CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 64 enrolled
Drug / intervention
3 mg DRSP/20 μg EEdrug
Likely dose
3 mg DRSP/20 μg EEfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01360996
NCT01360996Phase 4Completed
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Positive Clinical and Hormonal Effects of Ethinylestradiol Combined With Drospirenone (EE/DRSP) in Women With Polycystic Ovary Syndrome (PCOS): Impact of Body Weight and Relevance to Hyperandrogenism

Woman's·interventional·Posted May 26, 2011·Updated Mar 31, 2017

In Brief

A Phase 4 clinical trial evaluating 3 mg DRSP/20 μg EE for Polycystic Ovary Syndrome. Completed, enrolled 64 participants across 1 site.

Detailed Summary

The classic description of polycystic ovary syndrome (PCOS) is that it is a disorder characterized by menstrual irregularity, chronic anovulation, androgen excess, and abnormal gonadotropin secretion. Use of combined oral contraceptives (OCs) in women with PCOS effectively reduces circulating androgens. Although OCs are the most common and one of the oldest symptomatic treatment modalities for androgenic skin symptoms and for irregular menstrual cycles caused by hyperandrogenism, the data concerning the effect of treatment of PCOS women with different body mass index (BMI) are limited. This study is being done to compare the hormone and metabolic changes after treatment with low-dose oral birth control regimen of DRSP 3 mg/EE 0.02mg/levomefolate calcium 0.451 mg (Beyaz™) in women with PCOS with different body weights.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPolycystic Ovary Syndrome
CountriesUnited States
CollaboratorsBayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 26, 2011
Enrollment StartAug 1, 2011
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 15.1 years ago

Interventions

3 mg DRSP/20 μg EEdrug

1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only