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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01720459
Other study ID # 681/10
Secondary ID
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


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
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