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

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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02766803

Enrollment

Registered

2016-05-10

Start date

2016-05-31

Completion date

2018-06-30

Last updated

2016-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCOS, Insulin Resistance

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.

Interventions

DRUGSimvastatin and micronized trans-resveratrol

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
testosterone serum concentration	2 years

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026