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 year since any prior drug abuse or alcoholism