Simvastatin Therapy in Women With Polycystic Ovary Syndrome.
Study Details
Study Description
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).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
N/A |
Study Design
Outcome Measures
Primary Outcome Measures
- serum testosterone []
Secondary Outcome Measures
- serum lutropin []
- serum follitropin []
- serum lipids []
- serum DHEA-S []
- serum SHBG []
- serum insulin []
Eligibility Criteria
Criteria
Inclusion Criteria:
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PCO - ESHRE/ASRM criteria: oligomenorrhea (<8 spontaneous menses per year) and hyperandrogenism (hirsutism or acne) or hyperandrogenemia (testosterone >70ng/dl)
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Normal prolactin, TSH, 17-OH progesterone
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No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
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Age 18-40
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Reliable use of birth control pill for at least 3 months and no plans of pregnancy
Exclusion Criteria:
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Elevated creatinine kinase above 2 times upper limit of normal or liver enzymes (transaminases) above 2 times of upper limit of normal
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Use of any of the following medications: cyclosporine, fibrates, niacin, antifungal agents, macrolide antibiotics.
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Use of oral contraceptives and other steroid hormones 3 months prior to the study
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Contraindications to oral contraceptives
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics | Poznan | Poland | 60-184 |
Sponsors and Collaborators
- Poznan University of Medical Sciences
- Yale University
Investigators
- Principal Investigator: Leszek Pawelczyk, MD PhD, Poznan University of Medical Sciences
- Study Director: Antoni J Duleba, MD, Yale University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 636/04