Menu
Not yet recruiting NCT07663305

Evaluation of a Mobile Menopause Application

No phase Interventional N95.1 Menopausal and Female Climacteric States

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Menopause App.
Who it may be relevant to
Registry conditions: N95.1 Menopausal and Female Climacteric States. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Menopause-specific quality of life [Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)]
Secondary outcome measures (4)
  • Menopause-specific symptom severity [Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)]
  • Daily interference due to hot flashes [Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)]
  • Menopause-specific impairment in daily activities [Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)]
  • Patient activation [Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Germany · 1 center
  • Medicoles — Hanover

Identifiers

NCT: NCT07663305 · RCT_EMMA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗