Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
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|ClinicalTrials.gov Identifier: NCT00005104|
Recruitment Status : Completed
First Posted : April 7, 2000
Last Update Posted : June 24, 2005
I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome Hyperinsulinism||Drug: clomiphene citrate Drug: metformin||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||99 participants|
|Study Start Date :||January 2000|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005104
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294-3300|
|United States, Louisiana|
|Louisiana State University School of Medicine|
|Shreveport, Louisiana, United States, 71130-3932|
|United States, Missouri|
|Washington University - St. Louis|
|St. Louis, Missouri, United States, 63110|
|United States, Virginia|
|University of Virginia|
|Charlottesville, Virginia, United States, 22908|
|Medical College of Virginia School of Medicine|
|Richmond, Virginia, United States, 23298-0230|
|University Alma Mater|
|Bologna, Italy, 40100|
|Study Chair:||William S. Evans||University of Virginia|