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

Polycystic Ovary Syndrome (PCOS) Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01720459
• Other study ID #: 681/10
• Status: Not yet recruiting
• Phase: N/A
• First received: October 31, 2012
• Last updated: November 1, 2012
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: October 2012
• Source: Poznan University of Medical Sciences
• Contact: Beata Banaszewska, MD PhD
• Phone: +48 61 8419412
• Email: bbeata48[@]gmail.com
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Polycystic Ovary Syndrome (PCOS)
• Syndrome

Intervention

Dietary Supplement:
• Micronized trans-resveratrol

• Placebo

Locations

Country	Name	City	State
Poland	Poznan University of Medical Sciences	Poznan

Sponsors (2)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences	University of California, Davis

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	testosterone serum concentration		3 month therapy	No