NCT00365638CompletedNot Applicable
Effects of Simvastatin on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Prospective, Randomized Trial.
Poznan University of Medical Sciences2 sites in 1 countryStarted: April 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Locations
- 2
- Primary Endpoint
- serum testosterone
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
serum testosterone
Secondary Outcomes
- serum lipids
- serum DHEA-S
- serum SHBG
- serum insulin
- serum lutropin
- serum follitropin
Investigators
Study Sites (2)
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