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

NCT06987617 | Completed

• 1 other identifier: RCT_PilotMeno
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopausal and Other Perimenopausal Disorders

Keywords

Menopause; Digital Therapeutics; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Menopause-specific Quality of Life Questionnaire (MENQOL)

  Menopause-specific Quality of Life Questionnaire (MENQOL): Min=1, max=8. Higher scores mean a worse outcome.

  From enrollment (baseline) to the end of treatment at 12 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group has access to the menopause app and its functions in addition to care-as-usual

Device: Menopause App

Control Group

NO INTERVENTION

Control group has access to care-as-usual only

Interventions

Menopause App DEVICE

The menopause app facilitates the implementation of multimodal self-management strategies in the daily routines of individuals with a (peri-)menopausal disorder, through tools such as a symptom diary and guided interactive exercises.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endo Health GmbH: lead

Study Sites (1)

Endo Health GmbH

Chemnitz, Saxony, 09111, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: August 9, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)