An interventional study of Menopause App in N95.1 Menopausal and Female Climacteric States, sponsored by Endo Health GmbH. Recruiting at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by Endo Health GmbH · Not applicable, Interventional, and Supportive care
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.
Endo Health GmbH is the lead sponsor of 5 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The control group has access to care-as-usual only.
The intervention group has access to the menopause app and its functions in addition to care-as-usual.
Device: Menopause App
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.
Menopause-specific quality of life
Assessed with the Menopause-specific Quality of Life Questionnaire (MENQOL)
Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Menopause-specific symptom severity
Assessed with the Menopause Rating Scale (MRS II)
Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Daily interference due to hot flashes
Assessed with the Hot Flash Related Daily Interference Scale (HFRDIS)
Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Menopause-specific impairment in daily activities
Assessed with the Activity Impairment domain of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause)
Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Patient activation
Assessed with the Patient Activation Measure 13 (PAM-13)
Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Menopause-specific quality of life
Assessed with the Menopause-specific Quality of Life Questionnaire (MENQOL)
Time frame: Changes between time point T0 (baseline) and T4 (24 weeks after baseline)
Menopause-related absenteeism
Assessed with the absenteeism domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).
Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Menopause-related presenteeism
Assessed with the presenteeism domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).
Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
Menopause-related work productivity loss
Assessed with the work productivity loss domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).
Time frame: Changes between time point T0 (baseline) and T3 (12 weeks after baseline)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Endo Health GmbH