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:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT04163120
Eligibility Criteria:
Inclusion Criteria:
diagnosis of PCOS according Rotterdam Criteria (at least 2 of 3 between
* oligo/anovulation
* hyperandrogenism
* clinical (hirsutism or less commonly male pattern alopecia) or biochemical (raised FAI or free testosterone) polycystic ovaries on ultrasound Other inclusion criteria
* fertile age (18-45 years);
* BMI\> 25 kg/m2,
* desire to lose weight;
* acceptance not to use contraceptives during the experimental period
Exclusion Criteria:
* pregnancy and lactation,
* hormonal therapy and/or insulin-sensitizers in the last 2 months,
* hepatic, renal and heart diseases
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04163120
Study Brief:
Protocol Section:
NCT04163120