Pilot Study to Investigate the Impact of an App on the Quality of Life and Symptoms of Individuals Affected by Menopause

NCT ID: NCT06987617

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-09

Study Completion Date

2024-12-30

Brief Summary

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The study explores the impact of a digital app for the self-management of (peri-)menopausal disorders. A total of 224 participants were randomized into an intervention and a control group. Findings indicate that the app offers beneficial effects on menopausal symptoms and menopause-specific quality-of-life. The study also provided valuable insights for the design of future larger trials and highlights the promising potential of the app to enhance individualized care.

Detailed Description

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Conditions

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Menopausal and Other Perimenopausal Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

Menopause App

Intervention Type DEVICE

The menopause app facilitates the implementation of multimodal self-management strategies in the daily routines of individuals with a (peri-)menopausal disorder, through tools such as a symptom diary and guided interactive exercises.

Control Group

Control group has access to care-as-usual only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Menopause App

The menopause app facilitates the implementation of multimodal self-management strategies in the daily routines of individuals with a (peri-)menopausal disorder, through tools such as a symptom diary and guided interactive exercises.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Legal capacity
* Residency in Germany
* Female sex
* Age ≥18 years
* Known and medically confirmed (peri-)menopausal disorder (N95.1, N95.3, N95.8, N95.9)
* 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

Exclusion Criteria

* Changes in hormone therapy within eight weeks before the start of the study and/or planned within the next 12 weeks
* Changes in antidepressant treatment within eight weeks before the start of the study and/or planned within the next 12 weeks
* Previous or current access to the Endo-App or other comparable digital health applications, or current active prescription
* Current participation in other clinical studies
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Endo Health GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Endo Health GmbH

Chemnitz, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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RCT_PilotMeno

Identifier Type: -

Identifier Source: org_study_id

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