18 Years
40 Years
Female
Polycystic Ovary Syndrome, Hyperinsulinism
Trial Information
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Principal Investigator
William S. Evans
Investigator Role:
Study Chair
Investigator Affiliation:
University of Virginia
Authority:
United States: Federal Government
Study ID:
199/14915
NCT ID:
NCT00005104
Start Date:
January 2000
Completion Date:
Related Keywords:
- Polycystic Ovary Syndrome
- Hyperinsulinism
- endocrine disorders
- hyperinsulinism
- polycystic ovarian syndrome
- rare disease
- Hyperinsulinism
- Polycystic Ovary Syndrome
Name | Location |
|---|---|
| Louisiana State University School of Medicine | New Orleans, Louisiana 70112-2822 |
| Washington University - St. Louis | St. Louis, Missouri 63110 |
| University of Virginia | Charlottesville, Virginia 22908 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| Medical College of Virginia School of Medicine | Richmond, Virginia 23298-0230 |
