Status:
UNKNOWN
Evaluation of a Combination of a Plant Extract and a Probiotic on Glucidic Metabolism in Women With PCOS and High Insulin Levels
Lead Sponsor:
Biosearch S.A.
Conditions:
Polycystic Ovarian Syndrome
Insulin Resistance
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The aim of the present study is to evaluate the effect of the combination of a plant extract (BSL\_EP044) and Lactobacillus BSL\_PS6 on parameters of the glucidic metabolism, anthropometric parameters...
Detailed Description
Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy in women, affecting 4-15% of those who are of childbearing age. It is a complex and heterogeneous disease in which the gynecologic...
Eligibility Criteria
Inclusion
- Being diagnosed with polycystic ovarian syndrome according to the Rotterdam criteria.
- HOMA values between 2.5 and 3.
- Body mass index of less than 35 kg/m2.
- Accept freely to participate in the study and sign the informed consent document.
Exclusion
- Women in treatment with oral antidiabetics.
- Being pregnant or intending to get pregnant.
- Be in fertility treatment.
- To suffer from other diseases that affect the hormonal response or that could interfere with the glucidic metabolism.
Key Trial Info
Start Date :
May 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04029805
Start Date
May 29 2019
End Date
August 30 2020
Last Update
July 10 2020
Active Locations (1)
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1
Clinica Margen
Granada, Andalusia, Spain, 18006