Status:
UNKNOWN
Effect of Dietary Modifacation on Microbiota in Overweight and Obese Polycystic Ovary Syndrome Patients
Lead Sponsor:
Poznan University of Medical Sciences
Collaborating Sponsors:
University of California, San Diego
Sanprobi
Conditions:
PCOS
Eligibility:
FEMALE
18-40 years
Phase:
PHASE4
Brief Summary
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age. The pathogenesis of PCOS is not fully understood. The intestinal microbiota are believed to be a...
Detailed Description
Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age. The pathogenesis of PCOS is not fully understood. The intestinal microbiota are believed to be a...
Eligibility Criteria
Inclusion
- Written consent for participation in the clinical trial
- Age 18 to 45 years Irregular menstruation (\> 35 days) or secondary amenorrhea\> 3 months
- 4\. Hyperandrogenism (hirsutism and / or acne) and / or hyperandrogenemia (total serum testosterone\> 0.5 ng / mL) 5. BMI \> 25
Exclusion
- Ovarian cancer, adrenal gland tumor, endometrial cancer, cervical cancer, breast cancer
- Congenital adrenal hyperplasia (17-OH-progesterone\> 2.5 ng / mL)
- Clinically diagnosed Cushing's disease, acromegaly, gigantism
- Type I or II diabetes
- Unexplained bleeding from the genital tract
- Hormone treatment within the last 2 months
Key Trial Info
Start Date :
May 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 20 2018
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03325023
Start Date
May 20 2017
End Date
October 20 2018
Last Update
October 30 2017
Active Locations (1)
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1
Division of Infertility and Reproductive Endocrinology, Department of Gynecology and Obsterics
Poznan, Poland, 61701