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

Phase 4

• Conditions: PCOS, Insulin Resistance
• Interventions: Drug: Simvastatin and micronized trans-resveratrol

• Registration Number: NCT02766803
• Lead Sponsor: Poznan University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-09
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-10
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-06
• Last Update Posted: 2016-09-08
• Primary Completion: 2017-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• PCOs
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Simvastatin + resveratrol	Simvastatin and micronized trans-resveratrol	simvastatin 20 mg daily micronized trans-resveratrol 500 mg daily
simvastatin+ placebo	Simvastatin and micronized trans-resveratrol	simvastatin 20 mg daily Placebo

Primary Outcome Measures

Name	Time	Method
testosterone serum concentration	2 years

Trial Locations

Locations (1)

Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics; 🇵🇱 Poznan, Poland