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

NCT ID: NCT01720459

Last Updated: 2012-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Polycystic Ovary Syndrome (PCOS)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Micronized trans-resveratrol

Micronized trans-resveratrol

Group Type ACTIVE_COMPARATOR

Micronized trans-resveratrol

Intervention Type DIETARY_SUPPLEMENT

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Micronized trans-resveratrol

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Micronized trans-resveratrol 500 (Rev Genetics LLC - Miami, FL, USA)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of California, Davis

OTHER

Sponsor Role collaborator

Poznan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Beata Banaszewska

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leszek A Pawelczyk, MD PhD

Role: STUDY_CHAIR

Poznan University of Medical Sciences

Antoni J Duleba, MD

Role: STUDY_DIRECTOR

University of California, Davis

Locations

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Poznan University of Medical Sciences

Poznan, , Poland

Site Status

Countries

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Poland

Central Contacts

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Beata Banaszewska, MD PhD

Role: CONTACT

Phone: +48 61 8419412

Email: [email protected]

Robert Z Spaczynski, MD PhD

Role: CONTACT

Phone: +48 61 8419412

Email: [email protected]

References

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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.

Reference Type DERIVED
PMID: 27754722 (View on PubMed)

Other Identifiers

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681/10

Identifier Type: -

Identifier Source: org_study_id