Effects of Simvastatin and Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients
Status:
Unknown status
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of
reproductive age. Hyperandrogenism is the central feature of PCOS. Studies on isolated
ovarian theca-interstitial cells indicate that resveratrol, a natural polyphenol, reduces
androgen production.
This study is designed to evaluate the endocrine and metabolic effects of simvastatin and
resveratrol on PCOS.
Methods: A randomized (1:1) double-blind, placebo-controlled trial will evaluate the effects
of administering 20 mg of simvastatin daily and 500 mg of resveratrol daily, or administering
20 mg simvastatin and the placebo to women with PCOS at an academic hospital. PCOS is defined
according to the Rotterdam criteria. Evaluations are performed at baseline and repeated after
3 and 6 months of treatment. The main outcome is a change of the serum total testosterone and
the fasting insulin level.