Simvastatin and Metformin Therapy in PCOS Women. Prospective Randomised Trial.
Not Applicable
- Conditions
- Polycystic Ovary Syndrome
- Registration Number
- NCT00396513
- Lead Sponsor
- Poznan University of Medical Sciences
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Serum testosterone
- Secondary Outcome Measures
Name Time Method regularity of menstrual cycle serum lutropin serum follitropin serum lipids serum DHEAS serum SHBG serum insulin
Trial Locations
- Locations (1)
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obstetrics
🇵🇱Poznan, Poland