Status:
COMPLETED
Simvastatin Therapy in Women With Polycystic Ovary Syndrome.
Lead Sponsor:
Poznan University of Medical Sciences
Collaborating Sponsors:
Yale University
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether statins (simvastatin) improve clinical (excessive hair, skin problems), endocrine (androgens) and metabolic (lipids, markers of systemic inflammation)...
Eligibility Criteria
Inclusion
- PCO - ESHRE/ASRM criteria: oligomenorrhea (\<8 spontaneous menses per year) and hyperandrogenism (hirsutism or acne) or hyperandrogenemia (testosterone \>70ng/dl)
- Normal prolactin, TSH, 17-OH progesterone
- No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
- Age 18-40
- Reliable use of birth control pill for at least 3 months and no plans of pregnancy
Exclusion
- Elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminases) above 2 times of upper limit of normal
- Use of any of the following medications: cyclosporine, fibrates, niacin, antifungal agents, macrolide antibiotics.
- Use of oral contraceptives and other steroid hormones 3 months prior to the study
- Contraindications to oral contraceptives
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00365638
Start Date
April 1 2004
End Date
February 1 2005
Last Update
August 17 2006
Active Locations (1)
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1
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
Poznan, Poland, 60-184