Status:
COMPLETED
Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by Menopause
Lead Sponsor:
Endo Health GmbH
Conditions:
Menopausal and Other Perimenopausal Disorders
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The study explores the impact of a digital app for the self-management of (peri-)menopausal disorders. A total of 224 participants were randomized into an intervention and a control group. Findings in...
Eligibility Criteria
Inclusion
- Legal capacity
- Residency in Germany
- Female sex
- Age ≥18 years
- Known and medically confirmed (peri-)menopausal disorder (N95.1, N95.3, N95.8, N95.9)
- Ownership of a smartphone and ability to use it
- Internet access for app usage and questionnaire completion
- Email address for registration
- Willingness to complete questionnaires online
- Motivation for regular app usage
- Sufficient proficiency in the German language
- Absence of exclusion criteria
Exclusion
- Changes in hormone therapy within eight weeks before the start of the study and/or planned within the next 12 weeks
- Changes in antidepressant treatment within eight weeks before the start of the study and/or planned within the next 12 weeks
- Previous or current access to the Endo-App or other comparable digital health applications, or current active prescription
- Current participation in other clinical studies
- Failure to meet the inclusion criteria
Key Trial Info
Start Date :
August 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT06987617
Start Date
August 9 2024
End Date
December 30 2024
Last Update
May 23 2025
Active Locations (1)
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1
Endo Health GmbH
Chemnitz, Saxony, Germany, 09111