Status:
NOT_YET_RECRUITING
App Impact on Quality of Life and Symptoms in PCOS
Lead Sponsor:
Endo Health GmbH
Conditions:
Polycystic Ovary Syndrome (PCOS)
Eligibility:
FEMALE
18-65 years
Phase:
NA
Brief Summary
This study investigates the influence of a PCOS app on the quality of life and symptoms of individuals with polycystic ovary syndrome (PCOS). The intervention group can use the app over the study peri...
Detailed Description
The study aims to investigate the effect of a PCOS app on quality of life and symptoms of individuals with polycystic ovary syndrome (PCOS). PCOS is a widespread and distressing health problem that ca...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06912594
Start Date
April 2 2025
End Date
September 1 2025
Last Update
April 6 2025
Active Locations (1)
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1
Endo Health GmbH
Chemnitz, Saxony, Germany, 09111