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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

OBJECTIVES:

I. Determine whether reduction of serum insulin levels by metformin increases ovulatory response to clomiphene citrate in women with polycystic ovary syndrome.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Center for Research Resources (NCRR)
• Collaborator: University of Virginia
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Metformin; Zuclomiphene

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