[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524269":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":63,"collaborators":24,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":24,"enrollmentInfo":75,"targetDuration":24,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":24,"overallStatus":42,"whyStopped":24,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Reinier de Graaf Groep","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Venlafaxine","EXPERIMENTAL","In this open-label randomized controlled intrapatient cross-over study patients are randomly assigned to one of the two treatment groups.\n\nAfter a one week baseline period, group 1 starts with venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks followed by a two-week wash-out period (no medication), hereafter the group starts with oxybutynin 5 mg twice per day for 6 weeks total.",[13,14],"Drug: Oxybutynin","Drug: Venlafaxine",{"label":16,"type":10,"description":17,"interventionNames":18},"Oxybutynin","After a one week baseline period, group 2 starts with oxybutynin 5 mg twice per day for 6 weeks total followed by a two-week wash-out period (no medication), hereafter the group starts with venlafaxine 37.5 mg once daily for 7 days followed by 75mg once daily for 5 weeks.",[13,14],[20,25],{"type":21,"name":16,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Oxybutynin 5 mg twice per day for 6 weeks",[16,9],null,{"type":21,"name":9,"description":26,"armGroupLabels":27,"otherNames":24},"Venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks",[16,9],[29],{"name":30,"affiliation":31,"role":32},"Lemonitsa Mammatas, PhD","Reinier De Graaf Ziekenhuis","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":24,"email":38},"Marte Smits, MSc","CONTACT","+31152603870","marte.smits@rdgg.nl",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Reinier de Graaf Gasthuis","RECRUITING","Delft","South Holland","2625 AD","Netherlands","NL",{"type":49,"coordinates":50},"Point",[51,52],4.35556,52.00667,{"lat":52,"lon":51},[55,59,61],{"name":56,"role":36,"phone":57,"phoneExt":24,"email":58},"Maaike de Leeuw, MSc","+31152603035","M.deLeeuw@rdgg.nl",{"name":35,"role":60,"phone":24,"phoneExt":24,"email":24},"SUB_INVESTIGATOR",{"name":62,"role":32,"phone":24,"phoneExt":24,"email":24},"Lemonitsa Mammatas, PHD, MSc",{"type":64,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100524269","phase-3-reducing-hot-flashes-in-women-using-endocrine-therapy-100524269",false,"NCT06106529","REDucing Hot FLASHes in Women Using Endocrine Therapy.","A Randomized Intrapatient Cross-over Study to Assess the Efficacy of Oxybutynin Versus Venlafaxine in Reducing Hot Flashes in Women Using Endocrine Therapy After Breast Cancer.","REDFLASH","Inclusion Criteria:\n\n* Pre-, peri- or postmenopausal women of 18 years or above;\n* Indication for endocrine therapy and already started with tamoxifen, aromatase inhibitors or luteinizing hormone-releasing hormone analogues for at least 4 weeks and planning to continue for the duration of the study;\n* Experiencing hot flashes with a minimum of 14 per week for at least 1 month and desire to start a pharmacologic intervention.\n\nExclusion Criteria:\n\n* Pregnant;\n* Breast feeding;\n* Patients who receive chemotherapy or immunotherapy\u002FHER2 antibodies within the prior 8 weeks, and patients scheduled for chemotherapy during the study period;\n* Palliative setting;\n* Use of venlafaxine or any other antidepressants, also including St. John's wort within the previous year;\n* Creatinine clearance \\\u003C 30 ml\u002Fmin;\n* Liver cirrhosis;\n* Use of gabapentin and\u002For calcium channel antagonists within 2 weeks of study entry;\n* Use of oxybutynin before study entry;\n* Use of any other substances or therapies for the treatment of hot flashes, for instance acupuncture.","FEMALE","18 Years",{"count":76,"type":77},260,"ESTIMATED","INTERVENTIONAL",[80],"PHASE3","The goal of this randomized intrapatient cross-over study is to assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer.\n\nThe objectives it aims to answer are:\n\n* To assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer\n* To assess side effects of oxybutynin versus venlafaxine.\n* To assess the personal preference of women for oxybutynin versus venlafaxine in reducing hot flashes.\n* To assess quality of life of women when reducing hot flashes in women using endocrine therapy after breast cancer.\n\nParticipants will fill-out a patient diary during 15 weeks total on a daily basis and receive an (online) questionnaire three times total.\n\nResearchers will compare two groups (venlafaxine group versus oxubutynine group) to assess its efficacy concerning hot flashes.",[83,84],"Breast Cancer","Hot Flash Due to Medication","2025-01-31",{"date":87,"type":88},"2025-02-04","ACTUAL",{"date":90,"type":88},"2024-10-03",{"date":92,"type":77},"2029-01-01",{"name":5,"class":6},1]