[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636634":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":39,"responsibleParty":51,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":25,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":25,"overallStatus":73,"whyStopped":25,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm","EXPERIMENTAL","Fezolinetant 45 mg orally once daily for 12 weeks.",[13],"Drug: Fezolinetant",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Arm","PLACEBO_COMPARATOR","Placebo orally once daily for 12 weeks.",[19],"Drug: Placebo",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Fezolinetant",[9],null,{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Placebo",[15],[30],{"name":31,"affiliation":5,"role":32},"Chi Fai NG, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Alex LIU, RCSEd, MBBS","CONTACT","35052625","alexliu@surgery.cuhk.edu.hk",[40],{"facility":41,"status":25,"city":42,"state":25,"zip":25,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":25},"Prince of Wales Hospital","Shatin","Hong Kong","HK",{"type":46,"coordinates":47},"Point",[48,49],114.18333,22.38333,{"lat":49,"lon":48},{"type":32,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"NG Chi Fai","Professor","100636634","phase-2-a-trial-on-fezolinetant-for-vasomotor-symptoms-in-men-receiving-androgen-deprivation-therapy-adt-100636634",false,"NCT07568236","A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT)","A Phase II Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) for Prostate Cancer (Fez-Cap)","Inclusion Criteria:\n\n1. Patients aged at least 18 years old on the index date\n2. Histologically confirmed prostatic adenocarcinoma with localised or metastatic disease\n3. Karnofsky index score of 70% or more\n4. Started on androgen deprivation therapy (both medical or surgical), for at least 3 months at baseline\n5. Baseline daily hot flush score ≥4\n\nExclusion Criteria:\n\n1. Patients treated with drugs related to the study medications or with potential effect for vasomotor symptoms, including selective serotonin-re-uptake inhibitors, steroid hormones, clonidine, gabapentin, veralipride, or β-alanine\n2. Concomitant use of CYP1A2 inhibitors, e.g. fluoroquinolone, fluovoxamine, cimetidine, propranolol, verapamil, acyclovir, allopurinol, theophylline, etc.\n3. Active liver disease including:\n\n   \\- cirrhosis - liver failure - jaundice - elevated total or direct bilirubin - abnormal ALT \u002F AST - abnormal INR\n4. Severe (eGFR 15 to less than 30 mL\u002Fmin\u002F1.73 m2) renal impairment or end-stage renal disease (eGFR less than 15 mL\u002Fmin\u002F1.73 m2)","MALE","18 Years",{"count":64,"type":65},54,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to investigates the efficacy of fezolinetant in men undergoing ADT for prostate cancer in alleviating Vasomotor syndromes.",[71,72],"Vasomotor Symptoms","Prostate Cancer","NOT_YET_RECRUITING","2026-04-28",{"date":76,"type":77},"2026-05-05","ACTUAL",{"date":79,"type":65},"2026-07-01",{"date":81,"type":65},"2028-03-31",{"name":5,"class":6},1]