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

This study has been completed.
Sponsor:
Collaborator:
University of Virginia
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00005654
First received: May 2, 2000
Last updated: June 23, 2005
Last verified: April 2000
  Purpose

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.


Condition Intervention
Hyperinsulinism
Polycystic Ovary Syndrome
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 Office of Rare Diseases (ORD):

Estimated Enrollment: 88
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 (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.

  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--

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

  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: NCT00005654

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

No publications provided

ClinicalTrials.gov Identifier: NCT00005654     History of Changes
Other Study ID Numbers: 199/14914, UVA-WSE023
Study First Received: May 2, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
endocrine disorders
hyperinsulinism
polycystic ovarian syndrome
rare disease

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

ClinicalTrials.gov processed this record on August 25, 2014