Page last updated: 2024-12-05

medroxyprogesterone

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Cross-References

ID SourceID
PubMed CID10631
CHEMBL ID1390
CHEBI ID6715
SCHEMBL ID37494
MeSH IDM0013279

Synonyms (110)

Synonym
AC-14528
unii-hsu1c9yres
medrossiprogesterone
4-08-00-02211 (beilstein handbook reference)
hsu1c9yres ,
MLS001076098 ,
gtpl2879
smr000058769
mls002639162 ,
pregn-4-ene-3, 17-hydroxy-6-methyl-, (6.alpha.)-
u 8840
nsc27408
pregn-4-ene-3, 17-hydroxy-6.alpha.-methyl-
17-hydroxy-6.alpha.-methylprogesterone
6.alpha.-methyl-17.alpha.-hydroxyprogesterone
nsc-27408
medroxyprogesteron
17.alpha.-hydroxy-6.alpha.-methylprogesterone
pregn-4-ene-3,20-dione, 17-hydroxy-6-alpha-methyl-
medroxyprogesterone [inn:ban]
17alpha-hydroxy-6alpha-methylprogesterone
medroxyprogesteronum [inn-latin]
pregn-4-ene-3,20-dione, 17-hydroxy-6-methyl-, (6-alpha)-
17-hydroxy-6alpha-methyl-pregn-4-ene-3,20-dione
6alpha-methyl-17alpha-hydroxyprogesterone
17-hydroxy-6alpha-methylprogesterone
brn 2510965
medroxiprogesterona [inn-spanish]
nsc 27408
pregn-4-ene-3,20-dione, 17-hydroxy-6-methyl-, (6alpha)-
einecs 208-298-6
6alpha-methyl-4-pregnen-17alpha-ol-3,20-dione
medrossiprogesterone [dcit]
medroxiprogesteronum
hsdb 3114
6-alpha-methyl-17-alpha-hydroxyprogesterone
CHEBI:6715 ,
medroxiprogesterona
(6alpha)-17-hydroxy-6-methylpregn-4-ene-3,20-dione
medroxyprogesteronum
medroxyprogesterone ,
C07119
520-85-4
NCGC00023064-04
cpd000058769
MLS000069571 ,
17 alpha-hydroxy-6 alpha-methylprogesterone
(6 alpha)-17-hydroxy-6-methylpregn-4-ene-3,20-dione
17 alpha hydroxy 6 alpha methylprogesterone
HMS2052A13
g03ac06
farlutal inyectable
(6s,8r,9s,10r,13s,14s,17r)-17-acetyl-17-hydroxy-6,10,13-trimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1h-cyclopenta[a]phenanthren-3-one
medroxyprogesterone (inn)
farlutal inyectable (tn)
D08166
CHEMBL1390
LMST02030176
NCGC00183122-01
hydroxymethylprogesterone
cas-520-85-4
tox21_113401
dtxcid8016508
dtxsid0036508 ,
MLS001424229
HMS2230B08
S3635
AKOS015961681
CCG-101111
medroxyprogesterone [who-ip]
medroxyprogesterone [vandf]
medroxyprogesterone acetate impurity b [who-ip]
medroxyprogesterone [hsdb]
17-hydroxy-6.alpha.-methylpregn-4-ene-3,20-dione
medroxyprogesterone [who-dd]
medroxyprogesterone [mi]
medroxyprogesterone [inn]
medroxyprogesterone acetate impurity b [ep impurity]
HY-B0648
NC00361
SCHEMBL37494
tox21_113401_1
NCGC00023064-05
medroxy progesterone
(6?)-17-hydroxy-6-methylpregn-4-ene-3,20-dione
OPERA_ID_433
17alpha-hydroxy-6alpha-methyl-4-pregnene-3,20-dione
medroxyprogesterone, vetranal(tm), analytical standard
17-hydroxy-6a-methylprogesterone
MRF-0000022
(6s,8r,9s,10r,13s,14s,17r)-17-acetyl-17-hydroxy-6,10,13-trimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1h-cyclopenta[a]phenanthren-3(2h)-one
M3113
Q416667
17alpha-hydroxy-6alpha-methylprogesterone;u8840
C75441
A899740
(6s,8r,10r,13s,17r)-17-acetyl-17-hydroxy-6,10,13-trimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-cyclopenta[a]phenanthren-3-one
MS-25295
17-hydroxy-6-methylprogesterone;u8840
HY-B0648R
CS-0694930
medroxyprogesterone (standard)
Z1501485367
l02ab02
medroxyprogesteronum (inn-latin)
pren-4-ene-3,20-dione, 17-hydroxy-6-methyl-, (6alpha)-
17-hydroxy-6alpha-methylpregn-4-ene-3,20-dione
pregn-4-ene-3,20-dione, 17-hydroxy-6alpha-methyl-
medroxiprogesterona (inn-spanish)
g03da02

Research Excerpts

Overview

Medroxyprogesterone acetate (MPA) is an anti-cancer drug for mammary carcinomas and an angiostatic steroid. The clinical benefit regarding the development of AMS was unproven at high altitude.

ExcerptReferenceRelevance
"Medroxyprogesterone acts as a respiratory stimulant, but the clinical benefit regarding the development of AMS was unproven at high altitude. "( Medroxyprogesterone at high altitude. The effects on blood gases, cerebral regional oxygenation, and acute mountain sickness.
Beazley, MF; Bradwell, AR; Chesner, IM; Clayton, RN; Forster, PJ; Hillenbrand, P; Imray, CH; Wright, AD, 2004
)
3.21
"Medroxyprogesterone acetate is a steroid compound similar to progesterone in structure and function. "( The ultrastructural response of human endometrium to medroxyprogesterone acetate.
Horbelt, DV; Powell, LC; Roberts, DK, 1975
)
1.95
"Medroxyprogesterone therapy seems to be a valuable alternative for patients with autoimmune liver disease, particularly those who have not responded satisfactorily to other treatment."( Effects of medroxyprogesterone on the liver function and drug metabolism of patients with primary biliary cirrhosis and chronic active hepatitis.
Ahlqvist, J; Ahokas, JT; Hynnynen, T; Pelkonen, I; Puoskari, U; Sotaniemi, EA, 1978
)
1.27
"Medroxyprogesterone acetate (MPA) is an anti-cancer drug for mammary carcinomas and an angiostatic steroid. "( Medroxyprogesterone acetate, an anti-cancer and anti-angiogenic steroid, inhibits the plasminogen activator in bovine endothelial cells.
Ashino-Fuse, H; Iwaguchi, T; Oikawa, T; Shimamura, M; Takano, Y, 1989
)
3.16
"Medroxyprogesterone acetate (MPA) is a synthetic progestin, currently used in the adjuvant treatment of advanced breast cancer, which induces remission rates (30-40%) comparable to those obtained with other types of endocrine therapies. "( Androgen and glucocorticoid receptor-mediated inhibition of cell proliferation by medroxyprogesterone acetate in ZR-75-1 human breast cancer cells.
Baker, D; Labrie, F; Poirier, D; Poulin, R, 1989
)
1.95
"Medroxyprogesterone seems to be a useful agent to counteract the possible cocarcinogenetic effect of conjugated estrogens on account of the high incidence of induced secretory endometrium obtained (92.2%), the reversal of six pretreatment endometrial hyperplasias and the absence of any premalignant endometrial lesion after at least 3 yr of this sequential treatment."( Sequential use of conjugated estrogens and medroxyprogesterone in the climacteric syndrome: clinical and histological findings.
Figueroa-Casas, PR; Schlaen, I, 1988
)
1.26
"Medroxyprogesterone acetate (MPA) is a synthetic progestin that is reported to be effective in the treatment of paraphilic behavior, including paraphilic aggression, in men. "( Pre-optic and hypothalamic neurons accumulate [3H]medroxyprogesterone acetate in male cynomolgus monkeys.
Bonsall, RW; Michael, RP; Rees, HD, 1986
)
1.97
"Medroxyprogesterone acetate is an effective hormonal agent in the treatment of metastatic breast cancer."( Oral medroxyprogesterone acetate in the treatment of metastatic breast cancer.
Blumenschein, GR; Buzdar, AU; Fraschini, G; Frye, D; Halvorson, HC; Hortobagyi, GN; Hug, V; Pinnamaneni, K; Yap, HY, 1985
)
1.5
"Medroxyprogesterone (MPA) is a progestin with no clinically detectable estrogenic and androgenic properties used in the treatment of sexual precocity. "( Adverse effects of large doses of medroxyprogesterone (MPA) in idiopathic isosexual precocity.
French, FS; Richman, RA; Underwood, LE; Van Wyk, JJ, 1971
)
1.97
"Medroxyprogesterone acetate (MPA) is a strongly active contraceptive agent. "( [Extra-uterine pregnancy during contraception with Depo-Provera].
Stut, JC, 1973
)
1.69

Effects

Medroxyprogesterone acetate (MPA) exerts an antitumor effect in cancers of the endometrium, breast and kidney. It also exerts some clinical benefits in female manic patients and partially blocks amphetamine-induced hyperlocomotion.

ExcerptReferenceRelevance
"Medroxyprogesterone acetate (MPA) has an inducing effect on the hepatic drug-metabolizing enzyme system in the rat. "( Medroxyprogesterone acetate improvement of the hepatic drug-metabolizing enzyme system in rats after chemical liver injury.
Kärki, NT; Saarni, HU; Sotaniemi, EA; Stengård, J, 1983
)
3.15
"Medroxyprogesterone (MPA), which has antiestrogenic effects, also exerts some clinical benefits in female manic patients and partially blocks amphetamine-induced hyperlocomotion, indicating that the antiestrogenic effect of tamoxifen could contribute to its antimanic effect."( Antimanic-like effect of tamoxifen is not reproduced by acute or chronic administration of medroxyprogesterone or clomiphene.
Andreatini, R; Baretta, IP; Correia, D; Martynhak, BJ; Pereira, M; Siba, IP, 2011
)
1.31
"Medroxyprogesterone acetate (MPA) has been used extensively in the treatment of both breast and endometrial disorders as an endocrine therapy."( The correlation between the response to progestogen treatment and the expression of progesterone receptor B and 17beta-hydroxysteroid dehydrogenase type 2 in human endometrial carcinoma.
Ito, K; Konno, R; Moriya, T; Okamura, K; Sasano, H; Sato, S; Suzuki, T; Utsunomiya, H; Yaegashi, N, 2003
)
1.04
"Medroxyprogesterone acetate has been used prophylactically in 35 patients with stages I and IIIA renal cell carcinoma who had undergone radical nephrectomy. "( Postoperative prophylactic use of progesterone in renal cell carcinoma.
Fukushima, S; Furuhata, A; Kondo, I; Satomi, Y; Takai, S, 1982
)
1.71
"Medroxyprogesterone acetate (MPA) has an inducing effect on the hepatic drug-metabolizing enzyme system in the rat. "( Medroxyprogesterone acetate improvement of the hepatic drug-metabolizing enzyme system in rats after chemical liver injury.
Kärki, NT; Saarni, HU; Sotaniemi, EA; Stengård, J, 1983
)
3.15
"Medroxyprogesterone acetate has been used to treat metastatic renal cell carcinoma largely because of its observed inhibitory effects on the growth of estrogen-induced tumors in male Syrian golden hamsters. "( Role of hormones in growth kinetics of renal cell carcinoma in vitro.
Cummings, KB; Nelson, FW; Wheelis, RF, 1977
)
1.7
"Medroxyprogesterone acetate (MPA) has been used in high doses as hormone treatment for metastatic breast cancer. "( Hormone treatment of meningiomas: lack of response to medroxyprogesterone acetate (MPA). A pilot study of five cases.
Haltia, M; Jääskeläinen, J; Kärkkäinen, J; Laasonen, E; Troupp, H, 1986
)
1.96
"Medroxyprogesterone acetate (MPA) has been known to exert an antitumor effect in cancers of the endometrium, breast and kidney."( Possible role of hormones in treatment of metastatic testicular teratomas: tumour regression with medroxyprogesterone acetate.
Bloom, HJ; Hendry, WF, 1973
)
1.09

Treatment

Medroxyprogesterone acetate (MPA) treatment has been shown to exert several beneficial effects in cancer patients. Treatment tended to preserve bone mass by inhibiting the increased resorption indices while maintaining higher formation rates seen in ovariectomized rats.

ExcerptReferenceRelevance
"Oral medroxyprogesterone acetate treatment in two patients was associated with a striking decrease in both plasma testosterone concentration and height velocity."( Gonadotropin-independent familial sexual precocity with premature Leydig and germinal cell maturation (familial testotoxicosis): effects of a potent luteinizing hormone-releasing factor agonist and medroxyprogesterone acetate therapy in four cases.
Grumbach, MM; Kaplan, SL; Rosenthal, SM, 1983
)
0.91
"Medroxyprogesterone treatment tended to preserve bone mass by inhibiting the increased resorption indices while maintaining higher formation rates seen in ovariectomized rats."( Progesterone antagonist RU 486 has bone-sparing effects in ovariectomized rats.
Barengolts, EI; Lathon, PV; Lindh, FG, 1995
)
1.01
"Medroxyprogesterone acetate (MPA) treatment has been shown to exert several beneficial effects in cancer patients. "( Mass spectrometric and high-performance liquid chromatographic studies of medroxyprogesterone acetate metabolites in human plasma.
Bauer, T; Häberlein, H; Plaum, T; Stalker, DJ; Sturm, G, 1991
)
1.95
"Medroxyprogesterone acetate-treated and, above all, norethisterone-treated animals exhibit a more marked reduction of atherosclerosis than control rabbits fed the same diet."( High-dose synthetic progestogens inhibit foam and smooth muscle cell proliferation and atherosclerotic plaque formation in aortas of rabbits fed a hypercholesterolemic diet.
Bancheri, C; Mauriello, A; Orlandi, A; Palmieri, G; Pasetto, N; Spagnoli, LG, 1990
)
1
"Medroxyprogesterone acetate treatment was given also to the second girl, who had a high and rising serum concentration of estradiol."( Ovarian hyperstimulation syndrome in preterm infants.
Bergquist, C; Lindgren, PG; Sedin, G, 1985
)
0.99
"Treatment with medroxyprogesterone acetate resulted in disappearance of these cysts."( Cystic ovaries in a pre-term newborn infant.
Bergqvist, C; Esscher, T; Lindgren, PG; Lundkvist, K; Sedin, G, 1984
)
0.61
"Treatment with medroxyprogesterone acetate for several years lowered basal serum LH and FSH as did oral contraceptives but had much less effect on the responses to LRH."( Gonadotrophin hormone releasing tests in women receiving hormonal contraception.
L'Hermite, M; Perez-Lopez, FR; Robyn, C, 1975
)
0.59
"Treatment with medroxyprogesterone acetate resulted in an improved response to carbon dioxide, and assisted ventilation was no longer needed."( Alveolar hypoventilation treated with medroxyprogesterone.
Lagercrantz, H; Löfgren, O; Milerad, J, 1985
)
0.88

Toxicity

Medroxyprogesterone given alone does not cause adverse symptoms in postmenopausal women.

ExcerptReferenceRelevance
" Acceptance of this approach, however, appears to have preceded detailed evaluation of possible adverse side effects of progestins that could result in patient noncompliance."( A randomized, double-blind, placebo-controlled, cross-over trial to assess the side effects of medroxyprogesterone acetate in hormone replacement therapy.
Carmichael, JA; Hahn, PM; Kirkham, C; Reid, RL; Van Vugt, DA, 1991
)
0.5
" Climacteric symptoms, Kupperman index scores and potential adverse progestogen effects were recorded before treatment and three times per month during therapy."( Progestogens: therapeutic and adverse effects in early post-menopausal women.
Christiansen, C; Marslew, U; Riis, B, 1991
)
0.28
"Orchiectomy is considered a safe and simple procedure, free from serious side effects, in the treatment of prostatic carcinoma."( Flushing. Long-term side effect of orchiectomy in treatment of prostatic carcinoma.
Charig, CR; Rundle, JS, 1989
)
0.28
" Hematological changes in the peripheral blood were compared between concomitant MPA patients and those not receiving MPA to examine the effect of MPA in reducing the marrow depression which is the major side effect of CAP."( [Effect of medroxyprogesterone acetate on side effects of CAP therapy in gynecological malignant tumors].
Okamura, S; Okazaki, T; Sugimoto, O; Ueki, M; Yanagawa, Y, 1989
)
0.67
" and, especially, the presence of previous cardiovascular disease represented adverse factors in the development of cardiovascular toxicity."( Cardiovascular side effects of diethylstilbestrol, cyproterone acetate, medroxyprogesterone acetate and estramustine phosphate used for the treatment of advanced prostatic cancer: results from European Organization for Research on Treatment of Cancer tria
de Pauw, M; de Voogt, HJ; Pavone-Macaluso, M; Smith, PH; Suciu, S, 1986
)
0.5
"To determine whether cyclic medroxyprogesterone treatment given without estrogen causes adverse symptoms in postmenopausal women."( No adverse effects of medroxyprogesterone treatment without estrogen in postmenopausal women: double-blind, placebo-controlled, crossover trial.
Alojado, N; McKay, DW; Prior, JC; Vigna, YM, 1994
)
0.9
"Medroxyprogesterone given alone does not cause adverse symptoms in postmenopausal women."( No adverse effects of medroxyprogesterone treatment without estrogen in postmenopausal women: double-blind, placebo-controlled, crossover trial.
Alojado, N; McKay, DW; Prior, JC; Vigna, YM, 1994
)
2.05

Pharmacokinetics

The objective of this study was to evaluate a possible pharmacokinetic interaction between 17beta-estradiol (E2) and medroxyprogesterone (MP) when administered together in a combined tablet. Both hormones have common metabolic routes of biotransformation.

ExcerptReferenceRelevance
" However, we still lack information on such basic pharmacokinetic parameters as the bioavailability of several of these drugs."( Clinical pharmacokinetics of endocrine agents used in advanced breast cancer.
Kvinnsland, S; Lien, EA; Lundgren, S; Lønning, PE, 1992
)
0.28
" Following oral administration MPA is rapidly transferred from the gastrointestinal tract to the blood circulation with a half-life of the absorption process of 15-30 min."( Medroxyprogesterone acetate pharmacokinetics following oral high-dose administration in humans: a bioavailability evaluation of a new MPA tablet formulation.
Johansen, PB; Johansson, ED; Rasmussen, SN, 1986
)
1.71
" Model-independent pharmacokinetic analysis (statistical moment theory) revealed a significant dependence of plasma clearance and mean residence time on the dose administered in both conditions."( Medroxyprogesterone acetate plasma pharmacokinetics after intravenous administration in rabbits.
Camaggi, CM; Comparsi, R; Pannuti, F; Strocchi, E, 1987
)
1.72
" While the results from all centres indicated that the four preparations were all effective in inhibiting ovulation for at least one month, there were marked between centre differences in pharmacokinetic profiles."( A multicentered pharmacokinetic, pharmacodynamic study of once-a-month injectable contraceptives. I. Different doses of HRP112 and of DepoProvera. World Health Organization Task Force on Long-acting Systemic Agents for Fertility Regulation.
Garza-Flores, J; Hall, PE; Koloszar, S; Konsayreepong, R; Kovacs, L; Perez-Palacios, G; Rodriguez, V; Tang-Keow, P; Virutamasen, P, 1987
)
0.27
"The pharmacokinetic and bioavailability properties of medroxyprogesterone acetate (MPA) after single PO and IM doses in man were used as a basis to predict, on a theoretical pharmacokinetic basis, the blood level profile of the drug during repeated dose administration with various dosage schedules."( Pharmacokinetic approach to the selection of dose schedules for medroxyprogesterone acetate in clinical oncology.
Battaglia, A; Bernardo, G; Brunner, K; Cavalli, F; Ganzina, F; Goldhirsch, A; Isetta, AM; Robustelli della Cuna, G; Sacchetti, G; Tamassia, V, 1982
)
0.75
" The purpose of the study was to assess the pharmacokinetic and pharmacodynamic properties of the 2 formulations (depot medroxyprogesterone acetate and norethisterone enanthate)."( A preliminary pharmacokinetic and pharmacodynamic evaluation of depot-medroxyprogesterone acetate and norethisterone oenanthate.
Diczfalusy, E; Fotherby, K; Hingorani, V; Landgren, BM; Saxena, BN; Shrimanker, K; Takker, D, 1980
)
0.7
"The objective of this study was to evaluate a possible pharmacokinetic interaction between 17beta-estradiol (E2) and medroxyprogesterone (MP) when administered together in a combined tablet because both hormones have common metabolic routes of biotransformation."( A comparative pharmacokinetic study of micronized estradiol valerate administered alone and in combination with medroxyprogesterone acetate in postmenopausal women.
Gaete, L; León, J; López, F; Prado, J; Saavedra, I; Sánchez, MP, 2004
)
0.74

Compound-Compound Interactions

The effect of Lonidamine (LND) alone or combined with the antiestrogen Tamoxifen (TAM) or Medroxyprogesterone acetate (MPA) on cell proliferation and steroid hormone receptor content of a human estrogen sensitive breast cancer cell line was investigated.

ExcerptReferenceRelevance
"A comparative study of 5'-DFUR 600 mg/day alone (C-arm) or in combination with TAM 30 mg/day (A-arm) or MPA 600 mg/day (B-arm) was carried out."( [A comparative study with 5'-DFUR alone or in combination with tamoxifen (TAM) or medroxyprogesterone acetate (MPA) for advanced or recurrent breast cancer].
Aikawa, T; Hirai, T; Kotsuma, Y; Maeura, Y; Miyauchi, K; Takatsuka, Y; Yayoi, E, 1992
)
0.51
"We compared the effects on hemostatic variables of transdermal estradiol and oral equine conjugated estrogens (CEE), both combined with medroxyprogesterone acetate, in 40 postmenopausal women, 22 randomly allocated to transdermal estradiol and 18 to CEE."( Short- and long-term effects of hormone replacement therapy (transdermal estradiol vs oral conjugated equine estrogens, combined with medroxyprogesterone acetate) on blood coagulation factors in postmenopausal women.
Bertolli, V; Boschetti, C; Cortellaro, M; Della Volpe, A; Nencioni, T; Zanussi, C, 1991
)
0.69
"The effect of Lonidamine (LND) alone or combined with the antiestrogen Tamoxifen (TAM) or Medroxyprogesterone acetate (MPA) on cell proliferation and steroid hormone receptor content of a human estrogen sensitive breast cancer cell line was investigated."( Antitumor effect of lonidamine alone or combined with tamoxifen or medroxyprogesterone acetate in breast cancer cells.
Angelucći, C; Della Cuna, GR; Iacopino, F; Lama, G; Marchetti, P; Sica, G,
)
0.59
" The four groups receiving hormone replacement therapy were given 2 mg estradiol valerate equivalents (E), either sequentially combined with 75 micrograms levonorgestrel (E/LNG), 10 mg medroxyprogesterone acetate (E/MPA), or 150 micrograms desogestrel (E/DG), or continuously combined with 1 mg cyproterone acetate (E/CPA)."( Serum lipids, lipoproteins, and apolipoproteins during postmenopausal estrogen replacement therapy combined with either 19-nortestosterone derivatives or 17-hydroxyprogesterone derivatives.
Christiansen, C; Haarbo, J; Hassager, C; Jensen, SB; Riis, BJ, 1991
)
0.47
"Forty-eight patients with advanced or recurrent breast cancer unresponsive to other therapies were treated orally with medroxyprogesterone acetate (MPA) 1,200 mg/day alone (Group A: 28 patients) or in combination with cyclophosphamide (CPA) 100 mg/day (Group B: 20 patients)."( [A controlled study with medroxyprogesterone acetate (MPA) alone or in combination with cyclophosphamide (CPA) in the treatment of advanced or recurrent breast cancer unresponsive to other therapies. Osaka Study Group for the Treatment of Breast Cancer].
Aikawa, T; Maeura, Y; Miyauchi, K; Takatsuka, Y; Yayoi, E, 1991
)
0.79
" Synergistic activities were produced with TAM combined with either cisplatin or doxorubicin."( The effects of estrogen, progesterone, and tamoxifen alone and in combination with cytotoxic agents against human ovarian carcinoma in vitro.
Berens, ME; Duckett, Y; Geisinger, KR; Kute, TE; Morgan, TM; Welander, CE, 1990
)
0.28
" Combined with an appropriate P complement, it could be a useful contraceptive approach."( Fourteen-day versus twenty-one-day regimens of intermittent intranasal luteinizing hormone-releasing hormone agonist combined with an oral progestogen as antiovulatory contraceptive approach.
Faure, N; Lemay, A, 1986
)
0.27
" Some of the testosterone-supplemented rats were treated with medroxyprogesterone acetate (MPA) alone or in combination with epirubicin hydrochloride."( Effect of medroxyprogesterone acetate, alone or in combination with epirubicin hydrochloride, on the growth of the Dunning R3327H prostatic adenocarcinoma.
Damber, JE; Landström, M; Tomić, R, 1987
)
0.92
" In order to test whether IFN therapy combined with hormones would result in higher response rates we compared single agent IFN therapy with a combined therapy of rIFN alpha 2C plus medroxyprogesterone acetate (MPA) in a randomized multicenter trial."( Treatment of advanced renal cell cancer with recombinant interferon alpha as a single agent and in combination with medroxyprogesterone acetate. A randomized multicenter trial.
Aulitzky, W; Gottwald, A; Hautmann, R; Messerer, D; Moormann, JG; Porzsolt, F; Rasche, H; Schumacher, K; Sparwasser, H; Stockamp, K, 1988
)
0.68
" In conclusion, intermittent administration of appropriate LH-RH agonist dosing in combination with a progestogen would effectively block ovulation while preserving adequate cyclic estradiol secretion and could be an alternative contraceptive approach."( Inhibition of ovulation during discontinuous intranasal luteinizing hormone-releasing hormone agonist dosing in combination with gestagen-induced bleeding.
Faure, N; Fazekas, AT; Labrie, F; Lemay, A, 1985
)
0.27
" In conclusion, intermittent administration of appropriate LH-RH agonist dosing in combination with a progestogen would effectively block ovulation while preserving adequate cyclic estradiol secretion and could be an alternative contraceptive approach."( Inhibition of ovulation during discontinuous intranasal luteinizing hormone-releasing hormone agonist dosing in combination with gestagen-induced bleeding.
Faure, N; Fazekas, AT; Labrie, F; Lemay, A, 1985
)
0.27
"3 mg daily of CEE continuously combined with domestic MPA are effective in preventing postmenopausal osteoporosis."( [Comparative study on two different dosages of conjugated equine estrogen continuously combined with medroxyprogesterone in prevention of postmenopausal osteoporosis].
Liu, J; Wang, Y; Wu, Y; Xing, S; Xu, R; Zhang, Z, 2002
)
0.53
" The study assessed the mean pharmacokinetics parameters of E2 found after 1-dose administration of 2 different tablets containing E2, 1 containing 2 mg of micronized 17beta-estradiol valerate (E2V) and the other, administered after 2 weeks, 2 mg of E2V in combination with 5 mg of medroxyprogesterone acetate (MPA)."( A comparative pharmacokinetic study of micronized estradiol valerate administered alone and in combination with medroxyprogesterone acetate in postmenopausal women.
Gaete, L; León, J; López, F; Prado, J; Saavedra, I; Sánchez, MP, 2004
)
0.71
"To compare the effect on total cholesterol and LDL and HDL cholesterol of oral dydrogesterone and medroxyprogesterone administration combined with continuous transdermal supplementation of 17beta-estradiol in postmenopausal women."( [Plasma levels of total cholesterol, LDL-cholesterol, and HDL-cholesterol in postmenopausal women during 12 months' oral administration of dydrogesterone or medroxyprogesterone combined with continuous transdermal supplementation of 17beta-estradiol].
Kostecka, A; Krzysiek, J; Kwiatkowska-Panek, E; Milewicz, T; Radowick, S; Rogatko, I; Sztefko, K, 2007
)
0.75
"The evaluation of the influence of continuous transdermal estradiol supplementation combined with oral medroxyprogesterone on the somatotropic axis in postmenopausal women."( The somatotropic axis in postmenopausal women during six month of transdermal continuous 17beta-estradiol administration combined with oral medroxyprogesterone.
Hubalewska-Dydejczyk, A; Jach, R; Krzysiek, J; Milewicz, T; Radowicki, S; Rogatko, I; Stochmal, E; Sztefko, K, 2011
)
0.79
"25 women completed the study Group A--13 women received transdermal 17beta-estradiol (Oesclim 50 - Fournier-Solvay) combined with oral 5 mg daily medroxyprogesterone (Gestomikron - Adamed)."( The somatotropic axis in postmenopausal women during six month of transdermal continuous 17beta-estradiol administration combined with oral medroxyprogesterone.
Hubalewska-Dydejczyk, A; Jach, R; Krzysiek, J; Milewicz, T; Radowicki, S; Rogatko, I; Stochmal, E; Sztefko, K, 2011
)
0.77
"The administration of transdermal 17beta-estradiol combined with oral medroxyprogesterone increases the IGF-I bioavailability."( The somatotropic axis in postmenopausal women during six month of transdermal continuous 17beta-estradiol administration combined with oral medroxyprogesterone.
Hubalewska-Dydejczyk, A; Jach, R; Krzysiek, J; Milewicz, T; Radowicki, S; Rogatko, I; Stochmal, E; Sztefko, K, 2011
)
0.8

Bioavailability

The relative bioavailability of an orally administered aqueous suspension of medroxyprogesterone acetate (MPA) intended for intramuscular injection (Depo-Provera) was determined in relation to orally administered tablets. This suggests that, regardless of potential binding proteins, medroxy Progester one acetate displays greater bioavailability than that of the other progestogens studied.

ExcerptReferenceRelevance
"The bioavailability of three formulations of medroxyprogesterone acetate (MPA) was assessed in 30 healthy male volunteers in a three-way, open-label, cross-over-designed trial."( Bioavailability of medroxyprogesterone acetate from three oral dosage formulations.
Pollock, SR; Stalker, DJ; Welshman, IR,
)
0.72
" However, we still lack information on such basic pharmacokinetic parameters as the bioavailability of several of these drugs."( Clinical pharmacokinetics of endocrine agents used in advanced breast cancer.
Kvinnsland, S; Lien, EA; Lundgren, S; Lønning, PE, 1992
)
0.28
" Based on a pilot study, an open, randomized, crossover trial has been performed on 22 breast and endometrial cancer patients to evaluate the relative bioavailability of this new oral formulation (200-mg sachet, twice daily) as compared with a standard formulation (Farlutal, 500-mg tablet, twice daily)."( Improved bioavailability of a new oral preparation of medroxyprogesterone acetate.
Benedetti, MS; Efthymiopoulos, C; Etienne, MC; Frenay, M; Hurteloup, P; Milano, G; Montcuquet, P; Namer, M; René, N; Vo Van, ML, 1991
)
0.53
"Serum levels of cortisol (C), androstenedione (A), dehydroepiandrosterone (D), estrone (E1) and estradiol (E2) were chosen as parameters to compare the bioavailability of megestrol acetate (MA) and medroxyprogesterone acetate (MPA) in postmenopausal patients with advanced breast cancer."( Adrenal steroids as parameters of the bioavailability of MA and MPA.
Dikkeschei, LD; Sleijfer, DT; Tjabbes, T; van Veelen, H; Willemse, PH, 1990
)
0.47
" This suggests that, regardless of potential binding proteins, medroxyprogesterone acetate displays greater bioavailability than that of the other progestogens studied."( Comparison of in vivo bioavailability of progestational agents into the rat uterus and liver and the effect of plasma protein binding.
Matt, DW; Steingold, KA; Tedeschi, ML; Van Voorhis, B, 1989
)
0.52
" The in vitro dissolution rates of MPA from the tablet formulations were determined and compared with the results of the bioavailability studies, indicating that a rapid dissolution rate as well as the particle size of MPA are two important factors to ensure optimal absorption of MPA from the gastrointestinal tract."( Medroxyprogesterone acetate pharmacokinetics following oral high-dose administration in humans: a bioavailability evaluation of a new MPA tablet formulation.
Johansen, PB; Johansson, ED; Rasmussen, SN, 1986
)
1.71
" Relative bioavailability of preparations should be considered when prescribing or assessing treatment results when MPA is used."( Medroxyprogesterone acetate: variation in serum concentrations achieved with three commercially available preparations.
Chapman, D; Mould, GP; Rostom, AY; Stockdale, AD, 1987
)
1.72
"The pharmacokinetic and bioavailability properties of medroxyprogesterone acetate (MPA) after single PO and IM doses in man were used as a basis to predict, on a theoretical pharmacokinetic basis, the blood level profile of the drug during repeated dose administration with various dosage schedules."( Pharmacokinetic approach to the selection of dose schedules for medroxyprogesterone acetate in clinical oncology.
Battaglia, A; Bernardo, G; Brunner, K; Cavalli, F; Ganzina, F; Goldhirsch, A; Isetta, AM; Robustelli della Cuna, G; Sacchetti, G; Tamassia, V, 1982
)
0.75
"The relative bioavailability of an orally administered aqueous suspension of medroxyprogesterone acetate (MPA) intended for intramuscular injection (Depo-Provera) was determined in relation to orally administered tablets."( The bioavailability of an orally administered medroxyprogesterone acetate suspension.
Albert, KS; Antal, EJ; Gillespie, WR, 1983
)
0.75
" Extremely high interpatient variation in bioavailability is present with both administration routes."( Medroxyprogesterone acetate (MAP) plasma levels after multiple high-dose administration in advanced cancer patients.
Angelelli, B; Camaggi, CM; Costanti, B; Ferrari, P; Giovannini, M; Pannuti, F; Strocchi, E; Zebini, E, 1983
)
1.71
"The influence of injection volume on the absorption and bioavailability of medroxyprogesterone acetate (MPA) was studied."( Effect of injection volume on the bioavailability of sterile medroxyprogesterone acetate suspension.
Albert, KS; Antal, EJ; Gillespie, WR; Wright, CE,
)
0.6
" Finally, new perspectives are opened on combined anti-estrogen + progestogen treatment of all gynaecological malignancies, with special regard to the cytosol steroid receptor concentrations and to the bioavailability of progestogens and anti-estrogens."( The endometrial adenocarcinoma as a model for hormone-dependency and hormone-responsiveness of gynaecological cancers.
Bonte, J, 1984
)
0.27
" Following the administration, both decay phases are masked by prolonged absorption; peak levels are lower than after oral administration, but long-term bioavailability is higher, as demonstrated by comparison of the values for areas under curves in the 0-146-hour interval."( Medroxyprogesterone acetate (MAP) relative bioavailability after single high-dose administration in cancer patients.
Camaggi, CM; Costanti, B; Di Marco, AR; Giovannini, M; Pannuti, F; Strocchi, E, 1982
)
1.71
" In June 2000, InKine announced the completion of a study comparing the bioavailability of a commercially viable tablet formulation of CBP 1011 to the original capsule formulation that is currently being used in the company's phase III studies in patients with idiopathic thrombocytopenic purpura."( CBP 1011: Colirest, Hematrol.
, 2003
)
0.32
" Our data suggest that PR-responsive reporter gene bioassays can measure bioavailability of compounds, known and unknown, of complex botanicals for hormone replacement therapy."( Dynamics of progestogenic activity in serum following administration of Ligusticum chuanxiong.
Gong, YH; Lee, LS; Lim, LS; Shen, P; Yong, EL, 2006
)
0.33
"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

Dosage Studied

High dosage MAP (medroxyprogesterone acetate) was used in the treatment of very advanced breast cancer. 240 pre-, peri- or postmenopausal patients with early node-negative breast carcinoma were randomized to receive either no hormone therapy or adjuvant therapy.

ExcerptRelevanceReference
" No differences between the 2 dosage regimens or time of biopsy were found in regard to this effect."( Effect of medroxyprogesterone acetate contraception on cytoplasmic estrogen receptor content of the human cervix uteri.
Janssens, KY; Rall, HJ; Soto Ferreira, G, 1978
)
0.66
" The classification of the anti-androgens, their indications, side-effects, dosage schemes and results of treatment are reviewed."( [Clinical aspects of the anti-androgens].
Holtzhausen, GH, 1979
)
0.26
" DMPA when given in proper dosage and time reverted the condition."( Study of the effects of a long acting injectable-progesterone on the ovarian and uterine histomorphology of the androgenised female rats of Long-Evans strain.
Ahmed, F; Bari, MA, 1979
)
0.26
"High dosage MAP (medroxyprogesterone acetate) was used in the treatment of very advanced breast cancer."( High dose medroxyprogesterone-acetate treatment in advanced mammary carcinoma. A phase II investigation.
Mattsson, W, 1978
)
1
" This dosage did not appear to exert marked influence on endometrium ultrastructure beyond 90 days."( The ultrastructural response of human endometrium to medroxyprogesterone acetate.
Horbelt, DV; Powell, LC; Roberts, DK, 1975
)
0.5
" Regimen A (lower dosage group) reached a remission rate of 44%, whereas regimen B (higher dosage group) had a remission rate of 41%."( High dose medroxyprogesterone acetate (MPA) treatment in metastatic carcinoma of the breast: a dose-response evaluation.
Bumma, C; Calciati, A; Campio, L; Cuna, GR; Strada, MR, 1978
)
0.66
" Patients who received the 200 mg and 300 mg dosage of MPA orally exhibited higher mean plasma values."( Plasma medroxyprogesterone acetate levels following intramuscular or oral administration in patients with endometrial adenocarcinoma.
Adlercreutz, H; Laatikainen, T; Nieminen, U, 1979
)
0.71
" MPA dosage was 250 mg, intramuscularly, for 6 days."( Antipyrine metabolism and liver function in patients treated with high-dose medroxyprogesterone.
Kauppila, AJ; Rautio, A; Sotaniemi, EA; Tuimala, RJ, 1979
)
0.49
"Clinical studies were carried out with laboratory female rats to ascertain the effects of daily dosing with MPA (medroxyprogesterone acetate)."( Adrenocortical involution in rats during oestrus synchronisation with medroxyprogesterone.
Campbell, RM; Dinsdale, D; Fell, BF, 1977
)
0.7
" Dosage is 200 mg every 84 days, and it is not as effective as MPA."( [Pharmacological and clinical application of progestational hormone depot preparations].
Andor, J, 1978
)
0.26
" Malformations attributable to MPA did not occur in fetuses of mice or rats exposed to the largest dosage tested."( Prenatal toxicity of medroxyprogesterone acetate in rabbits, rats, and mice.
Andrew, FD; Staples, RE, 1977
)
0.58
" MPA was given in a dosage of 30 mg daily for 90 days."( Management of endometriosis with oral medroxyprogesterone acetate.
Boyce, CR; Moghissi, KS, 1976
)
0.53
" Dosage adjustment was allowed in one centre."( Oestrogen and cyclical progestogen in postmenopausal hormone replacement therapy.
Chambers, HM; Kirkgard, Y; MacLennan, A; MacLennan, AH; O'Neill, S; Wenzel, S, 1992
)
0.28
" Where dosage adjustment was allowed, almost all side effects were eliminated."( Oestrogen and cyclical progestogen in postmenopausal hormone replacement therapy.
Chambers, HM; Kirkgard, Y; MacLennan, A; MacLennan, AH; O'Neill, S; Wenzel, S, 1992
)
0.28
" Meanwhile, Provera exerted dose-response inhibition on both AE7 and ECC-1 cell lines."( Determination of hormonal response in uterine cancer cell lines by the ATP bioluminescence assay and flow cytometry.
Angioli, R; Averette, HE; Donato, D; Nguyen, HN; Penalver, M; Perras, J; Ramos, R; Sevin, BU; Voigt, W, 1992
)
0.28
" The results indicate that at a dosage of 3-4."( The effects of medroxyprogesterone acetate and ethinylestradiol on hemogram, prostate, testes, and semen quality in normal dogs.
Bamberg-Thalén, B; Linde-Forsberg, C, 1992
)
0.64
" There were no differences in terminal elimination rate constants among the dosage forms."( Bioavailability of medroxyprogesterone acetate from three oral dosage formulations.
Pollock, SR; Stalker, DJ; Welshman, IR,
)
0.46
" The metabolic ratio (MRP) of EM to NEM in plasma 60 min after dosage and the corresponding ratio in urine sampled for 6 h (MRU,1), measured on two occasions 14 days apart were used to reflect intraindividual variation in the rate of N-demethylation."( N-demethylation of ethylmorphine in pregnant and non-pregnant women and in men: an evaluation of the effects of sex steroids.
Gerdin, E; Rane, A, 1992
)
0.28
" In the first approach medroxyprogesterone dosage increased up to 400 mg a day, achieved better results in curative as well as adjuvant treatment of advanced or early gynecologic cancers."( New trends in the use of medroxyprogesterone acetate as a chemotherapeutic agent in gynecologic malignancies.
Bonte, J; Vanderstappen, D, 1992
)
0.9
" Research on combination norethynodrel-containing products revealed that the dosage was too high."( Oral contraception: a review.
Edgren, RA, 1991
)
0.28
" There was no significant difference in the suppression of spermatogenesis between the two dosage regimens."( Reversible azoospermia induced by an androgen-progestin combination regimen in Indonesian men.
Pangkahila, W, 1991
)
0.28
"25-mg dosage of conjugated estrogens."( Comparison of continuous versus sequential estrogen and progestin therapy in postmenopausal women.
Clisham, PR; de Ziegler, D; Judd, HL; Lozano, K, 1991
)
0.28
" Doubling the dose of either drug did not enhance hormone suppression, indicating that the drug dosage is maximally suppressive."( Adrenal steroids as parameters of the bioavailability of MA and MPA.
Dikkeschei, LD; Sleijfer, DT; Tjabbes, T; van Veelen, H; Willemse, PH, 1990
)
0.28
" Prolonged hormonal and incorrect treatments, mainly for too high dosage and absence of association with progesterone, assumption of oestrogens, can cause the growth of mammary tumours."( [Male transsexualism and hormonal therapy: radiologic pictures of the breast].
Bocchini, R; Cavallotti, GP; Genovese, MG; Godano, A; Grassi, G; Massara, D, 1990
)
0.28
" Many investigators have reported that progestogen with high dosage shows a good response to advanced endometrial cancer."( [Therapy of advanced endometrial cancer].
Okada, H; Yamamoto, T, 1990
)
0.28
" No increases in nongenital malformations were noted at any evaluated MPA dosage level."( Effect of gestational sex steroid exposure on limb development and endochondral ossification in the pregnant C57Bl/6J mouse: I. Medroxyprogesterone acetate.
Brent, RL; Buck, S; Carbone, JP; Figurska, K, 1990
)
0.48
" Attempts to further enhance the role of progestins have centered on dosage escalation, based on European data suggesting a dose-response effect."( Current status of high-dose progestins in breast cancer.
Abrams, JS; Aisner, J; Parnes, H, 1990
)
0.28
" The response rate and side-effect data from a pilot study, which used the old formulation Provera Tablets 100 mg at a dosage of 800 mg/day in 28 patients with recurrent breast cancer after treatment with tamoxifen, are compared with those from another study in which 59 similar patients received 800 mg/day of new formulation Provera Tablets 200 mg."( Treatment of carcinoma of the breast with high dose oral medroxyprogesterone acetate: does increased bioavailability improve the therapeutic ratio?
Bates, T; Bozzino, JM; Brock, JE; Clarke, DG; Durrant, KR; Evans, RG; Roberts, JT; Tobias, JS, 1990
)
0.52
"After initial surgery, 240 pre-, peri- or postmenopausal patients with early node-negative breast carcinoma were randomized to receive either no hormone therapy or adjuvant therapy with medroxyprogesterone acetate at high dosage (HD-MPA; 500 mg IM per day times 28 or 500 mg intramuscularly (i."( Adjuvant treatment with high dose medroxyprogesterone acetate in node-negative early breast cancer. A 3-year interim report on a randomized trial (I).
Baudoux, A; Beauduin, M; Bunescu, U; Dehasque, N; Dewasch, L; Focan, C; Lobelle, JP; Longeval, E; Majois, F; Mazy, V, 1989
)
0.75
" Intra-arterial injection of this drug alone or in conjunction with OK-432 can also be used, even though further studies will be required to determine the optimum dosage and reduce side effects."( Experimental local administration of CDDP to in vitro models of gynecological malignant tumors transplanted into nude mice (compared with medroxyprogesterone acetate orally administered).
Hashii, K; Kamitani, N; Kanto, T; Mori, T; Natsuyama, S; Tateyama, I; Tominaga, T, 1989
)
0.48
" Medroxyprogesterone acetate was given orally to the 6 study subjects over a 10-day period in an incremental dosage to mimic the luteal phase."( Opioidergic regulation of LH pulsatility in women with polycystic ovary syndrome.
Berga, SL; Yen, SS, 1989
)
1
"; USA) was administered intramuscularly on day 27 (+/- 2) of gestation to three dosage groups of pregnant baboons."( Embryotoxicity and maternal serum concentrations of medroxyprogesterone acetate (MPA) in baboons (Papio cynocephalus).
Carroad, E; Hendrickx, AG; Prahalada, S, 1985
)
0.52
" Cyproterone acetate allows differentiated treatment according to the various grades of hirsutism by modification of dosage and application."( [The concept of the causal therapy of hirsutism].
Schmidt, JB, 1986
)
0.27
" Thirty-four received treatment B: tamoxifen 30 mg per day and after relapse, high dosage of MPA alone."( [Hormonotherapy of metastatic breast cancer with tamoxifen and medroxyprogesterone acetate. Randomized trial comparing alternating sequences with successive applications].
Bonichon, F; Chauvergne, J; Durand, M; Mauriac, L, 1986
)
0.51
" MPA was administered at a dosage of 1,200mg orally per day."( [Phase II study of medroxyprogesterone acetate in advanced breast cancer].
Horikoshi, N; Imajo, K; Inoue, K; Ito, Y; Mukaiyama, T; Nakamura, T; Ogawa, M; Ozeki, H; Ueno, K, 1986
)
0.6
" The most appropriate dosage regimen for potential contraception was 200 micrograms/12 hours for 21 days because it was associated with small follicles and serum E2 was in the range of control cycles."( Ovarian sonographic findings during intermittent intranasal luteinizing hormone-releasing hormone agonist sequentially combined with an oral progestogen as antiovulatory contraceptive approach.
Bastide, A; Faure, N; Lemay, A, 1987
)
0.27
" The most appropriate dosage regimen for potential contraception is 200 mcg/12 hours for 21 days."( Ovarian sonographic findings during intermittent intranasal luteinizing hormone-releasing hormone agonist sequentially combined with an oral progestogen as antiovulatory contraceptive approach.
Bastide, A; Faure, N; Lemay, A, 1987
)
0.27
" This even occurs with those methods which do not usually suppress ovulation, but the disturbance is generally less severe with lower dosage systems."( Menstrual changes associated with progestogen-only contraception.
Fraser, IS, 1986
)
0.27
" No differences between the 3 treatment arms were observed except for medroxy-progesterone acetate, which showed less therapeutic effect in the dosage used."( Results of a Dutch trial with the LHRH agonist buserelin in patients with metastatic prostatic cancer and results of EORTC studies in prostatic cancer.
Debruyne, FM, 1988
)
0.27
" The peripheral serum levels of MPA exhibit enormous inter- and intraindividuell variations and only the high dosage schemes yield levels above 90 ng/ml which are claimed necessary by some authors."( [The medroxyprogesterone acetate serum level following various medroxyprogesterone acetate dose schedules in gynecologic oncology].
Egarter, C; Eppel, W; Husslein, P; Salzer, H; Spona, J, 1988
)
0.79
" A linear increase of cytosolic estrogen receptor concentration occurred over the dosage range of conjugated equine estrogen."( Biochemical and histologic effects of sequential estrogen/progestin therapy on the endometrium of postmenopausal women.
Gibbons, WE; Lobo, RA; Mishell, DR; Moyer, DL; Roy, S, 1986
)
0.27
" This is the first dosing study of contraceptive steroids in a murine model of lupus."( Suppression of reproductive function in autoimmune NZB/W mice: effective doses of four contraceptive steroids.
Keisler, LW; Walker, SE, 1987
)
0.27
" In conclusion, intermittent administration of appropriate LH-RH agonist dosing in combination with a progestogen would effectively block ovulation while preserving adequate cyclic estradiol secretion and could be an alternative contraceptive approach."( Inhibition of ovulation during discontinuous intranasal luteinizing hormone-releasing hormone agonist dosing in combination with gestagen-induced bleeding.
Faure, N; Fazekas, AT; Labrie, F; Lemay, A, 1985
)
0.27
" In conclusion, intermittent administration of appropriate LH-RH agonist dosing in combination with a progestogen would effectively block ovulation while preserving adequate cyclic estradiol secretion and could be an alternative contraceptive approach."( Inhibition of ovulation during discontinuous intranasal luteinizing hormone-releasing hormone agonist dosing in combination with gestagen-induced bleeding.
Faure, N; Fazekas, AT; Labrie, F; Lemay, A, 1985
)
0.27
"40), but not for MPA and estrone, indicating better adrenal suppression by higher MPA dosage and plasma levels."( Endocrine effects of medroxyprogesterone acetate: relation between plasma levels and suppression of adrenal steroids in patients with breast cancer.
Doorenbos, H; Sleijfer, DT; Sluiter, WJ; van Veelen, H; Willemse, PH, 1985
)
0.59
" It is concluded that, while the priming action exerted by E2B on PgRs might explain the potentiating effect shown by E2B on MPA activity, the synergism observed between TMX and MPA should be explained on an extrareceptorial basis, an induction on PgR synthesis by TMX not being evident at the dosage and priming time employed in this study."( Effects of tamoxifen, estradiol benzoate and medroxyprogesterone acetate on the growth of DMBA-induced rat mammary carcinoma.
Barbi, GP; Boccardo, F; Dandolo, G; De Menech, R; Guarneri, D; Moro, MG; Paganuzzi, M; Pino, G; Sanguineti, M; Zanardi, S, 1985
)
0.53
" Repetitive endometrial biopsy is impractical, and ethical constraints limit the dosage and duration of administration for some steroids."( Histologic response of normal human endometrium to steroid hormones in athymic mice.
Mortel, R; Satyaswaroop, PG; Zaino, RJ, 1985
)
0.27
" The results show a wide individual variation in plasma concentrations following similar dosing schedules--a finding reported by other workers."( Simple high-performance liquid chromatographic method for the determination of medroxyprogesterone acetate in human plasma.
Mould, G; Read, J; Stevenson, D, 1985
)
0.5
"2 mg/m2 (maximum dose, 2 mg), Adriamycin (A) (doxorubicin) 40 mg/m2, and cyclophosphamide (C) 500 mg/m2, all intravenously on day 1, every 4 weeks, in combination with medroxyprogesteron acetate (MPA) 600 mg orally on days 1 through 14, 500 mg intramuscularly on days 1 through 28, and twice weekly afterwards (combined chemoendocrine approach) or (2) the same combination chemotherapy (VAC) for three cycles alternating with MPA in the above-mentioned dosage during 8 weeks (alternating chemoendocrine approach)."( A randomized comparative trial of combined versus alternating therapy with cytostatic drugs and high-dose medroxyprogesteron acetate in advanced breast cancer.
Beex, LV; Bron, H; Pannebakker, M; Romme, A; Scheerder, H; Smeets, JB; Van Lange, L; Wils, JA, 1985
)
0.27
" The dosage regimen based on the daily oral administration of 1,000 mg MPA suspension."( Oral high-dose medroxyprogesterone acetate (MPA) treatment: cortisol/MPA serum profiles in relation to breast cancer regression.
Grill, HJ; Knapstein, P; Mahlke, M; Pollow, K; Wiegand, U, 1985
)
0.62
" If applicable, all anabolic agents were found to be present in a variety of esterified dosage forms."( [Anabolic steroid residues in administration sites in slaughtering cattle. October 1983 - January 1985].
Jansen, EH; Stephany, RW; van Blitterswijk, H, 1985
)
0.27
" This dosage seemed inadequate, since a total of 25."( Long-term contraceptive effect of injectable progestogens: inhibition and reestabilishment of fertility.
Zañartu, J,
)
0.13
" In patients whose renal function was stable at the time of initiation of MPG therapy, prednisone dosage could be lowered to an average of 37% of the previous dose and the patient's Cushingoid appearance or aseptic necrosis of the hips either did not progress or improved."( Allograft prolongation with synthetic progestins.
Gikas, PW; Haines, RF; Niederhuber, JE; Turcotte, JG, 1971
)
0.25
" This progestational compound is remarkably free from side-effects and can be given in high dosage for long periods without serious complications."( Medroxyprogesterone acetate (Provera) in the treatment of metastatic renal cancer.
Bloom, HJ, 1971
)
1.69
"19-nor steroids in high and medium dosage in continuous or cyclic combined regimens with oestrogen produce an endometrium characterized by hyperinvoluted glands, a prominent predecidual reaction, suppressed arterioles, and dilated venules."( Synthetic progestagen-oestrogen preparations and endometrial morphology.
Ober, WB, 1966
)
0.24
"The pharmacokinetic and bioavailability properties of medroxyprogesterone acetate (MPA) after single PO and IM doses in man were used as a basis to predict, on a theoretical pharmacokinetic basis, the blood level profile of the drug during repeated dose administration with various dosage schedules."( Pharmacokinetic approach to the selection of dose schedules for medroxyprogesterone acetate in clinical oncology.
Battaglia, A; Bernardo, G; Brunner, K; Cavalli, F; Ganzina, F; Goldhirsch, A; Isetta, AM; Robustelli della Cuna, G; Sacchetti, G; Tamassia, V, 1982
)
0.75
" Optimal dosage remains to be determined."( A phase II study of high-dose medroxyprogesterone acetate in advanced breast cancer.
Falkson, G; Falkson, HC, 1983
)
0.55
" Mean steady-state serum concentrations of MPA were simulated from single-dose data to reflect those achieved after standard dosage regimens."( Effect of injection volume on the bioavailability of sterile medroxyprogesterone acetate suspension.
Albert, KS; Antal, EJ; Gillespie, WR; Wright, CE,
)
0.37
" It has become evident that DES at a dosage of 3 mg/day carries a significantly higher risk of overall cardiovascular toxicity than does cyproterone acetate, but severe cardiovascular complications did not differ between treatment groups."( Treatment of prostatic cancer: the EORTC experience--preliminary results of prostatic carcinoma trials.
Schroeder, FH, 1984
)
0.27
" There is a tendency towards an increased response-rate with increased dosage of progestin, in both endometrial and breast carcinoma, while the route of administration appears to be of minor importance."( Progestin therapy of endometrial, breast and ovarian carcinoma. A review of clinical observations.
Kauppila, A, 1984
)
0.27
"A high-pressure liquid chromatography method for the quantitation of hydroxyprogesterone caproate, medroxyprogesterone acetate, and progesterone in pharmaceutical dosage forms was developed."( Quantitation of hydroxyprogesterone caproate, medroxyprogesterone acetate, and progesterone by reversed-phase high-pressure liquid chromatography.
Das Gupta, V, 1982
)
0.74
" This hormonal therapy should be suggested, where is possible, by the results of hormonal dosage on plasma and urine."( [Treatment of breast cancer in aged women].
Beani, G; Berta, V; Perelli-Ercolini, M, 1980
)
0.26
" In each patient the plasma concentration was monitored after the administration of a single oral and one intramuscular dose of MPA at the following dosage levels: 100 mg (5 patients), 400 mg (5 patients), 800 mg (5 patients) and 1 200 mg (4 patients)."( Pharmacokinetics of medroxyprogesterone acetate administered by oral and intramuscular route.
Johansson, E; Løber, J; Mouridsen, HT; Salimtschik, M, 1981
)
0.59
" The dosage and the different administration schedule of the hormone combination described here was inadequate to maintain azoospermia in all subjects during treatment."( Spermatogenesis in men treated with injections of medroxyprogesterone acetate combined with testosterone enanthate.
Danner, C; Frick, J; Joos, H; Köhle, R; Kunit, G, 1982
)
0.52
" These findings indicate that estrogen replacement therapy, in a dosage recommended for treatment of the menopause, stimulated a sustained rise in serum prolactin over 24 hours."( Circadian pattern of prolactin secretion in postmenopausal women receiving estrogen with or without progestin.
Carlson, HE; Chang, RJ; Davidson, BJ; Judd, HL, 1982
)
0.26
"Ten previously untreated patients with metastatic renal carcinoma underwent transperitoneal radical nephrectomy followed by high dosage MPA treatment."( Estrogen receptors and MPA treatment in metastatic renal carcinoma. A preliminary report.
Cataldo, I; Di Fronzo, G; Pizzocaro, G; Valente, M; Vezzoni, P, 1980
)
0.26
" The extent of delay in resumption of menses after cessation of therapy was related both to duration of treatment and dosage of the drug."( Medroxyprogesterone therapy for sexual precocity in girls.
Lee, PA, 1981
)
1.71
"It is well known that progestins given in sufficient dosage reduce the risk of endometrial cancer and endometrial hyperplasia."( Transvaginal sonography of the endometrium in postmenopausal women: monitoring the effect of hormone replacement therapy.
Castelo-Branco, C; Durán, M; Fortuny, A; Gratacós, E; Puerto, B; Torné, A; Vanrell, JA, 1994
)
0.29
" These time-course and dose-response relationships establish in vitro conditions with which to dissect factors controlling endometrial hemostasis, whereas the observed effects of steroid withdrawal establish a novel model for the study of mechanisms regulating normal and abnormal uterine bleeding."( Steroid-modulated stromal cell tissue factor expression: a model for the regulation of endometrial hemostasis and menstruation.
Alvarez, M; Guller, S; Hausknecht, V; Krikun, G; Lockwood, CJ; Markiewicz, L; Nemerson, Y; Schatz, F, 1993
)
0.29
"This study was designed to compare with placebo the dose-response effect of cyclical doses of the C21 progestogen, medroxyprogesterone acetate (MPA) on blood pressure (BP) when administered to normotensive postmenopausal women receiving a fixed mid-range daily dose of conjugated equine oestrogen (CEE)."( Dose response effect of cyclical medroxyprogesterone on blood pressure in postmenopausal women.
Harvey, PJ; Molloy, D; Upton, J; Wing, LM, 2001
)
0.8
" But ibuprofen both alone or with MPA had no effect on survival with gavage application of a 30 mg/kg/day dosing regime."( Vascularization pattern of C6 glioma is modified with medroxyprogesterone acetate and ibuprofen in Wistar rat brain.
Altinoz, MA; Altug, T; Aydiner, A; Bilir, A; Bozcali, E; Ozar, E; Sav, A; Taskin, M, 2001
)
0.56
" In the continuous regimen, both markers decreased as the MPA dosage increased."( How to use progestin in hormone replacement therapy: an animal experiment.
Sun, A; Wang, J; Zhu, P, 2001
)
0.31
" Two months later a side effect of MPA, her body weight gain, was observed, and the dosage of MPA was reduced from 1,200 mg/day to 800 mg/day."( [A case of long surviving advanced recurrent breast cancer with multiple bone metastases responding to treatment with 5'-DFUR combined with MPA].
Otsuka, T; Tashiro, S; Terashima, Y, 2002
)
0.31
"5 mg/d, are reasonable initial dosages, and if symptoms do not improve within a week or two, the dosage can be doubled."( Management of hot flashes in breast cancer survivors and men with prostate cancer.
Stearns, V, 2004
)
0.32
"We observed that endometrial polyp formation may be dependent on the type and dosage of the estrogen and progestogen."( The role of hormone replacement therapy in endometrial polyp formation.
Aytan, H; Kelekci, S; Mollamahmutoglu, L; Oguz, S; Sargin, A; Tapisiz, OL, 2005
)
0.33
" With multiple regression analysis, a statistically significant effect was observed only in boys using a pharmacologic dosage (5."( Growth-reductive therapy in children with marfan syndrome.
Hennekam, RC; le Cessie, S; Rozendaal, L; Wit, JM, 2005
)
0.33
" We conclude that TXA in 2 g/day dosage is an effective and safe option in DUB."( Role of tranexamic acid in management of dysfunctional uterine bleeding in comparison with medroxyprogesterone acetate.
Agarwal, N; Diwakar, S; Kriplani, A; Kulshrestha, V, 2006
)
0.55
" Low dosage endocrine agent-induced anthracycline sensitization may be independent of mitochondrial toxicity."( Medroxyprogesterone and tamoxifen augment anti-proliferative efficacy and reduce mitochondria-toxicity of epirubicin in FM3A tumor cells in vitro.
Altinoz, MA; Bilir, A; Gedikoglu, G; Muslumanoglu, M; Oktem, G; Ozcan, E, 2007
)
1.78
"5 years; all subjects received the lowest dosage for the next six months."( A 10-year follow-up of the effect of continuous-combined hormone replacement therapy and its discontinuation on bone in postmenopausal women.
Haapalahti, J; Heikkinen, J; Timonen, U; Vaheri, R, 2008
)
0.35
"Progressive increase of vertebral BMD was observed with all dosage regimens throughout nine years, with corresponding reduction in the proportion of women fulfilling criteria for osteoporosis or osteopaenia."( A 10-year follow-up of the effect of continuous-combined hormone replacement therapy and its discontinuation on bone in postmenopausal women.
Haapalahti, J; Heikkinen, J; Timonen, U; Vaheri, R, 2008
)
0.35
" We assessed the effects of daily dosing of progesterone or medroxyprogesterone (MPA), a non-metabolized synthetic progestin, upon the acquisition of a classically conditioned eyeblink response in ovariectomized (OVX) female rats."( Differential effects of progesterone and medroxyprogesterone on delay eyeblink conditioning in ovariectomized rats.
Beck, KD; Furst, SJ; Pang, KC; Servatius, RJ; Wasserman, MC, 2012
)
0.89
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (3)

RoleDescription
contraceptive drugA chemical substance that prevents or reduces the probability of conception.
progestinA synthetic progestogen.
synthetic oral contraceptiveAn oral contraceptive which owes its effectiveness to synthetic preparation.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (4)

ClassDescription
20-oxo steroidAn oxo steroid carrying an oxo group at position 20.
3-oxo-Delta(4) steroidA 3-oxo steroid conjugated to a C=C double bond at the alpha,beta position.
17alpha-hydroxy steroidThe alpha-stereoisomer of 17-hydroxy steroid.
tertiary alpha-hydroxy ketoneAn alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a carbon bearing two organyl groups.
[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 Targets (40)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, Beta-lactamaseEscherichia coli K-12Potency112.20200.044717.8581100.0000AID485294
RAR-related orphan receptor gammaMus musculus (house mouse)Potency4.21630.006038.004119,952.5996AID1159521; AID1159523
SMAD family member 2Homo sapiens (human)Potency16.93010.173734.304761.8120AID1346924
GALC proteinHomo sapiens (human)Potency0.707928.183828.183828.1838AID1159614
SMAD family member 3Homo sapiens (human)Potency16.93010.173734.304761.8120AID1346924
TDP1 proteinHomo sapiens (human)Potency15.28230.000811.382244.6684AID686978; AID686979
GLI family zinc finger 3Homo sapiens (human)Potency10.01510.000714.592883.7951AID1259369; AID1259392
Microtubule-associated protein tauHomo sapiens (human)Potency8.91250.180013.557439.8107AID1460
AR proteinHomo sapiens (human)Potency0.04740.000221.22318,912.5098AID1259243; AID1259247; AID1259381; AID743036; AID743040; AID743042; AID743053; AID743054
hypoxia-inducible factor 1, alpha subunit (basic helix-loop-helix transcription factor)Homo sapiens (human)Potency0.07940.00137.762544.6684AID914; AID915
PINK1Homo sapiens (human)Potency50.11872.818418.895944.6684AID624263
nuclear receptor subfamily 1, group I, member 3Homo sapiens (human)Potency18.68050.001022.650876.6163AID1224838; AID1224839; AID1224893
progesterone receptorHomo sapiens (human)Potency1.06760.000417.946075.1148AID1346784; AID1347036
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency0.14950.000214.376460.0339AID720691; AID720692; AID720719
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency27.70640.001530.607315,848.9004AID1224841; AID1224848; AID1224849; AID1259401; AID1259403
pregnane X nuclear receptorHomo sapiens (human)Potency26.60320.005428.02631,258.9301AID1346982
estrogen nuclear receptor alphaHomo sapiens (human)Potency2.15020.000229.305416,493.5996AID743069; AID743075; AID743078; AID743079; AID743080; AID743091
GVesicular stomatitis virusPotency21.87610.01238.964839.8107AID1645842
ParkinHomo sapiens (human)Potency50.11870.819914.830644.6684AID624263
peroxisome proliferator activated receptor gammaHomo sapiens (human)Potency13.33220.001019.414170.9645AID743191
vitamin D (1,25- dihydroxyvitamin D3) receptorHomo sapiens (human)Potency26.83250.023723.228263.5986AID743223
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency0.02370.001723.839378.1014AID743083
nuclear factor of kappa light polypeptide gene enhancer in B-cells 1 (p105), isoform CRA_aHomo sapiens (human)Potency23.914519.739145.978464.9432AID1159509
chromobox protein homolog 1Homo sapiens (human)Potency79.43280.006026.168889.1251AID540317
parathyroid hormone/parathyroid hormone-related peptide receptor precursorHomo sapiens (human)Potency50.11873.548119.542744.6684AID743266
thyroid hormone receptor beta isoform 2Rattus norvegicus (Norway rat)Potency11.88320.000323.4451159.6830AID743065; AID743067
nuclear factor erythroid 2-related factor 2 isoform 1Homo sapiens (human)Potency29.84700.000627.21521,122.0200AID743202
lamin isoform A-delta10Homo sapiens (human)Potency1.00000.891312.067628.1838AID1487
Interferon betaHomo sapiens (human)Potency11.14760.00339.158239.8107AID1347407; AID1645842
HLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)Potency21.87610.01238.964839.8107AID1645842
Spike glycoproteinSevere acute respiratory syndrome-related coronavirusPotency39.81070.009610.525035.4813AID1479145
Inositol hexakisphosphate kinase 1Homo sapiens (human)Potency21.87610.01238.964839.8107AID1645842
cytochrome P450 2C9, partialHomo sapiens (human)Potency21.87610.01238.964839.8107AID1645842
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Glucocorticoid receptorHomo sapiens (human)IC50 (µMol)0.01900.00000.495310.0000AID625263
Glucocorticoid receptorHomo sapiens (human)Ki0.00860.00010.38637.0010AID625263
Glycine receptor subunit alpha-1Rattus norvegicus (Norway rat)IC50 (µMol)0.01900.00150.76005.0740AID625263
Glycine receptor subunit alpha-1Rattus norvegicus (Norway rat)Ki0.00860.00070.76537.0010AID625263
Androgen receptorRattus norvegicus (Norway rat)IC50 (µMol)0.13700.00101.979414.1600AID625228
Androgen receptorRattus norvegicus (Norway rat)Ki0.09100.00031.21858.9270AID625228
Glycine receptor subunit betaRattus norvegicus (Norway rat)IC50 (µMol)0.01900.00150.76005.0740AID625263
Glycine receptor subunit betaRattus norvegicus (Norway rat)Ki0.00860.00070.78467.0010AID625263
Glycine receptor subunit alpha-2Rattus norvegicus (Norway rat)IC50 (µMol)0.01900.00150.80445.0740AID625263
Glycine receptor subunit alpha-2Rattus norvegicus (Norway rat)Ki0.00860.00070.78467.0010AID625263
Glycine receptor subunit alpha-3Rattus norvegicus (Norway rat)IC50 (µMol)0.01900.00150.76005.0740AID625263
Glycine receptor subunit alpha-3Rattus norvegicus (Norway rat)Ki0.00860.00070.78467.0010AID625263
Cytochrome P450 2C19Homo sapiens (human)IC50 (µMol)2.00000.00002.398310.0000AID625247
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (82)

Processvia Protein(s)Taxonomy
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell activation involved in immune responseInterferon betaHomo sapiens (human)
cell surface receptor signaling pathwayInterferon betaHomo sapiens (human)
cell surface receptor signaling pathway via JAK-STATInterferon betaHomo sapiens (human)
response to virusInterferon betaHomo sapiens (human)
positive regulation of autophagyInterferon betaHomo sapiens (human)
cytokine-mediated signaling pathwayInterferon betaHomo sapiens (human)
natural killer cell activationInterferon betaHomo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT proteinInterferon betaHomo sapiens (human)
cellular response to interferon-betaInterferon betaHomo sapiens (human)
B cell proliferationInterferon betaHomo sapiens (human)
negative regulation of viral genome replicationInterferon betaHomo sapiens (human)
innate immune responseInterferon betaHomo sapiens (human)
positive regulation of innate immune responseInterferon betaHomo sapiens (human)
regulation of MHC class I biosynthetic processInterferon betaHomo sapiens (human)
negative regulation of T cell differentiationInterferon betaHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIInterferon betaHomo sapiens (human)
defense response to virusInterferon betaHomo sapiens (human)
type I interferon-mediated signaling pathwayInterferon betaHomo sapiens (human)
neuron cellular homeostasisInterferon betaHomo sapiens (human)
cellular response to exogenous dsRNAInterferon betaHomo sapiens (human)
cellular response to virusInterferon betaHomo sapiens (human)
negative regulation of Lewy body formationInterferon betaHomo sapiens (human)
negative regulation of T-helper 2 cell cytokine productionInterferon betaHomo sapiens (human)
positive regulation of apoptotic signaling pathwayInterferon betaHomo sapiens (human)
response to exogenous dsRNAInterferon betaHomo sapiens (human)
B cell differentiationInterferon betaHomo sapiens (human)
natural killer cell activation involved in immune responseInterferon betaHomo sapiens (human)
adaptive immune responseInterferon betaHomo sapiens (human)
T cell activation involved in immune responseInterferon betaHomo sapiens (human)
humoral immune responseInterferon betaHomo sapiens (human)
positive regulation of T cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
adaptive immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class I via ER pathway, TAP-independentHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of T cell anergyHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
defense responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
detection of bacteriumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-12 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of interleukin-6 productionHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protection from natural killer cell mediated cytotoxicityHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
innate immune responseHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
regulation of dendritic cell differentiationHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class IbHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
negative regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
regulation of gluconeogenesisGlucocorticoid receptorHomo sapiens (human)
chromatin organizationGlucocorticoid receptorHomo sapiens (human)
regulation of DNA-templated transcriptionGlucocorticoid receptorHomo sapiens (human)
apoptotic processGlucocorticoid receptorHomo sapiens (human)
chromosome segregationGlucocorticoid receptorHomo sapiens (human)
signal transductionGlucocorticoid receptorHomo sapiens (human)
glucocorticoid metabolic processGlucocorticoid receptorHomo sapiens (human)
gene expressionGlucocorticoid receptorHomo sapiens (human)
microglia differentiationGlucocorticoid receptorHomo sapiens (human)
adrenal gland developmentGlucocorticoid receptorHomo sapiens (human)
regulation of glucocorticoid biosynthetic processGlucocorticoid receptorHomo sapiens (human)
synaptic transmission, glutamatergicGlucocorticoid receptorHomo sapiens (human)
maternal behaviorGlucocorticoid receptorHomo sapiens (human)
intracellular glucocorticoid receptor signaling pathwayGlucocorticoid receptorHomo sapiens (human)
glucocorticoid mediated signaling pathwayGlucocorticoid receptorHomo sapiens (human)
positive regulation of neuron apoptotic processGlucocorticoid receptorHomo sapiens (human)
negative regulation of DNA-templated transcriptionGlucocorticoid receptorHomo sapiens (human)
positive regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
astrocyte differentiationGlucocorticoid receptorHomo sapiens (human)
cell divisionGlucocorticoid receptorHomo sapiens (human)
mammary gland duct morphogenesisGlucocorticoid receptorHomo sapiens (human)
motor behaviorGlucocorticoid receptorHomo sapiens (human)
cellular response to steroid hormone stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to glucocorticoid stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to dexamethasone stimulusGlucocorticoid receptorHomo sapiens (human)
cellular response to transforming growth factor beta stimulusGlucocorticoid receptorHomo sapiens (human)
neuroinflammatory responseGlucocorticoid receptorHomo sapiens (human)
positive regulation of miRNA transcriptionGlucocorticoid receptorHomo sapiens (human)
intracellular steroid hormone receptor signaling pathwayGlucocorticoid receptorHomo sapiens (human)
regulation of transcription by RNA polymerase IIGlucocorticoid receptorHomo sapiens (human)
long-chain fatty acid metabolic processCytochrome P450 2C19Homo sapiens (human)
xenobiotic metabolic processCytochrome P450 2C19Homo sapiens (human)
steroid metabolic processCytochrome P450 2C19Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2C19Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2C19Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2C19Homo sapiens (human)
omega-hydroxylase P450 pathwayCytochrome P450 2C19Homo sapiens (human)
inositol phosphate metabolic processInositol hexakisphosphate kinase 1Homo sapiens (human)
phosphatidylinositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
negative regulation of cold-induced thermogenesisInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol phosphate biosynthetic processInositol hexakisphosphate kinase 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (51)

Processvia Protein(s)Taxonomy
cytokine activityInterferon betaHomo sapiens (human)
cytokine receptor bindingInterferon betaHomo sapiens (human)
type I interferon receptor bindingInterferon betaHomo sapiens (human)
protein bindingInterferon betaHomo sapiens (human)
chloramphenicol O-acetyltransferase activityInterferon betaHomo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
signaling receptor bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
peptide antigen bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
TAP bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
protein-folding chaperone bindingHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
RNA polymerase II transcription regulatory region sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
core promoter sequence-specific DNA bindingGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specificGlucocorticoid receptorHomo sapiens (human)
DNA-binding transcription factor activityGlucocorticoid receptorHomo sapiens (human)
RNA bindingGlucocorticoid receptorHomo sapiens (human)
nuclear receptor activityGlucocorticoid receptorHomo sapiens (human)
nuclear glucocorticoid receptor activityGlucocorticoid receptorHomo sapiens (human)
steroid bindingGlucocorticoid receptorHomo sapiens (human)
protein bindingGlucocorticoid receptorHomo sapiens (human)
zinc ion bindingGlucocorticoid receptorHomo sapiens (human)
TBP-class protein bindingGlucocorticoid receptorHomo sapiens (human)
protein kinase bindingGlucocorticoid receptorHomo sapiens (human)
identical protein bindingGlucocorticoid receptorHomo sapiens (human)
Hsp90 protein bindingGlucocorticoid receptorHomo sapiens (human)
steroid hormone bindingGlucocorticoid receptorHomo sapiens (human)
sequence-specific double-stranded DNA bindingGlucocorticoid receptorHomo sapiens (human)
estrogen response element bindingGlucocorticoid receptorHomo sapiens (human)
monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
iron ion bindingCytochrome P450 2C19Homo sapiens (human)
steroid hydroxylase activityCytochrome P450 2C19Homo sapiens (human)
oxidoreductase activityCytochrome P450 2C19Homo sapiens (human)
(S)-limonene 6-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
(S)-limonene 7-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
oxygen bindingCytochrome P450 2C19Homo sapiens (human)
enzyme bindingCytochrome P450 2C19Homo sapiens (human)
heme bindingCytochrome P450 2C19Homo sapiens (human)
(R)-limonene 6-monooxygenase activityCytochrome P450 2C19Homo sapiens (human)
aromatase activityCytochrome P450 2C19Homo sapiens (human)
long-chain fatty acid omega-1 hydroxylase activityCytochrome P450 2C19Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2C19Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2C19Homo sapiens (human)
inositol-1,3,4,5,6-pentakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol heptakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
protein bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
ATP bindingInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 1-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol hexakisphosphate 3-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol 5-diphosphate pentakisphosphate 5-kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
inositol diphosphate tetrakisphosphate kinase activityInositol hexakisphosphate kinase 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (32)

Processvia Protein(s)Taxonomy
extracellular spaceInterferon betaHomo sapiens (human)
extracellular regionInterferon betaHomo sapiens (human)
Golgi membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
endoplasmic reticulumHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
Golgi apparatusHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
cell surfaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
ER to Golgi transport vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
secretory granule membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
phagocytic vesicle membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
early endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
recycling endosome membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular exosomeHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
lumenal side of endoplasmic reticulum membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
MHC class I protein complexHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
extracellular spaceHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
external side of plasma membraneHLA class I histocompatibility antigen, B alpha chain Homo sapiens (human)
nucleusGlucocorticoid receptorHomo sapiens (human)
nucleusGlucocorticoid receptorHomo sapiens (human)
nucleoplasmGlucocorticoid receptorHomo sapiens (human)
cytoplasmGlucocorticoid receptorHomo sapiens (human)
mitochondrial matrixGlucocorticoid receptorHomo sapiens (human)
centrosomeGlucocorticoid receptorHomo sapiens (human)
spindleGlucocorticoid receptorHomo sapiens (human)
cytosolGlucocorticoid receptorHomo sapiens (human)
membraneGlucocorticoid receptorHomo sapiens (human)
nuclear speckGlucocorticoid receptorHomo sapiens (human)
synapseGlucocorticoid receptorHomo sapiens (human)
chromatinGlucocorticoid receptorHomo sapiens (human)
protein-containing complexGlucocorticoid receptorHomo sapiens (human)
plasma membraneGlycine receptor subunit betaRattus norvegicus (Norway rat)
endoplasmic reticulum membraneCytochrome P450 2C19Homo sapiens (human)
plasma membraneCytochrome P450 2C19Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C19Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2C19Homo sapiens (human)
cytoplasmCytochrome P450 2C19Homo sapiens (human)
virion membraneSpike glycoproteinSevere acute respiratory syndrome-related coronavirus
fibrillar centerInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
cytosolInositol hexakisphosphate kinase 1Homo sapiens (human)
nucleusInositol hexakisphosphate kinase 1Homo sapiens (human)
cytoplasmInositol hexakisphosphate kinase 1Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (133)

Assay IDTitleYearJournalArticle
AID496817Antimicrobial activity against Trypanosoma cruzi2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID467613Volume of distribution at steady state in human2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID404304Effect on human MRP2-mediated estradiol-17-beta-glucuronide transport in Sf9 cells inverted membrane vesicles relative to control2008Journal of medicinal chemistry, Jun-12, Volume: 51, Issue:11
Prediction and identification of drug interactions with the human ATP-binding cassette transporter multidrug-resistance associated protein 2 (MRP2; ABCC2).
AID496827Antimicrobial activity against Leishmania amazonensis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID467612Fraction unbound in human plasma2009European journal of medicinal chemistry, Nov, Volume: 44, Issue:11
Prediction of volume of distribution values in human using immobilized artificial membrane partitioning coefficients, the fraction of compound ionized and plasma protein binding data.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496831Antimicrobial activity against Cryptosporidium parvum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496818Antimicrobial activity against Trypanosoma brucei brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID496823Antimicrobial activity against Trichomonas vaginalis2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID497005Antimicrobial activity against Pneumocystis carinii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID496830Antimicrobial activity against Leishmania major2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496820Antimicrobial activity against Trypanosoma brucei2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496821Antimicrobial activity against Leishmania2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID496828Antimicrobial activity against Leishmania donovani2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496826Antimicrobial activity against Entamoeba histolytica2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496824Antimicrobial activity against Toxoplasma gondii2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496829Antimicrobial activity against Leishmania infantum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496825Antimicrobial activity against Leishmania mexicana2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID409947Inhibition of human recombinant MAOB at 1 mM by fluorimetric method2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID496819Antimicrobial activity against Plasmodium falciparum2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID409952Inhibition of human brain MAOB2008Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21
Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496832Antimicrobial activity against Trypanosoma brucei rhodesiense2010Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6
Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. 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.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. 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.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. 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.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1347119qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The 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.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS 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.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347113qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347412qHTS assay to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: Counter screen cell viability and HiBit confirmation2020ACS 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.
AID1347128qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings 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.
AID1347127qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347117qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347129qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347114qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347121qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347112qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347115qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The 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.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347109qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347125qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347111qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347110qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for A673 cells)2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347116qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347124qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347122qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347126qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347123qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347118qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
AID588460High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation Compound Set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588460High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation Compound Set2006Cytometry. 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.
AID588460High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation Compound Set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588461High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588461High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation compound set2006Cytometry. 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.
AID588461High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588459High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588459High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation compound set2006Cytometry. 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.
AID588459High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID1346851Human Progesterone receptor (3C. 3-Ketosteroid receptors)1998Journal of medicinal chemistry, Jan-29, Volume: 41, Issue:3
5-Aryl-1,2-dihydrochromeno[3,4-f]quinolines: a novel class of nonsteroidal human progesterone receptor agonists.
AID1224864HCS microscopy assay (F508del-CFTR)2016PloS one, , Volume: 11, Issue:10
Increasing the Endoplasmic Reticulum Pool of the F508del Allele of the Cystic Fibrosis Transmembrane Conductance Regulator Leads to Greater Folding Correction by Small Molecule Therapeutics.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (3,263)

TimeframeStudies, This Drug (%)All Drugs %
pre-19902314 (70.92)18.7374
1990's503 (15.42)18.2507
2000's294 (9.01)29.6817
2010's116 (3.56)24.3611
2020's36 (1.10)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 103.96

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 very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index103.96 (24.57)
Research Supply Index8.30 (2.92)
Research Growth Index4.16 (4.65)
Search Engine Demand Index195.41 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (103.96)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials490 (13.88%)5.53%
Reviews206 (5.84%)6.00%
Case Studies262 (7.42%)4.05%
Observational2 (0.06%)0.25%
Other2,570 (72.80%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (127)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Vascular Mechanisms for the Effects of Loss of Ovarian Hormone Function on Cognition in Women [NCT02122198]17 participants (Actual)Interventional2014-09-08Completed
The Impact of Different Hormone Therapy Regimens on Overactive Bladder Symptoms, Sexual Function, Depressive Symptoms, Autonomic Function, and Arterial Stiffness [NCT05280028]100 participants (Anticipated)Observational2022-02-07Recruiting
Pharmacodynamics (Suppression of Ovulation) and Pharmacokinetics Following a Single Subcutaneous Administration of Depo Provera® CI 150 mg/mL, Depo Provera® CI 300 mg/2 mL, or During Two Cycles of Depo-subQ Provera 104® [NCT02456584]Phase 142 participants (Actual)Interventional2015-09-30Completed
The Effectiveness of Cyclic Desogestrel Therapy for Abnormal Uterine Bleeding Associated With Anovulation: a Non-inferiority Double Blinded Randomized Control Trial [NCT02103764]Phase 3160 participants (Anticipated)Interventional2013-08-31Active, not recruiting
The Estrogen Replacement and Atherosclerosis Trial [NCT03097120]Phase 3309 participants (Actual)Interventional1995-01-31Completed
Is Endometrial Withdrawal Bleeding Necessary Prior to Ovulation Induction With Clomiphene Citrate? A Randomized Controlled Trial and Feasibility Study [NCT03309176]Phase 442 participants (Actual)Interventional2016-06-21Completed
Predictors of Abnormal Uterine Bleeding in Progestin-only Contraceptives Users [NCT03398811]390 participants (Actual)Observational2018-08-01Completed
A PHASE 1, RANDOMIZED, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO COMPARE THE PHARMACOKINETICS AND RELATIVE BIOAVAILABILITY OF MEDROXYPROGESTERONE ACETATE IN HEALTHY FEMALE PARTICIPANTS FOLLOWING SUBCUTANEOUS INJECTION OF SAYANA PRESS IN THE UPPER A [NCT04893798]Phase 168 participants (Anticipated)Interventional2021-09-16Recruiting
A Randomized Surgical Window Pilot Investigation of the Relationship of Short Term Medroxyprogesterone Acetate (NSC #26386) Compared to Medroxyprogesterone Acetate Plus Entinostat (NSC #706995) on the Morphologic, Biochemical, and Molecular Changes in Pri [NCT03018249]Early Phase 150 participants (Actual)Interventional2017-10-11Completed
A Randomized Clinical Trial on the Effects of Progestin-based Contraception in the Genital Tract of HIV-infected and Uninfected Women [NCT02103660]Phase 4131 participants (Actual)Interventional2014-04-08Completed
A 12-month Open-label Randomized Controlled Trial to Evaluate Sayana® Press Suitability for at Home Subcutaneous Self-injection Procedures in Adult Women [NCT02293694]735 participants (Actual)Interventional2015-09-17Completed
Pilot Study of Femring Estrogen Supplementation During Depo-Provera Initiation [NCT00563576]71 participants (Actual)Interventional2007-09-30Completed
HIV-Target Cell Response in Women Initiating Various Contraceptive Methods in High HIV-Incidence Areas: Zim CHIC [NCT02038335]451 participants (Actual)Observational2014-02-28Completed
Investigation of the Potential for Intramuscular Depot Medroxyprogesterone Acetate as Emergency Contraception [NCT03395756]Early Phase 130 participants (Actual)Interventional2018-08-31Completed
A Phase II Pilot Investigation Of The Relationship Of Short Term Depo-Provera (Medroxyprogesterone Acetate) Exposure To The Morphologic , Biochemical, And Molecular Changes In Primary Endometroid Adenocarcinoma of the Uterine Corpus [NCT00064025]Phase 275 participants (Actual)Interventional2004-04-30Completed
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 10 participants (Actual)Interventional2012-07-31Withdrawn(stopped due to Insufficient funding)
Value of Levonorgestrel-Releasing Intrauterine System (LNG-IUS) in the Fertility-preserving Treatment of Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma [NCT03463252]Phase 2/Phase 3224 participants (Anticipated)Interventional2018-04-01Recruiting
A Randomized Cross-Over Study to Evaluate Local Tolerability Following Subcutaneous Administration of TV-46046 [NCT03700658]Phase 127 participants (Actual)Interventional2019-01-15Completed
Modifiers of Tenofovir Exposure in the Female Genital Tract of African Women on Depo-provera [NCT03377608]50 participants (Actual)Observational2017-11-17Completed
Prospective Assessment of Acceptability and Adherence Associated With Use of the Copper Intrauterine Device (CuT380A-IUCD) Compared to Depo-medroxyprogesterone Acetate (DMPA) Among HIV Positive Women in Lilongwe, Malawi [NCT01191203]200 participants (Actual)Interventional2010-07-31Completed
Evaluation of Haematological Improvement in Patients With Low-risk MDS by Comparing VBaP With Danazol in Patients Who Have Either Received Erythropoiesis Stimulating Agents (ESA) and Lost Response, Not Responded to ESA or Are Deemed Unlikely to Respond to [NCT04997811]Phase 2120 participants (Anticipated)Interventional2021-12-21Recruiting
An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions Between Depo-Medroxyprogesterone Acetate (DMPA) and Lopinavir/Ritonavir (LPV/r) and of the Effects of DMPA on Cellular Immunity and Regulation in HIV-Infected Women [NCT01296152]Phase 225 participants (Actual)Interventional2011-05-31Completed
Randomized Clinical Trial of Self Versus Clinical Administration of Depot Medroxyprogesterone Acetate [NCT01019369]132 participants (Actual)Interventional2010-03-31Completed
Evaluation of Female Sexual Functions in Progestogen-only Contraceptive Users [NCT02579590]444 participants (Actual)Observational2017-05-01Completed
Mucosal and Systemic Responses to Contraceptives in HIV-Infected Women in Zambia [NCT00807625]Phase 266 participants (Actual)Interventional2008-11-30Completed
A Multi Center, Open-Label, Randomised Clinical Trial Comparing HIV Incidence and Contraceptive Benefits in Women Using Depot Medroxyprogesterone Acetate (DMPA), Levonorgestrel (LNG) Implant, and Copper Intrauterine Devices (IUDs) [NCT02550067]7,830 participants (Actual)Interventional2015-12-14Completed
Continuation Rates of Self-administered Subcutaneous Depot Medroxyprogesterone Acetate and Provider-administered Intramuscular Depot Medroxyprogesterone Acetate in Patients Seeking Post-abortion Contraception [NCT05505435]Phase 4653 participants (Anticipated)Interventional2022-08-01Recruiting
An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions Among Depot Medroxyprogesterone Acetate (DMPA), Rifampicin (RIF), and Efavirenz (EFV) in Women Co-infected With Human Immunodeficiency Virus (HIV) and Tuberculosis (TB) [NCT02412436]Phase 262 participants (Actual)Interventional2015-11-03Completed
A Randomized, Dose-range Finding Study to Evaluate Pharmacokinetics of Medroxyprogesterone Acetate Following a Single Subcutaneous Administration of TV-46046 in Healthy Women of Reproductive Age [NCT04682353]Phase 160 participants (Actual)Interventional2020-12-14Completed
The Pharmacokinetic and Pharmacodynamic Impacts of Depot Medroxyprogesterone Acetate on HIV Pre-exposure Prophylaxis (PrEP) [NCT03197961]Early Phase 115 participants (Actual)Interventional2017-11-17Completed
Depot-medroxy Progesterone Acetate Injectable Contraceptives in Lactating Women 1st Week Versus 6 Week Postpartum Initiation [NCT06100783]120 participants (Actual)Interventional2021-01-01Completed
A Study to Evaluate the Effectiveness, Pharmacokinetics, Safety, and Acceptability of Sayana® Press When Injected Every Four Months [NCT03154125]Phase 3750 participants (Actual)Interventional2017-09-22Completed
Gonadotropin-releasing Hormone Agonist Combined With Letrozole Compared With Megestrol Acetate or Medroxyprogesterone Acetate Alone as Fertility-sparing Treatment in Early Endometrial Cancer [NCT05247268]Phase 2104 participants (Anticipated)Interventional2022-03-11Recruiting
A Phase III Prospective, Randomized, Double-Blind Clinical Trial of Hormone Replacement Therapy In Postmenopausal Women With A History Of Node-Negative Or Ductal Carcinoma In Situ Who Are Receiving Adjuvant Tamoxifen [NCT00026286]Phase 30 participants Interventional2000-11-28Completed
A Study to Evaluate Suppression of Ovulation Following a Single Subcutaneous Administration of Various Doses of Depo-Provera CI [NCT02732418]Phase 160 participants (Actual)Interventional2016-12-02Completed
A Multicenter, Randomized, Open Label, Parallel Group, Active Control Study to Evaluate the Efficacy and Safety of LNG IUS (Mirena®) as Compared to Medroxyprogesterone Acetate During 6 Cycles of Treatment in Patients With Idiopathic Menorrhagia [NCT00360490]Phase 3165 participants (Actual)Interventional2006-07-31Completed
A Phase II, Randomized, Double-blind, Active-controlled Study to Assess the Safety and Efficacy of NBI-56418 in Subjects With Endometriosis [NCT00437658]Phase 2252 participants (Actual)Interventional2006-12-11Completed
The Effect of Male Hormonal Contraceptive Regimens on Prostate Tissue In Normal Men [NCT00490555]Phase 2/Phase 332 participants (Actual)Interventional2009-01-31Completed
Efficacy and Tolerance of Cyproterone Acetate Versus Medroxyprogesterone Acetate Versus Venlafaxine LP in the Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Patients Treated for a Prostate Adenocarcinoma [NCT01011751]Phase 3311 participants (Actual)Interventional2004-04-30Completed
Pharmacist-Administered Injections of Depo-Medroxyprogesterone Acetate for Contraception: A Pilot Randomized Controlled Trial [NCT00775047]50 participants (Actual)Interventional2006-08-31Completed
Comparing the Safety and Efficacy in the Use of Dienogest, Leuprolide Acetate, DMPA and Combined Oral Contraceptive Pills (Microgynon) on Endometriosis Patients After Conservative Surgery [NCT06145438]Phase 3100 participants (Anticipated)Interventional2023-09-04Recruiting
A Randomized Phase II Trial of Ridaforolimus (AP23573; MK-8669) Compared to Progestin or Chemotherapy in Female Adult Patients With Advanced Endometrial Carcinoma [NCT00739830]Phase 2130 participants (Actual)Interventional2008-08-31Completed
The Impact of Different Hormone Therapy Regimens on Lower Urinary Tract Symptoms, Sexual Function and Psychosomatic Disorder [NCT01822288]Phase 4125 participants (Actual)Interventional2012-11-16Completed
The Effect of Metformin and Medroxyprogesterone Acetate on Apoptotic Signaling Pathways in Wistar-Albino Rats With Induced Endometrial Hyperplasia [NCT02872818]Phase 440 participants (Actual)Interventional2014-10-31Completed
A Double-Blind, Randomized, Placebo And Active- Controlled Efficacy And Safety Study Of The Effects Of Bazedoxifene/Conjugated Estrogens Combinations On Endometrial Hyperplasia And Prevention Of Osteoporosis In Postmenopausal Women [NCT00808132]Phase 31,886 participants (Actual)Interventional2009-01-31Completed
[NCT00000559]Phase 30 participants Interventional1995-03-31Completed
Herbal Alternatives for Menopause Symptoms: A Randomized Trial [NCT00169299]Phase 4351 participants Interventional2001-06-30Active, not recruiting
Combined Oral Contraceptives, Progestogens, and Non-steroidal Anti-inflammatory Drugs for Heavy and/or Prolonged Menstrual Bleeding Without Organic Cause [NCT02943655]Phase 3240 participants (Actual)Interventional2017-11-01Completed
Male Hormonal Contraception Development: Suppression of Spermatogenesis With the Addition of a Potent GnRH Antagonist (Acyline) to Testosterone and DMPA (ACY-5) -Sub-Study (HOP 5) [NCT00156650]Phase 1/Phase 223 participants (Actual)Interventional2004-12-31Completed
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 292 participants (Actual)Interventional2007-01-31Completed
Postoperative Intramuscular Depot Medroxyprogesterone Acetate Versus Continuous Oral Contraceptive for Pelvic Pain Associated With Endometriosis : Randomized Comparative Trial. [NCT01056042]Phase 4112 participants (Anticipated)Interventional2007-06-30Completed
A Multicenter Study Comparing Mirena and Systemic Progestin for Endometrial Hyperplasia [NCT01074892]Phase 4170 participants (Actual)Interventional2005-05-31Completed
Co-benefits of Co-delivery of Long-acting Antiretrovirals and Contraceptives [NCT05044962]700 participants (Anticipated)Interventional2021-11-26Recruiting
Effect of Progestin-Induced Endometrial Shedding on Ovulation Induction Cycles With Clomiphene Citrate: A Randomized Study [NCT01966575]Phase 40 participants (Actual)Interventional2013-10-31Withdrawn(stopped due to Recent findings suggest that letrozole may be a superior Clomiphene Citrate.)
Hormonal Replacement Therapy and Small Artery Function [NCT00564031]Phase 366 participants (Actual)Interventional2003-01-31Completed
Pharmacokinetics of Subcutaneous Depot Medroxyprogesterone Acetate Injected in the Upper Arm [NCT01143207]26 participants (Actual)Interventional2010-05-31Completed
Hormonal Contraception and the Risk of HIV Acquisition [NCT00006324]6,360 participants Interventional1999-12-31Completed
[NCT00006133]970 participants Interventional2000-06-30Completed
[NCT00000466]Phase 30 participants Interventional1987-09-30Completed
Progesterone Amplifies Estrogen-stimulated Growth Hormone Secretion in Older Women [NCT02272647]Phase 147 participants (Actual)Interventional2014-12-31Completed
A Pivotal Study to Evaluate the Bioequivalence of 150 mg/1 mL Medroxyprogesterone Acetate Injection in Postmenopausal Women [NCT00830414]Phase 1124 participants (Actual)Interventional2002-04-30Completed
Medroxyprogesterone Acetate (MPA) Versus Dydrogesterone for Management of Endometrial Hyperplasia Without Atypia [NCT03675139]Phase 3471 participants (Actual)Interventional2019-02-26Completed
Effects of Estradiol and Soy on Menopausal Symptoms [NCT00997893]Phase 296 participants (Actual)Interventional2009-12-31Completed
Effect of Combined Estradiol and Drospirenone Treatment Versus Combined Estradiol and Medroxyprogesterone Acetate Treatment on Endothelial Function: A Crossover Study [NCT01109979]Phase 424 participants (Actual)Interventional2009-12-31Completed
Assessing the Effect of Contraception and the Menstrual Cycle on Pharmacokinetics, Pharmacodynamics, and Vaginal Safety in Tenofovir Vaginal Gel Users [NCT01421368]Phase 172 participants (Actual)Interventional2012-03-31Completed
Male Hormonal Contraceptive Development: Suppression of Spermatogenesis With the Addition of a Potent Antagonist (Acyline) to Testosterone and DMPA (ACY-5) [NCT00161447]Phase 1/Phase 243 participants (Actual)Interventional2004-05-31Completed
Estrogen, HDL, and Coronary Heart Disease in Women [NCT00083824]Phase 2/Phase 3309 participants (Actual)Interventional2004-03-31Completed
Humatrope Treatment to Final Height in Turner's Syndrome [NCT00191113]Phase 3154 participants (Actual)Interventional1989-02-28Completed
The Rate of Embryo Euploidy in Women Treated With Progestin-primed Ovarian Stimulation Versus Conventional Ovarian Stimulation: a Randomized Controlled Trial [NCT04654741]Phase 4396 participants (Anticipated)Interventional2020-09-01Recruiting
Medroxyprogesterone Acetate Plus Atorvastatin in Young Women With Atypical Endometrial Hyperplasia and Early Endometrial Carcinoma [NCT05675787]Phase 282 participants (Anticipated)Interventional2023-01-06Recruiting
Optimizing Fertility Treatment in Women With Polycystic Ovary Syndrome (PCOS) - A Randomized Controlled Trial: The Role of Progestin-induced Endometrial Shedding in PCOS (PIES in PCOS) [NCT01718444]27 participants (Actual)Interventional2015-03-31Terminated(stopped due to The primary investigator moved from academic practice to join a private group, and could not get any one to take over as PI for the study.)
Optimal Hormone Replacement for Women With Premature Ovarian Insufficiency [NCT02922348]Phase 30 participants (Actual)Interventional2016-03-01Withdrawn
[NCT02894151]Phase 250 participants (Actual)Interventional2015-04-30Completed
MPA Revisited: A Phase II Study of Anti-Metastatic, Anti-Angiogenic Therapy in Postmenopausal Patients With Hormone Receptor Negative Breast Cancer. A Translational Breast Cancer Research Consortium (TBCRC) Trial [NCT00577122]Phase 230 participants (Actual)Interventional2007-07-31Completed
[NCT00004650]Phase 3150 participants Interventional1993-08-31Completed
Postmenopausal Women,Treatment of Sleep Apnea and Co-morbidities [NCT01472315]Phase 2/Phase 334 participants (Actual)Interventional2000-01-31Completed
Effects of Tibolone Treatment on the Endometrium [NCT00294463]Phase 435 participants Interventional2003-02-28Completed
Hormonal Contraception, Cervical Ectopy, and STDs [NCT00091728]1,200 participants Observational1997-09-30Terminated
Depo-Provera: Evaluation of Bone Mineral Density and Total Body Calcium in Adolescent DP 150 CI Users and Matched Controls [NCT00139685]Phase 4350 participants Interventional1998-04-30Completed
Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome) [NCT00743574]36 participants (Actual)Interventional2008-08-31Completed
An Observational Pharmacokinetic Study to Evaluate Drug-drug Interactions Between Doravirine-containing ART and Hormonal Contraceptives Among Women Living With HIV in South Africa. [NCT04669678]Phase 4105 participants (Anticipated)Interventional2021-11-17Recruiting
Effect of Timing of Postpartum Depot Medroxyprogesterone Acetate Administration on Breastfeeding Continuation, Contraceptive Continuation, and Postpartum Depression: a Randomized Trial [NCT01463202]Phase 4184 participants (Actual)Interventional2011-11-30Completed
[NCT00000605]Phase 30 participants Interventional1996-08-31Completed
Depo Provera Self-Administration Study: Putting a Patient-Centered Practice to the Test at Planned Parenthood [NCT02509767]Phase 4401 participants (Actual)Interventional2015-08-31Completed
Modulation Of Putative Surrogate Endpoint Biomarkers In Endometrial Biopsies From Women With HNPCC [NCT00033358]Phase 252 participants (Actual)Interventional2002-02-28Completed
Alzheimer's Disease: Therapeutic Potential of Estrogen [NCT00066157]Phase 2/Phase 342 participants (Actual)Interventional2001-09-30Completed
An Open-Label, Non-Randomized Study of Pharmacokinetic Interactions Between Depo-Medroxyprogesterone Acetate (DMPA, Depo-Provera) and Selected Protease Inhibitor (PI) and Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI) Therapies Among HIV-Infected W [NCT00016601]76 participants Interventional2001-06-30Completed
Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes [NCT00030914]Phase 3227 participants (Actual)Interventional2002-04-30Completed
Levonorgestrel Containing Intrauterine Device in the Treatment of Endometrial Hyperplasia Without Atypia [NCT00123175]Phase 1/Phase 20 participants (Actual)Interventional2009-09-30Withdrawn(stopped due to Study has never received funding and has never been initiated)
A Phase I, Pharmacokinetic Study of Hormone Replacement Therapy in HIV-1-Infected, Postmenopausal Women on Nelfinavir, Lopinavir/Ritonavir, or Efavirenz [NCT00044837]Phase 1120 participants InterventionalTerminated
Effects of Different Progesterone Containing Contraceptive Methods on Safety and Endogenous Progesterone Level [NCT05742503]80 participants (Actual)Observational [Patient Registry]2021-03-30Completed
Tranexamic Acid Versus Depot-Medroxyprogesterone Acetate in the Treatment of Perimenopausal Irregular Uterine Bleeding: Randomized Clinical Trial [NCT04710017]110 participants (Anticipated)Interventional2021-02-01Recruiting
PERCY QUATTRO: Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis [NCT00291369]Phase 3456 participants Interventional1999-12-31Completed
Medroxyprogesterone, Interferon Alpha-2a, Interleukin 2 or Combination of Both Cytokines in Patients With Metastatic Renal Carcinoma of Intermediate Prognosis [PERCY QUATTRO] [NCT00416429]Phase 3456 participants (Anticipated)InterventionalCompleted
Heart and Estrogen-Progestin Replacement Study (HERS) [NCT00319566]Phase 32,430 participants Interventional1992-07-31Completed
Study of Vasomotor Symptoms in Postmenopausal Women Receiving Combination Raloxifene and Oral Estrogen [NCT00332553]Phase 2150 participants Interventional2002-02-28Completed
Modulation of Mucosal and Systemic Immunity by Hormonal Contraceptives [NCT01750476]7 participants (Actual)Observational2012-12-31Terminated(stopped due to PI and lab have re-located study to The Ohio State University)
Initiation of Medical Menopause With Depot Leuprolide Acetate vs Depot Leuprolide Acetate Plus Medroxyprogesterone Acetate: A Pilot Randomized [NCT01776203]Phase 48 participants (Actual)Interventional2012-01-31Terminated(stopped due to Inadequate enrollment)
Pilot Trial of Use of DMPA Injection and High Dose MPA Tablets in Outpatient [NCT01148420]Phase 448 participants (Actual)Interventional2009-01-31Completed
Relationship Between Drug Exposure and DNA Markers With Depot Medroxyprogesterone Acetate-associated Side Effects in Adolescents [NCT01461824]Phase 334 participants (Actual)Interventional2011-09-30Completed
Contraceptives and Dolutegravir-based ART [NCT04910711]Phase 4140 participants (Anticipated)Interventional2021-10-21Active, not recruiting
Comparison of Cetrorelix, Medroxyprogesterone Acetate and Dydrogesterone for Preventing Premature Ovulation in Ovarian Stimulation Cycles [NCT05767086]297 participants (Anticipated)Interventional2023-03-15Recruiting
The Effect of Neoadjuvant Depot Medroxyprogesterone Acetate on Glandular Cellularity in Women With Complex Atypical Hyperplasia or Grade 1-2 Endometrial Adenocarcinoma Awaiting Hysterectomy [NCT02335203]Phase 276 participants (Actual)Interventional2015-02-28Active, not recruiting
Effect of Raloxifene on Ovulation in Women With Polycystic Ovarian Syndrome. [NCT01607320]3 participants (Actual)Interventional2012-06-30Terminated(stopped due to Over budget, slow recruitment, and personnel change)
A Randomized Comparison Of Medroxyprogesterone Acetate (MA) And Observation For Prevention Of Endometrial Pathology In Postmenopausal Breast Cancer Patients Treated With Tamoxifen, Phase III [NCT00002920]Phase 3313 participants (Actual)Interventional1997-03-31Completed
The Therapeutic Effect of Medroxyprogesterone Acetate vs. LNG-IUS in Early-stage Endometrioid Carcinoma [NCT05565573]Phase 2/Phase 3148 participants (Anticipated)Interventional2022-11-01Recruiting
Safety of the Etonogestrel-releasing Implant During the Puerperium of Healthy Women [NCT00828542]40 participants (Actual)Interventional2007-07-31Completed
Acceptability of Depo-subQ Provera 104 in Uniject Versus Intramuscular Depo-Provera Among HIV-positive Women and Family Planning Providers in Rakai, Uganda [NCT01578447]356 participants (Actual)Interventional2012-04-30Completed
Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women: a Cluster-randomized Trial [NCT04005391]208 participants (Actual)Interventional2018-10-23Completed
Management of Uterine Arteriovenous Malformation- a Comparison of 2 Management Possibilities- Observation vs. Progesterone Treatment/ a Randomized Control Trial [NCT05491343]Phase 428 participants (Anticipated)Interventional2022-08-31Not yet recruiting
Tubal Patency During the Menstrual Cycle and During Treatment With Hormonal Contraceptives: a Pilot Study in Women [NCT02146248]11 participants (Actual)Interventional2014-05-31Completed
Effect of Transdermal Estradiol Replacement Therapy on Ovulation Rate in Women With Premature Ovarian Failure: A Randomized, Placebo-Controlled Trial [NCT00370019]Phase 20 participants (Actual)Interventional2006-08-25Withdrawn
Initiation of Injectable Contraception Immediately Postpartum Among Breastfeeding Women [NCT03844633]Phase 449 participants (Actual)Interventional2019-03-21Terminated(stopped due to Because of insufficient enrollment, we closed the RCT and replaced it with an observational design)
Rates of Contraceptive Failure When Unprotected Intercourse Has Occurred 6-14 Days Prior to Contraceptive Initiation [NCT02076217]1,030 participants (Anticipated)Observational2014-02-28Active, not recruiting
Counseling Among Gender Diverse Adolescents Who Use Depot Medroxyprogesterone [NCT05726903]Phase 440 participants (Anticipated)Interventional2022-12-06Recruiting
A Two-Part Study of the Treatment of Atypical Endometrial Hyperplasia: Part A: A Prospective Study of Immediate Hysterectomy; Part B: A Randomized Phase II Study of Medroxyprogesterone Acetate Versus Depoprovera [NCT00003179]Phase 2360 participants (Anticipated)Interventional1998-11-30Terminated
An Observational, Prospective, Multicentre Study to Assess the Sensitivity to Change of the SAMANTA Questionnaire in Women With Heavy Menstrual Bleeding (HMB) [NCT03751800]422 participants (Actual)Observational2018-12-12Completed
The Effect of Endometrial Shedding With Medroxyprogesterone Acetate Prior to Ovulation Induction With Clomiphene Citrate in Oligo-ovulatory and Anovulatory Women: a Pilot Study [NCT02340013]Phase 450 participants (Actual)Interventional2013-07-31Completed
The Impact of Contraception on Postpartum Weight Loss: a Prospective Study [NCT02144259]100 participants (Actual)Interventional2011-04-30Completed
A Randomized Phase II Trial of Everolimus and Letrozole or Hormonal Therapy (Tamoxifen/Medroxyprogesterone Acetate) in Women With Advanced, Recurrent, or Persistent Endometria Carcinoma [NCT02228681]Phase 274 participants (Actual)Interventional2015-02-28Active, not recruiting
A Randomized Control Trial to Compare the Live Birth Rate Between the Progestin-primed Ovarian Stimulation Protocol and the GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response Undergoing IVF [NCT04414761]Phase 3784 participants (Actual)Interventional2020-06-04Completed
[NCT01791413]Phase 1/Phase 240 participants (Actual)Interventional2012-03-31Completed
A Prospective Cohort Study Evaluating the Impact of Three Progestin-based Hormonal Contraceptive (HC) Methods on Immunologic Changes in the Female Genital Tract (FGT) and Systemically [NCT03660046]225 participants (Anticipated)Observational2018-12-07Recruiting
Impact of Hormonal Contraception on HIV Acquisition and Transmission Risk [NCT02357368]Phase 459 participants (Actual)Interventional2015-02-28Completed
Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features: the p53abn-RED Trial, the MMRd-GREEN Trial, the NSMP-ORANGE Trial and the POLEmut-BLUE Trial [NCT05255653]Phase 2/Phase 31,615 participants (Anticipated)Interventional2021-11-11Recruiting
Metabolic Profile of Users of Hormonal and Non-hormonal Contraceptives, 5-year Follow-up [NCT03383185]489 participants (Actual)Observational2010-01-01Completed
The UMPALA Study: A Clinical Study to Assess the Impact of Contraceptives on the Cervico-Vaginal Mucosa [NCT04814927]Phase 4112 participants (Actual)Interventional2021-03-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00064025 (3) [back to overview]Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative
NCT00064025 (3) [back to overview]Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression
NCT00064025 (3) [back to overview]Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression
NCT00191113 (18) [back to overview]Height (Centimeters [cm])
NCT00191113 (18) [back to overview]Glycosylated Hemoglobin, Change From Baseline
NCT00191113 (18) [back to overview]Fasting Glucose, Change From Baseline
NCT00191113 (18) [back to overview]Number of Participants With Hearing Loss, Audiologist Assessment
NCT00191113 (18) [back to overview]Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment
NCT00191113 (18) [back to overview]Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population
NCT00191113 (18) [back to overview]Minimum Fasting Glucose/Insulin Ratio Values
NCT00191113 (18) [back to overview]Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment
NCT00191113 (18) [back to overview]Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment
NCT00191113 (18) [back to overview]Number of Participants With Any Abnormal Fasting Glucose Value
NCT00191113 (18) [back to overview]Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value
NCT00191113 (18) [back to overview]Number of Participants With Any Abnormal Fasting Insulin Value
NCT00191113 (18) [back to overview]Maximum Glycosylated Hemoglobin
NCT00191113 (18) [back to overview]Maximum Fasting Insulin Values
NCT00191113 (18) [back to overview]Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value
NCT00191113 (18) [back to overview]Maximum Fasting Glucose Value
NCT00191113 (18) [back to overview]Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height
NCT00191113 (18) [back to overview]Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population
NCT00360490 (15) [back to overview]Percentage of Patients With Successful Treatment
NCT00360490 (15) [back to overview]Percentage of Patients With Improvement in the Investigator Global Assessment Scale
NCT00360490 (15) [back to overview]Percent Change From Baseline MBL to End of Study MBL (Cycle 6)
NCT00360490 (15) [back to overview]Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)
NCT00360490 (15) [back to overview]Total Number of Spotting Days
NCT00360490 (15) [back to overview]Percent Change in Hemoglobin
NCT00360490 (15) [back to overview]Percent Change in Hematocrit
NCT00360490 (15) [back to overview]Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group
NCT00360490 (15) [back to overview]The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)
NCT00360490 (15) [back to overview]Total Number of Spotting and Bleeding Days
NCT00360490 (15) [back to overview]Total Number of Bleeding Episodes
NCT00360490 (15) [back to overview]Total Number of Bleeding Days
NCT00360490 (15) [back to overview]Percentage of Patients With Improvement in the Patients Overall Assessment Scale
NCT00360490 (15) [back to overview]Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)
NCT00360490 (15) [back to overview]Percent Change in Serum Ferritin
NCT00420342 (12) [back to overview]Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8
NCT00420342 (12) [back to overview]Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough
NCT00420342 (12) [back to overview]Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements
NCT00420342 (12) [back to overview]Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements
NCT00420342 (12) [back to overview]Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis)
NCT00420342 (12) [back to overview]Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis)
NCT00420342 (12) [back to overview]Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis)
NCT00420342 (12) [back to overview]Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis)
NCT00420342 (12) [back to overview]Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population
NCT00420342 (12) [back to overview]Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements
NCT00420342 (12) [back to overview]Change From Baseline to Week 8 in Mean 24-hour SBP From the Ambulatory Blood Pressure Monitoring (ABPM) Measurements in Full Analysis Set (FAS) Population
NCT00420342 (12) [back to overview]Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis)
NCT00437658 (29) [back to overview]Change From Baseline in EHP-5 Emotional Well-being Dimension
NCT00437658 (29) [back to overview]Change From Baseline in EHP-5 Intercourse Dimension
NCT00437658 (29) [back to overview]Change From Baseline in EHP-5 Medical Profession Dimension
NCT00437658 (29) [back to overview]Change From Baseline in EHP-5 Relationship With Children Dimension
NCT00437658 (29) [back to overview]Change From Baseline in EHP-5 Self Image Dimension
NCT00437658 (29) [back to overview]Change From Baseline in EHP-5 Social Support Dimension
NCT00437658 (29) [back to overview]Change From Baseline in EHP-5 Treatment Dimension
NCT00437658 (29) [back to overview]Change From Baseline in EHP-5 Work Dimension
NCT00437658 (29) [back to overview]Change From Baseline in Endometriosis Health Profile-5 (EHP-5) Pain Dimension
NCT00437658 (29) [back to overview]Change From Baseline in in Monthly Mean Visual Analog Scale (VAS) for Pelvic Pain
NCT00437658 (29) [back to overview]Change From Baseline in N-telopeptide at Weeks 12, 24 and 48
NCT00437658 (29) [back to overview]Change From Baseline in Non-menstrual Pelvic Pain Component of the CPSSS During the Treatment Period
NCT00437658 (29) [back to overview]Change From Baseline in Pelvic Induration Component of the CPSSS During the Treatment Period
NCT00437658 (29) [back to overview]Change From Baseline in Pelvic Tenderness Component of the CPSSS During the Treatment Period
NCT00437658 (29) [back to overview]Change From Baseline in Total CPSSS During the Treatment Period
NCT00437658 (29) [back to overview]Change From Baseline in in Monthly Peak Visual Analog Scale (VAS) for Pelvic Pain
NCT00437658 (29) [back to overview]Percentage of Participants With a Response in the Dysmenorrhea Component of the CPSSS Over Time
NCT00437658 (29) [back to overview]Percentage of Participants Using Analgesics During the Treatment Phase
NCT00437658 (29) [back to overview]Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48
NCT00437658 (29) [back to overview]Percent Change From Baseline in Bone Mineral Density of the Femur at Weeks 12 and 48
NCT00437658 (29) [back to overview]Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS Over Time
NCT00437658 (29) [back to overview]Change From Baseline in Total CPSSS Excluding Dyspareunia During the Treatment Period
NCT00437658 (29) [back to overview]Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24
NCT00437658 (29) [back to overview]Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24
NCT00437658 (29) [back to overview]Percentage of Participants With a Response in the Dysmenorrhea Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) at Week 24
NCT00437658 (29) [back to overview]Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS at Week 24
NCT00437658 (29) [back to overview]Change From Baseline in Dysmenorrhea Component of the CPSSS During the Treatment Period
NCT00437658 (29) [back to overview]Change From Baseline in Dyspareunia Component of the CPSSS During the Treatment Period
NCT00437658 (29) [back to overview]Change From Baseline in EHP-5 Control and Powerlessness Dimension
NCT00490555 (5) [back to overview]Dehydroepiandrosterone (DHEA)
NCT00490555 (5) [back to overview]Androstenedione (AED)
NCT00490555 (5) [back to overview]Testosterone Concentration
NCT00490555 (5) [back to overview]Prostate-specific Antigen (PSA)
NCT00490555 (5) [back to overview]Dihydrotestosterone (DHT) Concentration
NCT00563576 (4) [back to overview]Percentage of Subjects Who Receive a 3rd Injection
NCT00563576 (4) [back to overview]Number of Subjects Who Receive a 2nd Injection of Depo-Provera
NCT00563576 (4) [back to overview]Mean Number of Bleeding or Spotting Days
NCT00563576 (4) [back to overview]Percentage of Users Who Were Satisfied With Femring
NCT00577122 (4) [back to overview]MPA Trough Concentration
NCT00577122 (4) [back to overview]MPA Trough Level > 50 ng/mL When Have Clinical Benefit
NCT00577122 (4) [back to overview]Grade 3 or 4 Adverse Events Related to Treatment
NCT00577122 (4) [back to overview]Clinical Benefit Rate (CR + PR + SD > 6 Months).
NCT00743574 (6) [back to overview]Fasting Insulin Levels at Study Completion After 3 Month Treatment
NCT00743574 (6) [back to overview]Fasting Glucose Levels at Completion of Treatment, at 3 Months
NCT00743574 (6) [back to overview]AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months
NCT00743574 (6) [back to overview]AUC (Area Under a Curve at 0, 0.5, 1, 1.5 and 2 Hours) Insulin During 2 Hour GTT at Completion, at 3 Months
NCT00743574 (6) [back to overview]Serum HbA1C at 3 Months
NCT00743574 (6) [back to overview]Serum Levels of C-reactive Protein at Completion of 3 Months Treatment
NCT00808132 (13) [back to overview]Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study
NCT00808132 (13) [back to overview]Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study
NCT00808132 (13) [back to overview]Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study
NCT00808132 (13) [back to overview]Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study
NCT00808132 (13) [back to overview]Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study
NCT00808132 (13) [back to overview]Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study
NCT00808132 (13) [back to overview]Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study
NCT00808132 (13) [back to overview]Percentage of Participants With Uterine Bleeding
NCT00808132 (13) [back to overview]Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study
NCT00808132 (13) [back to overview]Percentage of Participants With Breast Tenderness
NCT00808132 (13) [back to overview]Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study
NCT00808132 (13) [back to overview]Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study
NCT00808132 (13) [back to overview]Percentage of Participants With Cumulative Amenorrhea: Main Study
NCT00828542 (1) [back to overview]Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks
NCT00997893 (5) [back to overview]Memory for Emotionally Valent Words and Neutral Words
NCT00997893 (5) [back to overview]Changes in STAI-6 Scores Before and After Psychosocial Stressor Over Time
NCT00997893 (5) [back to overview]Change in Verbal Memory, Immediate Recall
NCT00997893 (5) [back to overview]Change in Verbal Memory, Delayed Recall
NCT00997893 (5) [back to overview]Change in STAI-6 Score
NCT01019369 (2) [back to overview]Number of Participants Continuing DMPA at 6 Months
NCT01019369 (2) [back to overview]Number of Participants Continuing DMPA
NCT01109979 (1) [back to overview]Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD)
NCT01143207 (6) [back to overview]AUC 0-91 (Area Under Curve)
NCT01143207 (6) [back to overview]Tmax (Time to Cmax)
NCT01143207 (6) [back to overview]MPA Concentration at Day 91 (C91)
NCT01143207 (6) [back to overview]MPA Concentration at Day 120 (C120)
NCT01143207 (6) [back to overview]MPA Concentration at Day 104 (C104)
NCT01143207 (6) [back to overview]Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))
NCT01148420 (3) [back to overview]Cessation of Bleeding Within 5 Days
NCT01148420 (3) [back to overview]Patient Perception of the Acceptability of the Treatment
NCT01148420 (3) [back to overview]Satisfaction and Willingness to Recommend Treatment
NCT01296152 (24) [back to overview]RTV PK Parameter Cmax.
NCT01296152 (24) [back to overview]RTV PK Parameter T1/2.
NCT01296152 (24) [back to overview]RTV PK Parameter Tmax.
NCT01296152 (24) [back to overview]RTV PK Parameter Cmin.
NCT01296152 (24) [back to overview]Medroxyprogesterone Acetate (MPA) Pharmacokinetic Parameter (PK) Area Under the Concentration-time Curve (AUC0-12weeks)
NCT01296152 (24) [back to overview]MPA PK Parameter Clearance (CL/F) Determined Based on MPA Levels.
NCT01296152 (24) [back to overview]MPA PK Parameter Half-Life (T1/2) Determined Based on MPA Levels.
NCT01296152 (24) [back to overview]MPA PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on MPA Levels.
NCT01296152 (24) [back to overview]MPA PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on MPA Levels.
NCT01296152 (24) [back to overview]MPA PK Parameter Time to Cmax (Tmax) Determined Based on MPA Levels.
NCT01296152 (24) [back to overview]Percentage of Participants With Menstrual Irregularities of Grade 1 and Higher Deemed Possibly, Probably or Definitely Related to Study Treatment.
NCT01296152 (24) [back to overview]AUC0-12hour for LPV at Baseline (Day 0) Before DMPA Administration and at Week 4 (Four Weeks After DMPA Administration)
NCT01296152 (24) [back to overview]Cell Mediated Immunity (CMI) to HIV and the Common Opportunistic Agent Varicella-zoster Virus (VZV) Using the Enzyme-linked Immunospot (ELISPOT) Assay.
NCT01296152 (24) [back to overview]CMI to HIV and the Common Opportunistic Agent VZV Using the Lymphocyte Proliferation Assay (LPA).
NCT01296152 (24) [back to overview]LPV PK Parameter CL/F.
NCT01296152 (24) [back to overview]LPV PK Parameter Cmax.
NCT01296152 (24) [back to overview]LPV PK Parameter Cmin.
NCT01296152 (24) [back to overview]LPV PK Parameter T1/2.
NCT01296152 (24) [back to overview]LPV PK Parameter Tmax.
NCT01296152 (24) [back to overview]Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL.
NCT01296152 (24) [back to overview]Percentage of Participants With Progesterone Levels Less Than the Lower Limit of Quantification (LLQ).
NCT01296152 (24) [back to overview]Regulatory T Cells (Tregs) at Baseline, Week 4 and Week 12 Using Flow Cytometry in Freshly Thawed PBMCs.
NCT01296152 (24) [back to overview]Ritonavir (RTV) PK Parameter AUC0-12h.
NCT01296152 (24) [back to overview]RTV PK Parameter CL/F.
NCT01461824 (3) [back to overview]Proportion of Participants With >5% Weight Gain at 24 Weeks
NCT01461824 (3) [back to overview]Percent Change in Total Hip BMD From Baseline to 48 Weeks
NCT01461824 (3) [back to overview]Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks
NCT01463202 (3) [back to overview]Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA
NCT01463202 (3) [back to overview]Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
NCT01463202 (3) [back to overview]Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA
NCT01791413 (1) [back to overview]Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation
NCT02122198 (16) [back to overview]Changes in Executive Cognitive Function: Digits Span Forward and Backward, 6 Months
NCT02122198 (16) [back to overview]Changes in Executive Cognitive Function: Controlled Oral Word Association Test, 6 Months
NCT02122198 (16) [back to overview]Changes in Artery Compliance at 6 Months
NCT02122198 (16) [back to overview]Changes in Executive Cognitive Function: Controlled Oral Word Association Test, 9 Months
NCT02122198 (16) [back to overview]Changes in Artery Compliance at 9 Months
NCT02122198 (16) [back to overview]Changes in Prefrontal Cortex Brain Activation at 9 Months
NCT02122198 (16) [back to overview]Changes in Prefrontal Cortex Brain Activation at 6 Months
NCT02122198 (16) [back to overview]Changes in Executive Cognitive Function: Digits, 9 Months
NCT02122198 (16) [back to overview]Changes in Executive Cognitive Function: Trails B, 9 Months
NCT02122198 (16) [back to overview]Changes in Executive Cognitive Function: Trails B, 6 Months
NCT02122198 (16) [back to overview]Changes in Executive Cognitive Function: Trails A, 9 Months
NCT02122198 (16) [back to overview]Changes in Executive Cognitive Function: Trails A, 6 Months
NCT02122198 (16) [back to overview]Changes in Executive Cognitive Function: Stroop, 9 Months
NCT02122198 (16) [back to overview]Changes in Executive Cognitive Function: Stroop, 6 Months
NCT02122198 (16) [back to overview]Changes in Executive Cognitive Function: RAVLT, 9 Months
NCT02122198 (16) [back to overview]Changes in Executive Cognitive Function: RAVLT, 6 Months
NCT02144259 (3) [back to overview]Contraceptive Satisfaction
NCT02144259 (3) [back to overview]Pregnancy Rate
NCT02144259 (3) [back to overview]Weight
NCT02228681 (4) [back to overview]Median Progression-free Survival
NCT02228681 (4) [back to overview]Frequency of Response
NCT02228681 (4) [back to overview]Median Survival
NCT02228681 (4) [back to overview]Frequency and Severity of CTCAE (Common Toxicity Criteria for Adverse Events) Version 4
NCT02357368 (4) [back to overview]Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood
NCT02357368 (4) [back to overview]Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood
NCT02357368 (4) [back to overview]Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood
NCT02357368 (4) [back to overview]Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood
NCT02412436 (11) [back to overview]DMPA CL/F
NCT02412436 (11) [back to overview]Cumulative Percentage of Participants With DMPA < 0.1 ng/mL
NCT02412436 (11) [back to overview]DMPA AUC
NCT02412436 (11) [back to overview]Percent of Participants With DMPA Concentrations Below 0.1 ng/mL at Weeks 2, 4, 6, 8, and 10
NCT02412436 (11) [back to overview]Time at Which Participant-specific Estimated Elimination Slopes for DMPA Level Cross the Threshold of 0.1 ng/mL
NCT02412436 (11) [back to overview]Percent of Participants With Progesterone Levels Above 1 ng/mL at Week 12
NCT02412436 (11) [back to overview]Percent of Participants With DMPA Concentrations Below 0.1 ng/mL at Week 12
NCT02412436 (11) [back to overview]Percent of Participants Who Experienced a Grade 3 or Higher Sign/Symptom or Laboratory Abnormality
NCT02412436 (11) [back to overview]DMPA Half-life
NCT02412436 (11) [back to overview]DMPA Cmin
NCT02412436 (11) [back to overview]DMPA Cmax
NCT02509767 (3) [back to overview]Number of Participants Who Were Satisfied With Home Use of Depot Medroxyprogesterone Acetate (DMPA sc) at One Year by Self-Report in the Self-Administration Arm
NCT02509767 (3) [back to overview]Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms
NCT02509767 (3) [back to overview]Number of Participants Who Were Satisfied With Depot Medroxyprogesterone Acetate (DMPA sc) at One Year by Self-Report in Both the Self- and Clinic Administration Arms
NCT03018249 (4) [back to overview]The Frequency and Severity of CTCAE Version 4.0 Graded Adverse Events (AE)
NCT03018249 (4) [back to overview]Mean Post-treatment Tumor Progesterone Receptor H-score (Histology Score)
NCT03018249 (4) [back to overview]Percent of Participants With a Ki67 Response
NCT03018249 (4) [back to overview]Percentage of Participants With a Histologic Response
NCT03700658 (4) [back to overview]Participant's Perception of Pain, as Assessed by an Overall Ranking of the 4 Study Injections From Least to Most Painful
NCT03700658 (4) [back to overview]Number of Participants With Injection Site Reactions (ISRs) (Excluding Injection Site Pain)
NCT03700658 (4) [back to overview]Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT03700658 (4) [back to overview]Injection Site Pain Score, as Assessed by Numerical Rating Scale (NRS)
NCT04005391 (5) [back to overview]Number of Participants With Contraceptive Continuation at Twelve Months
NCT04005391 (5) [back to overview]Number of Participants With Repeat Pregnancy at Twelve Months
NCT04005391 (5) [back to overview]Contraceptive Satisfaction at Twelve Months
NCT04005391 (5) [back to overview]Number of Participants With Any Contraceptive Use at Three Months
NCT04005391 (5) [back to overview]Number of Participants With Implant Use at Three Months

Histologic Response in Endometrial Adenocarcinomas of the Uterine Corpus That Are Progesterone Receptor Positive Compared With Those That Are Progesterone Receptor Negative

"To determine the presence of a histologic response, the slide from the initial sample was compared to the slide from the matching hysterectomy specimen. A complete histologic response was defined as the absence of identifiable adenocarcinoma in the hysterectomy specimen section. A partial histologic response was subjectively defined in advance of the study based on criteria slightly modified from Wheeler et al. (Am J Surg Pathol 2007;31:988-98) as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample. A complete or partial histologic response was considered a histologic response in the analysis of data.~PR Positivity is based on aggregate score >0.2 (vs. <=0.2). Aggregate score based on product of staining intensity and area." (NCT00064025)
Timeframe: During the hysterectomy, which is 21-24 days after administration of depo-provera

Interventionpercentage of participants (Number)
PR Negative (<=0.2)62.5
PR Positive (>0.2)68.9

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Change From Pre- to Post-treatment in Progestrogren Receptor (PR) Expression

Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3. (NCT00064025)
Timeframe: During the hysterectomy , which is 21-24 days after administration of depo-provera

InterventionAggregate Score from Immunohistochemistr (Mean)
Depo-Provera-1.12

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Change From Pre- to Post-treatment in Estrogren Receptor (ER) Expression

Expression is based on an aggregate score based on immunohistochemistry. Staining intensity was scored 1, 2, or 3; and staining area was scored as a percentage (0-100%). The aggregate score is the product of staining intensity and area and ranges from 0 to 3. (NCT00064025)
Timeframe: During the hysterectomy, which is 21-24 days after administration of depo-provera

InterventionAggregate Score from Immunohistochemistr (Mean)
Depo-Provera-0.77

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Height (Centimeters [cm])

Most mature measurement available, at or after attainment of Final Height. (NCT00191113)
Timeframe: every 3 months during core study, and at start and end of 4-year addendum

Interventioncentimeters (cm) (Least Squares Mean)
As-Treated No Growth Hormone141.63
As-Treated Growth Humatrope148.52

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Glycosylated Hemoglobin, Change From Baseline

Change from core study baseline to addendum 2 maximum. (NCT00191113)
Timeframe: At core study baseline, and at end of 4-year addendum

Interventionpercent (%) (Least Squares Mean)
Treated-As-Randomized Control0.215
Treated-As-Randomized Humatrope0.208

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Fasting Glucose, Change From Baseline

Change from core study baseline to addendum 2 maximum. (NCT00191113)
Timeframe: At core study baseline, and at end of 4-year addendum

Interventionmg / dL (Least Squares Mean)
Treated-As-Randomized Control5.495
Treated-As-Randomized Humatrope3.003

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Number of Participants With Hearing Loss, Audiologist Assessment

Sensorineural Hearing Loss (SNHL)=air conduction threshold >20 dB HL and air-bone gap ≤10 dB HL; Conductive Hearing Loss (CHL)= air conduction threshold >20 dB HL, bone conduction threshold ≤20 dB HL and air-bone gap >10 dB HL; Mixed Hearing Loss (MHL) = evidence of SNHL as defined above and CHL as defined above, in the same ear; Unspecified Hearing Loss (UHL)= abnormal hearing with none of SNHL, CHL, or MHL present. (NCT00191113)
Timeframe: at completion of core study or beginning of addendum

,
Interventionparticipants (Number)
Conductive Hearing LossSensorineural Hearing LossMixed Hearing LossUnspecified Hearing Loss
As-Treated Growth Hormone71591
As-Treated No Growth Hormone1821

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Number of Participants With Abnormal Impedance Tympanometry, Audiologist Assessment

(NCT00191113)
Timeframe: at completion of core study or beginning of addendum

Interventionparticipants (Number)
As-Treated No Growth Hormone2
As-Treated Growth Hormone18

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Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline, As-Treated Population

Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height. (NCT00191113)
Timeframe: every 3 months during core study, and at start and end of 4-year addendum

InterventionStandard Deviation Score (SDS) [NCHS] (Least Squares Mean)
As-Treated No Growth Hormone-0.09
As-Treated Growth Humatrope0.99

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Minimum Fasting Glucose/Insulin Ratio Values

Minimum measured value over addendum. In special cases an additional measurement is taken at 2 years. (NCT00191113)
Timeframe: At start and through end of 4-year addendum (up to an additional 2 years)

Interventionmilligrams per 10^-4 Units (mg/[10^-4]U) (Mean)
As-Treated No Growth Hormone12.5
As-Treated Growth Hormone12.2

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Number of Participants With Abnormal Speech Audiometry, Audiologist Assessment

(NCT00191113)
Timeframe: at completion of core study or beginning of addendum

Interventionparticipants (Number)
As-Treated No Growth Hormone3
As-Treated Growth Hormone12

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Number of Participants With an Abnormal Pure Tone Audiometry, Audiologist Assessment

(NCT00191113)
Timeframe: at completion of core study or beginning of addendum

Interventionparticipants (Number)
As-Treated No Growth Hormone10
As-Treated Growth Hormone29

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Number of Participants With Any Abnormal Fasting Glucose Value

Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Glucose=Fasting Glucose >=100 milligrams per deciliter (mg/dL). (NCT00191113)
Timeframe: At start and through end of 4-year addendum

Interventionparticipants (Number)
As-Treated No Growth Hormone0
As-Treated Growth Humatrope3

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Number of Participants With Any Abnormal Fasting Glucose/Insulin Ratio Value

Indicates if patient had any measured value below threshold of normality at any visit during addendum. Abnormal Fasting Glucose/Insulin Ratio = Fasting Glucose/Insulin Ratio <=4.5 milligrams per 10^-4 Units (mg/10^-4U). (NCT00191113)
Timeframe: At start and through end of 4-year addendum

Interventionparticipants (Number)
As-Treated No Growth Hormone1
As-Treated Growth Hormone3

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Number of Participants With Any Abnormal Fasting Insulin Value

Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Fasting Insulin = Fasting Insulin >=35 micro International Units per milliliter (uIU/mL). (NCT00191113)
Timeframe: At start and through end of 4-year addendum

Interventionparticipants (Number)
As-Treated No Growth Hormone1
As-Treated Growth Humatrope2

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Maximum Glycosylated Hemoglobin

Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years. (NCT00191113)
Timeframe: At start and through end of 4-year addendum (up to an additional 2 years)

Interventionpercent (%) (Mean)
As-Treated No Growth Hormone5.0
As-Treated Growth Hormone5.0

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Maximum Fasting Insulin Values

Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years. (NCT00191113)
Timeframe: At start and through end of 4-year addendum (up to an additional 2 years)

Interventionmicro International Units per milliliter (Mean)
As-Treated No Growth Hormone9.5
As-Treated Growth Hormone9.7

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Number of Participants With Any Abnormal Glycosylated Hemoglobin (HbA1c) Value

Indicates if patient had any measured value exceeding threshold of normality at any visit during addendum. Abnormal Glycosylated Hemoglobin = HbA1c ≥6.8% (up until 11-May-1998); and then HbA1c ≥6.1% (from 19-May-1998 onwards). (NCT00191113)
Timeframe: At start and through end of 4-year addendum

Interventionparticipants (Number)
As-Treated No Growth Hormone0
As-Treated Growth Hormone0

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Maximum Fasting Glucose Value

Maximum measured value over addendum. In special cases an additional measurement is taken at 2 years. (NCT00191113)
Timeframe: At start and through end of 4-year addendum (up to an additional 2 years)

Interventionmilligrams per deciliter (mg/dL) (Mean)
As-Treated No Growth Hormone85.2
As-Treated Growth Hormone85.2

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Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Last Measurement After Attainment of Final Height

SDS report the number of standard deviations from the mean for age and sex for an individual measurement (normal range: -2 to +2 SDS). Height SDS [NCHS] uses the NCHS US general female population reference height values for age (Kuczmarski RJ et al. 2000) as the population mean and standard deviation. Calculation of Height SDS is provided in Height SDS [Lyon] description (Baseline). Since data reported by Kuczmarski RJ et al provides US general female population standards, values of Height SDS [NCHS] for untreated patients with Turner syndrome tend to be below zero e.g, -2.0 to -4.0 SDS. (NCT00191113)
Timeframe: at completion of core study, or at end of 4-year addendum

InterventionStandard Deviation Score (SDS) [NCHS] (Least Squares Mean)
As-Treated No Growth Hormone-3.30
As-Treated Growth Hormone-2.25

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Height Standard Deviation Score (SDS) (National Center for Health Statistics [NCHS]), Change From Baseline to Last Measurement, As Randomized Population

Value analyzed is change from baseline to the most mature height measurement available. The terms Standard Deviation Score (SDS) and National Center for Health Statistics (NCHS) were defined in baseline characteristics. Greater height SDS values indicate greater height; positive values of change from baseline indicate increased height. (NCT00191113)
Timeframe: Baseline, and end of 4-year addendum

InterventionStandard Deviation Score (SDS) [NCHS] (Least Squares Mean)
As-Randomized Control0.09
As-Randomized Humatrope0.97

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Percentage of Patients With Successful Treatment

End-of-study MBL < 80 mL and a decrease to a value no greater than 50% of the Baseline MBL was considered to be treatment success. (NCT00360490)
Timeframe: At 6 months

InterventionPercentage of participants (Number)
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours84.8
Medroxyprogesterone Acetate (MPA)22.2

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Percentage of Patients With Improvement in the Investigator Global Assessment Scale

"Improved is classified as 'very much improved', 'much improved', or 'improved' and not improved is classified as 'no change', 'worse', 'much worse', or 'very much worse'" (NCT00360490)
Timeframe: Up to 6 months

,
Interventionpercentage (Number)
Cycle 3Cycle 6
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours94.793.6
Medroxyprogesterone Acetate (MPA)71.261.0

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Percent Change From Baseline MBL to End of Study MBL (Cycle 6)

The percent change = {(End of Study MBL - Baseline MBL)/Baseline MBL} x 100. (NCT00360490)
Timeframe: Baseline and up to 6 months

InterventionPercent change (Mean)
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours-70.75
Medroxyprogesterone Acetate (MPA)-21.54

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Absolute Change From Baseline MBL to Mid-study MBL (Cycle 3)

The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Mid-study MBL was measured during Cycle 3 of the Treatment Phase. (NCT00360490)
Timeframe: Baseline and up to 3 months

Interventionmilliliter (mL) (Median)
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours-115.13
Medroxyprogesterone Acetate (MPA)-3.15

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Total Number of Spotting Days

In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts. (NCT00360490)
Timeframe: Baseline and up to 6 months

,
Interventiondays (Mean)
BaselineCycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours1.239.479.587.275.656.485.38
Medroxyprogesterone Acetate (MPA)1.841.482.312.271.842.002.23

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Percent Change in Hemoglobin

(NCT00360490)
Timeframe: Baseline and up to 6 months

,
Interventionpercent change (Median)
Baseline to cycle 3Cycle 3 to cycle 6Baseline to cycle 6
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours3.823.287.50
Medroxyprogesterone Acetate (MPA)1.650.831.87

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Percent Change in Hematocrit

(NCT00360490)
Timeframe: Baseline and up to 6 months

,
Interventionpercent change (Median)
Baseline to cycle 3Cycle 3 to cycle 6Baseline to cycle 6
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours4.92.45.4
Medroxyprogesterone Acetate (MPA)0.00.00.0

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Percentage of Subjects Who Completed the Study in Levonorgestrel Intrauterine System (LNG IUS) Group

(NCT00360490)
Timeframe: Baseline and up to 6 months

Interventionpercentage of participants (Number)
0 days30 days60 days90 days120 days150 days180 days
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours97.5395.0693.8392.5991.3690.1290.12

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The Change in Absolute Value From Baseline Menstrual Blood Loss (MBL) to the End-of-study MBL (Cycle 6)

The MBL for each cycle included intermenstrual bleeding in addition to withdrawal bleeding. Baseline MBL was the composite MBL measured during each of the cycles during the Screening Phase. End-of-study MBL was measured during Cycle 6 of the Treatment Phase. (NCT00360490)
Timeframe: Baseline and up to 6 months

Interventionmilliliter (mL) (Median)
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours-128.78
Medroxyprogesterone Acetate (MPA)-17.7

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Total Number of Spotting and Bleeding Days

In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts. (NCT00360490)
Timeframe: Baseline and up to 6 months

,
Interventiondays (Mean)
BaselineCycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours6.3019.7017.4611.8910.4210.258.58
Medroxyprogesterone Acetate (MPA)6.806.657.466.926.666.896.90

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Total Number of Bleeding Episodes

A bleeding episode is defined as a light, normal or heavy bleeding, during a minimum of one day. In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts. (NCT00360490)
Timeframe: Baseline and up to 6 months

,
Interventionnumber of bleeding episodes (Mean)
BaselineCycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours1.011.750.880.990.760.770.70
Medroxyprogesterone Acetate (MPA)1.030.981.010.970.991.011.04

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Total Number of Bleeding Days

In the LNG IUS group, each cycle has 30 days. In the MPA group, each menstrual cycle starts on the 1st bleeding day (withdrawal bleeding) and lasts until the last non-bleeding day before next withdrawal bleeding starts. (NCT00360490)
Timeframe: Baseline and up to 6 months

,
Interventiondays (Mean)
BaselineCycle 1Cycle 2Cycle 3Cycle 4Cycle 5Cycle 6
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours5.6410.237.885.924.773.774.16
Medroxyprogesterone Acetate (MPA)5.645.175.155.254.824.895.29

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Percentage of Patients With Improvement in the Patients Overall Assessment Scale

"Improved is classified as 'very much improved', 'much improved', or 'improved' and not improved is classified as 'no change', 'worse', 'much worse', or 'very much worse'." (NCT00360490)
Timeframe: Up to 6 months

,
Interventionpercentage (Number)
Cycle 3Cycle 6
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours93.393.6
Medroxyprogesterone Acetate (MPA)74.067.1

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Percent Change From Baseline MBL to Mid-study MBL (Cycle 3)

The percent change = {(Mid-study MBL - Baseline MBL)/Baseline MBL} x 100. (NCT00360490)
Timeframe: Baseline and up to 3 months

InterventionPercent change (Mean)
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours-61.71
Medroxyprogesterone Acetate (MPA)-11.11

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Percent Change in Serum Ferritin

(NCT00360490)
Timeframe: Baseline and up to 6 months

,
Interventionpercent change (Median)
Baseline to cycle 3Cycle 3 to cycle 6Baseline to cycle 6
Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours13.848.368.8
Medroxyprogesterone Acetate (MPA)0.016.714.3

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Number of Subjects Who Are Sodium Sensitive at Baseline and Week 8

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

,,
Interventionparticipants (Number)
BaselineWeek 8
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)41
1.5 mg MPA / 0.3 mg CEE (Prempro)42
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)32

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Change From Baseline to Week 8 in Office Cuff SBP and DBP at Trough

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

,,
InterventionmmHg (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)-4.200.33
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)-6.02-0.36

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Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough SBP From the ABPM Measurements

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

,,
InterventionmmHg (Mean)
mean daytimemean nighttimemean trough
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)-2.081.57-1.91
1.5 mg MPA / 0.3 mg CEE (Prempro)1.533.97-1.51
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)-1.061.64-1.48

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Change From Baseline to Week 8 in Mean Day Time, Mean Nighttime and Mean Trough DBP From the ABPM Measurements

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

,,
InterventionmmHg (Median)
mean daytimemean nighttimemean trough
0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)-1.950.20-1.04
1.5 mg MPA / 0.3 mg CEE (Prempro)0.171.75-0.30
2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)-1.560.67-1.13

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Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 130 mmHg (Posthoc Analysis)

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

InterventionmmHg (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

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Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 120 mmHg (Posthoc Analysis)

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

InterventionmmHg (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

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Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 116 mmHg (Posthoc Analysis)

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

InterventionmmHg (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

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Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 112 mmHg (Posthoc Analysis)

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

InterventionmmHg (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

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Change From Baseline to Week 8 in Mean 24-hour SBP From the ABPM Measurements in Per Protocol Population

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

InterventionmmHg (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

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Change From Baseline to Week 8 in Mean 24-hour DBP From the ABPM Measurements

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

InterventionmmHg (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

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Change From Baseline to Week 8 in Mean 24-hour SBP From the Ambulatory Blood Pressure Monitoring (ABPM) Measurements in Full Analysis Set (FAS) Population

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

InterventionmmHg (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

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Change From Baseline to Week 8 in Mean 24-hours ABPM SBP Values, Baseline Mean > 124 mmHg (Posthoc Analysis)

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

InterventionmmHg (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

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Change From Baseline in EHP-5 Emotional Well-being Dimension

"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-5.1-13.4-14.6-14.9-18.4-25.5
Elagolix 150 mg QD-12.7-20.6-18.0-21.1-20.8-24.1
Elagolix 75 mg BID-10.4-16.0-21.9-20.7-22.8-23.8

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Change From Baseline in EHP-5 Intercourse Dimension

"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-17.4-20.5-20.5-23.3-25.0-29.5
Elagolix 150 mg QD-17.3-25.8-29.1-31.7-30.7-35.3
Elagolix 75 mg BID-18.5-27.2-29.5-29.2-31.7-33.9

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Change From Baseline in EHP-5 Medical Profession Dimension

"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-12.0-13.5-15.0-17.9-15.6-16.0
Elagolix 150 mg QD-13.2-15.3-16.7-18.9-18.2-18.8
Elagolix 75 mg BID-9.1-14.7-14.2-14.4-14.6-14.0

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Change From Baseline in EHP-5 Relationship With Children Dimension

"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-16.1-24.4-28.6-25.8-28.6-31.7
Elagolix 150 mg QD-16.1-19.9-23.0-24.2-27.8-29.8
Elagolix 75 mg BID-18.9-20.8-20.7-26.6-25.0-23.3

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Change From Baseline in EHP-5 Self Image Dimension

"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-11.1-17.5-18.3-18.9-19.3-24.5
Elagolix 150 mg QD-11.1-19.6-21.1-20.3-20.8-23.7
Elagolix 75 mg BID-20.1-22.7-22.6-25.7-26.1-26.9

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Change From Baseline in EHP-5 Social Support Dimension

"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-19.6-29.8-28.4-32.0-34.9-32.8
Elagolix 150 mg QD-25.3-31.4-36.8-42.2-42.1-43.4
Elagolix 75 mg BID-26.5-33.7-34.6-37.0-39.0-40.0

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Change From Baseline in EHP-5 Treatment Dimension

"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-26.8-29.8-28.0-28.6-35.6-28.9
Elagolix 150 mg QD-27.4-32.8-35.0-36.8-35.7-35.6
Elagolix 75 mg BID-30.2-37.0-37.2-38.3-34.8-39.3

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Change From Baseline in EHP-5 Work Dimension

"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), or Not Relevant (no score), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-21.0-25.8-25.4-26.6-29.4-27.8
Elagolix 150 mg QD-20.5-21.2-21.8-24.6-24.1-24.0
Elagolix 75 mg BID-20.9-25.8-24.2-26.6-27.5-26.7

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Change From Baseline in Endometriosis Health Profile-5 (EHP-5) Pain Dimension

"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-18.7-24.3-25.4-29.8-28.3-30.9
Elagolix 150 mg QD-20.7-22.0-23.2-30.9-26.3-28.9
Elagolix 75 mg BID-22.9-30.0-28.4-31.9-29.8-28.5

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Change From Baseline in in Monthly Mean Visual Analog Scale (VAS) for Pelvic Pain

"The VAS for pelvic pain was used as an assessment of pain intensity. The VAS was a horizontal line on which the left extreme was labeled no pain and the right extreme was labeled worst pain ever felt scored on a scale from of 0 (no pain) to 100 (worst pain ever felt). Participants indicated the worst level of pain felt over a 24-hour period by ''ticking'' the horizontal line on their e-Diary at approximately the same time each day. Monthly mean VAS for pelvic pain defined as the average of all VAS pain scores reported for an individual participant from the previous visit to the day of the current scheduled visit.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-10.2-15.9-15.5-17.3-17.1-17.9
Elagolix 150 mg QD-10.2-14.0-17.7-17.8-16.6-18.2
Elagolix 75 mg BID-11.7-17.8-23.4-23.6-24.1-23.4

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Change From Baseline in N-telopeptide at Weeks 12, 24 and 48

Blood samples to determine N-telopeptide concentrations were analyzed by a central laboratory using an enzyme-linked immunosorbent assay (ELISA). Change from baseline in N-telopeptide was analyzed using a one-way ANOVA model. (NCT00437658)
Timeframe: Baseline and weeks 12, 24 and 48

,,
InterventionnM bone collagen equivalents (BCE) (Least Squares Mean)
Week 12Week 24Week 48
DMPA-SC0.74-0.24-1.39
Elagolix 150 mg QD0.940.23-1.28
Elagolix 75 mg BID0.57-0.30-1.53

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Change From Baseline in Non-menstrual Pelvic Pain Component of the CPSSS During the Treatment Period

"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~The non-menstrual pelvic pain score was based on participant's response to the question Have you had pelvic pain during the last 28 days?.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-0.8-1.1-0.9-0.9-1.0-1.1
Elagolix 150 mg QD-0.9-1.1-1.0-1.2-1.1-1.2
Elagolix 75 mg BID-0.8-1.1-1.1-1.2-1.3-1.2

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Change From Baseline in Pelvic Induration Component of the CPSSS During the Treatment Period

"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~Pelvic induration was assessed by the investigator based on findings associated with a pelvic examination.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-0.5-0.6-0.6-0.7-0.8-0.8
Elagolix 150 mg QD-0.4-0.7-0.7-0.9-0.9-0.9
Elagolix 75 mg BID-0.5-0.6-0.8-0.8-0.8-0.9

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Change From Baseline in Pelvic Tenderness Component of the CPSSS During the Treatment Period

"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~Pelvic tenderness was assessed by the investigator based on findings associated with a pelvic examination.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-0.7-0.7-0.7-0.6-0.9-0.9
Elagolix 150 mg QD-0.6-0.8-0.8-1.0-1.0-1.0
Elagolix 75 mg BID-0.7-0.8-0.9-0.9-0.8-1.0

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Change From Baseline in Total CPSSS During the Treatment Period

"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~Dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain scores are based on the participant's assessment, pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination.~The total CPSSS has a maximum possible value of 15 (total score range: 0 to 15, where a lower score indicates less signs and symptoms of endometriosis or better functioning).~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-3.8-4.5-4.2-4.6-4.8-5.3
Elagolix 150 mg QD-3.9-4.9-4.6-5.5-5.1-5.5
Elagolix 75 mg BID-3.7-4.8-5.1-5.4-5.3-5.2

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Change From Baseline in in Monthly Peak Visual Analog Scale (VAS) for Pelvic Pain

"The VAS for pelvic pain was used as an assessment of pain intensity. The VAS was a horizontal line on which the left extreme was labeled no pain and the right extreme was labeled worst pain ever felt scored on a scale from of 0 (no pain) to 100 (worst pain ever felt). Participants indicated the worst level of pain felt over a 24-hour period by ''ticking'' the horizontal line on their e-Diary at approximately the same time each day. Monthly peak VAS for pelvic pain was defined as the maximum VAS pain score reported for an individual participant from the previous visit to the day of the current scheduled visit.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-15.4-27.1-24.9-30.8-31.0-35.8
Elagolix 150 mg QD-18.2-26.3-31.3-32.1-29.0-32.3
Elagolix 75 mg BID-14.4-28.1-32.7-37.8-37.9-32.9

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Percentage of Participants With a Response in the Dysmenorrhea Component of the CPSSS Over Time

"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The dysmenorrhea score was based on the participant's response to the question Have you had painful menstruation during the last 28 days?.~Participants were classified as responders for dysmenorrhea if they reported a 1 point or greater reduction (improvement) from baseline." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48

,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 36Week 48
DMPA-SC74.779.582.191.283.386.393.380.566.7
Elagolix 150 mg QD75.384.073.287.581.786.070.852.563.6
Elagolix 75 mg BID80.784.082.282.676.573.857.444.658.2

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Percentage of Participants Using Analgesics During the Treatment Phase

Analgesic use was collected as part of concomitant medications on a case report form that was administered at each scheduled visit. (NCT00437658)
Timeframe: 24 weeks

,,
Interventionpercentage of participants (Number)
Antiinflammatory/Antirheumatics, Non-SteroidsOpioidsOther Analgesics and Antipyretics
DMPA-SC68.733.734.9
Elagolix 150 mg QD65.523.845.2
Elagolix 75 mg BID64.325.046.4

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Percent Change From Baseline in Bone Mineral Density of the Spine at Weeks 12 and 48

Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD was assessed using a one-way analysis of variance (ANOVA) model. (NCT00437658)
Timeframe: Baseline and weeks 12 and 48

,,
Interventionpercent change (Least Squares Mean)
Week 12Week 48
DMPA-SC-0.57-0.56
Elagolix 150 mg QD-0.390.20
Elagolix 75 mg BID-1.05-0.49

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Percent Change From Baseline in Bone Mineral Density of the Femur at Weeks 12 and 48

Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in BMD was assessed using a one-way analysis of variance (ANOVA) model. (NCT00437658)
Timeframe: Baseline and weeks 12 and 48

,,
Interventionpercent change (Least Squares Mean)
Week 12Week 48
DMPA-SC-0.77-0.76
Elagolix 150 mg QD-0.63-0.38
Elagolix 75 mg BID-0.54-0.86

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Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS Over Time

"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The non-menstrual pelvic pain score was based on participant's response to the question Have you had pelvic pain during the last 28 days? Participants were classified as responders for non-menstrual pelvic pain if they reported a 1 point or greater reduction (improvement) from baseline." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, 24, 28, 36, and 48

,,
Interventionpercentage of participants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 36Week 48
DMPA-SC68.782.271.670.275.976.573.368.371.8
Elagolix 150 mg QD74.182.774.682.881.786.066.767.566.7
Elagolix 75 mg BID56.676.082.278.380.976.960.760.756.4

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Change From Baseline in Total CPSSS Excluding Dyspareunia During the Treatment Period

"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~Dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain scores are based on the participant's assessment, pelvic tenderness and induration were assessed by the investigator based on findings associated with a pelvic examination.~The total CPSSS excluding dyspareunia has a maximum possible value of 12 (total score range: 0 to 12, where a lower score indicates less signs and symptoms of endometriosis or better functioning).~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-3.3-3.8-3.7-3.9-4.1-4.5
Elagolix 150 mg QD-3.4-4.1-3.8-4.6-4.4-4.6
Elagolix 75 mg BID-3.4-4.2-4.4-4.6-4.4-4.4

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Percent Change From Baseline in Bone Mineral Density of the Femur at Week 24

Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24. (NCT00437658)
Timeframe: Baseline and week 24

Interventionpercent change (Least Squares Mean)
Elagolix 150 mg QD-0.47
Elagolix 75 mg BID-1.02
DMPA-SC-1.29

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Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24

Bone mineral density (BMD) was measured by dual X-ray absorptiometry (DXA). The percent change from baseline in spine and femur BMD at week 24 was assessed using a one-way analysis of variance (ANOVA) model. The absence of significant bone loss was supported if the lower bounds of the confidence intervals for the mean percent change in BMD were ≥ -2.2% for both the spine and femur at week 24. (NCT00437658)
Timeframe: Baseline and week 24

Interventionpercent change (Least Squares Mean)
Elagolix 150 mg QD-0.11
Elagolix 75 mg BID-1.29
DMPA-SC-0.99

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Percentage of Participants With a Response in the Dysmenorrhea Component of the Composite Pelvic Signs and Symptoms Score (CPSSS) at Week 24

"The CPSSS consists of 5 components that address dysmenorrhea (pain during menstruation), dyspareunia (painful intercourse), non-menstrual pelvic pain, pelvic tenderness, and pelvic induration (hardening). Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The dysmenorrhea score was based on the participant's response to the question Have you had painful menstruation during the last 28 days?.~Participants were classified as responders for dysmenorrhea if they reported a 1 point or greater reduction (improvement) from baseline." (NCT00437658)
Timeframe: Baseline and week 24

Interventionpercentage of participants (Number)
Elagolix 150 mg QD86.0
Elagolix 75 mg BID73.8
DMPA-SC86.3

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Percentage of Participants With a Response in the Non-menstrual Pelvic Pain Component of the CPSSS at Week 24

"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The non-menstrual pelvic pain score was based on participant's response to the question Have you had pelvic pain during the last 28 days? Participants were classified as responders for non-menstrual pelvic pain if they reported a 1 point or greater reduction (improvement) from baseline." (NCT00437658)
Timeframe: Baseline and week 24

Interventionpercentage of participants (Number)
Elagolix 150 mg QD86.0
Elagolix 75 mg BID76.9
DMPA-SC76.5

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Change From Baseline in Dysmenorrhea Component of the CPSSS During the Treatment Period

"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~The dysmenorrhea score was based on the participant's response to the question Have you had painful menstruation during the last 28 days?.~Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-1.3-1.5-1.5-1.8-1.4-1.7
Elagolix 150 mg QD-1.4-1.6-1.3-1.6-1.4-1.5
Elagolix 75 mg BID-1.5-1.7-1.7-1.8-1.5-1.4

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Change From Baseline in Dyspareunia Component of the CPSSS During the Treatment Period

"The CPSSS consists of 5 components that address dysmenorrhea, dyspareunia, non-menstrual pelvic pain, pelvic tenderness, and pelvic induration. Each component was scored on a scale of 0 to 3 (0 = absent, 1 = mild, 2 = moderate, and 3 = severe).~The dyspareunia score was based on the participant's response to the question Have you had painful intercourse during the last 28 days? Change from baseline was analyzed using a mixed-effects repeated measures (MERM) analysis of covariance model which included fixed effects for treatment, time, treatment-by-time interaction, a random effect for patient, and terms for baseline value and the baseline-by-time interaction." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Least Squares Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-0.5-0.8-0.6-0.8-0.8-0.8
Elagolix 150 mg QD-0.6-0.9-1.0-1.2-0.9-1.2
Elagolix 75 mg BID-0.4-0.7-0.8-1.0-1.0-1.0

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Change From Baseline in EHP-5 Control and Powerlessness Dimension

"The EHP-5 is an instrument to measure health-related quality of life in women with endometriosis. The EHP-5 consists of two parts:~A core questionnaire consisting of five questions that measure the areas of pain, control and powerlessness, emotional well-being, social support, and self-image~A supplemental questionnaire consisting of six additional questions, five of which were recorded in this study: work, relationship with children, sexual intercourse, feelings about the medical profession and treatment.~Each question was scored on a five point scale (Never = 0, Rarely = 25, Sometimes = 50, Often = 75, Always = 100), where 0 indicates the best health status and 100 worst health status. A negative change from baseline score indicates improvement in quality of life." (NCT00437658)
Timeframe: Baseline and weeks 4, 8, 12, 16, 20, and 24

,,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24
DMPA-SC-22.9-31.2-26.1-31.1-34.9-35.8
Elagolix 150 mg QD-19.8-27.7-30.6-34.4-32.9-37.3
Elagolix 75 mg BID-24.7-33.0-31.2-33.3-33.1-33.1

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Dehydroepiandrosterone (DHEA)

(NCT00490555)
Timeframe: 10 weeks

Interventionng/mL (Median)
1) Placebo4.3
2) Testosterone Gel3.5
3) T Gel +Dutasteride3.8
4) T Gel+ DMPA3.2

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Androstenedione (AED)

(NCT00490555)
Timeframe: 10 weeks

Interventionng/mL (Median)
1) Placebo0.9
2) Testosterone Gel0.9
3) T Gel +Dutasteride1.8
4) T Gel+ DMPA0.7

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Testosterone Concentration

(NCT00490555)
Timeframe: 10 weeks

Interventionng/mL (Median)
1) Placebo4.0
2) Testosterone Gel4.4
3) T Gel +Dutasteride7.0
4) T Gel+ DMPA1.8

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Prostate-specific Antigen (PSA)

PSA level week 10 end of treatment (NCT00490555)
Timeframe: 10 weeks

Interventionng/mL (Median)
1) Placebo0.8
2) Testosterone Gel0.9
3) T Gel +Dutasteride0.7
4) T Gel+ DMPA0.4

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Dihydrotestosterone (DHT) Concentration

(NCT00490555)
Timeframe: 10 weeks

Interventionng/mL (Median)
1) Placebo0.5
2) Testosterone Gel1.8
3) T Gel +Dutasteride0.5
4) T Gel+ DMPA0.6

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Percentage of Subjects Who Receive a 3rd Injection

(NCT00563576)
Timeframe: 6 months

InterventionParticipants (Count of Participants)
Femring13
Depot Medroxyprogesterone Acetate (DMPA) Alone10

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Number of Subjects Who Receive a 2nd Injection of Depo-Provera

(NCT00563576)
Timeframe: 3 months

Interventionparticipants (Number)
Femring20
Depot Medroxyprogesterone Acetate (DMPA) Alone16

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Mean Number of Bleeding or Spotting Days

Bleeding and spotting were defined using World Health Organization criteria and measured through daily diaries given to participants and collected at the 3 and 6 month followup. In addition, a study staff member called participants weekly to collect the daily bleeding and spotting calendar for that week to optimize the accuracy of this information. (NCT00563576)
Timeframe: 3 months

Interventiondays (Mean)
Femring16
Depot Medroxyprogesterone Acetate (DMPA) Alone28

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Percentage of Users Who Were Satisfied With Femring

Acceptability was measured using questionnaires that assessed satisfaction of Femring and usage of the ring. This outcome was only measured among the intervention group of women who actually were randomized to use of Femring. Acceptability of the vaginal ring was high among those in the intervention group. (NCT00563576)
Timeframe: 3 months

Interventionparticipants (Number)
Femring84

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MPA Trough Concentration

To explore genetic determinants of MPA bioavailability and trough concentration by showing average MPA levels at cycle 1 (Day 10-14) and cycle 2 (Day 1). (NCT00577122)
Timeframe: Cycle 1 (Day 10-14) and Cycle 2 (Day 1)

,
Interventionng/mL (Mean)
Cycle 1, Day 10-14Cycle 2, Day 1
Cohort I: MPA-Alone14.552.6
Cohort II: MPA+IdoCM42.166.4

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MPA Trough Level > 50 ng/mL When Have Clinical Benefit

To explore the relationship between MPA trough level and clinical benefit. This is done by seeing if the MPA concentrations remained > 50 ng/mL after initial dose escalation for those patients who showed clinical benefit. The number shows how many of the patients who showed clinical benefit had MPA concentrations > 50 ng/mL. (NCT00577122)
Timeframe: baseline through end of treatment

Interventionparticipants (Number)
Cohort I: MPA-Alone1
Cohort II: MPA+IdoCM1

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Clinical Benefit Rate (CR + PR + SD > 6 Months).

To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease > 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. This will show the percent of patients who had Clinical Benefit and the Exact 95% Confidence Interval. (NCT00577122)
Timeframe: baseline through end of study, up to 3 years

InterventionPercent of Participants (Number)
Cohort I: MPA-Alone7.1
Cohort 2: MPA+IdoCM6.3

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Fasting Insulin Levels at Study Completion After 3 Month Treatment

Fasting insulin levels at study completion after 3 month treatment (NCT00743574)
Timeframe: 3 months intervention

InterventionµIU/ml (Mean)
Vitamin D Plus Calcium (Ca) Supplementation25.17

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Fasting Glucose Levels at Completion of Treatment, at 3 Months

Fasting glucose levels drawn after 3 months completion during oral GTT (NCT00743574)
Timeframe: 3 months

Interventionmg/dl (Mean)
Vitamin D Plus Calcium (Ca) Supplementation103.79

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AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months

AUC (Area under the curve at 0, 0.5, 1, 1.5 and 2 hours)for glucose was determined at completion of 3 months intervention for 2 hour oral GTT (NCT00743574)
Timeframe: 3 months

Interventionmg/min/120min (Mean)
Vitamin D Plus Calcium (Ca) Supplementation16726.56

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AUC (Area Under a Curve at 0, 0.5, 1, 1.5 and 2 Hours) Insulin During 2 Hour GTT at Completion, at 3 Months

Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT (NCT00743574)
Timeframe: 3 months

InterventionµIU/ml/120min (Mean)
Vitamin D Plus Calcium (Ca) Supplementation16715.57

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Serum HbA1C at 3 Months

Fasting HbA1C levels at study completion after 3 month treatment (NCT00743574)
Timeframe: Completion

Interventionpercentage (Mean)
Vitamin D Plus Calcium (Ca) Supplementation5.55

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Serum Levels of C-reactive Protein at Completion of 3 Months Treatment

Serum levels of C-reactive protein upon completion, at 3 months (NCT00743574)
Timeframe: 3 months

Interventionmg/L (Median)
Vitamin D Plus Calcium (Ca) Supplementation5.3

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Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale at Month 3: Sleep Sub-Study

Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment. (NCT00808132)
Timeframe: Baseline, Month 3

,,,,
InterventionUnits on a Scale (Least Squares Mean)
SD (n=112, 121, 47, 52, 111)Snoring (n=110, 121, 47, 51, 108)ASoB or H (n=112,121,47,52,111)Somnolence (n=112,121,47,52,111)SA (n=112, 121, 47, 52, 111)SPI I (n=112, 121, 47, 52, 111)SPI II (n=112, 121, 47, 52,111)SQ (n=111, 121, 47, 52, 111)
Bazedoxifene 20 mg-11.64-2.54-3.12-6.129.10-8.92-9.640.32
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg-17.27-5.86-4.26-10.5414.22-13.19-14.010.28
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg-18.18-5.38-5.81-9.7214.30-13.99-14.530.44
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg-18.01-2.90-3.62-7.3615.10-13.71-14.120.41
Placebo-14.34-2.71-3.63-10.5511.46-11.84-12.040.36

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Change From Baseline in Menopause-Specific Quality of Life (MENQOL) Score at Month 3: Sleep Sub-Study

MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. (NCT00808132)
Timeframe: Baseline, Month 3

,,,,
InterventionUnits on a Scale (Least Squares Mean)
Vasomotor function (n=111, 121, 47, 52, 112)Psychosocial function (n=111, 121, 47, 52, 112)Physical function (n=111, 121, 47, 52, 112)Sexual function (n=110, 121, 47, 52, 112)MENQOL Total Score (n=110, 121, 47, 52, 112)
Bazedoxifene 20 mg-1.25-0.47-0.67-0.09-0.63
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg-2.37-0.67-0.92-1.20-1.27
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg-2.75-0.84-1.11-1.40-1.53
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg-3.19-0.83-0.76-0.76-1.39
Placebo-1.45-0.74-0.87-1.04-1.03

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Medical Outcomes Study (MOS) Sleep Scale at Baseline: Sleep Sub-Study

Participant-rated questionnaire to assess sleep quality and quantity. Consists of 12-item questionnaires answered on a range of 1 to 6 for questions (Q) 3 to 12, 1 to 5 for Q1 (some questions are reversed so that a high score reflects more of the attributes); and Q2 answered on 0 to 24. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range* 100); total score range: 0 to 100; higher score = greater intensity of attribute. The items contribute to each scale and are averaged to create the 7 scale scores and a sleep quantity scale. Scales with at least one item answered was used to generate a scale score. Scales include; sleep disturbance (SD), snoring, awaken short of breath (ASoB) or with a headache (H), somnolence, sleep adequacy (SA), sleep problem index (SPI) I and II (range: 0-100) and sleep quantity (SQ [range 0 to 24]). Except for sleep quantity, higher scores=greater impairment. (NCT00808132)
Timeframe: Baseline

,,,,
InterventionUnits on a Scale (Mean)
SD (n=112, 121, 47, 52, 111)Snoring (n=110, 121, 47, 51, 108)ASoB or H (n=112, 121, 47,52,111)Somnolence (n=112, 121, 47, 52, 111)SA (n=112, 121, 47, 52, 111)SPI I (n=112, 121, 47, 52, 111)SPI II (n=112, 121, 47, 52, 111)SQ (n=111, 121, 47, 52, 111)
Bazedoxifene 20 mg50.537.913.234.637.444.746.45.9
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg48.932.112.536.339.344.545.56.2
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg48.227.611.930.041.742.043.26.1
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg50.433.113.128.736.544.945.26.2
Placebo47.834.412.131.240.343.443.76.2

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Menopause-Specific Quality of Life (MENQOL) Score at Baseline: Sleep Sub-Study

MENQOL questionnaire assessed how bothered participants were due to menopause. It consists of 29 items divided into 4 domains: vasomotor function (3 items), psychosocial function (7 items), physical function (16 items), and sexual function (3 items). Each item scores a range from 1 to 8, with 1 indicating that the participant did not experience the symptom or problem, 8 indicating that the participant was extremely bothered by the symptom or problem. The total score for each domain is the average of item scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. The MENQOL total score is the mean of these 4 domain scores and ranged from 1 to 8 with higher score indicating worsening of symptoms. (NCT00808132)
Timeframe: Baseline

,,,,
InterventionUnits on a Scale (Mean)
Vasomotor function (n=111, 121, 47, 52, 112)Psychosocial function (n=111, 121, 47, 52, 112)Physical function (n=111, 121, 47, 52, 112)Sexual function (n=110, 121, 47, 52, 112)MENQOL Total Score (n=110, 121, 47, 52, 112)
Bazedoxifene 20 mg5.873.493.964.054.34
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg5.403.463.743.744.07
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg5.603.413.583.634.05
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg5.653.483.743.734.15
Placebo5.623.223.583.834.06

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Percent Change From Baseline in Bone Mineral Density (BMD) of Total Hip at Month 6, 12: Osteoporosis Sub-Study

BMD measurements of the total hip were acquired by using DXA scans, twice at Month 6 and 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported. (NCT00808132)
Timeframe: Baseline, Month 6, Month 12

,,,,
InterventionPercent Change (Least Squares Mean)
Change at Month 6 (n=117, 136, 55, 57, 134)Change at Month 12 (n=119, 139, 56, 59, 139)
Bazedoxifene 20 mg0.320.47
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg0.430.50
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg0.660.89
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg0.450.71
Placebo-0.90-0.72

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Percent Change From Baseline in Bone Turnover Markers (BTMs) at Month 6 and Month 12: Osteoporosis Sub-Study

Bone turnover is the removal of old bone from the body and its replacement by new bone. Bone turnover markers included serum osteocalcin, C-telopeptide, and procollagen type 1 N-propeptide (P1NP), were measured at Month 6 and Month 12 for a subset of participants who entered the osteoporosis substudy. Blood samples were collected to evaluate bone turnover markers levels. (NCT00808132)
Timeframe: Baseline, Month 6, 12

,,,,
InterventionPercent Change (Median)
Osteocalcin: Month 6 (n=115, 136, 56, 56, 134)Osteocalcin: Month 12 (n=104, 127, 52, 50, 125)C-Telopeptide: Month 6 (n=115, 136, 56, 56, 133)C-Telopeptide: Month 12 (n=104, 127, 52,50,124)P1NP: Month 6 (n=114,135, 57, 56, 133)P1NP: Month 12 (n=103, 127, 53, 50, 125)
Bazedoxifene 20 mg-15.60-16.05-29.37-27.39-17.38-23.97
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg-25.21-30.46-34.16-40.86-33.73-42.38
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg-27.79-37.02-41.41-50.06-30.26-43.58
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg-25.34-32.79-54.05-52.56-39.99-50.19
Placebo-3.19-5.28-10.17-5.525.99-11.13

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Percentage of Participants With Endometrial Hyperplasia at Month 12: Main Study

Endometrial hyperplasia was assessed by endometrial biopsies. All endometrial biopsies were read centrally by 2 primary pathologists. If both the pathologists disagreed on the presence of hyperplasia, a third pathologist was consulted. Results were summarized for two definitions of hyperplasia (simple hyperplasia with or without atypia or complex hyperplasia with or without atypia); definition 1: participants were considered to have a diagnosis of hyperplasia when the 3 pathologists disagreed but at least 1 pathologist determined hyperplasia; definition 2: participants were considered to have a diagnosis of hyperplasia if at least 2 of the 3 pathologists agreed on the diagnosis. (NCT00808132)
Timeframe: Month 12

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InterventionPercentage of Participants (Number)
Definition 1Definition 2
Bazedoxifene 20 mg0.000.00
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg0.300.30
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg0.540.27
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg0.000.00
Placebo0.850.28

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Percentage of Participants With Uterine Bleeding

Percentage of participants with uterine bleeding were calculated for each 4-week period for 1-year on therapy. (NCT00808132)
Timeframe: Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52

,,,,
InterventionPercentage of Participants (Number)
Week 1-4 (n=440, 468, 229, 216, 470)Week 5-8 (n=428, 458, 221, 205, 462)Week 9-12 (n=417, 451, 217, 199, 452)Week 13-16 (n=415, 446, 213, 196, 446)Week 17-20 (n=399,426,201,184,427)Week 21-24 (n=395, 424, 199, 183, 423)Week 25-28 (n=393, 422, 197, 182, 420)Week 29-32 (n=376, 416, 194, 173, 405)Week 33-36 (n=373, 413, 192, 170, 399)Week 37-40 (n=373, 411, 191, 168, 394)Week 41-44 (n=363, 396, 188, 162, 386)Week 45-48 (n=358, 394, 188, 160, 383)Week 49-52 (n=357, 392, 187, 159, 380)
Bazedoxifene 20 mg5.683.622.763.292.492.011.021.552.081.570.000.531.07
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg3.864.442.162.412.262.782.041.600.541.611.380.841.68
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg6.205.023.552.912.582.122.131.682.912.921.262.281.28
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg20.8324.3925.6324.4918.4818.5814.8412.1412.9414.2913.5814.388.81
Placebo4.684.114.423.363.513.313.331.732.264.821.552.091.58

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Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 12: Osteoporosis Sub-Study

BMD measurements of the anteroposterior lumbar spine were acquired by using dual-energy x-ray absorptiometry (DXA) scans, twice at Month 12 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported. (NCT00808132)
Timeframe: Baseline, Month 12

InterventionPercent Change (Least Squares Mean)
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg0.24
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg0.60
Bazedoxifene 20 mg0.07
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg1.30
Placebo-1.28

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Percentage of Participants With Breast Tenderness

Percentage of participants who reported at least 1 day of breast tenderness during each 4-week period for 1-year on therapy was calculated. (NCT00808132)
Timeframe: Screening, Week 1-4, 5-8, 9-12, 13-16, 17-20, 21-24, 25-28, 29-32, 33-36, 37-40, 41-44, 45-48, 49-52

,,,,
InterventionPercentage of Participants (Number)
Screening (n=429, 449, 220, 206, 457)Week 1-4 (n=426, 449, 220, 205, 457)Week 5-8 (n=423, 447, 216, 202, 456)Week 9-12 (n=412, 439, 212, 196, 447)Week 13-16 (n=411, 433, 208, 193, 440)Week 17-20 (n=395, 412, 197, 181, 420)Week 21-24 (n=391, 410, 195, 180, 416)Week 25-28 (n=389, 409, 193, 179, 416)Week 29-32 (n=372, 403, 190, 171, 401)Week 33-36 (n=369, 401, 188, 168, 395)Week 37-40 (n=369, 399, 187, 166, 390)Week 41-44 (n=359, 384, 184, 159, 382)Week 45-48 (n=354, 382, 184, 157, 379)Week 49-52 (n=353, 380, 183, 156, 376)
Bazedoxifene 20 mg4.555.917.876.608.656.095.644.151.583.192.671.632.171.64
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg6.299.398.045.837.064.054.603.084.572.984.073.623.673.12
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg6.469.136.947.978.314.373.905.623.973.494.012.603.142.89
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg7.2820.4924.2623.9821.2417.1315.0015.6415.2012.5012.059.4310.839.62
Placebo6.568.328.555.375.914.294.334.092.002.283.082.623.172.66

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Percent Change From Baseline in Bone Mineral Density (BMD) of Lumbar Spine at Month 6: Osteoporosis Sub-Study

BMD measurements of the anteroposterior lumbar spine were acquired by using DXA scans, twice at Month 6 for a subset of participants who entered the osteoporosis substudy. The second scan was to be performed on the same day as the first; however, the participant was to be removed completely from the table after the first scan and repositioned for the second scan. Mean percentage change from baseline of the 2 readings were reported. (NCT00808132)
Timeframe: Baseline, Month 6

InterventionPercent Change (Least Squares Mean)
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg0.12
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg0.51
Bazedoxifene 20 mg0.00
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg0.64
Placebo-0.68

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Percent Change From Baseline in Breast Density at Month 12: Breast Density Sub-Study

Breast density was assessed by digitalized mammograms which were centrally read by a single radiologist using specifically-developed software. Breast density was assessed for subset of participants who entered the breast density sub-study (NCT00808132)
Timeframe: Baseline, Month 12

InterventionPercent Change (Least Squares Mean)
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg-0.38
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg-0.45
Bazedoxifene 20 mg-0.25
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg1.60
Placebo-0.32

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Percentage of Participants With Cumulative Amenorrhea: Main Study

Cumulative amenorrhea was defined as the absence of any bleeding or spotting for cumulative 4-week periods throughout 1-year study. (NCT00808132)
Timeframe: Day 1 up to Day 364

InterventionPercentage of Participants (Number)
Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg87.89
Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg84.87
Bazedoxifene 20 mg82.35
Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg54.43
Placebo83.91

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Etonogestrel-releasing Contraceptive Subdermal Implant Inserted During the Immediate Puerperium Effects on the Hemostatic System of Healthy Women Over a Period of Twelve Weeks

"Activated protein C (APC) resistance is the most important marker of coagulation system in women using hormonal contraceptive methods.~APC resistance was determined by testing the effect of APC on the endogenous thrombin potential (ETP) using the Calibrated Automated Thrombogram® (CAT) assay. The sensitivity ratio or APC (APCsr) of each plasma sample was determined in the presence or absence of approximately 4 nM APC (Enzyme Research Laboratories, Swansea, United Kingdom). The APC concentration was adjusted to maintain the residual thrombin generation activity in normal pooled plasma at approximately 10%. Normal pooled plasma was run in parallel on each plate.~The normalized ratio (nAPCsr) was determined by dividing the APCsr of an individual sample by the APCsr of the pooled plasma.~Thus, nAPCsr >1.0 indicated APC resistance." (NCT00828542)
Timeframe: 12 weeks

Interventionratio (Mean)
Etonogestrel Implant5.9
Depot Medroxyprogesterone5.5

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Memory for Emotionally Valent Words and Neutral Words

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)

,,
InterventionProportion Correct (Mean)
Baseline (Week 0)- ControlBaseline (Week 0)- TSSTPost-Treatment (Week 12)- ControlPost-Treatment (Week 12)-TSST
Estradiol/Medroxyprogesterone Acetate0.450.480.470.51
Phytoestrogen0.450.400.420.46
Placebo0.380.470.370.44

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Changes in STAI-6 Scores Before and After Psychosocial Stressor Over Time

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)

,,
Interventionscore on STAI scale (Mean)
Baseline (Week 0), Before StressorBaseline (Week 0), After StressorPost-Treatment (Week 12), Before StressorPost-Treatment (Week 12), After Stressor
Estradiol/Medroxyprogesterone Acetate8.7312.618.2513.70
Phytoestrogen8.6912.9210.8715.37
Placebo9.7712.239.6112.69

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Change in Verbal Memory, Immediate Recall

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

Interventiontest scores on the Logical Memory test (Mean)
Estradiol/Medroxyprogesterone Acetate-.02
Phytoestrogen2.31
Placebo2.08

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Change in Verbal Memory, Delayed Recall

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

InterventionTest scores on the Logical Memory test (Mean)
Estradiol/Medroxyprogesterone Acetate.87
Phytoestrogen1.61
Placebo1.08

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Change in STAI-6 Score

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

,,
Interventionscore on STAI scale (Mean)
Baseline (Week 0)Early-Treatment(Week 10)Late-Treatment(Week 12)Post-Treatment (Week 16-18)
Estradiol/Medroxyprogesterone Acetate12.3111.6912.8811.84
Phytoestrogen11.8511.3810.9911.19
Placebo10.7611.2410.5511.15

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Number of Participants Continuing DMPA at 6 Months

The study was designed to examine if increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase participant continuation of DMPA (NCT01019369)
Timeframe: 6 months

Interventionparticipants (Number)
Self Administration of DMPA61
Clinic Administration of DMPA29

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Number of Participants Continuing DMPA

The study was designed to examine the increasing accessibility to DMPA by decreasing the need for multiple clinic visits will increase method continuation rates at all other endpoints. (NCT01019369)
Timeframe: 3, 9, 12 months

InterventionParticipants (Count of Participants)
Self Administration of DMPA61
Clinic Administration of DMPA29

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Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD)

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+MPA5.49
E+DRSP3.39

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AUC 0-91 (Area Under Curve)

(NCT01143207)
Timeframe: first 91 days following injection

Interventionng day/mL (Mean)
Medroxyprogesterone Acetate45.1

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Tmax (Time to Cmax)

(NCT01143207)
Timeframe: 120 days following injection

Interventiondays (Median)
Medroxyprogesterone Acetate8

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MPA Concentration at Day 91 (C91)

(NCT01143207)
Timeframe: day 91 after first injection

Interventionng/mL (Mean)
Medroxyprogesterone Acetate0.427

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MPA Concentration at Day 120 (C120)

(NCT01143207)
Timeframe: day 120 after injection

Interventionng/mL (Mean)
Medroxyprogesterone Acetate0.327

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MPA Concentration at Day 104 (C104)

(NCT01143207)
Timeframe: day 104 after injection

Interventionng/mL (Mean)
Medroxyprogesterone Acetate0.366

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Cmax (Maximal Serum Concentration of Medroxyprogesterone Acetate (MPA))

(NCT01143207)
Timeframe: 120 days following injection

Interventionng/mL (Mean)
Medroxyprogesterone Acetate0.953

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Cessation of Bleeding Within 5 Days

Patients were called within 24 hours and 48 hours following their first study visit to ascertain their bleeding status and their use of medication, as well as any significant side effects they msy have been experiencing. Patients were asked to return to the clinic on day 3 for a repeat hemoglobin and interval history. Those women who were still having any bleeding on day 3 were contacted on day 5 (NCT01148420)
Timeframe: 3-5 days

Interventionparticipants (Number)
DMPA + MPA48

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Patient Perception of the Acceptability of the Treatment

Results from a survey question that assessed the subjects' satisfaction with the therapy on a scale of 1-3. 1 = poor; 2 = good; 3 = excellent. (NCT01148420)
Timeframe: End of the trial; up to day 5

Interventionunits on a scale (Median)
DMPA + MPA3

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Satisfaction and Willingness to Recommend Treatment

Participants were asked whether they would recommend this treatment to a friend (NCT01148420)
Timeframe: End of the trial; up to day 5

Interventionparticipants (Number)
Participants who would recommend this treatmentParticipants who would not recommend it
DMPA + MPA480

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RTV PK Parameter Cmax.

This evaluates the effect of MPA on the PK parameter Cmax of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4. (NCT01296152)
Timeframe: Day 0 and Week 4

Interventionng/mL (Median)
RTV Cmax day 0RTV Cmax week 4
Depo-medroxyprogesterone Acetate (DMPA)884.00726.00

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RTV PK Parameter T1/2.

This evaluates the effect of MPA on the PK parameter T1/2 of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4. (NCT01296152)
Timeframe: Day 0 and Week 4

Interventionhour (Median)
RTV T1/2 day 0 (N=23)RTV T1/2 week 4
Depo-medroxyprogesterone Acetate (DMPA)4.566.32

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RTV PK Parameter Tmax.

This evaluates the effect of MPA on the PK parameter Tmax of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4. (NCT01296152)
Timeframe: Day 0 and Week 4

Interventionhour (Median)
RTV Tmax day 0RTV Tmax week 4
Depo-medroxyprogesterone Acetate (DMPA)3.003.00

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RTV PK Parameter Cmin.

This evaluates the effect of MPA on the PK parameter Cmin of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4. (NCT01296152)
Timeframe: Day 0 and Week 4

Interventionng/mL (Median)
RTV Cmin day 0RTV Cmin week 4
Depo-medroxyprogesterone Acetate (DMPA)181.00194.50

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Medroxyprogesterone Acetate (MPA) Pharmacokinetic Parameter (PK) Area Under the Concentration-time Curve (AUC0-12weeks)

This evaluates the effect of lopinavir/ritonavir (LPV/r) on pharmacokinetic parameter AUC of MPA by looking at the MPA AUC from day 0 to week 12. AUC0-12weeks was calculated using single MPA concentrations sampled immediately prior to DMPA administration on day 0, and at 2, 4, 6, 8, 10 and 12 weeks after administration of the single DMPA dose. (NCT01296152)
Timeframe: Day 0, Weeks 2, 4, 6, 8, 10 and 12

Interventionng*wk/mL (Median)
Depo-medroxyprogesterone Acetate (DMPA)18.08

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MPA PK Parameter Clearance (CL/F) Determined Based on MPA Levels.

This evaluates the effect of LPV/r on the secondary MPA PK parameter CL/F based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12. (NCT01296152)
Timeframe: 0, 2, 4, 6, 8, 10, and 12 weeks

InterventionL/week (Median)
Depo-medroxyprogesterone Acetate (DMPA)8297.35

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MPA PK Parameter Half-Life (T1/2) Determined Based on MPA Levels.

This evaluates the effect of LPV/r on the secondary MPA PK parameter T1/2 based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12. (NCT01296152)
Timeframe: 0, 2, 4, 6, 8, 10, and 12 weeks

Interventionweek (Median)
Depo-medroxyprogesterone Acetate (DMPA)3.37

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MPA PK Parameter Maximum Plasma Concentration (Cmax) Determined Based on MPA Levels.

This evaluates the effect of LPV/r on the secondary MPA PK parameter Cmax based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12. (NCT01296152)
Timeframe: 0, 2, 4, 6, 8, 10, and 12 weeks

Interventionng/mL (Median)
Depo-medroxyprogesterone Acetate (DMPA)2.88

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MPA PK Parameter Minimum Plasma Concentration (Cmin) Determined Based on MPA Levels.

This evaluates the effect of LPV/r on the secondary MPA PK parameter Cmin based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12. (NCT01296152)
Timeframe: 0, 2, 4, 6, 8, 10, and 12 weeks

Interventionng/mL (Median)
Depo-medroxyprogesterone Acetate (DMPA)0.47

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MPA PK Parameter Time to Cmax (Tmax) Determined Based on MPA Levels.

This evaluates the effect of LPV/r on the secondary MPA PK parameter Tmax based on MPA levels measured at weeks 0, 2, 4, 6, 8, 10, and 12. (NCT01296152)
Timeframe: 0, 2, 4, 6, 8, 10, and 12 weeks

Interventionweek (Median)
Depo-medroxyprogesterone Acetate (DMPA)4.00

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AUC0-12hour for LPV at Baseline (Day 0) Before DMPA Administration and at Week 4 (Four Weeks After DMPA Administration)

This evaluates the effect of DMPA on LPV PK parameter AUC by comparing PK AUCs of LPV from 0 to 12 hours obtained at study Day 0 (before DMPA was administered) with PK AUCs of LPV from 0 to 12 hours at study Week 4 (4 weeks after DMPA was administered). Blood samples were drawn for LPV concentration levels at time zero (before LPV/r dosing) and at 30 minutes and 1, 2, 3, 4, 5, 6, 8 and 10 hours after LPV/r dosing at day 0 and week 4. (NCT01296152)
Timeframe: Day 0 and Week 4

Interventionng*h/mL (Median)
LPV AUC0-12hour at day 0 (without DMPA)LPV AUC0-12hour at week 4 (with DMPA)
Depo-medroxyprogesterone Acetate (DMPA)98046.4697948.29

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Cell Mediated Immunity (CMI) to HIV and the Common Opportunistic Agent Varicella-zoster Virus (VZV) Using the Enzyme-linked Immunospot (ELISPOT) Assay.

This evaluates the effect of MPA on CMI to HIV and VZV at baseline before DMPA (day 0) and after DMPA (weeks 4 and 12) . Cytokines are interferon-gamma (IFN-gamma) and interleukin 2 (IL-2), and Stimuli are HIV and VZV. Summary of adjusted ELISPOT assay results is in spot forming cells (SFC)/10^6 peripheral blood mononuclear cells (PBMC) by study weeks 0, 4 and 12. The outcome measures of IFN-gamma and IL-2 measured for HIV and VZV are presented here together to provide all results pertaining to the same objective in a single data table. (NCT01296152)
Timeframe: Day 0, Weeks 4 and 12

InterventionSFC/10^6 PBMC (Median)
IFN-gamma*HIV Week 0 (N=22)IFN-gamma*HIV Week 4 (N=21)IFN-gamma*HIV Week 12 (N=20)IFN-gamma*VZV Week 0 (N=20)IFN-gamma*VZV Week 4 (N=20)IFN-gamma*VZV Week 12 (N=19)IL-2*HIV Week 0 (N=22)IL-2*HIV Week 4 (N=21)IL-2*HIV Week 12 (N=20)IL-2*VZV Week 0 (N=20)IL-2*VZV Week 4 (N=20)IL-2*VZV Week 12 (N=19)
Depo-medroxyprogesterone Acetate (DMPA)82.5046.5057.752.752.006.505.004.501.753.252.505.50

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CMI to HIV and the Common Opportunistic Agent VZV Using the Lymphocyte Proliferation Assay (LPA).

This evaluates the effect of MPA on CMI to HIV and VZV. This outcome was measured at Baseline Before DMPA (Day 0) and After DMPA (Weeks 4 and 12) using the Lymphocyte Proliferation Assay (LPA). The data table shows a summary of LPA assay results by study week with stimuli HIV and VZV. Proliferation results are reported as a stimulation index (SI) which represents the ratio of the stimulated counts per minute to unstimulated control counts per minute. (NCT01296152)
Timeframe: Day 0, Weeks 4 and 12

InterventionSI Ratio (Median)
HIV SI Week 0 (N=18)HIV SI Week 4 (N=17)HIV SI Week 12 (N=14)VZV SI Week 0 (N=22)VZV SI Week 4 (N=22)VZV SI Week 12 (N=21)
Depo-medroxyprogesterone Acetate (DMPA)50.6221.3954.6622.3817.7323.28

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LPV PK Parameter CL/F.

This evaluates the effect of MPA on the secondary LPV PK parameter CL/F obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4. (NCT01296152)
Timeframe: Day 0 and Week 4

InterventionL/hour (Median)
LPV CL/F day 0LPV CL/F week 4
Depo-medroxyprogesterone Acetate (DMPA)4.084.08

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LPV PK Parameter Cmax.

This evaluates the effect of MPA on the secondary LPV PK parameter Cmax obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4. (NCT01296152)
Timeframe: Day 0 and Week 4

Interventionng/mL (Median)
LPV Cmax day 0LPV Cmax week 4
Depo-medroxyprogesterone Acetate (DMPA)10750.0010950.00

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LPV PK Parameter Cmin.

This evaluates the effect of MPA on the secondary LPV PK parameter Cmin obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4. (NCT01296152)
Timeframe: Day 0 and Week 4

Interventionng/mL (Median)
LPV Cmin day 0LPV Cmin week 4
Depo-medroxyprogesterone Acetate (DMPA)5630.005700.00

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LPV PK Parameter T1/2.

This evaluates the effect of MPA on the secondary LPV PK parameter T1/2 obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4. (NCT01296152)
Timeframe: Day 0 and Week 4

Interventionhour (Median)
LPV T1/2 day 0LPV T1/2 week 4
Depo-medroxyprogesterone Acetate (DMPA)11.7612.64

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LPV PK Parameter Tmax.

This evaluates the effect of MPA on the secondary LPV PK parameter Tmax obtained from both sampling periods, before DMPA injection at study day 0 and four weeks after DMPA injection at study week 4. (NCT01296152)
Timeframe: Day 0 and Week 4

Interventionhour (Median)
LPV Tmax day 0LPV Tmax week 4
Depo-medroxyprogesterone Acetate (DMPA)3.003.00

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Percentage of Participants With HIV-1 RNA Levels <400 Copies/mL.

This evaluates the short-term impact of MPA on virologic suppression in participants taking LPV/r who have received a dose of DMPA by measuring percentage of participants with HIV-1 RNA levels <400 copies/mL at day 0 (prior to DMPA injection) and at weeks 2, 4, 8 and 12 (after DMPA injection). An FDA-approved HIV-1 RNA assay with a lower limit of detection of 75 copies/mL or less was required and the same HIV-1 RNA assay was required to be performed for each participant across all study visits. The Roche COBAS AmpliPrep/TaqMan HIV-1 and Abbott RealTime HIV-1 tests were used. (NCT01296152)
Timeframe: Day 0, Weeks 2, 4, 8, and 12

InterventionPercent of Participants (Number)
Pct with HIV RNA<400 at Week 0 (N=24)Pct with HIV RNA<400 at Week 2 (N=24)Pct with HIV RNA<400 at Week 4 (N=23)Pct with HIV RNA<400 at Week 8 (N=24)Pct with HIV RNA<400 at Week 12 (N=23)
Depo-medroxyprogesterone Acetate (DMPA)10010010010087

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Percentage of Participants With Progesterone Levels Less Than the Lower Limit of Quantification (LLQ).

This evaluates the suppression of ovulation due to the potential PK interaction between DMPA and LPV/r. The LLQ of progesterone is 0.5ng/mL. The threshold for suppression of ovulation is 5ng/mL. (NCT01296152)
Timeframe: 0, 2, 4, 6, 8, 10, and 12 weeks

InterventionPercent of Participants (Number)
Pct with ProgesteronePct with ProgesteronePct with ProgesteronePct with ProgesteronePct with ProgesteronePct with ProgesteronePct with Progesterone
Depo-medroxyprogesterone Acetate (DMPA)50.087.095.895.895.895.095.7

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Regulatory T Cells (Tregs) at Baseline, Week 4 and Week 12 Using Flow Cytometry in Freshly Thawed PBMCs.

This evaluates the effect of MPA on Tregs at baseline (Day 0), week 4 and week 12 using flow cytometry in freshly thawed PBMCs. A summary of CD4+ and cluster of differentiation 8 (CD8+) anchored T-cell subsets by study week, in percent that express the marker of interest, is presented here together to provide all results pertaining to this objective in a single data table. (NCT01296152)
Timeframe: Day 0, Weeks 4 and 12

InterventionPercent CD4/CD8 cells expressing marker (Median)
CD4+FOXP3+ Week 0CD4+FOXP3+ Week 4CD4+FOXP3+ Week 12CD4+CD25+FOXP3+ Week 0CD4+CD25+FOXP3+ Week 4CD4+CD25+FOXP3+ Week 12CD4+CD39+ Week 0CD4+CD39+ Week 4CD4+CD39+ Week 12CD4+TGFB+ Week 0CD4+TGFB+ Week 4CD4+TGFB+ Week 12CD4+IL10+ Week 0CD4+IL10+ Week 4CD4+IL10+ Week 12CD4+IL35+ Week 0CD4+Interleukin35+(IL35+) Week 4CD4+IL35+ Week 12CD8+FOXP3+ Week 0CD8+FOXP3+ Week 4CD8+FOXP3+ Week 12CD8+CD25+FOXP3+ Week 0CD8+CD25+FOXP3+ Week 4CD8+CD25+FOXP3+ Week 12CD8+CD39+ Week 0CD8+CD39+ Week 4CD8+CD39+ Week 12CD8+TGFB+ Week 0CD8+TGFB+ Week 4CD8+TGFB+ Week 12CD8+IL10+ Week 0CD8+IL10+ Week 4CD8+IL10+ Week 12CD8+IL35+ Week 0CD8+IL35+ Week 4CD8+IL35+ Week 12
Depo-medroxyprogesterone Acetate (DMPA)1.261.301.290.410.240.3310.1010.1011.604.323.623.084.666.015.641.861.591.350.850.910.740.070.060.083.384.203.121.261.221.181.461.531.451.221.520.89

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Ritonavir (RTV) PK Parameter AUC0-12h.

This evaluates the effect of MPA on the PK parameter AUC0-12h of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4. Blood samples were drawn for RTV concentration levels at time zero (before LPV/r dosing) and at 30 minutes and 1, 2, 3, 4, 5, 6, 8 and 10 hours after LPV/r dosing at day 0 and week 4. (NCT01296152)
Timeframe: Day 0 and Week 4

Interventionng*h/mL (Median)
RTV AUC0-12h day 0RTV AUC0-12h week 4
Depo-medroxyprogesterone Acetate (DMPA)5176.795014.73

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RTV PK Parameter CL/F.

This evaluates the effect of MPA on the PK parameter CL/F of RTV obtained from both sampling periods, before DMPA injection at study day 0 and after DMPA injection at study week 4. (NCT01296152)
Timeframe: Day 0 and Week 4

InterventionL/hour (Median)
RTV CL/F day 0RTV CL/F week 4
Depo-medroxyprogesterone Acetate (DMPA)19.3219.94

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Proportion of Participants With >5% Weight Gain at 24 Weeks

Individual subjects will be assessed after their Week 24 visit. (NCT01461824)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
150 mg DMPA1
104mg DMPA2
75mg DMPA2

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Percent Change in Total Hip BMD From Baseline to 48 Weeks

Total hip bone mineral density was assessed at baseline and 48 weeks. Percent change from baseline to 48 weeks was calculated. (NCT01461824)
Timeframe: Percent change from baseline to 48 weeks

InterventionPercent change (Mean)
150 mg DMPA-3.0
104mg DMPA-1.6
75mg DMPA-0.1

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Percent Change in Lumbar Spine Bone Mineral Density (BMD) From Baseline to 48 Weeks

Lumbar spine bone mineral density measured at baseline and 48 weeks. Percent change over this time was calculated. (NCT01461824)
Timeframe: Percent change from baseline to 48 Weeks

Interventionpercent change (Mean)
150 mg DMPA-4.0
104mg DMPA-3.1
75mg DMPA-0.6

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Rates of Postpartum Depression After Postpartum or Delayed Initiation of DMPA

Edinburgh Postnatal Depression Scale (EPDS) score after postpartum or delayed initiation of DMPA: minimum possible score 0, maximum possible score 30; score of 12 or greater is a positive screen for postpartum depression (NCT01463202)
Timeframe: 8 weeks postpartum

Interventionscores on a scale (Median)
DMPA Postpartum1.0
DMPA at 4-6 Weeks After Delivery0

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Exclusivity of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA

Exclusive breastfeeding at specific time intervals postpartum (NCT01463202)
Timeframe: 2, 4, 6, 8, 12, 16, 20,24 and 28 weeks postpartum

InterventionParticipants (Count of Participants)
2 weeks postpartum722463982 weeks postpartum722463994 weeks postpartum722463984 weeks postpartum722463996 weeks postpartum722463986 weeks postpartum722463998 weeks postpartum722463998 weeks postpartum7224639812 weeks postpartum7224639812 weeks postpartum7224639916 weeks postpartum7224639916 weeks postpartum7224639820 weeks postpartum7224639820 weeks postpartum7224639924 weeks postpartum7224639824 weeks postpartum7224639928 weeks postpartum7224639828 weeks postpartum72246399
Missed callExclusive breastfeedingAny formula
DMPA Postpartum38
DMPA at 4-6 Weeks After Delivery37
DMPA Postpartum37
DMPA Postpartum4
DMPA at 4-6 Weeks After Delivery3
DMPA Postpartum29
DMPA at 4-6 Weeks After Delivery28
DMPA Postpartum44
DMPA at 4-6 Weeks After Delivery45
DMPA at 4-6 Weeks After Delivery4
DMPA Postpartum25
DMPA at 4-6 Weeks After Delivery25
DMPA Postpartum45
DMPA at 4-6 Weeks After Delivery47
DMPA at 4-6 Weeks After Delivery5
DMPA Postpartum23
DMPA at 4-6 Weeks After Delivery19
DMPA Postpartum50
DMPA at 4-6 Weeks After Delivery50
DMPA Postpartum6
DMPA Postpartum17
DMPA at 4-6 Weeks After Delivery22
DMPA Postpartum56
DMPA at 4-6 Weeks After Delivery46
DMPA Postpartum13
DMPA at 4-6 Weeks After Delivery15
DMPA Postpartum57
DMPA at 4-6 Weeks After Delivery53
DMPA Postpartum8
DMPA at 4-6 Weeks After Delivery8
DMPA Postpartum11
DMPA at 4-6 Weeks After Delivery55
DMPA Postpartum10
DMPA at 4-6 Weeks After Delivery11
DMPA Postpartum9
DMPA at 4-6 Weeks After Delivery56
DMPA Postpartum12
DMPA at 4-6 Weeks After Delivery10
DMPA Postpartum7
DMPA at 4-6 Weeks After Delivery6
DMPA Postpartum60
DMPA at 4-6 Weeks After Delivery57
DMPA at 4-6 Weeks After Delivery13

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Duration of Breastfeeding Among Women Who Plan to Breastfeed Their Infants After Postpartum or Delayed (4-6 Weeks Postpartum) Initiation of DMPA

Any breastfeeding at specific time intervals postpartum (NCT01463202)
Timeframe: 2, 4, 6, 8 12, 16, 20, 24, and 28 weeks postpartum

InterventionParticipants (Count of Participants)
2 weeks postpartum722463982 weeks postpartum722463994 weeks postpartum722463994 weeks postpartum722463986 weeks postpartum722463996 weeks postpartum722463988 weeks postpartum722463998 weeks postpartum7224639812 weeks postpartum7224639912 weeks postpartum7224639816 weeks postpartum7224639816 weeks postpartum7224639920 weeks postpartum7224639920 weeks postpartum7224639824 weeks postpartum7224639924 weeks postpartum7224639828 weeks postpartum7224639828 weeks postpartum72246399
Formula onlyMissed callAny breastfeeding
DMPA Postpartum71
DMPA at 4-6 Weeks After Delivery70
DMPA Postpartum4
DMPA at 4-6 Weeks After Delivery4
DMPA at 4-6 Weeks After Delivery3
DMPA Postpartum69
DMPA at 4-6 Weeks After Delivery66
DMPA at 4-6 Weeks After Delivery7
DMPA Postpartum61
DMPA at 4-6 Weeks After Delivery63
DMPA Postpartum9
DMPA at 4-6 Weeks After Delivery9
DMPA at 4-6 Weeks After Delivery5
DMPA Postpartum59
DMPA at 4-6 Weeks After Delivery53
DMPA Postpartum14
DMPA at 4-6 Weeks After Delivery16
DMPA at 4-6 Weeks After Delivery8
DMPA Postpartum51
DMPA at 4-6 Weeks After Delivery47
DMPA Postpartum22
DMPA at 4-6 Weeks After Delivery21
DMPA Postpartum6
DMPA Postpartum40
DMPA at 4-6 Weeks After Delivery40
DMPA Postpartum30
DMPA at 4-6 Weeks After Delivery28
DMPA Postpartum8
DMPA at 4-6 Weeks After Delivery31
DMPA Postpartum29
DMPA at 4-6 Weeks After Delivery34
DMPA Postpartum10
DMPA at 4-6 Weeks After Delivery11
DMPA Postpartum34
DMPA at 4-6 Weeks After Delivery32
DMPA Postpartum32
DMPA Postpartum12
DMPA at 4-6 Weeks After Delivery10
DMPA Postpartum39
DMPA at 4-6 Weeks After Delivery38
DMPA Postpartum28
DMPA at 4-6 Weeks After Delivery25
DMPA Postpartum11
DMPA at 4-6 Weeks After Delivery13

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Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation

(NCT01791413)
Timeframe: Within the first 2 weeks and 3 months after surgery

Interventionpercentage of serum AMH change (Median)
2 wk Post op : No Depot Medroxyprogesterone Acetate-56.86
2 wk Post op:Depot Medroxyprogesterone Acetate-77.72
3 mo. Post op: No Depot Medroxyprogesterone Acetate-36.69
3 mo. Post op: Depot Medroxyprogesterone Acetate-66.84

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Changes in Executive Cognitive Function: Digits Span Forward and Backward, 6 Months

Change in score on the Digit Span Test between baseline and 6 month. Raw scores on the Digit Span test range from 0-16 (Digits Forward) and 0-10 (Digits Backward) with higher scores indicating better performance. A positive change score indicates improved performance. (NCT02122198)
Timeframe: Baseline, 6 months

,
Interventionnumber of correct trials (Mean)
Digits Forward (trials correct)Digits Backward (trials correct)
GnRH Agonist-0.880.00
Placebo1.00-0.67

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Changes in Executive Cognitive Function: Controlled Oral Word Association Test, 6 Months

Change in sum of scores on 3 COWAT trials (letters, F, A, and S) between baseline and 6 months. Participants are given one minute to think up as many words as they can associated with each letter (F, A, or S). Raw scores are the total number of words generated across all trials. Higher scores indicate more words generated and better performance. Positive change score indicates an increase in words generated, or improved performance. (NCT02122198)
Timeframe: Baseline, 6 months

Interventionwords generated (Mean)
Placebo-5.33
GnRH Agonist0.25

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Changes in Artery Compliance at 6 Months

Changes in carotid artery compliance will be measured using ultrasound in at baseline, 6 months. (NCT02122198)
Timeframe: Baseline, 6 months

Interventionmm^2/mmhgx10^-1 (Mean)
Placebo-0.048
GnRH Agonist-0.095

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Changes in Executive Cognitive Function: Controlled Oral Word Association Test, 9 Months

Change in sum of scores on 3 COWAT trials (letters, F, A, and S) between baseline and 9 months. Participants are given one minute to think up as many words as they can associated with each letter (F, A, or S). Raw scores are the total number of words generated across all trials. Higher scores indicate more words generated and better performance. Positive change score indicates an increase in words generated, or improved performance. (NCT02122198)
Timeframe: Baseline, 9 months

Interventionwords generated (Mean)
GnRH Agonist7.33

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Changes in Artery Compliance at 9 Months

Changes in carotid artery compliance will be measured using ultrasound in at baseline, 9 months. (NCT02122198)
Timeframe: Baseline, 9 months

Interventionmm^2/mmhgx10^-1 (Mean)
GnRH Agonist-0.002

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Changes in Prefrontal Cortex Brain Activation at 9 Months

Changes in patterns of brain activation in the prefrontal cortex using functional magnetic resonance imaging (fMRI) during a task of working memory will be measured at baseline, 6 months, and 9 months (GnRH agonist arm only). Beta weight is the percent signal change on the FMRI from one condition to another. The FMRI is measuring blood oxygen levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. A positive number/increase indicates more blood flow and brain activity in that area. (NCT02122198)
Timeframe: Baseline, 9 months

Interventionbeta-weight (Mean)
Frontal Pole (L)Frontal Orbital Cortex (L)Superior Frontal Gyrus (R)
GnRH Agonist-27.15-88.87-77.23

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Changes in Prefrontal Cortex Brain Activation at 6 Months

Changes in patterns of brain activation in the prefrontal cortex using functional magnetic resonance imaging (fMRI) during a task of working memory will be measured at baseline, 6 months, and 9 months (GnRH agonist arm only). Beta weight is the percent signal change on the FMRI from one condition to another. The FMRI is measuring blood oxygen levels and blood flow in different regions of the brain and using that to determine activity changes in the brain. A positive number/increase indicates more blood flow and brain activity in that area. (NCT02122198)
Timeframe: Baseline, 6 months

,
Interventionbeta-weight (Mean)
Frontal Pole (L)Frontal Orbital Cortex (L)Superior Frontal Gyrus (R)
GnRH Agonist-62.20-79.04-53.05
Placebo90.6428.0792.45

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Changes in Executive Cognitive Function: Digits, 9 Months

Change in score on the Digit Span Test between baseline and 9 months. Raw scores on the Digit Span test range from 0-16 (Digits Forward) and 0-10 (Digits Backward) with higher scores indicating better performance. A positive change score indicates improved performance. (NCT02122198)
Timeframe: Baseline, 9 months

Interventionnumber of trials correct (Mean)
Digits Forward (trials correct)Digits Backward (trials correct)
GnRH Agonist1.001.0

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Changes in Executive Cognitive Function: Trails B, 9 Months

Change in time (seconds) to complete Trails B test between baseline and 9 months. Negative value indicates faster time (better performance) at 9 months compared to baseline. (NCT02122198)
Timeframe: Baseline, 9 months

Interventiontime (seconds) (Mean)
GnRH Agonist14.14

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Changes in Executive Cognitive Function: Trails B, 6 Months

Change in time (seconds) to complete Trails B test between baseline and 6 months. Negative value indicates faster time (better performance) at 6 months compared to baseline. (NCT02122198)
Timeframe: Baseline, 6 months

Interventiontime (seconds) (Mean)
Placebo14.23
GnRH Agonist-4.32

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Changes in Executive Cognitive Function: Trails A, 9 Months

Change in time (seconds) to complete Trails A test between baseline and 9 months. Negative value indicates faster time (better performance) at 9 months compared to baseline. (NCT02122198)
Timeframe: Baseline, 9 months

Interventiontime (seconds) (Mean)
GnRH Agonist-5.46

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Changes in Executive Cognitive Function: Trails A, 6 Months

Change in time (seconds) to complete Trails A test between baseline and 6 months. Negative value indicates faster time (better performance) at 6 months compared to baseline. (NCT02122198)
Timeframe: Baseline, 6 months

Interventionseconds (Mean)
Placebo2.79
GnRH Agonist-5.82

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Changes in Executive Cognitive Function: Stroop, 9 Months

Change in number of correct responses in one minute on Stroop Color Word Interference test between baseline and 9 months. Positive number indicates more items correct indicating better performance. There is no maximum score because the test measures how many correct responses a participant can return within one minute (minimum = 0), however 40 or fewer is considered low. The change in the number of correct responses is reported, and so a positive number indicates more correct responses and better/improved cognitive function. (NCT02122198)
Timeframe: Baseline, 9 months

Interventionnumber correct in one minute (Mean)
GnRH Agonist7.33

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Changes in Executive Cognitive Function: Stroop, 6 Months

Change in number of correct responses in one minute on Stroop Color Word Interference test between baseline and 6 months. A positive number indicates more items correct indicating better performance. There is no maximum score because the test measures how many correct responses a participant can return within one minute (minimum = 0), however 40 or fewer is considered low. The change in the number of correct responses is reported, and so a positive number indicates more correct responses and better/improved cognitive function. (NCT02122198)
Timeframe: Baseline, 6 months

Interventionnumber correct in one minute (Mean)
Placebo-0.67
GnRH Agonist0.25

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Changes in Executive Cognitive Function: RAVLT, 9 Months

"Change in Rey Auditory Verbal Learning Test from baseline to 9 months.~Score is the change in the number of items correct on delayed recall trial. Scores on the RAVLT range from 0-15 with higher scores indicating better performance. A positive change indicates improvement in recall." (NCT02122198)
Timeframe: Baseline, 9 months

Interventionnumber of items recalled (Mean)
GnRH Agonist0

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Changes in Executive Cognitive Function: RAVLT, 6 Months

"Change in Rey Auditory Verbal Learning Test from baseline to 6 months.~Score is the change in the number of items correct on delayed recall trial. Scores on the RAVLT range from 0-15 with higher scores indicating better performance. A positive change indicates improvement in recall." (NCT02122198)
Timeframe: Baseline, 6 months

Interventionnumber of items recalled (Mean)
Placebo-1.00
GnRH Agonist-1.38

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Contraceptive Satisfaction

"Satisfaction will be measured in response to the question, How satisfied are you with your current birth control method? This question will be asked to the participant at the 6 month follow-up visit. Answer choices that participants could choose from range from Very Good to Very Poor. Good or Very Good responses will be analyzed as having been satisfied with the method." (NCT02144259)
Timeframe: 1 year

Interventionpercentage of women satisfied w. method (Number)
DMPA Group74
Implanon Group89
Control Group75

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Pregnancy Rate

The secondary outcome variable is pregnancy rate. Pregnancy testing will occur at 3, 6 and 12 months postpartum or at any time that a participant felt that she might be pregnant. (NCT02144259)
Timeframe: 1 year

Interventionnumber of pregnancies (Number)
DMPA Group1
Implanon Group1
Control Group4

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Weight

Weight will be measured at 6 months postpartum. Percent weight change will be compared amongst the groups (NCT02144259)
Timeframe: 6 months from postpartum (baseline)

Interventionpercent weight lost (Mean)
DMPA Group3.2
Implanon Group6.8
Control Group7.0

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Median Progression-free Survival

Progression-free Survival is defined as the duration alive from study entry until progression is documented, or death; whichever comes sooner. Progressive disease is defined as at least a 5 mm absolute increase and a 20% relative increase in the sum of measurable target lesions' longest dimensions relative to the smallest sum at baseline or on study or the appearance of new lesions or unequivocal progression of existing non-target lesions. (NCT02228681)
Timeframe: Tumor measurements were done at 8 and 16 weeks after initiating treatment and then every 12 weeks and compared with baseline measurements prior to treatment. Measurements are continued until disease progression is documented or death.

Interventionmonths (Median)
Everolimus and Letrozole6.4
Tamoxifen and Medroxyprogesterone Acetate3.7

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Frequency of Response

"A confirmed complete or partial response as defined by RECIST 1.1 was considered a response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR" (NCT02228681)
Timeframe: From date of randomization until the date of first documented progression or date of death , up to 3 years.

InterventionNumber of participants (Number)
Everolimus and Letrozole9
Tamoxifen and Medroxyprogesterone Acetate8

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Median Survival

Survival is defined as the duration alive from study entry until death. (NCT02228681)
Timeframe: Following treatment discontinuation, patients are followed quarterly for 2 years, semi-annually for 3 more years, annually thereafter.

InterventionMonths (Median)
Everolimus and LetrozoleNA
Tamoxifen and Medroxyprogesterone Acetate16.6

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Frequency and Severity of CTCAE (Common Toxicity Criteria for Adverse Events) Version 4

Maximum grade of physician assessed adverse events graded and categorized using Common Toxicity Criteria for Adverse Events (CTCAE) version 4 (NCT02228681)
Timeframe: Assessed throughout the treatment period and for 30 days after discontinuation of treatment. Treatment continues until progression of disease.

,
InterventionParticipants (Count of Participants)
Grade 1Grade 2Grade 3Grade 4Grade 5
Everolimus and Letrozole262720
Tamoxifen and Medroxyprogesterone Acetate2141721

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Ratio of CD4/Cluster of Differentiation 8 (CD8) T-Cells Within Female Genital Mucosa and Blood

CD4/CD8 ratios above 1 indicate a strong immune system while lower ratios indicate a viral infection. (NCT02357368)
Timeframe: Week 1, Week 17

,,,
InterventionCD4/CD8 (Mean)
CD4/CD8 Ratio Cervicovaginal Lavage (CVL) Week 1CD4/CD8 Ratio CVL Week 17CD4/CD8 Ratio Peripheral Blood Mononuclear Cell (PBMC) Week 1CD4/CD8 Ratio PBMC Week 17
Depot Medroxyprogesterone Acetate (DMPA)2.42.64.32.6
Etonogestrel Impant (Eng-Implant)2.62.33.13.3
Levonorgestrel Intrauterine Device (Lng-IUD)2.92.32.92.5
ParaGard® T 380A Intrauterine Copper Contraceptive3.94.94.75.4

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Concentration Levels of Secreted Cytokines and Chemokines Within the Female Genital Mucosa and Blood

The concentration levels of interleukin 1 (IL-1) family cytokines and interferon gamma-induced protein 10 (IP-10) chemokines were determined using multiplex Luminex® assays combined with a customized multi-analytical panel of 22 human cytokines and chemokines. IL-1 and IP-10 have been found to influence recruitment of HIV target cells to the female reproductive tract and this study is examining changes in IL-1 and PI-10 to gain further understanding of these mechanisms. (NCT02357368)
Timeframe: Week 1, Week 17

,,
Interventionpg/mL (Mean)
IP-10 Cervicovaginal Lavage (CVL) Week 1IP-10 CVL Week 17IP-10 Peripheral Blood Mononuclear Cell (PBMC) Week 1IP-10 PBMC Week 17IL-1a CVL Week 1IL-1a CVL Week 17IL-1a PBMC Week 1IL-1a PBMC Week 17IL-1b CVL Week 1IL-1b CVL Week 17IL-1b PBMC Week 1IL-1b PBMC Week 17
Depot Medroxyprogesterone Acetate (DMPA)689.8445.83298.53114.4752.2550.758.547.832.921.120.020.8
Etonogestrel Impant (Eng-Implant)2551.12417.64107.33954.31640.22120.6156.2144.1583.4485.851.446.5
Levonorgestrel Intrauterine Device (Lng-IUD)1100.21241.5204.4209.6256.4184.754.665.143.937.14.24.3

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Percent of HIV Target Immune Cells Within Female Genital Mucosa and Blood

Following exposure to HIV, initial infection occurs at the genital mucosa and may involve complex interactions between a number of HIV target immune cells. HIV often uses C-C Chemokine Receptor Type 5 (CCR5) for entrance into target immune cells, causing infection of the cell. The amount of CCR5 expressing macrophages is associated with HIV infection. Cluster of differentiation 4 (CD4) T Cells are targeted and infected by HIV and CD4 percentages are used to assess immune status. CD4 counts vary by individuals and generally decrease with HIV infection. (NCT02357368)
Timeframe: Week 1, Week 17

,,,
Interventionpercentage of HIV target immune cells (Mean)
CCR5+ CD4 T-cells Cervicovaginal Lavage (CVL) Week 1CCR5+ CD4 T-cells CVL Week 17CCR5+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1CCR5+ CD4 T-cells PBMC Week 17CD4% CVL Week 1CD4% CVL Week 17CD4% PBMC Week 1CD4% PBMC Week 17
Depot Medroxyprogesterone Acetate (DMPA)26.639.24.15.747.247.465.663.9
Etonogestrel Impant (Eng-Implant)22.832.23.94.248.747.067.467.5
Levonorgestrel Intrauterine Device (Lng-IUD)16.923.32.92.654.048.865.763.4
ParaGard® T 380A Intrauterine Copper Contraceptive22.415.38.37.563.447.573.371.1

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Percent of Markers of T-cell Activation and Trafficking Within the Female Genital Mucosa and Blood

T cell activation correlates with HIV infection progression and this study seeks to gain better understanding of these underlying mechanisms by assessment of HIV target cells. Changes in cluster of differentiation 38 (CD38) expression are indicators of HIV disease progression with increases seen in CD38+ when a chronic HIV infection is progressing. Human leukocyte antigen-antigen D related (HLA-DR)+ expression appears to be involved in HIV proliferation. (NCT02357368)
Timeframe: Week 1, Week 17

,,,
Interventionpercentage of T cell activation markers (Mean)
CD38+ CD4 T-cells Cervicovaginal Lavage (CVL) Week 1CD38+ CD4 T-cells CVL Week 17CD38+ CD4 T-cells Peripheral Blood Mononuclear Cell (PBMC) Week 1CD38+ CD4 T-cells PBMC Week 17HLA-DR+ CD4 T-cells CVL Week 1HLA-DR+ CD4 T-cells CVL Week 17HLA-DR+ CD4 T-cells PBMC Week 1HLA-DR+ CD4 T-cells PBMC Week 17CD38+ Target (CCR5+ CD4+) T cells CVL Week 1CD38+ Target (CCR5+ CD4+) T cells CVL Week 17CD38+ Target (CCR5+ CD4+) T cells PBMC Week 1CD38+ Target (CCR5+ CD4+) T cells PBMC Week 17HLA-DR+ Target (CCR5+ CD4+) T cells CVL Week 1HLA-DR+ Target (CCR5+ CD4+) T cells CVL Week 17HLA-DR+ Target (CCR5+ CD4+) T cells PBMC Week 1HLA-DR+ Target (CCR5+ CD4+) T cells PBMC Week 17
Depot Medroxyprogesterone Acetate (DMPA)36.735.917.117.725.021.24.84.462.552.522.724.130.730.024.423.2
Etonogestrel Impant (Eng-Implant)36.941.717.617.626.917.83.02.364.561.626.029.641.325.522.621.6
Levonorgestrel Intrauterine Device (Lng-IUD)32.644.017.017.215.411.43.33.666.270.828.231.728.217.628.325.5
ParaGard® T 380A Intrauterine Copper Contraceptive23.245.525.236.38.721.13.42.512.742.418.630.920.126.516.510.1

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DMPA CL/F

Describe the apparent DMPA clearance (CL/F) between 0 and 12 weeks. The Week 0 time point was drawn prior to DMPA injection. (NCT02412436)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, and 12

InterventionL/week (Median)
Arm A: Depot Medroxyprogesterone Acetate19681

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Cumulative Percentage of Participants With DMPA < 0.1 ng/mL

The cumulative percentage of participants having a DMPA concentration less than 0.1 ng/mL at week 12 was calculated using a Kaplan-Meier estimator with an associated standard error. The confidence interval was calculated using a log-log transformation. Suppression of ovulation generally occurs as long as the DMPA level is => 0.1 ng/mL. (NCT02412436)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, and 12

Interventioncumulative percentage of participants (Number)
Arm A: Depot Medroxyprogesterone Acetate11.9

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DMPA AUC

Describe the DMPA plasma area under the curve (AUC) between 0 and 12 weeks, where AUC(0-12wks) was calculated using non-compartmental methods.The Week 0 time point was drawn prior to DMPA injection. (NCT02412436)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, and 12

Interventionng*week/mL (Median)
Arm A: Depot Medroxyprogesterone Acetate7.63

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Percent of Participants With DMPA Concentrations Below 0.1 ng/mL at Weeks 2, 4, 6, 8, and 10

The percents of participants with plasma DMPA concentrations below 0.1 ng/mL at weeks 2, 4, 6, 8, and 10 were calculated with exact Clopper-Pearson 95% confidence intervals. Suppression of ovulation generally occurs as long as the DMPA level is => 0.1 ng/mL. (NCT02412436)
Timeframe: Weeks 2, 4, 6, 8, and 10

Interventionpercentage of participants (Number)
Week 2 DMPA < 0.1 ng/mLWeek 4 DMPA < 0.1 ng/mLWeek 6 DMPA < 0.1 ng/mLWeek 8 DMPA < 0.1 ng/mLWeek 10 DMPA < 0.1 ng/mL
Arm A: Depot Medroxyprogesterone Acetate0.00.00.00.02.4

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Time at Which Participant-specific Estimated Elimination Slopes for DMPA Level Cross the Threshold of 0.1 ng/mL

Describe the time at which DMPA levels drop below the threshold of 0.1 ng/mL, based on participant-specific estimated elimination slopes from nonlinear mixed-effects (NLME) models. The Week 0 time point was drawn prior to DMPA injection. (NCT02412436)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, and 12

Interventiondays (Median)
Arm A: Depot Medroxyprogesterone Acetate74.2

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Percent of Participants With Progesterone Levels Above 1 ng/mL at Week 12

The percent of participants with plasma progesterone levels above 1 ng/mL was calculated with an exact Clopper-Pearson 95% confidence interval. Ovulation generally occurs when the progesterone level is > 5 ng/mL. If there were participants with plasma progesterone levels > 1 ng/mL, then the percent of participants with plasma progesterone levels > 5 ng/mL would have been calculated by study week. (NCT02412436)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Arm A: Depot Medroxyprogesterone Acetate0.0

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Percent of Participants With DMPA Concentrations Below 0.1 ng/mL at Week 12

The percent of participants with plasma DMPA concentrations below 0.1 ng/mL was calculated with an exact Clopper-Pearson 95% confidence interval. Suppression of ovulation generally occurs as long as the DMPA level is => 0.1 ng/mL. (NCT02412436)
Timeframe: Week 12

Interventionpercentage of participants (Number)
Arm A: Depot Medroxyprogesterone Acetate11.9

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Percent of Participants Who Experienced a Grade 3 or Higher Sign/Symptom or Laboratory Abnormality

The percent of participants who experienced a grade 3 (severe) or higher sign/symptom or laboratory abnormality were calculated with an exact Clopper-Pearson 95% confidence interval. Events were graded (1=mild, 2=moderate, 3=severe, 4=life-threatening, 5=death) according to the DAIDS AE Grading Table (V1.0). (NCT02412436)
Timeframe: Weeks 2, 4, 6, 8, 10, and 12

Interventionpercentage of participants (Number)
Arm A: Depot Medroxyprogesterone Acetate12.9

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DMPA Half-life

Describe the terminal elimination half-life of DMPA (t½) between 0 and 12 weeks, where t½ was calculated using nonlinear mixed-effects (NLME) modelling. The Week 0 time point was drawn prior to DMPA injection. (NCT02412436)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, and 12

Interventionhours (Median)
Arm A: Depot Medroxyprogesterone Acetate55

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DMPA Cmin

Describe the DMPA minimum observed concentration (Cmin) between 0 and 12 weeks. The Week 0 time point was drawn prior to DMPA injection. (NCT02412436)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, and 12

Interventionng/mL (Median)
Arm A: Depot Medroxyprogesterone Acetate0.33

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DMPA Cmax

Describe the DMPA maximum observed concentration (Cmax) between 0 and 12 weeks. The Week 0 time point was drawn prior to DMPA injection. (NCT02412436)
Timeframe: Weeks 0, 2, 4, 6, 8, 10, and 12

Interventionng/mL (Median)
Arm A: Depot Medroxyprogesterone Acetate1.04

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Number of Participants Who Were Satisfied With Home Use of Depot Medroxyprogesterone Acetate (DMPA sc) at One Year by Self-Report in the Self-Administration Arm

Number of participants who were satisfied with home use of Depot Medroxyprogesterone Acetate (DMPA sc) at one year by self-report in the self-administration arm only as measured by self-administered questionnaire. (NCT02509767)
Timeframe: 12 months from enrollment

InterventionParticipants (Count of Participants)
Self-Administration137

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Number of Participants With Depot Medroxyprogesterone Acetate (DMPA sc) Continuation at One Year by Self-report in Both the Self- and Clinic Administration Arms

Number of participants with Depot Medroxyprogesterone Acetate (DMPA sc) continuation at one year by self-report in both the self- and clinic administration arms measured by self-administered questionnaire. (NCT02509767)
Timeframe: 12 months from enrollment

InterventionParticipants (Count of Participants)
Self-Administration108
Clinic Administration (Standard Care)85

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Number of Participants Who Were Satisfied With Depot Medroxyprogesterone Acetate (DMPA sc) at One Year by Self-Report in Both the Self- and Clinic Administration Arms

Number of participants who reported being very or somewhat satisfied with Depot Medroxyprogesterone Acetate (DMPA sc) at one year in both the self- and clinic administration arms measured by self-administered questionnaire. (NCT02509767)
Timeframe: 12 months from enrollment

InterventionParticipants (Count of Participants)
Clinic Administration (Standard Care)147
Self-Administration137

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The Frequency and Severity of CTCAE Version 4.0 Graded Adverse Events (AE)

Maximum grade of physician assessed adverse events reported during treatment and up to 45 days after surgery. Grades start with 1 which is considered mild through grade 5 which is death. Participants on this study had adverse event grades up to grade 3 which is considered moderately severe. (NCT03018249)
Timeframe: Up to 45 days after surgery

,
Interventionparticipants (Number)
Grade 1 AEGrade 2 AEGrade 3 AEGrade 4 AEGrade 5 AE
Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA114200
Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat96200

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Mean Post-treatment Tumor Progesterone Receptor H-score (Histology Score)

The H-score is defined as the percent cells staining positive (0-100) multiplied by the staining intensity (0, 1, 2 or 3) measured in the tumor by immunohistochemistry and averaged over 3 reviewers. This score can range from 0 to 300. In general, PRs are expected to decrease in response to medroxyprogesterone acetate. It was hypothesized that entinostat would mitigate the decrease in PR relative to the medroxyprogesterone acetate only arm post treatment. Higher PR H-scores post treatment in the arm with entinostat relative to the medroxyprogesterone alone arm would be consistent with this hypothesis. Arm II was thought to result in higher scores which was expected to have a more favorable outcome when treated with MPA therapy. (NCT03018249)
Timeframe: Specimens were collected at hysterectomy on day 21-24 and analyzed in batch.

Interventionunits on a scale (Mean)
Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA53.6
Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat42.7

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Percent of Participants With a Ki67 Response

A response was defined as a decrease in Ki-67 protein expression in tumor from pre- to post-treatment. (NCT03018249)
Timeframe: Specimens were collected at initial diagnostic biopsy and at hysterectomy on day 21-24 and analyzed in batch.

InterventionParticipants (Count of Participants)
Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA15
Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat18

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Percentage of Participants With a Histologic Response

Pre- and post-treatment slides for each patient were evaluated in pairs for complete or partial histologic response by one reviewer. Pre- and post-treatment slides for each patient were evaluated in pairs for complete or partial histologic response by one reviewer. A histologic response was defined as either the absence of identifiable adenocarcinoma in the hysterectomy specimen section (complete) or, subjectively, as the presence of a complex proliferation of glands that retain the architectural characteristics of adenocarcinoma, but with features of secretion, decreased nuclear stratification, or the presence of eosinophilic, squamous or mucinous metaplasia, when this was absent in the initial sample (partial). (NCT03018249)
Timeframe: Specimens were collected at initial diagnostic biopsy and at hysterectomy on day 21-24 and analyzed in batch.

InterventionParticipants (Count of Participants)
Arm I (Medroxyprogesterone Acetate, Hysterectomy) MPA16
Arm II (Medroxyprogesterone Acetate, Entinostat, Hysterectomy) MPA and Entinostat14

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Participant's Perception of Pain, as Assessed by an Overall Ranking of the 4 Study Injections From Least to Most Painful

Each participant was asked to rank the injections according to overall pain from least (score = 1) to most (score = 4) painful. If a participant could not rank all of her injections from least to most painful or could not uniquely identify which injection was the most painful, then her responses were appropriately weighted across groups (for example, if a participant ranked all 4 treatments as equally most painful, then that participant contributed a score of 0.25 to each group when assessing the distribution of the most painful injection and in the event of a tie between 2 rankings, 0.5 was assigned to each tied ranking). (NCT03700658)
Timeframe: Day 0 (1 hour after injection)

,,,
Interventionfrequency (number of times) of ranking (Number)
Pain Rank 1Pain Rank 2Pain Rank 3Pain Rank 4
Depo-subQ 1049571
TV-46046 Diluted58.54.54
TV-46046 Placebo40612
TV-46046 Undiluted48.54.55

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Number of Participants With Injection Site Reactions (ISRs) (Excluding Injection Site Pain)

ISRs were assessed by self-reports and direct observation for each injection at least twice on the day of injection. ISRs included erythema (redness), swelling, pruritus (itching), bleeding, bruising, injection site discoloration (for example, hypopigmentation), or atrophy (that is, dimple). (NCT03700658)
Timeframe: Day 0 (immediately after and 1 hour after the injection) up to Month 18

InterventionParticipants (Count of Participants)
TV-46046 Undiluted12
TV-46046 Diluted6
TV-46046 Placebo0
Depo-subQ 1048

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Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were considered treatment emergent if (a) the onset occurred on or after the time of first injection or (b) an event had an onset prior to the first injection but increased in severity after administration of the injection. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section. (NCT03700658)
Timeframe: Day 0 up to Month 18

InterventionParticipants (Count of Participants)
Overall Study23

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Injection Site Pain Score, as Assessed by Numerical Rating Scale (NRS)

Participants assessed their injection site pain using an 11-point NRS (0 = no pain at all; 10 = worst pain). Higher scores denote worse outcome. (NCT03700658)
Timeframe: Day 0 (Immediately after and 1 hour after injection)

,,,
Interventionunits on a scale (Mean)
Immediately after injection1 hour after injection
Depo-subQ 1041.20.1
TV-46046 Diluted1.90.2
TV-46046 Placebo3.30.6
TV-46046 Undiluted2.10.2

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Number of Participants With Contraceptive Continuation at Twelve Months

Continuation of any contraceptive method a woman started in the postpartum period assessed by a survey at three and twelve months after study enrollment (NCT04005391)
Timeframe: 12 Months

InterventionParticipants (Count of Participants)
Postpartum Contraceptives Offered to Intervention Clusters73
Routine Care Offered to Control Clusters59

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Number of Participants With Repeat Pregnancy at Twelve Months

Repeat pregnancy after enrollment in the study, as assessed at the enrollment (baseline) visit and at three and twelve months after study enrollment. (NCT04005391)
Timeframe: 12 Months

InterventionParticipants (Count of Participants)
Postpartum Contraceptives Offered to Intervention Clusters0
Routine Care Offered to Control Clusters4

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Contraceptive Satisfaction at Twelve Months

Participant satisfaction with any contraceptive method the woman might be using as determined by a survey question that asks if the woman is very satisfied, satisfied, dissatisfied, or very dissatisfied. (NCT04005391)
Timeframe: 12 Months

,
InterventionParticipants (Count of Participants)
"Very Satisfied or Satisfied""Dissatisfied or Very Dissatisfied"
Postpartum Contraceptives Offered to Intervention Clusters6826
Routine Care Offered to Control Clusters5734

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Number of Participants With Any Contraceptive Use at Three Months

Participants actively using any contraceptive method three months after enrollment in the study as assessed by the three-month survey (NCT04005391)
Timeframe: 3 Months

InterventionParticipants (Count of Participants)
Postpartum Contraceptives Offered to Intervention Clusters83
Routine Care Offered to Control Clusters56

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Number of Participants With Implant Use at Three Months

(NCT04005391)
Timeframe: Three months

InterventionParticipants (Count of Participants)
Postpartum Contraceptives Offered to Intervention Clusters28
Routine Care Offered to Control Clusters2

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