drugset / Trial / NCT02766803

Effects of Simvastatin and Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients

NCT02766803

RandomizedSingle-groupDouble-blindTreatment

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.

Timeline

Start
2016-05
Primary completion
2017-06
Completion
2018-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Resveratrol Small molecule 500 mg
Comparator Simvastatin Small molecule 20 mg