Polycystic Ovary Syndrome Clinical Trial
OBJECTIVES:
I. Determine whether reduction of serum insulin levels by metformin increases ovulatory
response to clomiphene citrate in women with polycystic ovary syndrome.
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 or oral placebo three times daily for 7 weeks. Patients
remaining anovulatory by day 49 receive metformin or placebo plus escalating doses of oral
clomiphene citrate daily for 5 consecutive days, beginning on days 50, 80, and 110.
Following ovulation, treatment with clomiphene citrate and metformin or placebo continues
until 6 ovulatory cycles occur, pregnancy occurs, or anovulation persists. Patients
receiving the placebo arm who have not ovulated on the highest dose of clomiphene citrate
may be crossed over to receive metformin after a 6 week washout.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
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