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 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT06912594
Eligibility Criteria:
Inclusion Criteria:
* Legal capacity
* Resident in Germany
* Female gender
* Age ≥18 years up to 65 years
* Diagnosed and medically confirmed Polycystic Ovary Syndrome (E28.2)
* Ownership of a smartphone with a compatible iOS or Android version and the ability to operate it
* Internet access and an email address for registration, app usage, and completing questionnaires
* Willingness to complete questionnaires online
* Motivation to use the app regularly
* Sufficient knowledge of the German language
Exclusion Criteria:
* Changes in hormone therapy within eight weeks prior to the start of the study and/or planned within the next 12 weeks
* Changes in treatment with metformin within eight weeks prior to the start of the study and/or planned within the next 12 weeks
* Current treatment with medications for obesity (e.g., liraglutide, orlistat)
* Changes in treatment with anti-androgens (e.g., spironolactone, cyproterone acetate, flutamide) within eight weeks prior to the start of the study and/or planned within the next 12 weeks
* Pregnancy or breastfeeding
* Current hormonal fertility treatment
* Changes in treatment with psychotropic medications within eight weeks prior to the start of the study and/or planned within the next 12 weeks
* Current psychotherapeutic treatment
* Previous or current access to the Endo-App or other digital health applications (DiGAs)
* Current participation in other clinical studies
* Current nutritional counseling according to §20 SGB V or nutritional therapy according to §43 SGB V, or participation in weight reduction programs
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06912594
Study Brief:
Protocol Section:
NCT06912594