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

Information source: Poznan University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Polycystic Ovary Syndrome (PCOS)

Intervention: Micronized trans-resveratrol (Dietary Supplement); Placebo (Dietary Supplement)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Poznan University of Medical Sciences

Official(s) and/or principal investigator(s):
Leszek A Pawelczyk, MD PhD, Study Chair, Affiliation: Poznan University of Medical Sciences
Antoni J Duleba, MD, Study Director, Affiliation: University of California, Davis

Overall contact:
Beata Banaszewska, MD PhD, Phone: +48 61 8419412, Email: bbeata48@gmail.com

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).

Clinical Details

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

Primary outcome: testosterone serum concentration

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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

Locations and Contacts

Beata Banaszewska, MD PhD, Phone: +48 61 8419412, Email: bbeata48@gmail.com

Poznan University of Medical Sciences, Poznan 60-535, Poland; Not yet recruiting
Additional Information

Starting date: December 2012
Last updated: November 1, 2012

Page last updated: August 23, 2015

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