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.
Overview
- Phase
- Phase 4
- Intervention
- Simvastatin and micronized trans-resveratrol
- Conditions
- PCOS, Insulin Resistance
- Sponsor
- Poznan University of Medical Sciences
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- testosterone serum concentration
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
Beata Banaszewska
MD PhD Ass Professor
Poznan University of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •insulin resistance
- •normal prolactin, TSH, 17 OH progesterone No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
Exclusion Criteria
- •use of oral contraceptives and/or other steroid hormones 3 months prior to the study
Arms & Interventions
Simvastatin + resveratrol
simvastatin 20 mg daily micronized trans-resveratrol 500 mg daily
Intervention: Simvastatin and micronized trans-resveratrol
simvastatin+ placebo
simvastatin 20 mg daily Placebo
Intervention: Simvastatin and micronized trans-resveratrol
Outcomes
Primary Outcomes
testosterone serum concentration
Time Frame: 2 years