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

Primary Purpose

PCOS, Insulin Resistance

Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Simvastatin and micronized trans-resveratrol
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS, Insulin Resistance

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Division of Infertility and Reproductive Endocrinology, Department of Gynecology and ObstericsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Simvastatin + resveratrol

simvastatin+ placebo

Arm Description

simvastatin 20 mg daily micronized trans-resveratrol 500 mg daily

simvastatin 20 mg daily Placebo

Outcomes

Primary Outcome Measures

testosterone serum concentration

Secondary Outcome Measures

Full Information

First Posted
May 9, 2016
Last Updated
September 6, 2016
Sponsor
Poznan University of Medical Sciences
Collaborators
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT02766803
Brief Title
Effects of Simvastatin and Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Medical Sciences
Collaborators
University of California, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PCOS, Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Simvastatin + resveratrol
Arm Type
Active Comparator
Arm Description
simvastatin 20 mg daily micronized trans-resveratrol 500 mg daily
Arm Title
simvastatin+ placebo
Arm Type
Placebo Comparator
Arm Description
simvastatin 20 mg daily Placebo
Intervention Type
Drug
Intervention Name(s)
Simvastatin and micronized trans-resveratrol
Primary Outcome Measure Information:
Title
testosterone serum concentration
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
City
Poznan
ZIP/Postal Code
60-184
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beata Banaszewska, Md Ph D
Phone
+48618419412
Email
bbeata48@gmail.com
First Name & Middle Initial & Last Name & Degree
Robert Z Spaczynski, Md PhD Prof
Phone
+48618419412
Email
rspaczynski@yahoo.com
First Name & Middle Initial & Last Name & Degree
Leszek A Pawelczyk, MD PhD Prof
First Name & Middle Initial & Last Name & Degree
Antoni J Duleba, MD Prof

12. IPD Sharing Statement

Learn more about this trial

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

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