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
N/A
18 Years
40 Years
18 Years
40 Years
Not Enrolling
Female
Polycystic Ovary Syndrome (PCOS)
Female
Polycystic Ovary Syndrome (PCOS)
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
testosterone serum concentration
Outcome Time Frame:
3 month therapy
Safety Issue:
No
Principal Investigator
Leszek A Pawelczyk, MD PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Poznan University of Medical Sciences
Authority:
Poland: Ministry of Health
Study ID:
681/10
NCT ID:
NCT01720459
Start Date:
December 2012
Completion Date:
December 2014
Related Keywords:
- Polycystic Ovary Syndrome (PCOS)
- Polycystic Ovary Syndrome
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