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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Polycystic Ovary Syndrome; Hyperinsulinism	Drug: clomiphene citrate; Drug: metformin	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	99 participants
Allocation:	Randomized
Masking:	Double
Primary Purpose:	Treatment
Study Start Date :	January 2000

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, Louisiana
Louisiana State University School of Medicine
Shreveport, Louisiana, United States, 71130-3932
United States, Missouri
Washington University - St. Louis
St. Louis, Missouri, United States, 63110
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Medical College of Virginia School of Medicine
Richmond, Virginia, United States, 23298-0230
Italy
University Alma Mater
Bologna, Italy, 40100

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of Virginia

Investigators

Study Chair:	William S. Evans	University of Virginia

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00005104 History of Changes
Other Study ID Numbers:	199/14915; UVA-HIC-7538; UVA-WSE026
First Posted:	April 7, 2000
Last Update Posted:	June 24, 2005
Last Verified:	December 2003

Keywords provided by National Center for Research Resources (NCRR):

endocrine disorders; hyperinsulinism; polycystic ovarian syndrome; rare disease

Additional relevant MeSH terms:

Hyperinsulinism; Syndrome; Polycystic Ovary Syndrome; Disease; Pathologic Processes; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Gonadal Disorders; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases	Citric Acid; Clomiphene; Enclomiphene; Zuclomiphene; Anticoagulants; Calcium Chelating Agents; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Fertility Agents, Female; Fertility Agents