Simvastatin Therapy in Women With Polycystic Ovary Syndrome.

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: Female

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) in women with polycystic ovary syndrome (PCOS).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poznan University of Medical Sciences
• Collaborator: Yale University
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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