CompletedNot Applicable

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

Germany224 participantsStarted 2024-08-09

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Menopause-specific Quality of Life Questionnaire (MENQOL)

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

Trial details

NCT IDNCT06987617

SponsorEndo Health GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-30

View on ClinicalTrials.gov More Menopausal and Other Perimenopausal Disorders trials