Page last updated: 2024-11-07

drospirenone and ethinyl estradiol combination

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

drospirenone and ethinyl estradiol combination: female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes) [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID147740
SCHEMBL ID8464101
MeSH IDM0528511

Synonyms (26)

Synonym
yasmin 28
drospirenone/ethinyl estradiol
drospirenone-ethinylestradiol mixt
19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17alpha)-, mixt. with (2's,6r,7r,8r,9s,10r,13s,14s,15s,16s)-3',4',6,7,8,9,10,11,12,13,14,15,16,20,21-hexadecahydro-10,13-dimethylspiro(17h-dicyclopropa(6,7:15,16)cyclopenta(a)phenanthrene-17,2'(5'h)-furan)-3
ethinylestradiol-drospirenone mixt
drospirenone and ethinyl estradiol combination
gianvi
ee20/drsp
dr1021
vestura
nikki
syeda
164017-31-6
zarah
ocella
drospirenone; ethinyl estradiol
loryna
yaz-28
bay 86-5300
SCHEMBL8464101
petibelle
DTXSID80936898
5a,7a-dimethyl-1,1a,5,5a,5b,6,7,7a,8a,9,9a,9b,9c,9d-tetradecahydrospiro[cyclopropa[4,5]cyclopenta[1,2-a]cyclopropa[l]phenanthrene-8,2'-oxolane]-3,5'(4h)-dione--19-norpregna-1(10),2,4-trien-20-yne-3,17-diol (1/1)
(1r,2r,4r,10r,11s,14s,15s,16s,18s,19s)-10,14-dimethylspiro[hexacyclo[9.8.0.02,4.05,10.014,19.016,18]nonadec-5-ene-15,5'-oxolane]-2',7-dione;(8r,9s,13s,14s,17r)-17-ethynyl-13-methyl-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthrene-3,17-diol
(4ar,4bs,6as,7s,7as,8as,8bs,8cr,8dr,9ar)-4a,6a-dimethyl-3',4,4a,4b,4',5,6,6a,7a,8,8a,8b,8c,8d,9,9a-hexadecahydro-5'h-spiro[cyclopropa[4,5]cyclopenta[1,2-a]cyclopropa[l]phenanthrene-7,2'-furan]-2,5'(3h)-dione compound with (8r,9s,13s,14s,17r)-17-ethynyl-13
AKOS040751644

Research Excerpts

Toxicity

ExcerptReferenceRelevance
"02 mg EE is a safe and significantly effective treatment for moderate truncal acne."( A single-center, randomized double-blind, parallel-group study to examine the safety and efficacy of 3mg drospirenone/0.02 mg ethinyl estradiol compared with placebo in the treatment of moderate truncal acne vulgaris.
Kimball, AB; Lima, XT; Palli, MB; Reyes-Habito, CM, 2013
)
0.39
" After 3 months of treatment, anthropometric assessments along with variations in sex hormones related index, glucolipid metabolic index, changes in bilateral ovarian volume, as well as adverse effect of the combination were evaluated."( Effectiveness and safety assessment of drospirenone/ethinyl estradiol tablet in treatment of PCOS patients: a single center, prospective, observational study.
Chen, Z; Huang, L; Ke, H; Li, L; Li, TT; Li, X; Peng, X; Tan, Q; Yang, Y; Zeng, J; Zhang, H; Zhang, R, 2020
)
0.56
" It was seen that 81 patients reported no adverse reactions."( Effectiveness and safety assessment of drospirenone/ethinyl estradiol tablet in treatment of PCOS patients: a single center, prospective, observational study.
Chen, Z; Huang, L; Ke, H; Li, L; Li, TT; Li, X; Peng, X; Tan, Q; Yang, Y; Zeng, J; Zhang, H; Zhang, R, 2020
)
0.56

Pharmacokinetics

ExcerptReferenceRelevance
" The co- administration of EE had no relevant effect on the pharmacokinetic parameters of 3 mg DRSP."( Pharmacokinetics of drospirenone and ethinylestradiol in Caucasian and Japanese women.
Blode, H; Kowal, K; Reif, S; Roth, K, 2012
)
0.38
"A moderate pharmacokinetic drug-drug interaction between DRSP and KTZ was demonstrated in this study."( Pharmacokinetic interaction between the CYP3A4 inhibitor ketoconazole and the hormone drospirenone in combination with ethinylestradiol or estradiol.
Berse, M; Gschwend, S; Höchel, J; Klein, S; Schütt, B; Wiesinger, H; Zollmann, FS, 2015
)
0.42

Compound-Compound Interactions

ExcerptReferenceRelevance
" Mean plasma concentration-time profiles for atazanavir, tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), darunavir (DRV, administered with ritonavir [RTV]), and drospirenone/ethinylestradiol were similar following co-administration of GSK2248761."( Drug interaction profile for GSK2248761, a next generation non-nucleoside reverse transcriptase inhibitor.
de Serres, M; Gould, E; Johnson, M; Kim, J; Lou, Y; Mayers, D; Pietropaolo, K; Piscitelli, S; White, S; Zhou, XJ, 2012
)
0.38
"The objective of this study was to evaluate the effect of three contraceptive pills containing ethinylestradiol (EE) (20 or 30 mcg) in combination with drospirenone (DRSP) and levonorgestrel (LNG) on plasma concentration of adhesion molecules vascular cell adhesion molecule -1 (VCAM-1), intercellular adhesion molecule-1 (ICAM-1) and E-selectin."( Drospirenone and levonorgestrel in combination with either 30 or 20 mcg ethinylestradiol reduce soluble adhesion molecules in Brazilian women; cross-sectional study.
Franceschini, SA; Fumagalli, HF; Martinez, EZ; Marzocchi-Machado, CM; Stocco, B; Toloi, MR, 2012
)
0.38
"A cross-sectional study was conducted with 72 participants (18-30 years old) distributed into three groups that used oral contraceptives containing EE 20 or 30 mcg combined with DRSP 3 mg or EE 30 mcg/LNG 150 mcg for at least 6 months."( Drospirenone and levonorgestrel in combination with either 30 or 20 mcg ethinylestradiol reduce soluble adhesion molecules in Brazilian women; cross-sectional study.
Franceschini, SA; Fumagalli, HF; Martinez, EZ; Marzocchi-Machado, CM; Stocco, B; Toloi, MR, 2012
)
0.38
"The aim of this study was to investigate the effects of treatment with drospirenone/ethinyl oestradiol (E/E) alone or in combination with metformin on the elastic properties of the aorta in women with PCOS."( The effects of treatment with drospirenone/ethinyl oestradiol alone or in combination with metformin on elastic properties of aorta in women with polycystic ovary syndrome.
Akpek, M; Calapkorur, B; Celik, A; Karaca, Z; Kaya, MG; Kelestimur, F; Unluhizarci, K; Yildirim, S, 2012
)
0.38
"The present study was conducted to investigate the influence of the strong CYP3A4 inhibitor ketoconazole (KTZ) on the pharmacokinetics of drospirenone (DRSP) administered in combination with ethinylestradiol (EE) or estradiol (E2)."( Pharmacokinetic interaction between the CYP3A4 inhibitor ketoconazole and the hormone drospirenone in combination with ethinylestradiol or estradiol.
Berse, M; Gschwend, S; Höchel, J; Klein, S; Schütt, B; Wiesinger, H; Zollmann, FS, 2015
)
0.42
"A moderate pharmacokinetic drug-drug interaction between DRSP and KTZ was demonstrated in this study."( Pharmacokinetic interaction between the CYP3A4 inhibitor ketoconazole and the hormone drospirenone in combination with ethinylestradiol or estradiol.
Berse, M; Gschwend, S; Höchel, J; Klein, S; Schütt, B; Wiesinger, H; Zollmann, FS, 2015
)
0.42

Dosage Studied

ExcerptRelevanceReference
" EE/DRSP 24+4 (24 tablets containing hormones plus 4 containing placebo) features an innovative dosing regimen."( [Extracontraceptive benefits of EE/DRSP (Yaz) in 24+4 day regimen].
Bruni Bresciani, V, 2010
)
0.36
" The bleeding patterns of two variants of a flexible dosing regimen designed to manage intracyclic bleeding problems during extended cycles were compared with that of a conventional OC regimen."( Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study.
Elliesen, J; Garie, SG; Jensen, JT; Trummer, D, 2012
)
0.38
" The primary regimen [management of intracyclic bleeding (flexible(MIB)) regimen] was an extended dosing regimen that required subjects to initiate 4-day tablet-free intervals after 3 days of breakthrough bleeding/spotting."( Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study.
Elliesen, J; Garie, SG; Jensen, JT; Trummer, D, 2012
)
0.38
"A flexible(MIB) dosing regimen of EE 20 mcg/drospirenone 3 mg is associated with good contraceptive efficacy and fewer bleeding/spotting days than the conventional 24/4 regimen."( Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study.
Elliesen, J; Garie, SG; Jensen, JT; Trummer, D, 2012
)
0.38
" Flexible extended dosing of a contraceptive containing drospirenone (DRSP) and ethinyl estradiol (EE) was designed to improve bleeding profiles during extended cycles through active management of bleeding symptoms."( Expert opinion on a flexible extended regimen of drospirenone/ethinyl estradiol contraceptive.
Han, L; Jensen, JT, 2014
)
0.4
"We examine the rationale for flexible extended dosing as well as review the dosing regimen."( Expert opinion on a flexible extended regimen of drospirenone/ethinyl estradiol contraceptive.
Han, L; Jensen, JT, 2014
)
0.4
"Flexible extended dosing of DRSP/EE (3 mg/20 μg) has similar pharmacokinetics and contraceptive efficacy of both conventional and fixed extended regimens."( Expert opinion on a flexible extended regimen of drospirenone/ethinyl estradiol contraceptive.
Han, L; Jensen, JT, 2014
)
0.4
"Although traditionally dosed combined oral contraceptives (COCs) (21 days of active pills, 7 days of inactive pills) have not been demonstrated as superior to placebo for the treatment of premenstrual dysphoria (PMD), some randomized controlled trials (RCTs) indicate that oral contraceptives administered with a shortened or eliminated hormone-free interval are superior to placebo."( Treatment of premenstrual dysphoria with continuous versus intermittent dosing of oral contraceptives: Results of a three-arm randomized controlled trial.
Eisenlohr-Moul, TA; Girdler, SS; Johnson, JL; Rubinow, DR; Schmidt, PJ, 2017
)
0.46
"Fifty-five women with prospectively confirmed PMD completed a three-arm, RCT in which they were randomized to 3 months of placebo (n = 22), intermittent drospirenone/ethinyl estradiol dosed on a 21-7 schedule (n = 17), or continuous drospirenone/estradiol (n = 16) following a baseline assessment month."( Treatment of premenstrual dysphoria with continuous versus intermittent dosing of oral contraceptives: Results of a three-arm randomized controlled trial.
Eisenlohr-Moul, TA; Girdler, SS; Johnson, JL; Rubinow, DR; Schmidt, PJ, 2017
)
0.46
"Background Combined oral contraceptive (COC) use has been associated with an increased risk of insulin resistance (IR) and other adverse cardiovascular events, despite efforts to reduce the dosage and/or progestin type."( Drospirenone-containing oral contraceptives do not affect glucose regulation and circulating corticosterone.
Adeyanju, OA; Olatunji, LA, 2019
)
0.51
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (125)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's11 (8.80)29.6817
2010's103 (82.40)24.3611
2020's11 (8.80)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 31.17

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be moderate demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index31.17 (24.57)
Research Supply Index5.20 (2.92)
Research Growth Index5.11 (4.65)
Search Engine Demand Index44.56 (26.88)
Search Engine Supply Index2.25 (0.95)

This Compound (31.17)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials51 (39.23%)5.53%
Reviews15 (11.54%)6.00%
Case Studies19 (14.62%)4.05%
Observational5 (3.85%)0.25%
Other40 (30.77%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (43)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Angeliq Regulatory Post Marketing Surveillance [NCT01064453]4,078 participants (Actual)Observational2007-06-30Completed
A Double-Blind Study to Evaluate the Pharmacokinetics of an Oral Contraceptive Containing Drospirenone and Ethinyl Estradiol When Co-administered With GSK2248761 in Healthy Adult Female Subjects [NCT01195974]Phase 113 participants (Actual)Interventional2010-09-14Terminated(stopped due to In a Phase II study in HIV-infected patients there were a number of seizures, although exact causality could not be assessed phase 1 activity was terminated.)
The Role of Dysbiosis of Gut Microbiota in the Pathogenesis of Polycystic Ovary Syndrome. [NCT03843736]Phase 3200 participants (Anticipated)Interventional2019-02-21Recruiting
Prospective, Open-label Observational Survey Evaluating Patients Compliance to Administration Regimen During Low Dose Combined Oral Contraceptive Use in Everyday Praxis Data on Oral Contraceptives Compliance - DOC Study [NCT01198444]11,884 participants (Actual)Observational2007-12-31Completed
Efficacy and Safety of Dingkundan Combined With Combination Oral Contraceptives in the Treatment of PCOS: an Open-label, Non-randomized Controlled Clinical Study [NCT05872425]120 participants (Anticipated)Interventional2023-02-01Recruiting
Continuous Versus Cyclic Use of Oral Contraceptives Following Surgery for Symptomatic Endometriosis [NCT02237131]Phase 450 participants (Anticipated)Interventional2014-04-30Recruiting
Low Dose of Aspirin for the Management of Endometriosis-associated Pelvic Pain: a Randomized, Open, Controlled Trial [NCT05156879]Phase 4220 participants (Anticipated)Interventional2021-12-23Recruiting
A Study in Healthy Female Participants to Investigate the Effect of JNJ-64530440 on the Single-dose of Ethinylestradiol and Drospirenone (Oral Contraceptive), and Midazolam, and the Effect of a High-fat Meal on the Single-dose of JNJ-64530440 [NCT03890341]Phase 10 participants (Actual)Interventional2021-06-01Withdrawn(stopped due to Stopped due to a strategic decision.)
A Single-Center, Randomized Double-Blind, Parallel-Group Study to Examine the Safety and Efficacy of YAZ Compared With Placebo In The Treatment Of Hidradenitis Suppurativa [NCT00722800]Phase 24 participants (Actual)Interventional2008-10-31Terminated(stopped due to Poor recruitment)
Continuous Versus Cyclical OCP Use in PCOS: A Pilot Study [NCT03819140]Phase 460 participants (Actual)Interventional2019-02-01Completed
Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC)) [NCT00905684]5,446 participants (Actual)Observational2009-06-30Completed
Continuous OC Treatment in PMDD: Steroid Hormone Mechanisms [NCT00927095]Phase 467 participants (Actual)Interventional2008-07-31Completed
Single Center, Double-blind, Randomized Study to Compare the Effect of SH T 00186 D on Follicular Development in a 24-day Regimen Versus a 21-day Regimen in Healthy Female Volunteers [NCT00673686]Phase 2105 participants (Actual)Interventional2004-05-31Completed
An Open-label, Fixed-sequence Cross-over, Two-period, Phase I Trial to Evaluate the Effect of Multiple Doses of BI 1358894 on the Pharmacokinetics of a Combination of Ethinylestradiol and Drospirenone in Healthy Female Subjects [NCT05934942]Phase 132 participants (Anticipated)Interventional2023-09-08Recruiting
Multi-Center, Randomized, Double-Blind Active-Controlled, Parallel Group Study to Investigate Plasma Folate, Red Blood Cell Folate and Homocysteine Levels During a 24 Week Oral Administration of an OC Containing Folate Compared to OC Alone [NCT00468481]Phase 3385 participants (Actual)Interventional2007-04-30Completed
Drospirenone and Ethinyl Estradiol Combinations (Yasmin) as Infertility Treatments for Premature Ovarian Failure: a Perspective Follow-up Study. [NCT02757469]20 participants (Anticipated)Interventional2016-05-31Not yet recruiting
Obesity, Insulin Resistance, and Bone Metabolism in Adolescents With PCOS: Effects of Insulin Sensitizers Versus Oral Contraceptives [NCT00640224]Phase 465 participants (Actual)Interventional2005-03-31Completed
Yasmin Regulatory Post Marketing Surveillance [NCT00923572]777 participants (Actual)Observational2007-12-31Completed
A Single-Center, Randomized Double-Blind, Parallel-Group Study to Examine the Safety and Efficacy Of YAZ Compared With Placebo In The Treatment Of Moderate Truncal Acne Vulgaris [NCT00722761]Phase 330 participants (Actual)Interventional2009-04-30Completed
An Open Label Study to Evaluate Cycle Control With Ortho Tri-Cyclen Lo (Norgestimate/Ethinyl Estradiol) and Yaz (Drospirenone/Ethinyl Estradiol) in Healthy Sexually Active Females [NCT00745901]Phase 4355 participants (Actual)Interventional2008-05-31Completed
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
[NCT01581814]Phase 399 participants (Actual)Interventional2008-10-31Completed
A Relative Bioavailability Study of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets Under Non-Fasting Conditions. [NCT01182207]Phase 133 participants (Actual)Interventional2006-07-31Completed
The Changes of Hemocoagulation and Lipoperoxidation in Women Using Combined Oral Contraceptives With Antiandrogenic Activity, Correction by Antioxidants [NCT02027337]Phase 4200 participants (Anticipated)Interventional2013-12-31Recruiting
A Multi-center, Open-label, Randomized, Controlled, Parallel-group Study to Assess Efficacy and Safety of an Extended Flexible Regimen of the Combined Oral Contraceptive SH T00186D (0.02 mg Ethinylestradiol as Beta-cyclodextrin Clathrate and 3 mg Drospire [NCT00569244]Phase 3223 participants (Actual)Interventional2007-12-31Completed
[NCT01603745]Phase 110 participants (Anticipated)Interventional2012-04-30Recruiting
A Phase 1, Open-label Study in Healthy Female Subjects to Investigate the Effects of Odalasvir and AL-335 at Steady-state, Given as Single Agents and in Combination With Simeprevir, on the Single-dose Pharmacokinetics of Ethinylestradiol and Drospirenone [NCT02885454]Phase 124 participants (Actual)Interventional2016-08-31Completed
A Relative Bioavailability Study of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets Under Fasting Conditions. [NCT01182194]Phase 132 participants (Actual)Interventional2006-06-30Completed
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
Open, Randomized, Parallel Multi-center Comparison of Cycle Control and Safety of the Oral Contraceptive Yasmin 20 in a 24-day Regimen vs. Mercilon for 7 Cycles in 440 Healthy Female Volunteers [NCT00624130]Phase 3453 participants (Actual)Interventional2004-03-31Completed
A Multicenter, Double-blind, Randomized, Placebo-controlled Study Comparing 3 Continuous Oral Angeliq (Drospirenone 3 mg/17ß-estradiol 1 mg, Drospirenone 2 mg /17ß-estradiol 1 mg, Drospirenone 1 mg /17ß-estradiol 1 mg) Combinations and 17ß-estradiol (1 mg [NCT00102141]Phase 3750 participants (Actual)Interventional2004-04-30Completed
Research on Risk Factors and Comprehensive Intervention Measures of Polycystic Ovary Syndrome Complicated With Mental Diseases Such as Depression and Anxiety [NCT04984070]100 participants (Anticipated)Interventional2021-01-01Recruiting
[NCT01511822]Phase 40 participants InterventionalCompleted
The Treatment of Menstrually-Related Mood Disorders With Extended Versus Interrupted Oral Contraceptives [NCT00089414]Phase 25 participants (Actual)Interventional2004-07-31Terminated(stopped due to Informed by manufacturer that CDB-2914 crosses blood-brain barrier invalidating Arm #3 of protocol.)
Comparison of Levonorgestrel Intrauterine System, Copper T Intrauterine Device and Oral Contraceptives on Life Quality [NCT01805817]Phase 40 participants (Actual)Interventional2012-12-31Withdrawn
Treatment of Polycystic Ovary Syndrome (POS) in Overweight Adolescents [NCT00714233]Phase 343 participants (Actual)Interventional2002-08-31Completed
Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri [NCT03037944]Early Phase 132 participants (Anticipated)Interventional2016-03-01Recruiting
A Mechanistic Examination of Continuous Cycle Oral Contractive Administration in Binge Eating [NCT04278755]Phase 28 participants (Actual)Interventional2020-09-24Terminated(stopped due to Halted prematurely due to COVID-19-related enrollment challenges.)
The Oral Contraceptive Pill for Premenstrual Worsening of Depression. [NCT00633360]32 participants (Actual)Interventional2008-02-29Completed
A Phase 1, Open-label Study in Healthy Female Subjects to Investigate the Effect of JNJ-56136379 at Steady-state on the Single-dose Pharmacokinetics of Ethinylestradiol and Drospirenone (Oral Contraceptive) and on the Single-dose Pharmacokinetics of Midaz [NCT03111511]Phase 118 participants (Actual)Interventional2017-03-27Completed
A Phase 1, Open-label, Fixed-sequence Study to Investigate the Effects of Multiple Doses of BMS-986278 on the Pharmacokinetics of Combined Oral Contraceptives (Drospirenone/Ethinyl Estradiol) in Healthy Female Participants [NCT05985590]Phase 136 participants (Anticipated)Interventional2023-08-18Recruiting
A Phase 1, Open-label Study in Healthy Female Subjects to Investigate the Drug-drug Interaction Between JNJ-64155806 and Ethinylestradiol/Drospirenone [NCT03126097]Phase 118 participants (Actual)Interventional2017-04-13Terminated(stopped due to Study stopping rules were met.)
The Association of Hormonal Intake and Demographic Factors With Breast Cancer Risk. An Egyptian Case-controlled Study [NCT05135013]200 participants (Anticipated)Observational2021-11-16Not yet recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
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 > 124 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 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-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]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
NCT00468481 (47) [back to overview]Mean Change From Baseline in Plasma Homocysteine Levels at Week 24
NCT00468481 (47) [back to overview]Mean Change From Baseline in Plasma Homocysteine Levels at Week 4
NCT00468481 (47) [back to overview]Mean Change From Baseline in Plasma Homocysteine Levels at Week 8
NCT00468481 (47) [back to overview]Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12
NCT00468481 (47) [back to overview]Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16
NCT00468481 (47) [back to overview]Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8
NCT00468481 (47) [back to overview]Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4
NCT00468481 (47) [back to overview]Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8
NCT00468481 (47) [back to overview]Mean Neural Tube Defect (NTD) Risk Reduction at Week 24
NCT00468481 (47) [back to overview]Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline
NCT00468481 (47) [back to overview]Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12
NCT00468481 (47) [back to overview]Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16
NCT00468481 (47) [back to overview]Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20
NCT00468481 (47) [back to overview]Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24
NCT00468481 (47) [back to overview]Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4
NCT00468481 (47) [back to overview]Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8
NCT00468481 (47) [back to overview]Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline
NCT00468481 (47) [back to overview]Mean Change From Baseline in Plasma Folate Levels at Week 4
NCT00468481 (47) [back to overview]Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16
NCT00468481 (47) [back to overview]Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20
NCT00468481 (47) [back to overview]Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24
NCT00468481 (47) [back to overview]Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4
NCT00468481 (47) [back to overview]Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20
NCT00468481 (47) [back to overview]Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline
NCT00468481 (47) [back to overview]Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12
NCT00468481 (47) [back to overview]Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16
NCT00468481 (47) [back to overview]Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20
NCT00468481 (47) [back to overview]Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24
NCT00468481 (47) [back to overview]Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4
NCT00468481 (47) [back to overview]Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8
NCT00468481 (47) [back to overview]Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline
NCT00468481 (47) [back to overview]Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12
NCT00468481 (47) [back to overview]Mean Change From Baseline in Plasma Folate Levels at Week 12
NCT00468481 (47) [back to overview]Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20
NCT00468481 (47) [back to overview]Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24
NCT00468481 (47) [back to overview]Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4
NCT00468481 (47) [back to overview]Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8
NCT00468481 (47) [back to overview]Plasma Folate Level at 24 Weeks
NCT00468481 (47) [back to overview]Red Blood Cell (RBC) Folate Level at 24 Weeks
NCT00468481 (47) [back to overview]Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12
NCT00468481 (47) [back to overview]Mean Change From Baseline in Plasma Folate Levels at Week 16
NCT00468481 (47) [back to overview]Mean Change From Baseline in Plasma Folate Levels at Week 20
NCT00468481 (47) [back to overview]Mean Change From Baseline in Plasma Folate Levels at Week 8
NCT00468481 (47) [back to overview]Mean Change From Baseline in Plasma Homocysteine Levels at Week 12
NCT00468481 (47) [back to overview]Mean Change From Baseline in Plasma Homocysteine Levels at Week 16
NCT00468481 (47) [back to overview]Mean Change From Baseline in Plasma Homocysteine Levels at Week 20
NCT00468481 (47) [back to overview]Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16
NCT00633360 (2) [back to overview]Percent Change in Daily Record of Severity of Problems (DRSP)
NCT00633360 (2) [back to overview]Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS)
NCT00640224 (23) [back to overview]SHBG at Baseline and 6 Months
NCT00640224 (23) [back to overview]Free Testosterone at Baseline and 6 Months
NCT00640224 (23) [back to overview]LDL at Baseline and 6 Months
NCT00640224 (23) [back to overview]DHEAS at Baseline and 6 Months
NCT00640224 (23) [back to overview]Adiponectin at Baseline and 6 Months
NCT00640224 (23) [back to overview]Cholesterol at Baseline and 6 Months
NCT00640224 (23) [back to overview]Delta 17-OHPreg at Baseline and 6 Months
NCT00640224 (23) [back to overview]Delta 17-OHProg at Baseline and 6 Months
NCT00640224 (23) [back to overview]Delta Androstenedione at Baseline and 6 Months
NCT00640224 (23) [back to overview]Delta DHEA at Baseline and 6 Months
NCT00640224 (23) [back to overview]Total Fat Mass at Baseline and 6 Months
NCT00640224 (23) [back to overview]Total Testosterone at Baseline and 6 Months
NCT00640224 (23) [back to overview]Triglycerides at Baseline and 6 Months
NCT00640224 (23) [back to overview]Percent Body Fat at Baseline and 6 Months
NCT00640224 (23) [back to overview]Peripheral Insulin Sensitivity at Baseline and 6 Months.
NCT00640224 (23) [back to overview]Morning Blood Pressure at Baseline and 6 Months
NCT00640224 (23) [back to overview]Non-HDL Cholesterol at Baseline and 6 Months
NCT00640224 (23) [back to overview]Leptin at Baseline and 6 Months
NCT00640224 (23) [back to overview]Night Blood Pressure at Baseline and 6 Months
NCT00640224 (23) [back to overview]Hs-CRP at Baseline and 6 Months
NCT00640224 (23) [back to overview]Hepatic Insulin Sensitivity at Baseline and 6 Months.
NCT00640224 (23) [back to overview]HDL at Baseline and 6 Months
NCT00640224 (23) [back to overview]Glucose Tolerance Status at Baseline and 6 Months.
NCT00714233 (6) [back to overview]Change in Free Androgen Index (FAI)
NCT00714233 (6) [back to overview]Change in SHBG
NCT00714233 (6) [back to overview]Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification
NCT00714233 (6) [back to overview]Triglyceride Concentration by Treatment Group
NCT00714233 (6) [back to overview]Weight Loss in Lifestyle Intervention Group
NCT00714233 (6) [back to overview]Change in Fasting Glucose
NCT00722761 (2) [back to overview]Percent Change in Truncal Lesion Counts
NCT00722761 (2) [back to overview]Percentage of Subjects Rated Clear or Almost Clear on the IGA and SGA at Week 24/ Early Termination
NCT00722800 (3) [back to overview]Mean Improvement in the Sartorius Severity Score at Month 6.
NCT00722800 (3) [back to overview]Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 6.
NCT00722800 (3) [back to overview]Change From Baseline in VAS Pain Scale at Month 6.
NCT00745901 (20) [back to overview]Overall Number of Days of Total Blood Loss
NCT00745901 (20) [back to overview]Overall Number of Days of Unscheduled Blood Loss
NCT00745901 (20) [back to overview]Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes
NCT00745901 (20) [back to overview]Patient Satisfaction - Overall
NCT00745901 (20) [back to overview]Number of Participants With Unscheduled Bleeding Cycle 3
NCT00745901 (20) [back to overview]Number of Days of Scheduled Blood Loss - Cycle 1
NCT00745901 (20) [back to overview]Number of Days of Scheduled Blood Loss - Cycle 2
NCT00745901 (20) [back to overview]Number of Days of Scheduled Blood Loss - Cycle 3
NCT00745901 (20) [back to overview]Number of Days of Total Blood Loss - Cycle 1
NCT00745901 (20) [back to overview]Number of Days of Total Blood Loss - Cycle 2
NCT00745901 (20) [back to overview]Number of Days of Total Blood Loss - Cycle 3
NCT00745901 (20) [back to overview]Number of Days of Unscheduled Blood Loss - Cycle 1
NCT00745901 (20) [back to overview]Number of Days of Unscheduled Blood Loss - Cycle 2
NCT00745901 (20) [back to overview]Number of Days of Unscheduled Blood Loss - Cycle 3
NCT00745901 (20) [back to overview]Number of Participants With Breakthrough Bleeding/Spotting Cycle 1
NCT00745901 (20) [back to overview]Number of Participants With Breakthrough Bleeding/Spotting Cycle 2
NCT00745901 (20) [back to overview]Number of Participants With Breakthrough Bleeding/Spotting Cycle 3
NCT00745901 (20) [back to overview]Number of Participants With Unscheduled Bleeding Cycle 1
NCT00745901 (20) [back to overview]Number of Participants With Unscheduled Bleeding Cycle 2
NCT00745901 (20) [back to overview]Overall Number of Days of Scheduled Blood Loss
NCT00927095 (1) [back to overview]Pre-Post Change in Premenstrual Symptom Severity
NCT01109979 (1) [back to overview]Brachial Artery Reactivity % Flow Mediated Dilation (BAR %FMD)
NCT01182194 (6) [back to overview]AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)
NCT01182194 (6) [back to overview]AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
NCT01182194 (6) [back to overview]AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
NCT01182194 (6) [back to overview]Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)
NCT01182194 (6) [back to overview]Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)
NCT01182194 (6) [back to overview]AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)
NCT01182207 (6) [back to overview]AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)
NCT01182207 (6) [back to overview]AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)
NCT01182207 (6) [back to overview]AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
NCT01182207 (6) [back to overview]AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)
NCT01182207 (6) [back to overview]Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)
NCT01182207 (6) [back to overview]Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)
NCT04278755 (8) [back to overview]Change From Pre-intervention to Intervention Endpoint in Binge Eating Sum Score
NCT04278755 (8) [back to overview]Change From Pre-intervention to Intervention Endpoint in Delay Discounting Parameter k
NCT04278755 (8) [back to overview]Change From Pre-intervention to Intervention Endpoint in Nucleus Accumbens Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
NCT04278755 (8) [back to overview]Change From Pre-intervention to Intervention Endpoint in Prefrontal Cortex Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
NCT04278755 (8) [back to overview]Change From Pre-intervention to Intervention Endpoint in Self-reported Reward Sensitivity Subscale Score
NCT04278755 (8) [back to overview]Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency
NCT04278755 (8) [back to overview]Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)
NCT04278755 (8) [back to overview]Change From Pre-intervention to Intervention Endpoint in Behavioral Inhibition Subscale Score

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 > 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 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 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-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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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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Mean Change From Baseline in Plasma Homocysteine Levels at Week 24

Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting. (NCT00468481)
Timeframe: baseline and up to week 24

Interventionµg/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)-0.3
Drospirenone (DRSP)/Ethinylestradiol (EE)0.1

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Mean Change From Baseline in Plasma Homocysteine Levels at Week 4

Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting. (NCT00468481)
Timeframe: baseline and up to week 4

Interventionµg/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)0
Drospirenone (DRSP)/Ethinylestradiol (EE)0

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Mean Change From Baseline in Plasma Homocysteine Levels at Week 8

Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting. (NCT00468481)
Timeframe: baseline and up to week 8

Interventionµg/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)-0.2
Drospirenone (DRSP)/Ethinylestradiol (EE)0

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Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 12

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: baseline and up to week 12

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)405.8
Drospirenone (DRSP)/Ethinylestradiol (EE)86.5

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Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 16

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: baseline and up to week 16

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)448.9
Drospirenone (DRSP)/Ethinylestradiol (EE)68.0

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Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: up to week 8

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)60.8
Drospirenone (DRSP)/Ethinylestradiol (EE)41.8

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Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 4

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: baseline and up to week 4

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)110.9
Drospirenone (DRSP)/Ethinylestradiol (EE)-37.6

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Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 8

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: baseline and up to week 8

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)310.3
Drospirenone (DRSP)/Ethinylestradiol (EE)68.2

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Mean Neural Tube Defect (NTD) Risk Reduction at Week 24

The mean NTD risk reduction evaluated as the change from Baseline to Week 24 in NTD risk based on the formula of Daly et al (J Amer Med Assoc 1995;274(21):1698-702); NTD risk=exp (1.6463-1.2193 x natural log [RBC folate]) where natural log [RBC folate] is the natural log of RBC folate measured in nmol/L; Change from Baseline to Week 24 in NTD risk=NTD risk at Week 24 - NTD risk at Baseline (NCT00468481)
Timeframe: Baseline and week 24

Interventionper 1000 birth (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)-0.51
Drospirenone (DRSP)/Ethinylestradiol (EE)-0.03

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Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: at baseline (week 0)

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)50.3
Drospirenone (DRSP)/Ethinylestradiol (EE)47.1

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Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: up to week 12

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)67.4
Drospirenone (DRSP)/Ethinylestradiol (EE)46.4

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Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: up to week 16

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)67.5
Drospirenone (DRSP)/Ethinylestradiol (EE)51.8

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Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: up to week 20

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)61.5
Drospirenone (DRSP)/Ethinylestradiol (EE)45.9

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Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: up to week 24

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)64.0
Drospirenone (DRSP)/Ethinylestradiol (EE)43.7

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Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: up to week 4

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)60.4
Drospirenone (DRSP)/Ethinylestradiol (EE)45.9

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Mean Plasma Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: up to week 8

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)68.1
Drospirenone (DRSP)/Ethinylestradiol (EE)54.1

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Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: at baseline (week 0)

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)41.7
Drospirenone (DRSP)/Ethinylestradiol (EE)41.5

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Mean Change From Baseline in Plasma Folate Levels at Week 4

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: baseline and up to week 4

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)15.2
Drospirenone (DRSP)/Ethinylestradiol (EE)0.6

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Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: up to week 16

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)59.4
Drospirenone (DRSP)/Ethinylestradiol (EE)43.2

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Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: up to week 20

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)59.8
Drospirenone (DRSP)/Ethinylestradiol (EE)39.7

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Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: up to week 24

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)58.7
Drospirenone (DRSP)/Ethinylestradiol (EE)39.8

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Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: up to week 4

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)59.6
Drospirenone (DRSP)/Ethinylestradiol (EE)43.1

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Mean Change From Baseline in Red Blood Cell (RBC) Folate Levels at Week 20

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: baseline and up to week 20

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)452.7
Drospirenone (DRSP)/Ethinylestradiol (EE)64.6

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Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Baseline

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: at baseline (week 0)

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)1122.8
Drospirenone (DRSP)/Ethinylestradiol (EE)1345.0

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Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 12

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: up to week 12

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)1469.8
Drospirenone (DRSP)/Ethinylestradiol (EE)1378.4

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Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 16

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: up to week 16

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)1460.5
Drospirenone (DRSP)/Ethinylestradiol (EE)1454.7

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Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 20

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: up to week 20

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)1486.6
Drospirenone (DRSP)/Ethinylestradiol (EE)1435.9

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Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 24

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: up to week 24

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)1500.3
Drospirenone (DRSP)/Ethinylestradiol (EE)1316.1

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Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 4

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: up to week 4

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)1175.7
Drospirenone (DRSP)/Ethinylestradiol (EE)1256.1

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Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (With Additional Folate Supplementation) at Week 8

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: up to week 8

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)1412.7
Drospirenone (DRSP)/Ethinylestradiol (EE)1407.6

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Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Baseline

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: at baseline (week 0)

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)910.9
Drospirenone (DRSP)/Ethinylestradiol (EE)915.1

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Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: up to week 12

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)1308.9
Drospirenone (DRSP)/Ethinylestradiol (EE)1025.2

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Mean Change From Baseline in Plasma Folate Levels at Week 12

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: baseline and up to week 12

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)17.6
Drospirenone (DRSP)/Ethinylestradiol (EE)0.3

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Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 20

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: up to week 20

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)1419.8
Drospirenone (DRSP)/Ethinylestradiol (EE)981.3

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Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 24

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: up to week 24

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)1355.3
Drospirenone (DRSP)/Ethinylestradiol (EE)949.2

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Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 4

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: up to week 4

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)1007.1
Drospirenone (DRSP)/Ethinylestradiol (EE)889.5

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Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 8

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: up to week 8

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)1184.8
Drospirenone (DRSP)/Ethinylestradiol (EE)970.4

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Plasma Folate Level at 24 Weeks

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: Week 24

Interventionnmol/L (Least Squares Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)60.55
Drospirenone (DRSP)/Ethinylestradiol (EE)41.67

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Red Blood Cell (RBC) Folate Level at 24 Weeks

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: Week 24

Interventionnmol/L (Least Squares Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)1406.91
Drospirenone (DRSP)/Ethinylestradiol (EE)1022.21

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Mean Plasma Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 12

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: up to week 12

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)59.5
Drospirenone (DRSP)/Ethinylestradiol (EE)42.3

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Mean Change From Baseline in Plasma Folate Levels at Week 16

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: baseline and up to week 16

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)17.6
Drospirenone (DRSP)/Ethinylestradiol (EE)2.4

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Mean Change From Baseline in Plasma Folate Levels at Week 20

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: baseline and up to week 20

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)15.1
Drospirenone (DRSP)/Ethinylestradiol (EE)-1.6

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Mean Change From Baseline in Plasma Folate Levels at Week 8

Folate concentrations in plasma were determined by an appropriately validated microbiological assay. (NCT00468481)
Timeframe: baseline and up to week 8

Interventionµg/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)18.4
Drospirenone (DRSP)/Ethinylestradiol (EE)2.2

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Mean Change From Baseline in Plasma Homocysteine Levels at Week 12

Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting. (NCT00468481)
Timeframe: baseline and up to week 12

Interventionµg/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)-0.3
Drospirenone (DRSP)/Ethinylestradiol (EE)0

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Mean Change From Baseline in Plasma Homocysteine Levels at Week 16

Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting. (NCT00468481)
Timeframe: baseline and up to week 16

Interventionµg/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)-0.2
Drospirenone (DRSP)/Ethinylestradiol (EE)-0.1

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Mean Change From Baseline in Plasma Homocysteine Levels at Week 20

Homocysteine concentrations in plasma were determined by Fluorescence Polarization Immunoassays (FPIA) using the Abbot AxSym analyzer in a clinical laboratory setting. (NCT00468481)
Timeframe: baseline and up to week 20

Interventionµg/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)-0.2
Drospirenone (DRSP)/Ethinylestradiol (EE)-0.2

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Mean Red Blood Cell (RBC) Folate Levels by Additional Folate Supplementation (Without Additional Folate Supplementation) at Week 16

RBC folate=([whole blood folate*100]-[plasma folate*(100-hematocrit)])/hematocrit (NCT00468481)
Timeframe: up to week 16

Interventionnmol/L (Mean)
Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)1365.2
Drospirenone (DRSP)/Ethinylestradiol (EE)967.6

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Percent Change in Daily Record of Severity of Problems (DRSP)

The DRSP is a 24-item self-administered daily dairy that assesses the severity of mood and physical symptoms which occur as part of the premenstrual syndrome and PMDD. Each question is rated on a scale of 1-6 with a total score range from 24-144. A higher score indicates greater symptom burden. (NCT00633360)
Timeframe: Baseline and 2 months

Interventionpercent change (Median)
Drospirenone and Ethinyl Estradiol-23.5
Placebo-20.9

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Percent Change in Luteal Montgomery-Asberg Depression Rating Scale (MADRS)

The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and during 2nd treatment month in order to calculate the change in MADRS score. (NCT00633360)
Timeframe: Baseline and 2 months

Interventionpercent change (Median)
Drospirenone and Ethinyl Estradiol-43.6
Placebo-38.9

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SHBG at Baseline and 6 Months

SHBG (sex hormone-binding globulin) was measured by immunoradiometric assay. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionnmol/L (Mean)
SHBG, BaselineSHBG, 6 months
Drospirenone/Ethinyl Estradiol22.7154.5
Rosiglitazone28.137.0

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Free Testosterone at Baseline and 6 Months

Free testosterone was measured by equilibrium dialysis. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionpg/mL (Mean)
Free Testosterone, BaselineFree Testosterone, 6 months
Drospirenone/Ethinyl Estradiol7.51.9
Rosiglitazone10.77.7

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LDL at Baseline and 6 Months

LDL (low-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionmg/dL (Mean)
LDL, BaselineLDL, 6 months
Drospirenone/Ethinyl Estradiol85.997.7
Rosiglitazone85.484.3

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DHEAS at Baseline and 6 Months

DHEAS (dehydroepiandrosterone sulfate) was measured by radioimmunoassay in dilute serum after hydrolysis. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionug/dL (Mean)
DHEAS, BaselineDHEAS, 6 months
Drospirenone/Ethinyl Estradiol212.2197.5
Rosiglitazone165.4160.9

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Adiponectin at Baseline and 6 Months

Adiponectin was measured by radioimmunoassay. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionug/mL (Mean)
Adiponectin, BaselineAdiponectin, 6 months
Drospirenone/Ethinyl Estradiol5.96.7
Rosiglitazone6.511.6

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Cholesterol at Baseline and 6 Months

Cholesterol was measured using the standards of the Centers for Disease Control and Prevention. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionmg/dL (Mean)
Cholesterol, BaselineCholesterol, 6 months
Drospirenone/Ethinyl Estradiol156.5185.2
Rosiglitazone149.5146.2

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Delta 17-OHPreg at Baseline and 6 Months

Delta 17-OHPreg (17-hydroxypregnenolone) was measured by HPLC-tandem mass spectroscopy. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionng/dL (Mean)
Delta 17-OHPreg, BaselineDelta 17-OHPreg, 6 months
Drospirenone/Ethinyl Estradiol1024.31088.9
Rosiglitazone912.8914.7

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Delta 17-OHProg at Baseline and 6 Months

Delta 17-OHProg (17-hydroxyprogesterone) was measured by HPLC-tandem mass spectroscopy. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionng/dL (Mean)
Delta 17-OHProg, BaselineDelta 17-OHProg, 6 months
Drospirenone/Ethinyl Estradiol169.8175.4
Rosiglitazone207.0178.0

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Delta Androstenedione at Baseline and 6 Months

Delta Androstenedione was measured by HPLC-tandem mass spectroscopy. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionng/dL (Mean)
Delta Androstenedione, BaselineDelta Androstenedione, 6 months
Drospirenone/Ethinyl Estradiol82.6117.0
Rosiglitazone79.258.4

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Delta DHEA at Baseline and 6 Months

Delta DHEA was measured by HPLC-tandem mass spectroscopy. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionug/dL (Mean)
Delta DHEA, BaselineDelta DHEA, 6 months
Drospirenone/Ethinyl Estradiol1001.61092.1
Rosiglitazone817.4643.4

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Total Fat Mass at Baseline and 6 Months

DXA (dual-energy x-ray absorptiometry) scans were done to measure total fat mass. (NCT00640224)
Timeframe: Baseline and 6 months

,
InterventionKg (Mean)
Fat mass, BaselineFat mass, 6 months
Drospirenone/Ethinyl Estradiol48.049.1
Rosiglitazone44.545.4

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Total Testosterone at Baseline and 6 Months

Total testosterone was measured by HPLC(high-performance liquid chromatography)-tandem mass spectroscopy. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionng/dL (Mean)
Total Testosterone, BaselineTotal Testosterone, 6 months
Drospirenone/Ethinyl Estradiol34.530.6
Rosiglitazone45.736.9

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Triglycerides at Baseline and 6 Months

Triglycerides were measured using the standards of the Centers for Disease Control and Prevention. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionmg/dL (Mean)
Triglycerides, BaselineTriglycerides, 6 months
Drospirenone/Ethinyl Estradiol148.4163.5
Rosiglitazone106.779.2

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Percent Body Fat at Baseline and 6 Months

DXA scans were done to measure the percentage of body fat. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionpercentage of body fat (Mean)
Percent body fat, BaselinePercent body fat, 6 months
Drospirenone/Ethinyl Estradiol47.348.2
Rosiglitazone46.246.6

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Peripheral Insulin Sensitivity at Baseline and 6 Months.

Peripheral insulin sensitivity was evaluated during the hyperinsulinemic-euglycemic clamp. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionmg/kg/min per uU/mL (Mean)
Peripheral insulin sensitivity, BaselinePeripheral insulin sensitivity, 6 months
Drospirenone/Ethinyl Estradiol2.12.0
Rosiglitazone2.23.2

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Morning Blood Pressure at Baseline and 6 Months

Morning blood pressure was measured with an automated sphygmomanometer. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionmm Hg (Mean)
Morning Systolic BP, BaselineMorning Diasytolic BP, BaselineMorning Systolic BP, 6 monthsMorning Diastolic BP, 6 months
Drospirenone/Ethinyl Estradiol108.558.1112.259.5
Rosiglitazone108.258.1107.558.7

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Non-HDL Cholesterol at Baseline and 6 Months

Non-HDL cholesterol was measured using the standards of the Centers for Disease Control and Prevention. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionmg/dL (Mean)
Non-HDL cholesterol, BaselineNon-HDL cholesterol, 6 months
Drospirenone/Ethinyl Estradiol70.687.6
Rosiglitazone65.362.3

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Leptin at Baseline and 6 Months

Leptin was measured by radioimmunoassay. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionng/mL (Mean)
Leptin, BaselineLeptin, 6 months
Drospirenone/Ethinyl Estradiol40.646.8
Rosiglitazone43.842.7

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Night Blood Pressure at Baseline and 6 Months

Night blood pressure was measured with an automated sphygmomanometer. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionmm Hg (Mean)
Night Systolic BP, BaselineNight Diastolic BP, BaselineNight Systolic BP, 6 monthsNight Diastolic BP, 6 months
Drospirenone/Ethinyl Estradiol112.958.6116.962.6
Rosiglitazone117.563.0115.261.7

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Hs-CRP at Baseline and 6 Months

hs-CRP(high-sensitivity C-reactive protein) was measured by COAG-Nephelometry. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionmg/L (Mean)
hs-CRP, Baselinehs-CRP, 6 months
Drospirenone/Ethinyl Estradiol1.73.8
Rosiglitazone2.12.2

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Hepatic Insulin Sensitivity at Baseline and 6 Months.

Hepatic insulin sensitivity was evaluated prior to the hyperinsulinemic-euglycemic clamp. (NCT00640224)
Timeframe: Baseline and 6 months

,
Intervention(mg/kg/min x uU/mL)-1 (Mean)
Hepatic insulin sensitivity, BaselineHepatic insulin sensitivity, 6 months
Drospirenone/Ethinyl Estradiol17.416.8
Rosiglitazone17.324.1

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HDL at Baseline and 6 Months

HDL (high-density lipoprotein) was measured using the standards of the Centers for Disease Control and Prevention. (NCT00640224)
Timeframe: Baseline and 6 months

,
Interventionmg/dL (Mean)
HDL, BaselineHDL, 6 months
Drospirenone/Ethinyl Estradiol40.955.0
Rosiglitazone42.746.1

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Glucose Tolerance Status at Baseline and 6 Months.

Glucose tolerance status was classified according to the ADA (American Diabetes Association) criteria. (NCT00640224)
Timeframe: Baseline and 6 months

,
InterventionParticipants (Count of Participants)
Normal glucose tolerance, baselineImpaired glucose tolerance, baselineNormal glucose tolerance, 6 monthsImpaired glucose tolerance, 6 months
Drospirenone/Ethinyl Estradiol128137
Rosiglitazone152152

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Change in Free Androgen Index (FAI)

Secondary measures of reduction in androgen measures of the different treatment arms. This is a ratio of total testosterone to sex hormone binding globulin (SHBG). The lower values correlate with lower amount of free testosterone. FAI <4 is consistent with a normal range. (NCT00714233)
Timeframe: baseline and 24 weeks

Interventiontotal T/SHBG (Mean)
Metformin-0.1
Oral Contraceptive-16.7
Lifestle-13.7
Placebo to Metformin1.2

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Change in SHBG

Measurement of SHBG by treatment group pre and post intervention (NCT00714233)
Timeframe: baseline and 24 weeks

Interventionratio (Mean)
Metformin2.6
Oral Contraceptive77
Lifestyle Counseling17.6
Placebo to Metformin2

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Measure Number of Adolescent Girls With PCOS Who Can be Successfully Recruited Into a Randomized Clinical Trial That Includes Lifestyle Modification

The measure is to determine a number of successfully recruited overweight or obese adolescents to a randomized trial of lifestyle therapy in the community of Rochester, NY (NCT00714233)
Timeframe: 24 week

Interventionparticipants (Number)
Metformin10
Oral Contraceptive11
Lifestyle Counseling11
Placebo to Metformin10

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Triglyceride Concentration by Treatment Group

Change in triglyceride measures pre and post intervention as representative of lipid changes by treatment group; metformin, lifestyle intervention, oral contraceptive or placebo (NCT00714233)
Timeframe: baseline and 24 weeks

Interventionmg/dL (Mean)
Metformin-22.3
Oral Contraceptive4.6
Lifestyle Counseling2.2
Placebo to Metformin-6.6

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Weight Loss in Lifestyle Intervention Group

In the adolescent women assigned to the lifestyle program, did the intervention program obtain weight reduction as measured by change in BMI (NCT00714233)
Timeframe: baseline and 24 weeks

Interventionkg/m^2 (Mean)
Lifestyle Program-1.1

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Change in Fasting Glucose

Change in fasting glucose concentration by treatment group pre to post intervention (NCT00714233)
Timeframe: baseline and 24 weeks

Interventionmg/dL (Mean)
Metformin-6.7
Oral Contraceptive6.9
Lifestyle Counseling0.4
Placebo to Metformin-1.1

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Percent Change in Truncal Lesion Counts

Acne lesion count (noninflammatory, inflammatory and total lesions) difference between week 0 (baseline) and week 24 is divided by the acne lesion count at week 0 and multiplied by 100. A positive change indicates a decrease in truncal acne lesions. (NCT00722761)
Timeframe: 0-24 weeks

,
Interventionpercentage change of lesions (Mean)
Noninflammatory lesionsInflammatory lesionsTotal acne lesions
Drosperinone and Ethinyl Estradiol52.153.251.8
Placebo Tablet-9.218.217

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Percentage of Subjects Rated Clear or Almost Clear on the IGA and SGA at Week 24/ Early Termination

Percentage of subjects rated Clear (score 0) or Almost Clear (score 1) on the Investigator's Global Assessment (IGA) of truncal acne at Week 24 as well as Subject's Assessment of Acne at Week 24/Early Termination were taken. It was computed by: number of successes (those scored 0 or 1)divided by the number of participants multiplied by 100. (NCT00722761)
Timeframe: 24 weeks

,
Interventionpercentage of participants (Number)
Investigator Global Assessment IGASubject Assessment SGA
Drosperinone and Ethinyl Estradiol53.360
Placebo Tablet2080

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Mean Improvement in the Sartorius Severity Score at Month 6.

The Sartorius Severity score reflects changes in hidradenitis suppurative symptoms, namely the number of lesions (abscesses, nodules, and fistulas) and the longest distance between lesions. A total score is derived based on assessments at up to 8 distinct anatomical regions and ranges from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement, thus decreases (negative changes) from baseline indicate improvement in severity of disease. (NCT00722800)
Timeframe: 6 months

Interventionunits on a scale (Mean)
Drospirenone and Ethinyl Estradiol (YAZ)-3.5
Placebo Tablets12

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Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 6.

Dermatology Life Quality Index (DLQI) Score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much, a lot, a little, or not at all. The DLQI score ranges from 0 (best) to 30 (worst). (NCT00722800)
Timeframe: 6 months

Interventionpoints (Mean)
Drospirenone and Ethinyl Estradiol (YAZ)3
Placebo Tablets8.5

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Change From Baseline in VAS Pain Scale at Month 6.

"For this pain assessment, the participant indicated the level of average pain experienced over the past 24 hours on a horizontal line, 10 cm in length. A score of 0 indicated no pain and a score of 10 indicated worst pain. The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity." (NCT00722800)
Timeframe: 6 months from Baseline

Interventionunits on a scale (Mean)
Drospirenone and Ethinyl Estradiol (YAZ)-2.25
Placebo Tablets2

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Overall Number of Days of Total Blood Loss

cycle control between treatment groups, overall. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. (NCT00745901)
Timeframe: Cycle 1 to 3 (Day 8 to Day 84)

InterventionDays (Mean)
NGM/25mcg EE15.8
DRSP/20mcg EE13.2

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Overall Number of Days of Unscheduled Blood Loss

cycle control between treatment groups, for three 28-day cycles. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 1 to Cycle 3 (Day 8 to Day 80)

InterventionDays (Mean)
NGM/25mcg EE4.6
DRSP/20mcg EE6.1

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Number of Participants With the Indicated Number of Unscheduled Blood Loss Episodes

Unscheduled blood loss episodes are bounded on both sides by at least 1 non- bleeding day. (NCT00745901)
Timeframe: Cycle 1 to Cycle 3 (Day 8 to Day 80)

,
InterventionParticipants (Number)
0 Episode1 Episode2 Episodes3 Episodes4 Episodes5 Episodes6 Episodes8 Episodes9 Episodes
DRSP/20mcg EE29415022118231
NGM/25mcg EE55462321137000

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Patient Satisfaction - Overall

patient satisfaction based on 5 questions during three 28-day cycles - Question 1 (Overall Satisfaction). On a scale of 1 to 5 where 1=Very satisfied and 5=Very dissatisfied. (NCT00745901)
Timeframe: Cycle 1 to Cycle 3

,
InterventionParticipants (Number)
Number of responses1. Very Satisfied2. Somewhat satisfied3. Neither satisfied or dissatisfied4. Dissatisfied5. Very dissatisfied
DRSP/20mcg EE16211532681
NGM/25mcg EE159993512112

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Number of Participants With Unscheduled Bleeding Cycle 3

Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)

InterventionParticipants (Number)
NGM/25mcg EE65
DRSP/20mcg EE94

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Number of Days of Scheduled Blood Loss - Cycle 1

cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. (NCT00745901)
Timeframe: Cycle 1 (Day 22 to 32 for NGM/25mcg EE and day 25 to 32 for DRSP/20mcg EE)

InterventionDays (Mean)
NGM/25mcg EE4.3
DRSP/20mcg EE3.2

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Number of Days of Scheduled Blood Loss - Cycle 2

cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. (NCT00745901)
Timeframe: Cycle 2 (Day 50 to 60 for NGM/25mcg EE and day 53 to 60 for DRSP/20mcg EE)

InterventionDays (Mean)
NGM/25mcg EE4.0
DRSP/20mcg EE2.8

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Number of Days of Scheduled Blood Loss - Cycle 3

cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. (NCT00745901)
Timeframe: Cycle 3 (Day 78 to 84 for NGM/25mcg EE and day 81 to 84 for DRSP/20mcg EE)

InterventionDays (Mean)
NGM/25mcg EE3.1
DRSP/20mcg EE1.2

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Number of Days of Total Blood Loss - Cycle 1

cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. (NCT00745901)
Timeframe: Cycle 1 (Day 8 to Day 28)

InterventionDays (Mean)
NGM/25mcg EE6.2
DRSP/20mcg EE5.2

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Number of Days of Total Blood Loss - Cycle 2

cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. (NCT00745901)
Timeframe: Cycle 2 (day 29 to Day 56)

InterventionDays (Mean)
NGM/25mcg EE5.3
DRSP/20mcg EE4.6

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Number of Days of Total Blood Loss - Cycle 3

cycle control between treatment groups, cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. (NCT00745901)
Timeframe: Cycle 3 (Day 57 to Day 84)

InterventionDays (Mean)
NGM/25mcg EE4.6
DRSP/20mcg EE3.6

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Number of Days of Unscheduled Blood Loss - Cycle 1

cycle control between treatment groups, cycle 1. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)

InterventionDays (Mean)
NGM/25mcg EE1.9
DRSP/20mcg EE2.0

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Number of Days of Unscheduled Blood Loss - Cycle 2

cycle control between treatment groups, cycle 2. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)

InterventionDays (Mean)
NGM/25mcg EE1.3
DRSP/20mcg EE1.9

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Number of Days of Unscheduled Blood Loss - Cycle 3

Number of Days of Unscheduled Blood Loss - Cycle 3. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)

InterventionDays (Mean)
NGM/25mcg EE1.4
DRSP/20mcg EE2.4

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Number of Participants With Breakthrough Bleeding/Spotting Cycle 1

Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding. (NCT00745901)
Timeframe: Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)

InterventionParticipants (Number)
NGM/25mcg EE53
DRSP/20mcg EE56

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Number of Participants With Breakthrough Bleeding/Spotting Cycle 2

Breakthrough bleeding/spotting is any bleeding or spotting during active pills excluding days contiguous with withdrawal bleeding or continual withdrawal bleeding. (NCT00745901)
Timeframe: Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)

InterventionParticipants (Number)
NGM/25mcg EE39
DRSP/20mcg EE62

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Number of Participants With Breakthrough Bleeding/Spotting Cycle 3

Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 3 (Day 57 to 77 for NGM/25mcg EE and day 57 to 80 for DRSP/20mcg EE)

InterventionParticipants (Number)
NGM/25mcg EE47
DRSP/20mcg EE74

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Number of Participants With Unscheduled Bleeding Cycle 1

Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 1 (Day 8 to 21 for NGM/25mcg EE and day 8 to 24 for DRSP/20mcg EE)

InterventionParticipants (Number)
NGM/25mcg EE72
DRSP/20mcg EE74

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Number of Participants With Unscheduled Bleeding Cycle 2

Unscheduled bleeding is any bleeding during active pills except days 1-4 of cycle 2 or 3 if contiguous with withdrawal bleeding and days 1-7 of the first cycle. (NCT00745901)
Timeframe: Cycle 2 (Day 29 to 49 for NGM/25mcg EE and day 29 to 52 for DRSP/20mcg EE)

InterventionParticipants (Number)
NGM/25mcg EE57
DRSP/20mcg EE87

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Overall Number of Days of Scheduled Blood Loss

summary of the overall number of days of scheduled blood loss. Cycle control includes number of days of blood loss, incidence of blood loss, number of blood loss episodes, and blood loss flow intensity. Scheduled bleeding was defined as any bleeding that occurred while not taking active hormones, regardless of the duration of regimen. (NCT00745901)
Timeframe: Cycle 1 to Cycle 3 (Day 8 to Day 84)

InterventionDays (Mean)
NGM/25mcg EE11.2
DRSP/20mcg EE7.0

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Pre-Post Change in Premenstrual Symptom Severity

"Pre-post change (pre minus post) in mean premenstrual week severity of the worst emotional symptom as measured using the Daily Record of Severity of Problems items 1-8. Worst symptom for each individual was defined as the symptom in the baseline month demonstrating the highest mean severity during the premenstrual week. Mean premenstrual week severity scores were calculated to correspond to mean ratings; therefore, the mean premenstrual severity values ranged as follows: 1=Not at All, 2=Minimal, 3=Mild, 4=Moderate, 5=Severe, 6=Extreme. The change variable presented here is calculated as follows: mean rating on the individual's worst symptom during the premenstrual week at baseline minus mean rating during the premenstrual week during the last on-treatment cycle. Therefore, higher values on this outcome variable correspond to greater reductions in premenstrual symptoms across the trial." (NCT00927095)
Timeframe: monthly

Interventionunits on a scale (Mean)
Continuous Low Dose Oral Contraceptive1.93
Interrupted Low Dose Oral Contraceptive (21/7 Platform)1.73
Continuous Placebo1.64

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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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AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)

Bioequivalence based on Ethinyl Estradiol AUC0-inf. (NCT01182194)
Timeframe: Blood samples collected over a 72 hour period.

Interventionpg*h/mL (Mean)
Drospirenone/Ethinyl Estradiol (Test)1236.96
YAZ® (Reference)1235.91

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AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on Drospirenone AUC0-t. (NCT01182194)
Timeframe: Blood samples collected over a 120 hour period.

Interventionng*h/mL (Mean)
Drospirenone/Ethinyl Estradiol (Test)814.32
YAZ® (Reference)824.41

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AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on Ethinyl Estradiol AUC0-t. (NCT01182194)
Timeframe: Blood samples collected over a 72 hour period.

Interventionpg*h/mL (Mean)
Drospirenone/Ethinyl Estradiol (Test)1145.90
YAZ® (Reference)1155.31

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Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Drospirenone Cmax. (NCT01182194)
Timeframe: Blood samples collected over a 120 hour period.

Interventionng/mL (Mean)
Drospirenone/Ethinyl Estradiol (Test)67.69
YAZ® (Reference)74.33

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Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Ethinyl Estradiol Cmax. (NCT01182194)
Timeframe: Blood samples collected over a 72 hour period.

Interventionpg/mL (Mean)
Drospirenone/Ethinyl Estradiol (Test)128.87
YAZ® (Reference)126.03

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AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)

Bioequivalence based on Drospirenone AUC0-inf. (NCT01182194)
Timeframe: Blood samples collected over a 120 hour period.

Interventionng*h/mL (Mean)
Drospirenone/Ethinyl Estradiol (Test)866.91
YAZ® (Reference)884.24

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AUC0-inf of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Infinity)

Bioequivalence based on Drospirenone AUC0-inf. (NCT01182207)
Timeframe: Blood samples collected over a 120 hour period.

Interventionng*h/mL (Mean)
Drospirenone/Ethinyl Estradiol (Test)951.18
YAZ® (Reference)930.38

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AUC0-inf of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Infinity)

Bioequivalence based on Ethinyl Estradiol AUC0-inf. (NCT01182207)
Timeframe: Blood samples collected over a 72 hour period.

Interventionpg*h/mL (Mean)
Drospirenone/Ethinyl Estradiol (Test)1155.69
YAZ® (Reference)1175.76

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AUC0-t of Drospirenone(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on Drospirenone AUC0-t. (NCT01182207)
Timeframe: Blood samples collected over a 120 hour period.

Interventionng*h/mL (Mean)
Drospirenone/Ethinyl Estradiol (Test)889.67
YAZ® (Reference)867.10

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AUC0-t of Ethinyl Estradiol(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration)

Bioequivalence based on Ethinyl Estradiol AUC0-t. (NCT01182207)
Timeframe: Blood samples collected over a 72 hour period.

Interventionpg*h/mL (Mean)
Drospirenone/Ethinyl Estradiol (Test)1066.24
YAZ® (Reference)1079.54

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Cmax of Drospirenone(Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Drospirenone Cmax. (NCT01182207)
Timeframe: Blood samples collected over a 120 hour period.

Interventionng/mL (Mean)
Drospirenone/Ethinyl Estradiol (Test)52.77
YAZ® (Reference)53.65

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Cmax of Ethinyl Estradiol(Maximum Observed Concentration of Drug Substance in Plasma)

Bioequivalence based on Ethinyl Estradiol Cmax. (NCT01182207)
Timeframe: Blood samples collected over a 72 hour period.

Interventionpg/mL (Mean)
Drospirenone/Ethinyl Estradiol (Test)87.95
YAZ® (Reference)91.23

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Change From Pre-intervention to Intervention Endpoint in Binge Eating Sum Score

"Binge eating will be measured using the 8-item binge eating subscale of the Eating Pathology Symptoms Inventory (EPSI), which measures features of binge eating (e.g., consumption of large quantities of food, mindless eating) on a 5-point Likert scale from never to very often. The EPSI scale is designed to assess behavior over the past 28 days. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior. Change is defined as the average change in the binge eating scale score from pre-intervention to intervention." (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Interventionscore on a scale (Mean)
Continuous OC-6.60

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Change From Pre-intervention to Intervention Endpoint in Delay Discounting Parameter k

The Monetary Choice Questionnaire will be used to measure delay discounting. Participants will be asked to make a series of hypothetical choices between small, sooner (impulsive) vs. larger, later (self controlled) hypothetical monetary outcomes. k is a hyperbolic function with larger k values indicating more valuation of a larger delayed reward and smaller values indicating preference for more immediate, smaller rewards (more impulsivity). k can range from 0 to .25 with scores of .25 indicating complete valuation of the immediate reward and 0 indicating complete valuation of the larger, delayed reward. Change is defined as the average change in k from pre-intervention to intervention. (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Interventionk value (Mean)
Continuous OC.01

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Change From Pre-intervention to Intervention Endpoint in Nucleus Accumbens Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)

"Nucleus Accumbens (NAcc) reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment." (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Interventionpercentage signal change (Mean)
Continuous OC.0423

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Change From Pre-intervention to Intervention Endpoint in Prefrontal Cortex Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)

"Prefrontal cortex reactivity to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment." (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Interventionpercentage signal change (Mean)
Continuous OC.01

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Change From Pre-intervention to Intervention Endpoint in Self-reported Reward Sensitivity Subscale Score

Sensitivity to Punishment/Sensitivity to Reward Questionnaire will be used to measure reward sensitivity. The reward sensitivity subscale will be used, which is rated on a true/false scale with scores ranging 0-24. Higher scores indicate more sensitivity to reward. Change is defined as the average change in reward sensitivity from pre-intervention to intervention. (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Interventionscore on a scale (Mean)
Continuous OC1.60

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Change From Pre-intervention to Intervention Endpoint in Weekly Average Binge-eating Frequency

Binge eating frequency is based on a weekly diary of self-reported binge eating frequency. Participants were asked how many times during the past week they had a binge eating episode. Scores can range from 0 to infinity as frequency is self-reported as the number of binge eating episodes in the previous week. Higher scores indicate more episodes of binge eating. Change is defined as the average change in self-reported binge eating frequency from pre-intervention to intervention. (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Interventionepisodes/week (Mean)
Continuous OC-0.43

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Change From Pre-intervention to Intervention Endpoint in Dorsal Striatum Signal Intensity in Response to Reward During the Monetary Incentive Delay Task (MIDT)

"Dorsal striatum reactivity (defined as caudate signal intensity and putamen signal intensity) to reward during the Monetary Incentive Delay (MIDT) task compared pre and post treatment. During MIDT task, participants respond to win trials by pressing a button on a button box in the MRI as quickly as possible when they see a target. Reactivity is measured by examining participant's change in blood-oxygen-level dependent (BOLD) (i.e., measurement of oxygen level that is carried to neurons by red blood cells since areas of the brain that are thought to be more active or involved in certain tasks require more oxygen) in response to a stimulus of interest (win trials) versus non-stimulus (non-win trials). Percent signal change in BOLD activation between monetary reward versus non-reward is the outcome of interest. Percent signal change is then compared pre- and post-treatment." (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Interventionpercentage signal change (Mean)
CaudatePutamen
Continuous OC-.012.02

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Change From Pre-intervention to Intervention Endpoint in Behavioral Inhibition Subscale Score

The Behavioral Inhibition/Behavioral Activation questionnaire will be used to assess behavioural inhibition (BI). The minimum score on the BI subscale is 7, maximum 28. Greater scores indicate greater BI. Change is defined as the average change in BI from pre-intervention to intervention. (NCT04278755)
Timeframe: Pre-intervention (week 1) to intervention endpoint (week 12)

Interventionscore on a scale (Mean)
Continuous OC1.43

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