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

Polycystic Ovary Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005104
• Other study ID #: 199/14915
• Secondary ID: UVA-HIC-7538UVA-
• Status: Completed
• Phase: N/A
• First received: April 6, 2000
• Last updated: June 23, 2005
• Start date: January 2000

Study information

• Verified date: December 2003
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

OBJECTIVES:

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperinsulinism
• Polycystic Ovary Syndrome

Intervention

Drug:
• clomiphene citrate

• metformin

Locations

Country	Name	City	State
Italy	University Alma Mater	Bologna
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Virginia	Charlottesville	Virginia
United States	Medical College of Virginia School of Medicine	Richmond	Virginia
United States	Louisiana State University School of Medicine	Shreveport	Louisiana
United States	Washington University - St. Louis	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	University of Virginia

Countries where clinical trial is conducted

United States,  Italy,