Low Dose OC Therapy in Women With Polycystic Ovary Syndrome (PCOS): Impact of BMI on Hyperandrogenism

Conditions:Ovarian Cancer, Women's Studies, Endocrine
Therapuetic Areas:Endocrinology, Oncology, Reproductive
Age Range:16 - 35
Start Date:August 2011
End Date:February 2015

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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

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.

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

- 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
We found this trial at
Baton Rouge, Louisiana 70815
Baton Rouge, LA
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