Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to compare effects of statins (simvastatin) and metformin on clinical (menstrual cycle, excessive hair, skin problems), endocrine (androgens), metabolic (lipids, markers of systemic inflammation), and endothelial function parameters 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: Metformin; Simvastatin

Criteria

Inclusion Criteria:

• PCO - ESHRE/ASRM criteria:oligomenorrhea (<8 spontaneus menses per year) and hyperandrogenism(hirsutism or acne) or hyperandrogenemia(testosterone > 70 ng/ml) 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 (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and other steroid hormones 3 months prior to the study