Phase 4
Completed N=64
Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism
Source: ClinicalTrials.gov NCT01360996 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Biochemical Assessment of Hyperandrogenism — 0.7; 0.7 Index — p=<.0001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biochemical Assessment of Hyperandrogenism |
0.7; 0.7 | <.0001 sig |
| SECONDARY Cardiometabolic Measures |
120; 125 | >0.05 |
| SECONDARY Post Therapy BMI. |
24.6; 32.7 | >0.05 |
| SECONDARY Biochemical Indicator of B-vitamin Status |
65.8; 60.8 | <0.001 sig |
| SECONDARY Menstrual Cycle Regularity |
11.3; 11 | <0.0001 sig |
| SECONDARY Adrenal Androgen DHEAS |
4.9; 4.3 | <0.001 sig |
| SECONDARY Oral Disposition Index |
732; 272 | <0.04 sig |
Eligibility Criteria
Inclusion Criteria
- •Adult female-16 years to 35 years of age who have been diagnosed with PCOS desiring contraception
- Actual BMI >18 to <35kg/ m2
- Written consent for participation in the study
- Patient completed lactation
Exclusion Criteria
- Metabolic abnormalities requiring pharmacological intervention (except controlled thyroid disease)
- Uncontrolled hypertension
- Cancer or history of hormone-dependent cancer
- History of cholestasis
- Presence of contradictions for OC administration
- Personal history of cardiovascular events.
- Use of drugs known to exacerbate glucose tolerance.
- No prescription or over-the-counter weight-loss drugs
- Diabetes
- Use of medications that affect blood pressure or lipid profile
- Smoking in past 6 months
- Known thrombogenic mutations (e.g. Factor V Leiden)
- Current or history of deep venous thrombosis/pulmonary embolism
- Major surgery with prolonged immobilization
- Injectable hormonal contraceptive use within 6 months
- Use of hormonal (e.g., oral contraceptive [OC] pill) or insulin-sensitizing medication unless willing to cease medications for 3 months before study measurements
Data sourced from ClinicalTrials.gov (NCT01360996). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.