Status:
COMPLETED
Impact of an App on the Quality of Life and Symptoms in Individuals With Premenstrual Syndrome
Lead Sponsor:
Endo Health GmbH
Conditions:
Premenstrual Syndrome
Premenstrual Syndrome-PMS
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This pilot study explored the effectiveness and acceptance of a digital app for the self-management of PMS. A total of 175 participants were randomized into an intervention and a control group. Findin...
Eligibility Criteria
Inclusion
- Legal capacity
- Residency in Germany
- Female gender
- Age ≥18 years
- Diagnosed and medically confirmed current PMS (N94.3)
- 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
Exclusion
- Pregnancy, breastfeeding, or the onset of menopause during the study period
- Changes in hormonal therapy and/or use of antidepressants within eight weeks prior to the study start and/or planned in the upcoming 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 :
May 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2024
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT06991413
Start Date
May 16 2024
End Date
October 25 2024
Last Update
May 28 2025
Active Locations (1)
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1
Endo Health GmbH
Chemnitz, Saxony, Germany, 09111