Polycystic Ovary Syndrome
Conditions
Keywords
PCOS, statin, testosterone, lipids
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).
Interventions
DRUGsimvastatin
Sponsors
Yale University
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum testosterone | — |
Secondary
| Measure | Time frame |
|---|---|
| serum SHBG | — |
| serum insulin | — |
| serum DHEA-S | — |
| serum follitropin | — |
| serum lipids | — |
| serum lutropin | — |
Countries
Poland
Outcome results
None listed