Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by Menopause

Not Applicable

Completed

• Conditions: Menopausal and Other Perimenopausal Disorders

• Registration Number: NCT06987617
• Lead Sponsor: Endo Health GmbH

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 indicate that the app offers beneficial effects on menopausal symptoms and menopause-specific quality-of-life. The study also provided valuable insights for the design of future larger trials and highlights the promising potential of the app to enhance individualized care.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-09
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30
• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-22
• Last Update Submitted: 2025-05-22
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 224

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Menopause-specific Quality of Life Questionnaire (MENQOL)	From enrollment (baseline) to the end of treatment at 12 weeks	Menopause-specific Quality of Life Questionnaire (MENQOL): Min=1, max=8. Higher scores mean a worse outcome.

Trial Locations

Locations (1)

Endo Health GmbH; 🇩🇪 Chemnitz, Saxony, Germany