OBJECTIVES:

I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene or spontaneous ovulation in obese women with polycystic ovary syndrome.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control

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 (arm I) or oral placebo (arm II) three times daily for 8 weeks. All patients who do not ovulate by day 28 receive oral clomiphene citrate daily on days 36-40.

Intervention(s) in this Clinical Trial

• Drug: clomiphene citrate
• Drug: metformin

PROTOCOL ENTRY CRITERIA:

• -Disease Characteristics--
• Obese women with chronic anovulation due to polycystic ovary syndrome (PCOS)
• Must have oligoamenorrhea and hyperandrogenemia
• -Prior/Concurrent Therapy--
• At least 2 months since prior standard therapy (including over the counter drugs) At least 2 months since prior investigational agents
• -Patient Characteristics--
• Hematopoietic: Hematocrit greater than 38%
• Hepatic: Liver function normal No clinically significant hepatic disease
• Renal: No clinically significant renal disease Creatinine less than 1.4 mg/dL No proteinuria
• Cardiovascular: No clinically significant cardiac disease
• Pulmonary: No clinically significant pulmonary disease
• Hormonal: Thyroid function normal Prolactin normal Fasting 17 alpha-hydroxy progesterone less than 200 mg/dL OR No late onset adrenal hyperplasia 21 alpha-hydroxylase deficiency
• Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception No diabetes mellitus No clinically significant neurologic, psychiatric, infectious, neoplastic, or metabolic disease No clinically significant malignant disease except nonmelanomatous skin cancer At least 1 year since any prior drug abuse or alcoholism

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Center for Research Resources (NCRR)

Overall Clinical Trial Officials and Contacts

William S. Evans Study Chair University of Virginia  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00005654

Study ID Number: 199/14914

ClinicalTrials.gov Identifier: NCT00005654

Health Authority: United States: Federal Government