NCT00005104

Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.

Detailed description

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.

Conditions

• Polycystic Ovary Syndrome
• Hyperinsulinism

Interventions

Type	Name	Description
DRUG	clomiphene citrate
DRUG	metformin

Timeline

• Start date: 2000-01-01
• First posted: 2000-04-07
• Last updated: 2005-06-24

Locations

6 sites across 2 countries: United States, Italy