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
16 Years
35 Years
Female
Polycystic Ovary Syndrome
Trial Information
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
Clinically, polycystic ovary syndrome (PCOS) is a heterogeneous disorder of functional
androgen excess and the features of PCOS can run through a spectrum of severity. The
optimal modality for long-term treatment of PCOS should positively influence androgen
synthesis, sex hormone binding globulin (SHBG) production, insulin sensitivity, the lipid
profile, and clinical symptoms including hirsutism and irregular menstrual cycles. Combined
oral contraceptives have been a key component of the chronic treatment of women with PCOS;
improving androgen excess and regulating menstrual cycles. The effect of OCs on ovarian
folliculogenesis significantly decreases androgen production. This mechanism was confirmed
in both healthy women and women with PCOS. In obese patients with PCOS, it is likely that
the suppression of androgen production is not as significant. It is thus possible to
hypothesize that the effects of OCs in PCOS could be dependent on body weight and what is
needed is a head-to-head comparison. The aim of this study is to compare the effect of 6
months of a low-dose oral contraceptive regimen of 24/4 DRSP 3 mg/EE 0.02mg/levomefolate
calcium 0.451 mg on androgen profiles, cardiometabolic measures, B-vitamin status, and
menstrual cycle regulation in three groups, normal (BMI 18-24.9 kg/ m2) overweight (BMI
25-29.9 kg/ m2) and obese (BMI 30-35 kg/ m2) women with PCOS.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
biochemical assessment of hyperandrogenism
Outcome Description:
The primary outcome measures are changes pre and post-treatment in free androgen index {[FAI = testosterone concentration (nmol/l)/ concentration of sex hormone binding globulin [SHBG (nM/L) x100] and adrenal androgen levels of dehydroepiandrosterone sulfate
Outcome Time Frame:
24 weeks
Safety Issue:
No
Principal Investigator
Karen E Elkind-Hirsch, M.Sc.,Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Woman's Hospital
Authority:
United States: Institutional Review Board
Study ID:
RP 11-003
NCT ID:
NCT01360996
Start Date:
August 2011
Completion Date:
February 2014
Related Keywords:
- Polycystic Ovary Syndrome
- PCOS
- Polycystic Ovary Syndrome
- Hyperandrogenism
Name | Location |
|---|---|
| Woman's Hospital | Baton Rouge, Louisiana 70815 |
