,1-benzoxathiole; arenesulfonate ester; phenols; sultone | acid-base indicator; diagnostic agent; two-colour indicator |
Picrotin, analytical standard [no description available] | 2.11 | 1 | 0 | furopyran | |
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 | |
pomiferin pomiferin: structure in first source | 2.11 | 1 | 0 | isoflavanones | |
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 |
pridinol pridinol: antispasmodic & muscle relaxant; RN given refers to parent cpd; structure in Merck Index, 9th ed, #7539. pridinol : A piperidine substituted at position 1 by a 3-hydroxy-3,3-diphenylpropyl group. | 2.11 | 1 | 0 | piperidines; tertiary alcohol | antiparkinson drug; muscle relaxant |
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 |
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 |
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 |
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 | |
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 | |
sulfaquinoxaline Sulfaquinoxaline: An antiprotozoal agent used to combat coccidial infections of swine, cattle, fowl, and other veterinary animals. Also used in controlling outbreaks of fowl typhoid and fowl cholera and in treatment of infectious enteritis. | 2.11 | 1 | 0 | benzenes; sulfonamide | |
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 | ||
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 |
suramin Suramin: A polyanionic compound with an unknown mechanism of action. It is used parenterally in the treatment of African trypanosomiasis and it has been used clinically with diethylcarbamazine to kill the adult Onchocerca. (From AMA Drug Evaluations Annual, 1992, p1643) It has also been shown to have potent antineoplastic properties.. suramin : A member of the class of phenylureas that is urea in which each of the amino groups has been substituted by a 3-({2-methyl-5-[(4,6,8-trisulfo-1-naphthyl)carbamoyl]phenyl}carbamoyl)phenyl group. An activator of both the rabbit skeletal muscle RyR1 and sheep cardiac RyR2 isoform ryanodine receptor channels, it has been used for the treatment of human African trypanosomiasis for over 100 years. | 2.11 | 1 | 0 | naphthalenesulfonic acid; phenylureas; secondary carboxamide | angiogenesis inhibitor; antinematodal drug; antineoplastic agent; apoptosis inhibitor; EC 2.7.11.13 (protein kinase C) inhibitor; GABA antagonist; GABA-gated chloride channel antagonist; purinergic receptor P2 antagonist; ryanodine receptor agonist; trypanocidal drug |
4-methylglutamic acid 4-methylglutamic acid : A glutamic acid derivative that is glutamic acid substituted by a methyl group at position 4. | 2.11 | 1 | 0 | amino dicarboxylic acid; glutamic acid derivative | |
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 |
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 |
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 |
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 |
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 |
pilocarpine hydrochloride pilocarpine hydrochloride : The hydrochloride salt of (+)-pilocarpine, a medication used to treat increased pressure inside the eye and dry mouth. | 2.11 | 1 | 0 | hydrochloride | |
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 |
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 |
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. | 2.02 | 1 | 0 | steroid ester | |
veratramine veratramine: structure. veratramine : A piperidine alkaloid comprising the 14,15,16,17-tetradehydro derivative of veratraman having two hydroxy groups at the 3- and 23-positions. | 2.11 | 1 | 0 | piperidine alkaloid | |
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 |
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 |
medroxyprogesterone acetate [no description available] | 2.02 | 1 | 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 |
gibberellic acid gibberellic acid: RN given refers to (1alpha,2beta,4aalpha,4bbeta,10beta)-isomer; structure. gibberellin A3 : A C19-gibberellin that is a pentacyclic diterpenoid responsible for promoting growth and elongation of cells in plants. Initially identified in Gibberella fujikuroi,it differs from gibberellin A1 in the presence of a double bond between C-3 and C-4. | 2.11 | 1 | 0 | C19-gibberellin; gibberellin monocarboxylic acid; lactone; organic heteropentacyclic compound | mouse metabolite; plant metabolite |
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 |
santowhite powder 4,4'-butylidenebis(6-tert-butyl-m-cresol): putatively both an androgen and estrogen antagonist; structure in first source | 2.11 | 1 | 0 | ||
fentichlor fentichlor: structure. fenticlor : An aryl sulfide having two 5-chloro-2-hydroxyphenyl groups attached to sulfur; an antiinfective drug mostly used in veterinary medicine. | 2.11 | 1 | 0 | aryl sulfide; bridged diphenyl antifungal drug; monochlorobenzenes; polyphenol | antiinfective agent; drug allergen |
pyrrolidonecarboxylic acid Pyrrolidonecarboxylic Acid: A cyclized derivative of L-GLUTAMIC ACID. Elevated blood levels may be associated with problems of GLUTAMINE or GLUTATHIONE metabolism.. 5-oxo-L-proline : An optically active form of 5-oxoproline having L-configuration. | 2.11 | 1 | 0 | 5-oxoproline; L-proline derivative; non-proteinogenic L-alpha-amino acid | algal metabolite |
hexadecanolide hexadecanolide: structure in first source | 2.11 | 1 | 0 | macrolide | |
estradiol dipropionate estradiol dipropionate: RN given refers to (17beta)-isomer; RN for cpd without isomeric designation not in Chemline 7/83 | 2.02 | 1 | 0 | steroid ester | |
pamoic acid pamoic acid: RN given refers to parent cpd; structure | 2.11 | 1 | 0 | dicarboxylic acid | |
carzenide [no description available] | 2.11 | 1 | 0 | sulfonamide | |
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 |
testosterone enanthate [no description available] | 2.02 | 1 | 0 | heptanoate ester; sterol ester | androgen |
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) | 2.02 | 1 | 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 |
lithocholic acid Lithocholic Acid: A bile acid formed from chenodeoxycholate by bacterial action, usually conjugated with glycine or taurine. It acts as a detergent to solubilize fats for absorption and is itself absorbed. It is used as cholagogue and choleretic.. lithocholic acid : A monohydroxy-5beta-cholanic acid with a alpha-hydroxy substituent at position 3. It is a bile acid obtained from chenodeoxycholic acid by bacterial action.. lithocholate : A bile acid anion that is the conjugate base of lithocholic acid. | 2.11 | 1 | 0 | bile acid; C24-steroid; monohydroxy-5beta-cholanic acid | geroprotector; human metabolite; mouse metabolite |
jervine jervine: teratogen from Veratrum grandiflorum; RN given refers to parent cpd(3beta,23beta)-isomer; structure | 2.11 | 1 | 0 | piperidines | |
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 |
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. | 2.11 | 1 | 0 | benzylisoquinoline alkaloid; isoquinoline alkaloid; isoquinolines | agrochemical; central nervous system stimulant; GABA-gated chloride channel antagonist; GABAA receptor antagonist; neurotoxin |
salicylurate salicylurate: RN given refers to parent cpd. salicyluric acid : An N-acylglycine in which the acyl group is specified as 2-hydroxybenzoyl.. salicylurate : A monocarboxylic acid anion that is the conjugate base of salicyluric acid, obtained by deprotonation of the carboxy group; major species at pH 7.3. | 2.11 | 1 | 0 | N-acylglycine; secondary carboxamide | human xenobiotic metabolite; uremic toxin |
3,5-pyridinedicarboxylic acid 3,5-pyridinedicarboxylic acid: structure in first source | 2.11 | 1 | 0 | pyridinedicarboxylic acid | |
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 |
ricinine [no description available] | 2.11 | 1 | 0 | nitrile; pyridine alkaloid; pyridone | |
carinamide [no description available] | 2.11 | 1 | 0 | ||
3,5-dibromotyrosine 3,5-dibromotyrosine: used to synthesize various secondary metabolites from marine sponges | 2.11 | 1 | 0 | monocarboxylic acid | |
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) |
hematoporphyrin Hematoporphyrins: Iron-free derivatives of heme with 4 methyl groups, 2 hydroxyethyl groups and 2 propionic acid groups attached to the pyrrole rings. Some of these PHOTOSENSITIZING AGENTS are used in the PHOTOTHERAPY of malignant NEOPLASMS.. hematoporphyrin : A dicarboxylic acid that is protoporphyrin in which the vinyl groups at positions 7 and 12 are replaced by 1-hydroxyethyl groups. | 2.11 | 1 | 0 | ||
megestrol acetate [no description available] | 2.02 | 1 | 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 |
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 | |
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. | 2.02 | 1 | 0 | 17beta-hydroxy steroid; 3-oxo-Delta(4) steroid; terminal acetylenic compound | contraceptive drug; female contraceptive drug; progestin; synthetic oral contraceptive |
1H-indazol-3-amine 1H-indazol-3-amine: structure in first source | 2.11 | 1 | 0 | indazoles | |
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 |
1,1'-methylenedi-2-naphthol 1,1'-methylenedi-2-naphthol: piscicide | 2.11 | 1 | 0 | ||
tricarballylic acid tricarballylic acid: RN given refers to parent cpd. tricarballylic acid : A tricarboxylic acid that is glutaric acid in which one of the beta-hydrogens is substituted by a carboxy group. | 2.11 | 1 | 0 | tricarboxylic acid | |
popop [no description available] | 2.11 | 1 | 0 | 1,3-oxazoles | fluorochrome |
2-tert-butylhydroquinone 2-tert-butylhydroquinone: an anticarcinogenic and chemopreventive agent. 2-tert-butylhydroquinone : A member of the class of hydroquinones in which one of the ring hydrogens of hydroquinone is replaced by a tert-butyl group. | 2.11 | 1 | 0 | hydroquinones | food antioxidant |
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 |
7-hydroxychlorpromazine 7-hydroxychlorpromazine: RN given refers to parent cpd | 2.11 | 1 | 0 | phenothiazines | |
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 | |
cme-carbodiimide [no description available] | 2.11 | 1 | 0 | ||
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. | 2.46 | 2 | 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 |
strombine N-methyliminodiacetic acid: structure in first source | 2.11 | 1 | 0 | ||
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 |
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 |
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 |
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 |
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 |
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. | 2.02 | 1 | 0 | 17beta-hydroxy steroid; terminal acetylenic compound | anti-estrogen; estrogen antagonist; geroprotector |
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. | 2.02 | 1 | 0 | indole alkaloid | antidyskinesia agent; antiparkinson drug; dopamine agonist; hormone antagonist |
thymolphthalein Thymolphthalein: Used as a pH indicator and as a reagent for blood after decolorizing the alkaline solution by boiling with zinc dust. | 2.11 | 1 | 0 | terpene lactone | |
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 |
1,4,5,8-naphthalenetetracarboxylic acid 1,4,5,8-naphthalenetetracarboxylic acid: structure given in first source | 2.11 | 1 | 0 | ||
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 | |
(7S,9S)-7-[(4-amino-5-hydroxy-6-methyl-2-oxanyl)oxy]-6,9,11-trihydroxy-9-(2-hydroxy-1-oxoethyl)-4-methoxy-8,10-dihydro-7H-tetracene-5,12-dione [no description available] | 2.11 | 1 | 0 | anthracycline | |
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 |
hydroxyphenylazouracil Hydroxyphenylazouracil: Inhibitor of DNA replication in gram-positive bacteria. | 2.11 | 1 | 0 | ||
canadine canadine: RN given refers to cpd without isomeric designation; structure. canadine : A berberine alkaloid that is 5,8,13,13a-tetrahydro-6H-[1,3]dioxolo[4,5-g]isoquino[3,2-a]isoquinoline substituted by methoxy groups at positions 9 and 10. | 2.11 | 1 | 0 | aromatic ether; berberine alkaloid; organic heteropentacyclic compound; oxacycle | |
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 |
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 |
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 |
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 | 2.02 | 1 | 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 |
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 |
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 |
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 |
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 |
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. | 2.02 | 1 | 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. | 2.02 | 1 | 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 |
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 |
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 |
pimonidazole pimonidazole: structure given in first source | 2.11 | 1 | 0 | ||
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 |
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. | 2.02 | 1 | 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 |
flavone acetic acid flavone acetic acid: structure given in first source | 2.11 | 1 | 0 | ||
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. | 2.02 | 1 | 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 |
trichlorophene trichlorophene: contains 20 carbon atoms; do not confuse with trichlorophene as name for trichloro derivs of 2,2'-methylenebisphenol (contain 13 carbon atoms) | 2.11 | 1 | 0 | ||
verapamil hydrochloride verapamil hydrochloride : A racemate comprising equimolar amounts of dexverapamil hydrochloride and (S)-verapamil hydrochloride. | 2.11 | 1 | 0 | ||
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 | |
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 |
4-aminomethylbenzoic acid [no description available] | 2.11 | 1 | 0 | benzoic acids | |
cedrol cedrol: a cyclic terpenoid from cedarwood oil; 8-epicedrol is an epimer | 2.11 | 1 | 0 | cedrane sesquiterpenoid; tertiary alcohol | |
propazole propazole: RN given refers to parent cpd; structure | 2.11 | 1 | 0 | benzimidazoles | |
reserpic acid reserpic acid: inhibitor of norepinephrine transport into chromaffin vesicle ghosts; RN given refers to (3beta,16beta,17alpha,18beta,20alpha)-isomer parent cpd; structure given in first source | 2.11 | 1 | 0 | yohimban alkaloid | |
pifexole pifexole: structure | 2.11 | 1 | 0 | ||
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 |
Diphenolic acid diphenolic acid: an estrogenic ligand | 2.11 | 1 | 0 | bisphenol | |
Melicopidine [no description available] | 2.11 | 1 | 0 | acridines | |
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 |
resorufin [no description available] | 2.11 | 1 | 0 | phenoxazine | |
vinburnine [no description available] | 2.11 | 1 | 0 | alkaloid | |
erythromycin propionate erythromycin propionate: form in which erythromycin estolate is principally absorbed | 2.02 | 1 | 0 | erythromycin derivative | |
fosquidone [no description available] | 2.07 | 1 | 0 | ||
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 | |
pacein PAcein: structure. pacein : A member of the class of benzofurans that is dibenzo[b,d]furan-3,7-dione bearing two methyl substituents at positions 1 and 9 as well as two 2,4-dihydroxy-6-methylanilino substituents at positions 2 and 8.. orcein : A variable mixture of several compounds isolated from lichens, the eight most abundant being alpha-aminoorcein, alpha-hydroxyorcein, beta-aminoorcein, gamma-aminoorcein, beta-hydroxyorcein, gamma-hydroxyorcein, beta-aminoorceimine and beta-aminoorceimine (all are phenoxazine-based). It is used for the demonstration of elastic fibres as well as to stain the rough endoplasmic reticulum of hepatitis B infected liver cells. | 2.11 | 1 | 0 | ||
alantolactone alantolactone: allergenic sesquiterpene lactone; crystalline mixture of alantolactones from group of sesquiterpenes; structure. alantolactone : A sesquiterpene lactone that is 3a,5,6,7,8,8a,9,9a-octahydronaphtho[2,3-b]furan-2-one bearing two methyl substituents at positions 5 and 8a as well as a methylidene substituent at position 3. | 2.11 | 1 | 0 | naphthofuran; olefinic compound; sesquiterpene lactone | antineoplastic agent; apoptosis inducer; plant metabolite |
2-(4'-methylpiperazino-1-methyl)-1,3-diazafluoranthene 1-oxide 2-(4'-methylpiperazino-1-methyl)-1,3-diazafluoranthene 1-oxide: structure | 2.11 | 1 | 0 | ||
tetrandrine tetrandrine: a bisbenzylisoquinoline that exhibits antifibrogenic activity | 2.11 | 1 | 0 | bisbenzylisoquinoline alkaloid; isoquinolines | |
stictic acid stictic acid: antioxidant from lichen, Usnea articulata; structure in first source | 2.11 | 1 | 0 | aromatic ether | |
gallocyanine gallocyanine: structure; gallocyanine-chrome alum is used as a nuclear stain to quantitate nucleic acids. gallocyanin : An organic chloride salt composed of 1-carboxy-7-(dimethylamino)-3,4-dihydroxyphenoxazin-5-ium and chloride ions in a 1:1 ratio. A histological dye used in solution with an iron alum mordant as a hematoxylin substitute in the H&E stain. | 2.11 | 1 | 0 | ||
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. | 2.02 | 1 | 0 | hydroxy-1,2-naphthoquinone | |
propylsulfonic acid propylsulfonic acid: RN given refers to cpd without locant for propyl moiety | 2.11 | 1 | 0 | ||
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 |
1-cyclohexyl-3-(2-(4-morpholinyl)ethyl)carbodiimide N-cyclohexyl-N'-(2-(4-morpholinyl)ethyl)carbodiimide : A carbodiimide having cyclcohexyl and 2-(4-morpholinyl)ethyl as the two N-substituents. | 2.11 | 1 | 0 | carbodiimide; morpholines | cross-linking reagent |
6,6'-dithiodinicotinic acid 6,6'-dithiodinicotinic acid: RN given refers to parent cpd; structure | 2.11 | 1 | 0 | ||
va 061 VA 061: a water-soluble radical initiator; structure in first source | 2.11 | 1 | 0 | ||
n-acetyltyrosine, (dl)-isomer N-acetyltyrosine: RN given refers to (L)-isomer. N-acetyltyrosine : An N-acetyl-amino acid that is tyrosine with an amine hydrogen substituted by an acetyl group. | 2.11 | 1 | 0 | N-acetyl-amino acid; phenols; tyrosine derivative | human urinary metabolite |
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. | 2.02 | 1 | 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 |
cinchonine [no description available] | 2.11 | 1 | 0 | (8xi)-cinchonan-9-ol; cinchona alkaloid | metabolite |
moexipril [no description available] | 2.02 | 1 | 0 | peptide | |
n(6)-(delta(2)-isopentenyl)adenine N(6)-dimethylallyladenine : A 6-isopentenylaminopurine in which has the isopentenyl double bond is located between the 2 and 3 positions of the isopentenyl group. | 2.11 | 1 | 0 | 6-isopentenylaminopurine | cytokinin |
2-Phthalimidoglutaricacid [no description available] | 2.11 | 1 | 0 | glutamic acid derivative | |
nsc-87877 NSC-87877: potent Shp2 (nonreceptor protein tyrosine phosphatase) inhibitor; structure in first source | 2.49 | 2 | 0 | ||
methyl lithocholate methyl lithocholate: RN given refers to (3alpha,5beta)-isomer | 2.11 | 1 | 0 | ||
nipecotic acid amide nipecotic acid amide: RN & N1 form 9th CI Form Index; RN given refers to cpd without isomeric designation. nipecotamide : The amide resulting from the formal condensation of nipecotic acid with ammonia. | 2.11 | 1 | 0 | piperidinecarboxamide | |
dimethacrine dimethacrine: minor descriptor (75-84); on-line & Index Medicus search ACRIDINES (75-84); RN given refers to parent cpd without isomeric designation | 2.11 | 1 | 0 | acridines | |
dehydroabietic acid dehydroabietic acid: major aquatic toxicant in effluent of pulp and paper mills. dehydroabietic acid : An abietane diterpenoid that is abieta-8,11,13-triene substituted at position 18 by a carboxy group.. dehydroabietate : A monocarboxylic acid anion that is the conjugate base of dehydroabietic acid, obtained by deprotonation of the carboxy group. | 2.11 | 1 | 0 | abietane diterpenoid; carbotricyclic compound; monocarboxylic acid | allergen; metabolite |
4-deoxypyridoxine 5'-phosphate [no description available] | 2.11 | 1 | 0 | ||
4-(phenylthio)butanoic acid 4-(phenylthio)butanoic acid: structure in first source | 2.11 | 1 | 0 | ||
bis-a-tda bis-A-TDA: structure given in first source | 2.11 | 1 | 0 | ||
1-amino-2-phenylethylphosphonic acid 1-amino-2-phenylethylphosphonic acid: RN given refers to cpd without isomeric designation: structure given in first source | 2.11 | 1 | 0 | ||
4-fluoro-alpha-hydroxybenzeneacetic acid 4-fluoro-alpha-hydroxybenzeneacetic acid: an aprepitant urinary metabolite; structure in first source | 2.11 | 1 | 0 | ||
Isopteropodin [no description available] | 2.11 | 1 | 0 | indolizines | |
benzpiperylone benzpiperylone: spelled benzopiperylone in title | 2.11 | 1 | 0 | pyrazoles; ring assembly | |
carboxyamido-triazole carboxyamido-triazole: structure given in first source; coccidiostat; U.S. patent No. 4,590,201 | 2.11 | 1 | 0 | ||
nsc 607097 [no description available] | 2.11 | 1 | 0 | ||
pacifenol pacifenol: isolated from sea weeds and marine alga Laurencia claviformis; RN refers to (2R,5R,5aR,7S,8S,9aS)-isomer; structure in first source | 2.11 | 1 | 0 | ||
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-phenyliminodiacetic acid [no description available] | 2.11 | 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 |
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 |
cyc 202 seliciclib : 2,6-Diaminopurine carrying benzylamino, (2R)-1-hydroxybutan-2-yl and isopropyl substituents at C-6, C-2-N and N-9 respectively. It is an experimental drug candidate in the family of pharmacological cyclin-dependent kinase (CDK) inhibitors. | 2.11 | 1 | 0 | 2,6-diaminopurines | antiviral drug; EC 2.7.11.22 (cyclin-dependent kinase) inhibitor |
cystamine hydrochloride [no description available] | 2.11 | 1 | 0 | ||
dipiperidinoethane-di-n-oxide dipiperidinoethane-di-N-oxide: oxidized neurotoxic dipiperidinoethane deriv; structure given in first source | 2.11 | 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 |
benzyl-beta-d-xyloside benzyl-beta-D-xyloside: RN given refers to (beta-D)-isomer | 2.11 | 1 | 0 | ||
2,2'-(3-methylcyclohexane-1,1-diyl)diacetic acid [no description available] | 2.11 | 1 | 0 | dicarboxylic acid | |
2,4-dinitrophenylacetic acid 2,4-dinitrophenylacetic acid: RN given refers to parent cpd | 2.11 | 1 | 0 | ||
sitosterol, (3beta)-isomer Sobatum: tradename; active fraction of Solanum trilobatum; reduces side-effects of radiation-induced toxicity. sitosterol : A member of the class of phytosterols that is stigmast-5-ene substituted by a beta-hydroxy group at position 3. | 2.11 | 1 | 0 | 3beta-hydroxy-Delta(5)-steroid; 3beta-sterol; C29-steroid; phytosterols; stigmastane sterol | anticholesteremic drug; antioxidant; mouse metabolite; plant metabolite; sterol methyltransferase inhibitor |
(5-Phenyl-1,2,4-triazol-3-yl)urea [no description available] | 2.11 | 1 | 0 | benzenes | |
estradiol 3-benzoate 17beta-estradiol 3-benzoate : A benzoate ester resulting from the formal condensation of benzoic acid with the phenolic hydroxy group of 17beta-estradiol. | 2.02 | 1 | 0 | 17beta-hydroxy steroid; benzoate ester | estrogen receptor agonist; xenoestrogen |
fumagillol fumagillol: from Penicillium jensenii; FR 65814 is an analog; structure given in first source. fumagillol : A sesquiterpenoid with antimicrobial properties. | 2.11 | 1 | 0 | secondary alcohol; sesquiterpenoid; spiro-epoxide | antimicrobial agent |
vacquinol-1 [no description available] | 2.11 | 1 | 0 | ||
aspidospermine aspidospermine: an indole fused to a qunoline; isolated from Aspidosperma tree; structure given in first source. aspidospermine : An indole alkaloid having the structure of aspirospermidine methoxylated at C-17 and acetylated at N-1. | 2.11 | 1 | 0 | indole alkaloid | |
guaiol guaiol: structure in first source | 2.11 | 1 | 0 | guaiane sesquiterpenoid | |
benzatropine methanesulfonate [no description available] | 2.11 | 1 | 0 | ||
pseudoyohimbine [no description available] | 2.11 | 1 | 0 | methyl 17-hydroxy-20xi-yohimban-16-carboxylate | |
gant58 GANT58: inhibits hedgehog signalling; structure in first source | 2.11 | 1 | 0 | pyridines | |
nsc 88915 4-pregnen-21-ol-3,20-dione-21-(4-bromobenzenesufonate): a tyrosyl-DNA phosphodiesterase inhibitor; structure in first source | 2.11 | 1 | 0 | ||
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 |
o-acetylsolasodine [no description available] | 2.11 | 1 | 0 | ||
viroallosecurinine [no description available] | 2.11 | 1 | 0 | indolizines | |
4-methyl-2-quinazolinamine 4-methyl-2-quinazolinamine: from Streptomyces of TCM plant; structure in first source | 2.11 | 1 | 0 | ||
1-amino-9,10-dioxo-4-(3-sulfamoylanilino)anthracene-2-sulfonic acid 1-amino-9,10-dioxo-4-(3-sulfamoylanilino)anthracene-2-sulfonic acid: inhibits PH domain leucine-rich repeat protein phosphatase; structure in first source | 2.11 | 1 | 0 | ||
adamantoylcytarabine adamantoylcytarabine: RN given refers to parent cpd; structure in Negwer, 5th ed, #4393 | 2.11 | 1 | 0 | ||
6,11-dioxo-12-naphtho[2,3-b]indolizinecarboxylic acid ethyl ester [no description available] | 2.11 | 1 | 0 | naphthalenes | |
noscapine Noscapine: A naturally occurring opium alkaloid that is a centrally acting antitussive agent.. (-)-noscapine : A benzylisoquinoline alkaloid that is 1,2,3,4-tetrahydroisoquinoline which is substituted by a 4,5-dimethoxy-3-oxo-1,3-dihydro-2-benzofuran-1-yl group at position 1, a methylenedioxy group at positions 6-7 and a methoxy group at position 8. Obtained from plants of the Papaveraceae family, it lacks significant painkilling properties and is primarily used for its antitussive (cough-suppressing) effects. | 2.11 | 1 | 0 | aromatic ether; benzylisoquinoline alkaloid; cyclic acetal; isobenzofuranone; organic heterobicyclic compound; organic heterotricyclic compound; tertiary amino compound | antineoplastic agent; antitussive; apoptosis inducer; plant metabolite |
LSM-1290 [no description available] | 2.11 | 1 | 0 | benzazepine alkaloid; cyclic acetal | |
2-glycineamide-5-chlorophenyl-2-pyrryl ketone [no description available] | 2.11 | 1 | 0 | ||
nsc 154020 [no description available] | 2.11 | 1 | 0 | N-glycosyl compound | |
4-[(1-naphthalenylamino)-oxomethyl]benzene-1,3-dicarboxylic acid [no description available] | 2.11 | 1 | 0 | 2-hydroxyisophthalic acid | |
2,2-bis(hydroxymethyl)-1-azabicyclo(2,2,2,)octan-3-one 2,2-bis(hydroxymethyl)-1-azabicyclo(2,2,2,)octan-3-one: structure in first source | 2.11 | 1 | 0 | cyclic ketone; quinuclidines | |
5-(1,3-benzodioxol-5-yl)-N-(2,4-dimethylphenyl)-1,3,4-oxadiazol-2-amine [no description available] | 2.11 | 1 | 0 | benzodioxoles | |
croton factor f1 croton factor F1: induces ornithine decarboxylase activity; structure given in first source. 16-hydroxyphorbol 13-decanoate 12-palmitate : A phorbol ester that consists of 16-hydroxyphorbol bearing O-hexadecanoyl (palmitoyl) and O-decanoyl substituents at position 12 and 13 respectively. | 2.11 | 1 | 0 | phorbol ester; tertiary alpha-hydroxy ketone | |
medicarpin (-)-medicarpin : The (-)-enantiomer of medicarpin. | 2.11 | 1 | 0 | medicarpin | plant metabolite |
gitoxigenin gitoxigenin: structure | 2.11 | 1 | 0 | 14beta-hydroxy steroid; 16beta-hydroxy steroid; 3beta-hydroxy steroid | |
aromoline aromoline: from roots of Stephania cepharantha; structure given in first source | 2.11 | 1 | 0 | ||
nsc668394 [no description available] | 2.11 | 1 | 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 |
gant 61 GANT 61: a sonic hedgehog pathway inhibitor and Gli inhibitor; structure in first source. GANT61 : An aminal that is hexahydropyrimidine which is substituted on each nitrogen by a 2-(dimethylamino)benzyl group, and at the aminal carbon by a pyridin-4-yl group. A Hedgehog signaling pathway and Gli protein inhibitor. | 2.11 | 1 | 0 | aminal; dialkylarylamine; pyridines; substituted aniline; tertiary amino compound | antineoplastic agent; apoptosis inducer; glioma-associated oncogene inhibitor; Hedgehog signaling pathway inhibitor |
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 |
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 |
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 |
nortriptyline hydrochloride [no description available] | 2.11 | 1 | 0 | organic tricyclic compound | geroprotector |
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 |
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 | |
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. | 2.02 | 1 | 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 |
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 |
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 |
nsc 45641 [no description available] | 2.11 | 1 | 0 | ||
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 |
geraniol [no description available] | 2.11 | 1 | 0 | 3,7-dimethylocta-2,6-dien-1-ol; monoterpenoid; primary alcohol | allergen; fragrance; plant metabolite; volatile oil component |
aconitic acid cis-aconitic acid : The cis-isomer of aconitic acid. | 2.11 | 1 | 0 | aconitic acid | fundamental metabolite |
amygdalin [no description available] | 2.11 | 1 | 0 | ||
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 |
cholinophyllin [no description available] | 2.02 | 1 | 0 | ||
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 | ||
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 |
alpha-phenylcinnamate alpha-phenylcinnamate: RN given refers to parent cpd | 2.11 | 1 | 0 | ||
thiothixene [no description available] | 2.02 | 1 | 0 | N-methylpiperazine | anticoronaviral agent |
curcumin Curcumin: A yellow-orange dye obtained from tumeric, the powdered root of CURCUMA longa. It is used in the preparation of curcuma paper and the detection of boron. Curcumin appears to possess a spectrum of pharmacological properties, due primarily to its inhibitory effects on metabolic enzymes.. curcumin : A beta-diketone that is methane in which two of the hydrogens are substituted by feruloyl groups. A natural dyestuff found in the root of Curcuma longa. | 2.11 | 1 | 0 | aromatic ether; beta-diketone; diarylheptanoid; enone; polyphenol | anti-inflammatory agent; antifungal agent; antineoplastic agent; biological pigment; contraceptive drug; dye; EC 1.1.1.205 (IMP dehydrogenase) inhibitor; EC 1.1.1.21 (aldehyde reductase) inhibitor; EC 1.1.1.25 (shikimate dehydrogenase) inhibitor; EC 1.6.5.2 [NAD(P)H dehydrogenase (quinone)] inhibitor; EC 1.8.1.9 (thioredoxin reductase) inhibitor; EC 2.7.10.2 (non-specific protein-tyrosine kinase) inhibitor; EC 3.5.1.98 (histone deacetylase) inhibitor; flavouring agent; food colouring; geroprotector; hepatoprotective agent; immunomodulator; iron chelator; ligand; lipoxygenase inhibitor; metabolite; neuroprotective agent; nutraceutical; radical scavenger |
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 | |
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 |
enclomiphene Enclomiphene: The trans or (E)-isomer of clomiphene. | 2.02 | 1 | 0 | ||
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 |
ethyldimethylaminopropyl carbodiimide 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide hydrochloride: structure in first source | 2.11 | 1 | 0 | ||
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 | ||
tamoxifen citrate [no description available] | 2.11 | 1 | 0 | citrate salt | angiogenesis inhibitor; anticoronaviral agent |
tamoxifen [no description available] | 2.02 | 1 | 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 |
eskazine [no description available] | 2.11 | 1 | 0 | ||
nsc 336628 [no description available] | 2.11 | 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 |
1,3-dimethyl-8-[2-(1-pyrrolidinyl)ethylthio]-6-sulfanylidene-7H-purin-2-one [no description available] | 2.11 | 1 | 0 | oxopurine | |
cambinol cambinol: inhibitor of human silent information regulator 2 enzymes; structure in first source | 2.11 | 1 | 0 | ||
nsc 117199 [no description available] | 2.11 | 1 | 0 | ||
flosequinan [no description available] | 2.02 | 1 | 0 | quinolines | |
calcitriol dihydroxy-vitamin D3: as a major in vitro metabolite of 1alpha,25-dihydroxyvitamin D3, produced in primary cultures of neonatal human keratinocytes | 2.02 | 1 | 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 |
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 | |
mangostin mangostin: xanthone from rind of Garcinia mangostana Linn. fruit. alpha-mangostin : A member of the class of xanthones that is 9H-xanthene substituted by hydroxy group at positions 1, 3 and 6, a methoxy group at position 7, an oxo group at position 9 and prenyl groups at positions 2 and 8. Isolated from the stems of Cratoxylum cochinchinense, it exhibits antioxidant, antimicrobial and antitumour activities. | 2.11 | 1 | 0 | aromatic ether; phenols; xanthones | antimicrobial agent; antineoplastic agent; antioxidant; plant metabolite |
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. | 2.11 | 1 | 0 | coumestans; delta-lactone; polyphenol | anti-inflammatory agent; antioxidant; plant metabolite |
rottlerin rottlerin: an angiogenesis inhibitor; an inhibitor of protein kinase Cdelta (PKCdelta) and calmodulin kinase III; RN refers to (E)-isomer; do not confuse this chalcone with an anthraquinone that is also called rottlerin (RN 481-72-1);. rottlerin : A chromenol that is 2,2-dimethyl-2H-chromene substituted by hydroxy groups at positions 5 and 7, a 3-acetyl-2,4,6-trihydroxy-5-methylbenzyl group at position 6 and a (1E)-3-oxo-1-phenylprop-1-en-3-yl group at position 8. A potassium channel opener, it is isolated from Mallotus philippensis. | 2.11 | 1 | 0 | aromatic ketone; benzenetriol; chromenol; enone; methyl ketone | anti-allergic agent; antihypertensive agent; antineoplastic agent; apoptosis inducer; K-ATP channel agonist; metabolite |
ellagic acid [no description available] | 2.11 | 1 | 0 | catechols; cyclic ketone; lactone; organic heterotetracyclic compound; polyphenol | antioxidant; EC 1.14.18.1 (tyrosinase) inhibitor; EC 2.3.1.5 (arylamine N-acetyltransferase) inhibitor; EC 2.4.1.1 (glycogen phosphorylase) inhibitor; EC 2.5.1.18 (glutathione transferase) inhibitor; EC 2.7.1.127 (inositol-trisphosphate 3-kinase) inhibitor; EC 2.7.1.151 (inositol-polyphosphate multikinase) inhibitor; EC 2.7.4.6 (nucleoside-diphosphate kinase) inhibitor; EC 2.7.7.7 (DNA-directed DNA polymerase) inhibitor; EC 5.99.1.2 (DNA topoisomerase) inhibitor; EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor; food additive; fungal metabolite; geroprotector; plant metabolite; skin lightening 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 |
betamethasone benzoate [no description available] | 2.02 | 1 | 0 | 21-hydroxy steroid | |
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 |
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 | |
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 |
calcipotriene [no description available] | 2.02 | 1 | 0 | cyclopropanes; hydroxy seco-steroid; seco-cholestane; secondary alcohol; triol | antipsoriatic; drug allergen |
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 |
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 | |
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 |
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 |
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 |
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. | 2.02 | 1 | 0 | (trifluoromethyl)benzenes; 5-methoxyvalerophenone O-(2-aminoethyl)oxime | antidepressant; anxiolytic drug; serotonin uptake inhibitor |
7,8-dimethylalloxazine 7,8-dimethylalloxazine: structure. 7,8-dimethylisoalloxazine : A 7,8-dimethylbenzo[g]pteridine-2,4-dione that is isoalloxazine substituted by methyl groups at positions 7 and 8.. lumichrome : A compound showing blue fluorescence, formed by a photolysis of riboflavin in acid or neutral solution. | 2.11 | 1 | 0 | 7,8-dimethylbenzo[g]pteridine-2,4-dione | plant metabolite |
(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 |
dihydrothobainone [no description available] | 2.11 | 1 | 0 | ||
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. | 2.02 | 1 | 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 |
piperic acid piperinic acid: from Piper longum; structure in first source. (E,E)-piperic acid : A monocarboxylic acid that is (E)-penta-2,4-dienoic acid substituted by a 1,3-benzodioxol-5-yl group at position 5. It has been isolated from black pepper (Piper nigrum). | 2.11 | 1 | 0 | alpha,beta-unsaturated monocarboxylic acid; benzodioxoles | plant metabolite |
abscisic acid 2-trans-abscisic acid : An abscisic acid in which the two acyclic double bonds both have trans-geometry. | 2.11 | 1 | 0 | abscisic acids | |
radicinin radicinin: mold metabolite from plant pathogen Stemphylium radicinum; RN given refers to (2S-(2alpha,3beta,7E))-isomer; structure | 2.11 | 1 | 0 | aromatic ketone | |
5,6-dichloro-1H-imidazo[4,5-b]pyrazine-2-carboxylic acid [no description available] | 2.11 | 1 | 0 | imidazopyrazine | |
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 |
hispanolone hispanolone: structure in first source | 2.11 | 1 | 0 | ||
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 |
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 | |
cefpodoxime [no description available] | 2.02 | 1 | 0 | carboxylic acid; cephalosporin | antibacterial drug |
dirithromycin [no description available] | 2.02 | 1 | 0 | macrolide antibiotic | prodrug |
6-benzylthioinosine 6-benzylthioinosine: a subversive substrate of T gondii adenosine kinase; structure in first source | 2.07 | 1 | 0 | ||
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 |
dantrolene [no description available] | 2.02 | 1 | 0 | ||
fosinopril [no description available] | 2.02 | 1 | 0 | ||
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 | |
veratridine Veratridine: A benzoate-cevane found in VERATRUM and Schoenocaulon. It activates SODIUM CHANNELS to stay open longer than normal. | 2.11 | 1 | 0 | ||
zimelidine hydrochloride [no description available] | 2.11 | 1 | 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 | |
cefamandole nafate [no description available] | 2.02 | 1 | 0 | organic sodium salt | antibacterial drug; prodrug |
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 | ||
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] | 2.02 | 1 | 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 | ||
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 | |
chlortetracycline hydrochloride Alexomycin: a thiopeptide; a cyclic peptide antibiotic produced by Streptomyces arginensis isolated from the soil | 2.11 | 1 | 0 | ||
viridicatumtoxin viridicatumtoxin: isolated from cultures of Penicillium viridicatum; RN given refers to 2'alpha,7'beta,11'abeta,12'beta-(-) isomer. viridicatumtoxin : A tetracycline-like polyketide antibiotic that is produced by several species of Penicillium and Aspergillus. | 2.11 | 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 |
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 |
dacarbazine (E)-dacarbazine : A dacarbazine in which the N=N double bond adopts a trans-configuration. | 2.11 | 1 | 0 | dacarbazine | |
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 |
hematein hematein: structure. hematein : An organic heterotetracyclic compound that is -6a,7-dihydrobenzo[b]indeno[1,2-d]pyran-9-one carrying four hydroxy substituents at positions 3, 4, 6a and 10. | 2.11 | 1 | 0 | ||
rifabutin [no description available] | 2.02 | 1 | 0 |
Condition | Indicated | Relationship Strength | Studies | Trials |
---|---|---|---|---|
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 | 2.05 | 1 | 0 |
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 | 2.05 | 1 | 0 |
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 | 2.25 | 1 | 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 |