Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome

Inclusion Criteria

• •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