[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644349":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":43,"studyPopulation":43,"armGroups":50,"interventions":61,"overallOfficials":43,"centralContacts":43,"locations":67,"responsibleParty":83,"collaborators":43,"id":85,"slug":43,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":43,"enrollmentInfo":93,"targetDuration":43,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":106,"whyStopped":43,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Endo Health GmbH","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Menopause-specific quality of life","Assessed with the Menopause-specific Quality of Life Questionnaire (MENQOL)","Changes between time point T0 (baseline) and T3 (12 weeks after baseline)",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Menopause-specific symptom severity","Assessed with the Menopause Rating Scale (MRS II)",{"measure":18,"description":19,"timeFrame":12},"Daily interference due to hot flashes","Assessed with the Hot Flash Related Daily Interference Scale (HFRDIS)",{"measure":21,"description":22,"timeFrame":12},"Menopause-specific impairment in daily activities","Assessed with the Activity Impairment domain of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause)",{"measure":24,"description":25,"timeFrame":12},"Patient activation","Assessed with the Patient Activation Measure 13 (PAM-13)",[27,29,32,35],{"measure":10,"description":11,"timeFrame":28},"Changes between time point T0 (baseline) and T4 (24 weeks after baseline)",{"measure":30,"description":31,"timeFrame":12},"Menopause-related absenteeism","Assessed with the absenteeism domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).",{"measure":33,"description":34,"timeFrame":12},"Menopause-related presenteeism","Assessed with the presenteeism domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).",{"measure":36,"description":37,"timeFrame":12},"Menopause-related work productivity loss","Assessed with the work productivity loss domain score of the Work Productivity and Activity Impairment-Menopause questionnaire (WPAI-Menopause).",{"allocation":39,"interventionModel":40,"interventionModelDescription":41,"primaryPurpose":42,"observationalModel":43,"timePerspective":43,"maskingInfo":44},"RANDOMIZED","PARALLEL","Randomization will be stratified by the presence of concomitant treatment (non-hormonal concomitant treatment vs no concomitant treatment at baseline) to ensure balanced allocation across this prognostic factor.","SUPPORTIVE_CARE",null,{"masking":45,"maskingDescription":46,"whoMasked":47},"DOUBLE","The external statistician (responsible for data analysis and\u002For interpretation) will be blinded to group assignment until after the analysis code for the primary analysis (ANCOVA) has been prepared and stored.",[48,49],"CARE_PROVIDER","INVESTIGATOR",[51,55],{"label":52,"type":53,"description":54,"interventionNames":43},"Control Group","NO_INTERVENTION","The control group has access to care-as-usual only.",{"label":56,"type":57,"description":58,"interventionNames":59},"Intervention Group","EXPERIMENTAL","The intervention group has access to the menopause app and its functions in addition to care-as-usual.",[60],"Device: Menopause App",[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":43},"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.",[56],[68],{"facility":69,"status":43,"city":70,"state":43,"zip":43,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Medicoles","Hanover","Germany","DE",{"type":74,"coordinates":75},"Point",[76,77],9.73322,52.37052,{"lat":77,"lon":76},[80],{"name":81,"role":82,"phone":43,"phoneExt":43,"email":43},"Elisabeth Siegmund-Schultze, Dr. med.","PRINCIPAL_INVESTIGATOR",{"type":84,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100644349",false,"NCT07663305","Evaluation of a Mobile Menopause Application","EMMA","Inclusion Criteria:\n\n* Legal capacity\n* Ability to provide informed consent\n* Residency in Germany\n* Female gender\n* Age ≥18 years\n* Medically confirmed menopausal or other perimenopausal disorder (N95.1)\n* Ownership of a smartphone and ability to use it\n* Internet access for app usage and questionnaire completion\n* Email address for registration\n* Willingness to complete questionnaires online\n* Motivation for regular app usage\n* Sufficient proficiency in the German language\n* MRS II ≥ 9\n* Absence of exclusion criteria\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding during the study period\n* Current hormonal replacement therapy (HRT), initiation of HRT within eight weeks prior to study start and\u002For planned start of HRT during the study period\n* Changes in treatment with psychotropic medication within eight weeks prior to study start and\u002For planned during the study period\n* Start of psychotherapy within eight weeks prior to study start and\u002For planned during the study period\n* Start of a rehabilitation program within eight weeks prior to study start and\u002For planned during the study period\n* Surgery performed within eight weeks prior to study start and\u002For planned during the study period\n* Previous or current access to the Endo-App or other comparable digital health applications, or current active prescription\n* Current participation in other clinical studies\n* Failure to meet the inclusion criteria","FEMALE","18 Years",{"count":94,"type":95},426,"ESTIMATED","INTERVENTIONAL",[98],"NA","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.",[101],"N95.1 Menopausal and Female Climacteric States",[103,104,105],"Menopause","Digital Therapeutics","Quality of Life","NOT_YET_RECRUITING","2026-06-17",{"date":109,"type":110},"2026-06-23","ACTUAL",{"date":112,"type":95},"2026-06",{"date":114,"type":95},"2027-06",{"name":5,"class":6},1]