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

Polycystic Ovary Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005654
• Other study ID #: 199/14914
• Secondary ID: UVA-WSE023
• Status: Completed
• Phase: N/A
• First received: May 2, 2000
• Last updated: June 23, 2005
• Start date: January 2000

Study information

• Verified date: April 2000
• Source: Office of Rare Diseases (ORD)
• 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 or spontaneous ovulation in obese 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 (arm I) or oral placebo (arm II) three times daily for 8 weeks. All patients who do not ovulate by day 28 receive oral clomiphene citrate daily on days 36-40.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Obese women with chronic anovulation due to polycystic ovary syndrome (PCOS)

Must have oligoamenorrhea and hyperandrogenemia

--Prior/Concurrent Therapy--

At least 2 months since prior standard therapy (including over the counter drugs) At least 2 months since prior investigational agents

--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 Fasting 17 alpha-hydroxy progesterone less than 200 mg/dL OR No late onset adrenal hyperplasia 21 alpha-hydroxylase deficiency

Other: Not pregnant Negative pregnancy test Fertile patients must use effective contraception 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
n/a

Sponsors (2)

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