PCOS, Insulin Resistance Clinical Trial
Official title:
Prospective, Randomized, Double - Blind Placebo Controlled Trial of Simvastatin and Resveratrol Therapy on Clinical, Endocrinological, Biochemical and Endothelial Dysfunction Parameters in Women With Polycystic Ovary Syndrome.
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment