Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
NCT ID:
NCT04453306
Eligibility Criteria:
Inclusion Criteria:
* age between 18 and 40 years
* diagnostic criteria for PCOS
* overweight with a BMI ≥ 27 kg / m² associated with at least one comorbidity (hypertension, type 2 diabetes mellitus, dyslipidemia) or obesity with a BMI between 30 and 45 kg / m² with or without comorbidities
Exclusion Criteria:
* severe systemic arterial hypertension (≥180 / 100 mmHg)
* pregnant or lactating women
* diabetics using sulfonylurea or insulin
* any known allergy or intolerance to topiramate medication
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04453306
Study Brief:
Protocol Section:
NCT04453306