Simvastatin Therapy in Women With Polycystic Ovary Syndrome.

Poznan University of Medical Sciences (PUMS)

Status

Completed

Conditions

Polycystic Ovary Syndrome

Treatments

Drug: simvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00365638

636/04

Details and patient eligibility

About

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).

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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