Polycystic Ovary Syndrome Clinical Trial
NCT number | NCT00005654 |
Other study ID # | 199/14914 |
Secondary ID | UVA-WSE023 |
Status | Completed |
Phase | N/A |
First received | May 2, 2000 |
Last updated | June 23, 2005 |
Start date | January 2000 |
Verified date | April 2000 |
Source | Office of Rare Diseases (ORD) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
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 |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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National Center for Research Resources (NCRR) | University of Virginia |
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