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

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

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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