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Trial record 1 of 1 for:    simvastatin and resveratrol
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Effects of Simvastatin and Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
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

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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

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02766803


Locations
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Poland
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics Recruiting
Poznan, Poland, 60-184
Contact: Beata Banaszewska, Md Ph D    +48618419412    bbeata48@gmail.com   
Contact: Robert Z Spaczynski, Md PhD Prof    +48618419412    rspaczynski@yahoo.com   
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

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Responsible Party: Beata Banaszewska, MD PhD Ass Professor, Poznan University of Medical Sciences
ClinicalTrials.gov 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:
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Resveratrol
Simvastatin
Polycystic Ovary Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents