Metformin or Placebo with Clomiphene Citrate for Ovulation in Women With Polycystic Ovary Syndrome

Study start date: January 1, 2000

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