COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00005104
Recruitment Status : Completed
First Posted : April 7, 2000
Last Update Posted : June 24, 2005
University of Virginia
Information provided by:
National Center for Research Resources (NCRR)

Brief Summary:


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.

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

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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


--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


  • 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%


  • Liver function normal
  • No clinically significant hepatic disease


  • 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


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00005104

Layout table for location information
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
University Alma Mater
Bologna, Italy, 40100
Sponsors and Collaborators
National Center for Research Resources (NCRR)
University of Virginia
Layout table for investigator information
Study Chair: William S. Evans University of Virginia
Layout table for additonal information Identifier: NCT00005104    
Other Study ID Numbers: 199/14915
First Posted: April 7, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: December 2003
Keywords provided by National Center for Research Resources (NCRR):
endocrine disorders
polycystic ovarian syndrome
rare disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators