Simvastatin Therapy in Women With Polycystic Ovary Syndrome.
Not Applicable
Completed
- Conditions
- Polycystic Ovary Syndrome
- Registration Number
- NCT00365638
- Lead Sponsor
- Poznan University of Medical Sciences
- 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) in women with polycystic ovary syndrome (PCOS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method serum testosterone
- Secondary Outcome Measures
Name Time Method serum lutropin serum follitropin serum lipids serum DHEA-S serum SHBG serum insulin
Trial Locations
- Locations (1)
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
🇵🇱Poznan, Poland