Conditions: Polycystic Ovary Syndrome Metabolic Syndrome
Keywords: Polycystic Ovary Syndrome Metabolic Syndrome PCOS overweight infertility Insulin Resistance menstrual cycle
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 97
Healthy volunteers: no

Brief summary:
The purpose of this study is to investigate the metabolic effects of anti-androgens and oral contraceptive pills (OCPs), compared with placebo, in the treatment of women with PCOS. We hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs would produce improvement in metabolic markers in PCOS women and would reduce their long term metabolic risk.

Detailed description:
Polycystic ovary syndrome (PCOS) is one of the most common conditions of young women, and it is frequently associated with insulin resistance or metabolic syndrome (MBS). In addition, affected women have significantly elevated mean low-density lipoprotein (LDL) levels and an increased prevalence of at risk LDL levels, independent of obesity. We are directly testing the role of androgens in the metabolic abnormalities in PCOS by examining the impact of direct androgen receptor blockade by anti-androgen medications and indirect suppression of androgen production through suppression of leutinizing hormone (LH) with oral contraceptive pills (OCPs), compared with placebo, on visceral adiposity, circulating LDL levels, insulin secretion and sensitivity as measured by frequently-sampled IV glucose tolerance tests (FSIGT) and oral glucose tolerance tests (OGTT), resting energy expenditure, and maximal aerobic capacity measurement.

Note: Originally there were 2 additional study arm, Metformin only and Metformin + Flutamide. These study arms were ultimately eliminated and were not included in analysis of baseline characteristics or endpoints.

Arms:
arm 1: oral contraceptive (35 mg ethinyl estradiol) arm 2: Flutamide 250 mg twice daily arm 3: Placebo

Interventions: intervention 1: flutamide intervention 2: ethinyl estradiol 35 mcg and drospirenone 3 mg intervention 3: placebo
Intervention descriptions: intervention 1: 250 mg twice daily intervention 2: one active pill per day for three weeks and then 1 sugar pill per day for one week intervention 3: None

Protocol document: