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NCT01360996 · ClinicalTrials.gov registry record · Phase 4
Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism
A Phase 4 study, sponsored by Woman's.
- Completed
- Registry status
- Phase 4
- Development phase
- 64
- Enrollment target
NCT01360996 is a Phase 4 study that has completed, run by Woman's. The registered enrollment target is 64 participants.
The verdict
NCT01360996, a Phase 4 study, has completed, sponsored by Woman's.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 64 participants
- Enrollment target
Study 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.
Interventions
- DRUG 3 mg DRSP/20 μg EE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2011-08 |
| Est. Completion | 2015-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01360996
The ClinicalTrials.gov registry entry for NCT01360996 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Woman's, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 3 mg DRSP/20 μg EE is the first listed.
NCT01360996 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01360996 about?
NCT01360996 is a clinical study titled "Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism". 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 androg...
What is the current status of trial NCT01360996?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 64 participants. The study started on 2011-08. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01360996?
The interventions under investigation include: 3 mg DRSP/20 μg EE (DRUG).
Who is sponsoring clinical trial NCT01360996?
This trial is sponsored by Woman's, which has 17 total clinical trials registered on ClinicalTrials.gov.
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