Polycystic Ovary Syndrome Clinical Trial
OBJECTIVES:
I. Determine whether reduction of serum insulin levels by metformin increases ovulatory
response to clomiphene citrate in women with polycystic ovary syndrome.
Status | Completed |
Enrollment | 99 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
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: - At least 2 months since prior standard therapy (including over the counter drugs) - At least 2 months since prior investigational drugs - Prior multi/prenatal vitamins allowed --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 - Estradiol normal - Fasting 17 alpha-hydroxy progesterone less than 200 ng/dL OR No late onset adrenal hyperplasia 21 alpha-hydroxylase deficiency Other: - Not pregnant - Negative pregnancy test - Male partner must have a normal semen analysis by WHO criteria - Must be in acceptable health by interview, medical history, physical exam, and laboratory tests - 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 |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | University Alma Mater | Bologna | |
United States | 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 | Louisiana State University School of Medicine | Shreveport | Louisiana |
United States | Washington University - St. Louis | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
National Center for Research Resources (NCRR) | University of Virginia |
United States, Italy,
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---|---|---|---|
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