Randomized Study of Decreased Hyperinsulinemia on the Ovulatory Response to Clomiphene Citrate in Women With Polycystic Ovary Syndrome
Information source: National Center for Research Resources (NCRR)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Polycystic Ovary Syndrome; Hyperinsulinism
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 citrate in 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 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
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
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
Locations and Contacts
University Alma Mater, Bologna 40100, Italy
University of Alabama at Birmingham, Birmingham, Alabama 35294-3300, United States
Louisiana State University School of Medicine, Shreveport, Louisiana 71130-3932, United States
Washington University - St. Louis, St. Louis, Missouri 63110, United States
Medical College of Virginia School of Medicine, Richmond, Virginia 23298-0230, United States
University of Virginia, Charlottesville, Virginia 22908, United States
Additional Information
Starting date: January 2000
Last updated: June 23, 2005
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