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OpenTrials
Completed

NCT Number: NCT06987617

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

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.

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Key information

Conditions

Menopausal and Other Perimenopausal Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Endo Health GmbH

Chemnitz, Saxony, 09111, Germany

Who can participate

Healthy volunteers accepted: No

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

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
  • Absence of exclusion criteria

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
  • 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 (peri-)menopausal disorder, through tools such as a symptom diary and guided interactive exercises.

Primary outcomes

  1. Menopause-specific Quality of Life Questionnaire (MENQOL)

    Time frame: From enrollment (baseline) to the end of treatment at 12 weeks

    Menopause-specific Quality of Life Questionnaire (MENQOL): Min=1, max=8. Higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Endo Health GmbH

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 23, 2025
Registry last updated
May 23, 2025

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.

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