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

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ClinicalTrials.gov Identifier: NCT01720459
Recruitment Status : Unknown
Verified October 2012 by Beata Banaszewska, Poznan University of Medical Sciences.
Recruitment status was:  Not yet recruiting
First Posted : November 2, 2012
Last Update Posted : November 2, 2012
University of California, Davis
Information provided by (Responsible Party):
Beata Banaszewska, Poznan University of Medical Sciences

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).

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : December 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. testosterone serum concentration [ Time Frame: 3 month therapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720459

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

Poznan University of Medical Sciences Not yet recruiting
Poznan, Poland, 60-535
Sponsors and Collaborators
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

Responsible Party: Beata Banaszewska, MD PhD, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01720459     History of Changes
Other Study ID Numbers: 681/10
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: November 2, 2012
Last Verified: October 2012

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