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

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 y…