Androgen Excess as a Cause for Adipogenic Dysfunction in PCOS Women

Study 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 32 women will take part in this study (16 without PCOS and 16 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., DXA scan) and a modified frequently-sampled intravenous glucose tolerance test (FSIGTT). The women without PCOS will 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. After the six 28-day cycles are completed they will then undergo additional blood tests, removal of a small amount of subcutaneous abdominal fat, measurement of regional body fat (i.e., DXA scan) and a modified frequently-sampled intravenous glucose tolerance test (FSIGTT). Six months following the completion of all study protocol procedures, participants who received flutamide/placebo will be contacted by phone to check on the status of their health. They wil

Primary Outcome

Lipid content of PCOS subcutaneous (SC) abdominal stem cells during adipocyte maturation in vitro at baseline and after 6 months treatment Lipid staining and immunofluorescence: Newly-formed adipocytes were fixed and stained with Oil-Red-O (Sigma Aldrich, St. Louis, MO) for 20 min at room temperature to visualize lipid droplets. Nuclei were identified by the nuclear staining marker 4',6-diamidino-2-phenoylidole (DAPI) (1:3000 \[Invitrogen, Carlsbad, CA\]). After 4 washes with deionized water,

Interventions

• OTHER Placebo
• DRUG Flutamide