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

P

Poznan University of Medical Sciences (PUMS)

Status and phase

Unknown
Phase 4

Conditions

PCOS, Insulin Resistance

Treatments

Drug: Simvastatin and micronized trans-resveratrol

Study type

Interventional

Funder types

Other

Identifiers

NCT02766803
PoznanUMS 3

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

60 participants in 2 patient groups, including a placebo group

Simvastatin + resveratrol
Active Comparator group
Description:
simvastatin 20 mg daily micronized trans-resveratrol 500 mg daily
Treatment:
Drug: Simvastatin and micronized trans-resveratrol
simvastatin+ placebo
Placebo Comparator group
Description:
simvastatin 20 mg daily Placebo
Treatment:
Drug: Simvastatin and micronized trans-resveratrol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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