Effects of Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2012
CompletedFirst Posted
Study publicly available on registry
November 2, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedNovember 2, 2012
October 1, 2012
1 year
October 31, 2012
November 1, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
testosterone serum concentration
3 month therapy
Study Arms (2)
Micronized trans-resveratrol
ACTIVE COMPARATORMicronized trans-resveratrol
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Use of oral contraceptives and/or other steroid hormones 3 months prior to the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Poznan University of Medical Sciences
Poznan, 60-535, Poland
Related Publications (1)
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.
PMID: 27754722DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Leszek A Pawelczyk, MD PhD
Poznan University of Medical Sciences
- STUDY DIRECTOR
Antoni J Duleba, MD
University of California, Davis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
October 31, 2012
First Posted
November 2, 2012
Study Start
December 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2014
Last Updated
November 2, 2012
Record last verified: 2012-10