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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Virginia |
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Information provided by: | National Center for Research Resources (NCRR) |
ClinicalTrials.gov Identifier: | NCT00005104 |
OBJECTIVES:
I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.
Condition | Intervention |
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Polycystic Ovary Syndrome Hyperinsulinism |
Drug: clomiphene citrate Drug: metformin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Estimated Enrollment: | 99 |
Study Start Date: | January 2000 |
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.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Patients with chronic anovulation due to polycystic ovary syndrome (PCOS) who have failed clomiphene citrate
Must have oligoovulation and hyperandrogenemia
--Prior/Concurrent Therapy--
Endocrine therapy: At least 2 months since prior clomiphene citrate
Other:
--Patient Characteristics--
Hematopoietic: Hematocrit greater than 38%
Hepatic:
Renal:
Cardiovascular: No clinically significant cardiac disease
Pulmonary: No clinically significant pulmonary disease
Hormonal:
Other:
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 | |
Medical College of Virginia School of Medicine | |
Richmond, Virginia, United States, 23298-0230 | |
University of Virginia | |
Charlottesville, Virginia, United States, 22908 | |
Italy | |
University Alma Mater | |
Bologna, Italy, 40100 |
Study Chair: | William S. Evans | University of Virginia |
Study ID Numbers: | 199/14915, UVA-HIC-7538, UVA-WSE026 |
Study First Received: | April 6, 2000 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00005104 |
Health Authority: | United States: Federal Government |
endocrine disorders hyperinsulinism polycystic ovarian syndrome rare disease |
Metabolic Diseases Gonadal Disorders Citric Acid Metformin Rare Diseases Clomiphene Endocrine System Diseases Ovarian Diseases |
Cysts Genital Diseases, Female Hyperinsulinism Polycystic Ovary Syndrome Endocrinopathy Glucose Metabolism Disorders Metabolic disorder Ovarian Cysts |
Estrogen Antagonists Disease Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Selective Estrogen Receptor Modulators Pharmacologic Actions |
Adnexal Diseases Estrogen Receptor Modulators Neoplasms Pathologic Processes Therapeutic Uses Syndrome Fertility Agents, Female Fertility Agents |