Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome
I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene or spontaneous ovulation in obese women with polycystic ovary syndrome.
|Hyperinsulinism Polycystic Ovary Syndrome||Drug: clomiphene citrate Drug: metformin|
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||January 2000|
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of two treatment arms.
Patients receive oral metformin (arm I) or oral placebo (arm II) three times daily for 8 weeks. All patients who do not ovulate by day 28 receive oral clomiphene citrate daily on days 36-40.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005654
|Study Chair:||William S. Evans||University of Virginia|