Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Androgen Excess as a Mechanism for Adipogenic Dysfunction in PCOS Women
Brief Summary:
The purpose of this research study is to collect specimen samples and study medical information from women with Polycystic Ovary Syndrome (PCOS) and women without PCOS. The goal is to learn more about the changes that take place in the body that result in PCOS.
We anticipate that 59 women will take part in this study (15 without PCOS and 44 with PCOS). All patients will undergo a physical exam, blood tests, and ultrasound of their ovaries. If they meet the criteria for this study, they will then undergo additional blood tests, removal of a small amount of subcutaneous abdominal fat, measurement of regional body fat (i.e., MRI, DXA scan), a modified frequently-sampled intravenous glucose tolerance test (FSIGTT), and determination of ovarian function (via a follicle stimulating hormone [FSH] test). The women without PCOS will be complete the study at this point.
The women with PCOS will be randomized to receive the drug flutamide 125 mg/day or placebo. They will take the drug every day for six 28-day cycles. They will be asked to collect and store a urine sample once a week. They will also be asked to complete a pill diary and menstrual diary. Once a month while they are taking the flutamide/placebo, they will return to the clinic and bring their frozen urine samples. At that time they will undergo a physical exam, toxicity assessment, and blood draw.
Quality of Life assessments will be done at the beginning of the study for all participants. Women with PCOS who are taking the flutamide or placebo will be asked to repeat the Quality of Life assessments during the study and at the end of the study.
Six months following the completion of protocol procedures, participants who received flutamide/placebo will be contacted by phone