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

June 23, 2005 updated by: National Center for Research Resources (NCRR)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 (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.

Study Type

Interventional

Enrollment

88

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Virginia

Investigators

  • Study Chair: William S. Evans, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2000

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

May 2, 2000

First Posted (Estimate)

May 3, 2000

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

April 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/14914
  • UVA-WSE023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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