Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
- Conditions
- Polycystic Ovary SyndromeHyperinsulinism
- Registration Number
- NCT00005104
- Lead Sponsor
- National Center for Research Resources (NCRR)
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 99
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Louisiana State University School of Medicine
🇺🇸Shreveport, Louisiana, United States
Washington University - St. Louis
🇺🇸St. Louis, Missouri, United States
University Alma Mater
🇮🇹Bologna, Italy
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Medical College of Virginia School of Medicine
🇺🇸Richmond, Virginia, United States