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

This study is not yet open for participant recruitment.
Verified October 2012 by Poznan University of Medical Sciences
Sponsor:
Collaborator:
University of California, Davis
Information provided by (Responsible Party):
Beata Banaszewska, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01720459
First received: October 31, 2012
Last updated: November 1, 2012
Last verified: October 2012
History of Changes

October 31, 2012
November 1, 2012
December 2012
December 2013   (final data collection date for primary outcome measure)
testosterone serum concentration [ Time Frame: 3 month therapy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01720459 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Micronized Trans-resveratrol Treatment on Polycystic Ovary Syndrome (PCOS) Patients
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

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).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Polycystic Ovary Syndrome (PCOS)
  • Dietary Supplement: Micronized trans-resveratrol
    Other Name: Micronized trans-resveratrol 500 (Rev Genetics LLC - Miami, FL, USA)
  • Dietary Supplement: Placebo
  • Active Comparator: Micronized trans-resveratrol
    Micronized trans-resveratrol
    Intervention: Dietary Supplement: Micronized trans-resveratrol
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
40
December 2014
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
No
Contact: Beata Banaszewska, MD PhD +48 61 8419412 bbeata48@gmail.com
Contact: Robert Z Spaczynski, MD PhD +48 61 8419412 rspaczynski@yahoo.com
Poland
 
NCT01720459
681/10
No
Beata Banaszewska, Poznan University of Medical Sciences
Poznan University of Medical Sciences
University of California, Davis
Study Chair: Leszek A Pawelczyk, MD PhD Poznan University of Medical Sciences
Study Director: Antoni J Duleba, MD University of California, Davis
Poznan University of Medical Sciences
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP