Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
220 participants
INTERVENTIONAL
2025-04-02
2025-09-30
Brief Summary
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Detailed Description
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The present study is designed as a single-blind, two-arm, randomised controlled trial in which participants will either receive the PCOS app over a 12-week period in addition to care-as-usual (intervention group) or only care-as-usual as typically available (control group). The study will be conducted online. The aim is to evaluate the effectiveness of the app by analysing various questionnaires as endpoints. The primary endpoint is the Polycystic Ovary Syndrome Questionnaire (PCOSQ-G). The questionnaires/endpoints will be completed at T0 (baseline) and after 12 weeks. Statistical analyses will be conducted using R and SPSS. Exploratory evaluations of change scores in the relevant questionnaires will be performed.
Overall, this study aims to provide important insights into whether and to what extent a PCOS app can have a positive impact on the quality of life and symptoms of women with PCOS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Control Group
Control group has access to care-as-usual only.
No interventions assigned to this group
Intervention Group
The intervention group has access to the PCOS app and its functions in in addition to care-as-usual
PCOS-App
The PCOS-App helps to implement multimodal self-help measures in the daily lives of PCOS patients through various functions such as symptom diary and interactive exercises.
Interventions
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PCOS-App
The PCOS-App helps to implement multimodal self-help measures in the daily lives of PCOS patients through various functions such as symptom diary and interactive exercises.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
FEMALE
No
Sponsors
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Endo Health GmbH
INDUSTRY
Responsible Party
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Locations
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Endo Health GmbH
Chemnitz, Saxony, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RCT_PilotPCOS
Identifier Type: -
Identifier Source: org_study_id
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