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