Evaluation of a Mobile Menopause Application (NCT07663305) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of a Mobile Menopause Application
Germany426 participantsStarted 2026-06
Plain-language summary
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.
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
* 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
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
1
Menopause-specific quality of life
Timeframe: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)