Randomized Study of the Effect of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Obese Women With Polycystic Ovary Syndrome
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperinsulinism; Polycystic Ovary Syndrome
Intervention: clomiphene citrate (Drug); metformin (Drug)
Phase: N/A
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
William S. Evans, Study Chair, Affiliation: University of Virginia
Summary
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control
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
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Starting date: January 2000
Last updated: June 23, 2005
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