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:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT04452968
Eligibility Criteria:
Inclusion Criteria:
* PCOS as described by Rotterdam's criteria
Exclusion Criteria:
* endocrine disorders
* diabetic
* hypertensive
* Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
* The body weight fluctuated more than 5% in recent 3 months.
* Liver and kidney dysfunction: renal impairment, creatinine clearance rate \< 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit;
* History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
* History of thyroid diseases;
* pregnant
* Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight)
* Patients who cannot be followed for 16 months (due to a health situation or migration)
* Patients who are unwilling or unable to give informed consent
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
20 Years
Maximum Age:
35 Years
Study:
NCT04452968
Study Brief:
Protocol Section:
NCT04452968