Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.
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ClinicalTrials.gov Identifier: NCT00396513
Recruitment Status : Unknown
Verified November 2006 by Poznan University of Medical Sciences. Recruitment status was: Recruiting
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).
Condition or disease
Polycystic Ovary Syndrome
Drug: SimvastatinDrug: Simvastatin and MetforminDrug: Metformin
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Ages Eligible for Study:
18 Years to 40 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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