Evaluation of a Mobile Menopause Application

NCT07663305 | Not Yet Recruiting

• 1 other identifier: RCT_EMMA
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 1

Brief Summary

This study examines whether a digital app can help women manage symptoms of menopause. A total of 426 women with medically confirmed menopausal symptoms are randomly assigned to either use the app in addition to their usual medical care for 24 weeks, or to continue with usual care alone. The app provides evidence-based content and exercises for multimodal menopause management. Participants are followed up over 24 weeks, with the primary outcome assessed at 12 weeks. The main goal is to evaluate whether the app improves menopause-specific quality of life.

Conditions

N95.1 Menopausal and Female Climacteric States

Keywords

Menopause; Digital Therapeutics; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Menopause-specific quality of life

  Assessed with the Menopause-specific Quality of Life Questionnaire (MENQOL)

  Changes between time point T0 (baseline) and T3 (12 weeks after baseline)

Secondary Outcomes (4)

• Menopause-specific symptom severity

  Changes between time point T0 (baseline) and T3 (12 weeks after baseline)

• Daily interference due to hot flashes

  Changes between time point T0 (baseline) and T3 (12 weeks after baseline)

• Menopause-specific impairment in daily activities

  Changes between time point T0 (baseline) and T3 (12 weeks after baseline)

• Patient activation

  Changes between time point T0 (baseline) and T3 (12 weeks after baseline)

Other Outcomes (4)

• Menopause-specific quality of life

  Changes between time point T0 (baseline) and T4 (24 weeks after baseline)

• Menopause-related absenteeism

  Changes between time point T0 (baseline) and T3 (12 weeks after baseline)

• Menopause-related presenteeism

  Changes between time point T0 (baseline) and T3 (12 weeks after baseline)

Study Arms (2)

Control Group

NO INTERVENTION

The control group has access to care-as-usual only.

Intervention Group

EXPERIMENTAL

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

Device: Menopause App

Interventions

Menopause App DEVICE

The menopause app facilitates the implementation of multimodal self-management strategies in the daily routines of individuals with a 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
• Ability to provide informed consent
• Residency in Germany
• Female gender
• Age ≥18 years
• Medically confirmed menopausal or other perimenopausal disorder (N95.1)
• 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
• MRS II ≥ 9

You may not qualify if:

• Pregnancy or breastfeeding during the study period
• Current hormonal replacement therapy (HRT), initiation of HRT within eight weeks prior to study start and/or planned start of HRT during the study period
• Changes in treatment with psychotropic medication within eight weeks prior to study start and/or planned during the study period
• Start of psychotherapy within eight weeks prior to study start and/or planned during the study period
• Start of a rehabilitation program within eight weeks prior to study start and/or planned during the study period
• Surgery performed within eight weeks prior to study start and/or planned during the study period
• 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)

Medicoles

Hanover, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: The external statistician (responsible for data analysis and/or interpretation) will be blinded to group assignment until after the analysis code for the primary analysis (ANCOVA) has been prepared and stored.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization will be stratified by the presence of concomitant treatment (non-hormonal concomitant treatment vs no concomitant treatment at baseline) to ensure balanced allocation across this prognostic factor.

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Locations

DE (1)