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

Primary Purpose

Polycystic Ovary Syndrome (PCOS)

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Micronized trans-resveratrol
Placebo
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome (PCOS)

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • PCO - Androgen Excess Society criteria: hyperandrogenism (hirsutism) / hyperandrogenemia (testosterone >70ng/dl) and/or oligomenorrhea (<8 spontaneous menses per year) and/or polycystic ovarian morphology on ultrasound
  • Normal prolactin, TSH, 17-OH progesterone
  • No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly
  • Age 18-40

Exclusion Criteria:

  • Use of oral contraceptives and/or other steroid hormones 3 months prior to the study

Sites / Locations

  • Poznan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Micronized trans-resveratrol

Placebo

Arm Description

Micronized trans-resveratrol

Outcomes

Primary Outcome Measures

testosterone serum concentration

Secondary Outcome Measures

Full Information

First Posted
October 31, 2012
Last Updated
November 1, 2012
Sponsor
Poznan University of Medical Sciences
Collaborators
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT01720459
Brief Title
Effects of Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients
Official Title
Effects of Micronized Trans-resveratrol Treatment on Clinical, Endocrine, Metabolic and Biochemical Parameters of Women With Polycystic Ovary Syndrome: Placebo-controlled Randomized Single-blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether micronized trans-resveratrol improves clinical (excessive hair, menstrual cycle), endocrine (androgens)and metabolic (lipids, markers of systemic inflammation) in women with polycystic ovary syndrome (PCOS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome (PCOS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Micronized trans-resveratrol
Arm Type
Active Comparator
Arm Description
Micronized trans-resveratrol
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Micronized trans-resveratrol
Other Intervention Name(s)
Micronized trans-resveratrol 500 (Rev Genetics LLC - Miami, FL, USA)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
testosterone serum concentration
Time Frame
3 month therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PCO - Androgen Excess Society criteria: hyperandrogenism (hirsutism) / hyperandrogenemia (testosterone >70ng/dl) and/or oligomenorrhea (<8 spontaneous menses per year) and/or polycystic ovarian morphology on ultrasound Normal prolactin, TSH, 17-OH progesterone No evidence of androgen producing malignancy, Cushing's syndrome or acromegaly Age 18-40 Exclusion Criteria: Use of oral contraceptives and/or other steroid hormones 3 months prior to the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beata Banaszewska, MD PhD
Phone
+48 61 8419412
Email
bbeata48@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Z Spaczynski, MD PhD
Phone
+48 61 8419412
Email
rspaczynski@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leszek A Pawelczyk, MD PhD
Organizational Affiliation
Poznan University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Antoni J Duleba, MD
Organizational Affiliation
University of California, Davis
Official's Role
Study Director
Facility Information:
Facility Name
Poznan University of Medical Sciences
City
Poznan
ZIP/Postal Code
60-535
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27754722
Citation
Banaszewska B, Wrotynska-Barczynska J, Spaczynski RZ, Pawelczyk L, Duleba AJ. Effects of Resveratrol on Polycystic Ovary Syndrome: A Double-blind, Randomized, Placebo-controlled Trial. J Clin Endocrinol Metab. 2016 Nov;101(11):4322-4328. doi: 10.1210/jc.2016-1858. Epub 2016 Oct 18.
Results Reference
derived

Learn more about this trial

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

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