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

P

Poznan University of Medical Sciences (PUMS)

Status

Unknown

Conditions

Polycystic Ovary Syndrome (PCOS)

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Micronized trans-resveratrol

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Enrollment

40 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups, including a placebo group

Micronized trans-resveratrol
Active Comparator group
Description:
Micronized trans-resveratrol
Treatment:
Dietary Supplement: Micronized trans-resveratrol
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Central trial contact

Beata Banaszewska, MD PhD; Robert Z Spaczynski, MD PhD

Data sourced from clinicaltrials.gov

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