[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630650":3},{"organization":4,"outcomesModule":7,"designInfo":69,"detailedDescription":11,"studyPopulation":72,"armGroups":73,"interventions":79,"overallOfficials":11,"centralContacts":85,"locations":11,"responsibleParty":91,"collaborators":11,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":11,"maxAge":11,"enrollmentInfo":102,"targetDuration":11,"studyType":105,"phases":11,"briefSummary":106,"conditions":107,"keywords":11,"overallStatus":109,"whyStopped":11,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":11},{"fullName":5,"class":6},"Bayer","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":29,"otherOutcomes":11},[9,13,16,18,20,24,27],{"measure":10,"description":11,"timeFrame":12},"Socio-demographic characteristics",null,"Day 1",{"measure":14,"description":15,"timeFrame":12},"Menopausal status","Perimenopausal, natural postmenopaulsa, surgical-induced menopuase, early\u002Fpremature menopause.",{"measure":17,"description":11,"timeFrame":12},"Time since menopause onset and time since onset of menopausal symptoms",{"measure":19,"description":11,"timeFrame":12},"Descriptive analyses of prior vasomotor symptoms (VMS) related clinical history",{"measure":21,"description":22,"timeFrame":23},"Menopausal symptoms measured by MENQOL","MENQOL: Menopause-Specific Quality of Life Questionnaire. It contains 29 items questionnaire that assess presence of menopausal symptoms and how bothersome they are, across four domains: vasomotor, psychosocial, physical and sexual.\n\nFor each item, the participant indicates if they have experienced the symptom (yes\u002Fno). If participants select yes, participants rate how bothered they were by the symptom using a scale with response options ranging from 0 'not at all bothered' to 6 'extremely bothered'. Based on the individual responses, item scores, domain scores, and a total MENQOL score are calculated. Each score ranges from 1-8, higher scores indicate greater bother.","Day 1, week 4,12 and when applicable at week 24, 52, 104",{"measure":25,"description":11,"timeFrame":26},"Height","Day 1, week 4 and week 12",{"measure":28,"description":11,"timeFrame":26},"Weight",[30,34,38,41,44,48,51,53,55,57,61,65],{"measure":31,"description":32,"timeFrame":33},"Change in VMS from the baseline period to week 4 and 12","Baseline period: Time prior to first dose of elizanetant","Week 4 and 12",{"measure":35,"description":36,"timeFrame":37},"Change in sleep disturbances measured by PROMIS-SD-SF-8b questionnaire","PROMIS-SD-SF-8b: Patient-Reported Outcomes Measurement Information System Sleep Disturbance - Short Form 8b. It includes 8 items that assess self-reported sleep quality and sleep difficulties. Participants respond to the items on a 5-point scale from not at all, never or very poor to very much, always or very good. Four of the items are scored reversely. Total scores range from 8 to 40, with higher scores indicating greater severity of sleep disturbance.","Week 4, 12 and when applicable week 24, 52 and 104",{"measure":39,"description":11,"timeFrame":40},"Number of SAE and serious TEAE","From Day 1 to week 12 or week 104 when applicable",{"measure":42,"description":43,"timeFrame":12},"HCP reasons for prescribing elinzanetant","HCP: Health care professionals.",{"measure":45,"description":46,"timeFrame":47},"Participants' satisfaction with treatment for symptoms associated with menopause","Measured by Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ). The MS-TSQ comprises 8 items and assesses satisfaction over the past four weeks to evaluate treatment satisfaction related to menopausal symptoms. Items are scored 1-5 on a Likert scale where 1 = very dissatisfied\u002Fnot at all and 5 = very satisfied\u002Fvery much","Week 12 and week 52 when applicable",{"measure":49,"description":11,"timeFrame":50},"Reasons for initiation, discontinuation or switching of elizanetant","Week 4, week 12 and when applicable week 52",{"measure":52,"description":11,"timeFrame":50},"Amount of elizanetant prescribed",{"measure":54,"description":11,"timeFrame":50},"Number of missed doses",{"measure":56,"description":11,"timeFrame":50},"Reasons for missed doses",{"measure":58,"description":59,"timeFrame":60},"Change in menopauase-related QoL","Measured by Menopause-Specific Quality of Life Questionnaire (MENQOL)","Day 1 to week 4, 12 and when applicable week 24, 52 and 104",{"measure":62,"description":63,"timeFrame":64},"Change in participant's affect","Measured by Positive and Negative Affect Schedule - Short Form (PANAS-SF). PANAS-SF Comprises 10 items evaluating how frequently individuals experience positive and negative affect. Items are scored in a 1-5 Likert scale where 1 = Very slightly or not at all and 5 = Extremely.","From week 1 to week 4, 12 and when applicable to week 24, 52 and 104",{"measure":66,"description":67,"timeFrame":68},"Change in work productivity and daily activity impairment","Measured by menopause-related Work Productivity and Activity Impairment (WPAI: Menopause).\n\nWPAI: Menopuase consists of 6 items assessing employment status, work hours, absenteeism, presenteeism (on-the-job productivity), and the impact of menopausal symptoms on both work and nonwork daily activities. Items are scored as yes\u002Fno or ranked from 0 \"no effect\" to 10 \"completely affected\".","From day 1 to week 4, 12 and when applicable to week 24, 52 and 104",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":70,"timePerspective":71,"maskingInfo":11},"COHORT","PROSPECTIVE","Women in the US who are newly initiating treatment with elizanetant",[74],{"label":75,"type":11,"description":76,"interventionNames":77},"Group 1","Elizanetant users",[78],"Other: No intervention",[80],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":11},"OTHER","No intervention","The study is observational and does not mandate any specific diagnostic or monitoring procedures beyond standard of care",[75],[86],{"name":87,"role":88,"phone":89,"phoneExt":11,"email":90},"Bayer Clinical Trials Contact","CONTACT","18888422937","clinical-trials-contact@bayer.com",{"type":92,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100630650","an-observational-study-to-learn-more-about-how-elinzanetant-is-used-and-how-well-it-works-for-women-with-menopause-symptoms-in-united-states-100630650",false,"NCT07490431","An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Symptoms in United States","RELIEF: Real World Evidence on ELInzanEtant For the Treatment of Vasomotor Symptoms in Postmenopausal Women","RELIEF","Inclusion Criteria:\n\n* Women who newly initiate elinzanetant for treatment of menopausal VMS according to the current local label.\n* Signed ICF.\n* Ability and willingness to use study-related digital tools and to complete electronic questionnaires (ePROs), requiring access to an internet-connected device.\n\nExclusion Criteria:\n\n• Participation in an investigational trial with interventions outside of routine clinical practice.","FEMALE",{"count":103,"type":104},2400,"ESTIMATED","OBSERVATIONAL","Menopause is a natural stage in a woman's life happening between ages 45 and 55. It is often associated with disruptive symptoms like hot flashes and sleep disturbances that can affect up to 8 out of 10 women and make daily life harder. Elinzanetant is a new, hormone free medicine that works by blocking certain signals in the brain that are linked to these symptoms. It has already been shown in clinical studies to help reduce hot flashes. This study is being done to learn about how elinzanetant is used, how well it works, and how safe it is for women with menopause symptoms in real-world, everyday medical care. The main goal is to understand who is starting treatment with elinzanetant and what symptoms they have. The study will also look at how well elinzanetant helps with hot flashes, night sweats, and sleep problems, how safe it is, how satisfied women are with the treatment, and how it affects their quality of life and daily activities. To do this, researchers will follow about 1,500 women in the United States who are starting elinzanetant as part of their usual care. Women will answer questions about their symptoms, sleep, and daily life using a secure app on their phone or computer. Some women will also wear a smart ring for a few weeks to collect information about their sleep. The study will last about 12 weeks for most women, but some will be followed for up to 2 years. No extra treatments or tests will be given as part of the study-researchers will only collect information about how women are doing while taking elinzanetant as prescribed by their own doctor. The results will help doctors and patients understand how elinzanetant works in real life and support better care for women going through menopause.",[108],"Vasomotor Symptoms (VMS) Associated With Menopause","NOT_YET_RECRUITING","2026-09-22",{"date":112,"type":113},"2026-09-24","ACTUAL",{"date":115,"type":104},"2026-11-30",{"date":117,"type":104},"2029-11-30",{"name":5,"class":6}]