Polycystic Ovary Syndrome
Conditions
Keywords
PCOS, Statin, Metformin, Testosterone, Menstrual cycle, Lipids
Brief summary
The purpose of this study is to compare effects of statins (simvastatin) and metformin on clinical (menstrual cycle, excessive hair, skin problems), endocrine (androgens), metabolic (lipids, markers of systemic inflammation), and endothelial function parameters in women with polycystic ovary syndrome (PCOS).
Interventions
DRUGSimvastatin
DRUGSimvastatin and Metformin
DRUGMetformin
Sponsors
Yale University
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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 spontaneus menses per year) and hyperandrogenism(hirsutism or acne) or hyperandrogenemia(testosterone \> 70 ng/ml) 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 (transaminase) above 2 times of upper limit of normal use of any following medications: cyclosporine, fibrates niacin,antifungal agents, macrolide antibiotics use of oral contraceptives and other steroid hormones 3 months prior to the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum testosterone | — |
Secondary
| Measure | Time frame |
|---|---|
| serum lutropin | — |
| serum follitropin | — |
| serum lipids | — |
| regularity of menstrual cycle | — |
| serum SHBG | — |
| serum insulin | — |
| serum DHEAS | — |
Countries
Poland
Contacts
Primary ContactBeata E Banaszewska, MD PhD
Backup ContactRobert Z Spaczynski, MD PhD
Outcome results
None listed