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

Sponsors and Collaborators:	National Center for Research Resources (NCRR) University of Virginia
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00005104

Purpose

OBJECTIVES:

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

Condition	Intervention
Polycystic Ovary Syndrome Hyperinsulinism	Drug: clomiphene citrate Drug: metformin

Drug Information available for: Clomiphene citrate Zuclomiphene Enclomiphene Citric acid Metformin Clomiphene Sodium Citrate trans-Clomifene citrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:	99
Study Start Date:	January 2000

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.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005104

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
Medical College of Virginia School of Medicine
Richmond, Virginia, United States, 23298-0230
University of Virginia
Charlottesville, Virginia, United States, 22908
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

No publications provided

Study ID Numbers:	199/14915, UVA-HIC-7538, UVA-WSE026
Study First Received:	April 6, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00005104 History of Changes
Health Authority:	United States: Federal Government

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

endocrine disorders
hyperinsulinism
polycystic ovarian syndrome
rare disease

Study placed in the following topic categories:

Estrogen Antagonists
Estrogens
Metabolic Diseases
Gonadal Disorders
Hormone Antagonists
Citric Acid
Metformin
Hormones, Hormone Substitutes, and Hormone Antagonists
Rare Diseases
Clomiphene
Endocrine System Diseases
Ovarian Diseases

Selective Estrogen Receptor Modulators
Cysts
Hormones
Polycystic Ovarian Syndrome
Genital Diseases, Female
Estrogen Receptor Modulators
Hyperinsulinism
Polycystic Ovary Syndrome
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Ovarian Cysts

Additional relevant MeSH terms:

Gonadal Disorders
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Clomiphene
Ovarian Diseases
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Genital Diseases, Female
Hyperinsulinism
Estrogen Receptor Modulators
Pathologic Processes
Therapeutic Uses
Syndrome

Estrogen Antagonists
Metabolic Diseases
Disease
Endocrine System Diseases
Cysts
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Fertility Agents, Female
Polycystic Ovary Syndrome
Fertility Agents
Glucose Metabolism Disorders
Ovarian Cysts

ClinicalTrials.gov processed this record on May 07, 2009