Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome (PCOS) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PCOS-App | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Control group has access to care-as-usual only.
- type
- EXPERIMENTAL
- label
- Intervention Group
- description
- The intervention group has access to the PCOS app and its functions in in addition to care-as-usual
- interventionNames
- Device: PCOS-App
Primary outcomes (1)
- measure
- Polycystic Ovary Syndrome Questionnaire (PCOSQ-G)
- timeFrame
- From enrollment to the end of treatment at 12 weeks
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available