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NCT Number: NCT07663305

Evaluation of a Mobile Menopause Application

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.

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Key information

Conditions

N95.1 Menopausal and Female Climacteric States

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medicoles

Hanover, Germany

Location contact

Elisabeth Siegmund-Schultze, Dr. med.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Menopause-specific quality of life

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

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

Secondary outcomes

  1. Menopause-specific symptom severity

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

    Assessed with the Menopause Rating Scale (MRS II)

  2. Daily interference due to hot flashes

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

    Assessed with the Hot Flash Related Daily Interference Scale (HFRDIS)

  3. Menopause-specific impairment in daily activities

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

    Assessed with the Activity Impairment domain of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause)

  4. Patient activation

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

    Assessed with the Patient Activation Measure 13 (PAM-13)

Other outcomes

  1. Menopause-specific quality of life

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

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

  2. Menopause-related absenteeism

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

    Assessed with the absenteeism domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).

  3. Menopause-related presenteeism

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

    Assessed with the presenteeism domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).

  4. Menopause-related work productivity loss

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

    Assessed with the work productivity loss domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).

Sponsors and collaborators

Lead sponsor

Endo Health GmbH

Industry

Registry information

Acronym: EMMA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.