Evaluation of a Mobile Menopause Application

N/ANot Yet RecruitingNCT07663305

Endo Health GmbH426 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

426

Conditions

N95.1 Menopausal and Female Climacteric States

Interventions

Menopause AppDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medicoles

Hanover, Germany