Trial Information

Pregnancy in Polycystic Ovary Syndrome: A 30 Week Double-Blind Randomized Trial of Clomiphene Citrate, Metformin XR, and Combined Clomiphene Citrate/Metformin XR For the Treatment of Infertility in Women With Polycystic Ovary Syndrome

PCOS is characterized by excess circulating androgen levels and chronic anovulation. The
fundamental pathophysiologic defect is unknown, but PCOS is characterized by insulin
resistance and compensatory hyperinsulinemia. Improvements in insulin sensitivity in PCOS
women, either through lifestyle changes or through pharmaceutical intervention, have
consistently resulted in a marked improvement in the reproductive and metabolic
abnormalities in PCOS. Resumption of ovulation occurs in up to 70% of women treated for
PCOS. This study will evaluate the safety and effectiveness of clomiphene citrate and
metformin XR in achieving a successful pregnancy in infertile PCOS women.

Women with PCOS who are seeking pregnancy will be enrolled in this study. Women will be
randomized to one of three different treatment arms: A) metformin XR 1000 mg twice/day; B)
clomiphene citrate 50 mg every day for 5 days (day 3-7 of cycle); or C) metformin XR 1000 mg
twice/day with clomiphene citrate 50 mg/day for 5 days (day 3-7 of cycle). Women will
continue on study medications for 30 weeks, 6 treatment cycles, or until they become
pregnant. Progesterone levels will be drawn weekly to monitor ovulation.