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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
  Purpose

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).


Condition Intervention
Polycystic Ovary Syndrome (PCOS)
 Dietary Supplement: Micronized trans-resveratrol
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Resveratrol
U.S. FDA Resources

Further study details as provided by Poznan University of Medical Sciences:

Primary Outcome Measures:
  • testosterone serum concentration [ Time Frame: 3 month therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: December 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Micronized trans-resveratrol
Micronized trans-resveratrol
 Dietary Supplement: Micronized trans-resveratrol
Other Name: Micronized trans-resveratrol 500 (Rev Genetics LLC - Miami, FL, USA)
Placebo Comparator: Placebo Dietary Supplement: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720459

Contacts
Contact: Beata Banaszewska, MD PhD +48 61 8419412 bbeata48@gmail.com
Contact: Robert Z Spaczynski, MD PhD +48 61 8419412 rspaczynski@yahoo.com

Locations
Poland
Poznan University of Medical Sciences Not yet recruiting
Poznan, Poland, 60-535
Sponsors and Collaborators
Poznan University of Medical Sciences
University of California, Davis
Investigators
Study Chair: Leszek A Pawelczyk, MD PhD Poznan University of Medical Sciences
Study Director: Antoni J Duleba, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Beata Banaszewska, MD PhD, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01720459     History of Changes
Other Study ID Numbers: 681/10
Study First Received: October 31, 2012
Last Updated: November 1, 2012
Health Authority: Poland: Ministry of Health

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents

ClinicalTrials.gov processed this record on June 17, 2013