NCT06912594Not yet recruiting
App Impact on Quality of Life and Symptoms in PCOS
Pilot Study to Investigate the Influence of an App on the Quality of Life and Symptoms of Patients With Polycystic Ovary Syndrome
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 period of twelve weeks in addition to care-as-usual (CAU). In the control group, this is compared with no use of the PCOS-App for a twelve-week period, that is, care-as-usual only/ continuation of the current treatment (waitlist design). The aim is to evaluate the effectiveness of the app and to gain insights for the design of future studies. The study is expected to last seven months and include 220 participants.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- First submitted
- 26 Mar 2025
- Start date
- 2 Apr 2025
- Primary completion date
- Sept 2025
- Lead sponsor
- Endo Health GmbH
- NCT number
- NCT06912594
What you commit to
- Study type: Interventional
- Planned participants: 220
- From 2 Apr 2025 to the primary completion date, Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Changes in treatment with psychotropic medications within eight weeks prior to the start of the study and/or planned within the next 12 weeks
- Previous or current access to the Endo-App or other digital health applications (DiGAs)
- Current nutritional counseling according to §20 SGB V or nutritional therapy according to §43 SGB V, or participation in weight reduction programs
Other
- Pregnancy or breastfeeding
- Current hormonal fertility treatment
- Current psychotherapeutic treatment
- Current participation in other clinical studies
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Endo Health GmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.