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

This study has been completed.
Sponsor:
Collaborator:
University of Virginia
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00005104
First received: April 6, 2000
Last updated: June 23, 2005
Last verified: December 2003
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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
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
University of Virginia
Investigators
Study Chair: William S. Evans University of Virginia
  More Information

No publications provided

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

Keywords provided by National Center for Research Resources (NCRR):
endocrine disorders
hyperinsulinism
polycystic ovarian syndrome
rare disease

Additional relevant MeSH terms:
Hyperinsulinism
Polycystic Ovary Syndrome
Syndrome
Adnexal Diseases
Cysts
Disease
Endocrine System Diseases
Genital Diseases, Female
Glucose Metabolism Disorders
Gonadal Disorders
Metabolic Diseases
Neoplasms
Ovarian Cysts
Ovarian Diseases
Pathologic Processes
Clomiphene
Enclomiphene
Zuclomiphene
Estrogen Antagonists
Estrogen Receptor Modulators
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014