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

NCT ID: NCT00005104

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-01-31

Brief Summary

OBJECTIVES:

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

Detailed Description

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to one of two treatment arms.

Patients receive oral metformin or oral placebo three times daily for 7 weeks. Patients remaining anovulatory by day 49 receive metformin or placebo plus escalating doses of oral clomiphene citrate daily for 5 consecutive days, beginning on days 50, 80, and 110. Following ovulation, treatment with clomiphene citrate and metformin or placebo continues until 6 ovulatory cycles occur, pregnancy occurs, or anovulation persists. Patients receiving the placebo arm who have not ovulated on the highest dose of clomiphene citrate may be crossed over to receive metformin after a 6 week washout.

Conditions

Polycystic Ovary Syndrome; Hyperinsulinism

Keywords

endocrine disorders; hyperinsulinism; polycystic ovarian syndrome; rare disease

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

clomiphene citrate

Intervention Type: DRUG

metformin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role: lead

Principal Investigators

William S. Evans

Role: STUDY_CHAIR

University of Virginia

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Louisiana State University School of Medicine

Shreveport, Louisiana, United States

Washington University - St. Louis

St Louis, Missouri, United States

University of Virginia

Charlottesville, Virginia, United States

Medical College of Virginia School of Medicine

Richmond, Virginia, United States

University Alma Mater

Bologna, , Italy

Countries

United States; Italy

Other Identifiers

UVA-HIC-7538

Identifier Type: -

Identifier Source: secondary_id

UVA-WSE026

Identifier Type: -

Identifier Source: secondary_id

199/14915

Identifier Type: -

Identifier Source: org_study_id