Evaluation of a Mobile Menopause Application (EMMA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: N95.1 Menopausal and Female Climacteric States
• Intervention / Treatment: Device: Menopause App

• Study Type: Interventional
• Enrollment (Estimated): 426
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hanover, Germany
    • Medicoles
    • Principal Investigator: Elisabeth Siegmund-Schultze, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Absence of exclusion criteria

Exclusion Criteria:

• 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
• Failure to meet the inclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; The control group has access to care-as-usual only.
Experimental: Intervention Group; The intervention group has access to the menopause app and its functions in addition to care-as-usual.	Device: Menopause App; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menopause-specific symptom severity	Assessed with the Menopause Rating Scale (MRS II)	Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Daily interference due to hot flashes	Assessed with the Hot Flash Related Daily Interference Scale (HFRDIS)	Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Menopause-specific impairment in daily activities	Assessed with the Activity Impairment domain of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause)	Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Patient activation	Assessed with the Patient Activation Measure 13 (PAM-13)	Changes between time point T0 (baseline) and T3 (12 weeks after baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menopause-specific quality of life	Assessed with the Menopause-specific Quality of Life Questionnaire (MENQOL)	Changes between time point T0 (baseline) and T4 (24 weeks after baseline)
Menopause-related absenteeism	Assessed with the absenteeism domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).	Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Menopause-related presenteeism	Assessed with the presenteeism domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).	Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Menopause-related work productivity loss	Assessed with the work productivity loss domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).	Changes between time point T0 (baseline) and T3 (12 weeks after baseline)

Collaborators and Investigators

• Sponsor: Endo Health GmbH

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: June 17, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 23, 2026

Study Record Updates

• Last Update Posted (Actual): June 23, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Menopause; Digital Therapeutics
• Other Study ID Numbers: RCT_EMMA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No