Working… Menu
Trial record 1 of 1 for:    simvastatin and resveratrol
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02766803
Recruitment Status : Unknown
Verified September 2016 by Beata Banaszewska, Poznan University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : May 10, 2016
Last Update Posted : September 8, 2016
University of California, San Diego
Information provided by (Responsible Party):
Beata Banaszewska, 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.

Condition or disease Intervention/treatment Phase
PCOS, Insulin Resistance Drug: Simvastatin and micronized trans-resveratrol Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : May 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Simvastatin + resveratrol
simvastatin 20 mg daily micronized trans-resveratrol 500 mg daily
Drug: Simvastatin and micronized trans-resveratrol
Placebo Comparator: simvastatin+ placebo
simvastatin 20 mg daily Placebo
Drug: Simvastatin and micronized trans-resveratrol

Primary Outcome Measures :
  1. testosterone serum concentration [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02766803

Layout table for location information
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics Recruiting
Poznan, Poland, 60-184
Contact: Beata Banaszewska, Md Ph D    +48618419412   
Contact: Robert Z Spaczynski, Md PhD Prof    +48618419412   
Principal Investigator: Leszek A Pawelczyk, MD PhD Prof         
Sub-Investigator: Antoni J Duleba, MD Prof         
Sponsors and Collaborators
Poznan University of Medical Sciences
University of California, San Diego

Layout table for additonal information
Responsible Party: Beata Banaszewska, MD PhD Ass Professor, Poznan University of Medical Sciences Identifier: NCT02766803     History of Changes
Other Study ID Numbers: PoznanUMS 3
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: September 8, 2016
Last Verified: September 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Polycystic Ovary Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents