[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613733":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":26,"collaborators":11,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":34,"eligibilityCriteria":35,"healthyVolunteers":30,"sex":36,"minAge":37,"maxAge":11,"enrollmentInfo":38,"targetDuration":11,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":11,"overallStatus":47,"whyStopped":11,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":11},{"fullName":5,"class":6},"Ache Laboratorios Farmaceuticos S.A.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Product DNN.65.21.005","EXPERIMENTAL",null,[13],"Drug: Product DNN.65.21.005",{"label":15,"type":16,"description":11,"interventionNames":17},"Combodart®","ACTIVE_COMPARATOR",[18],"Drug: Combodart®",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","One capsule every 24 hours",[9],{"type":21,"name":15,"description":22,"armGroupLabels":25,"otherNames":11},[15],{"type":27,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100613733","phase-3-efficacy-safety-of-product-dnn6521005-in-patients-with-benign-prostatic-hyperplasia-100613733",false,"NCT07270432","Efficacy\u002F Safety of Product DNN.65.21.005 in Patients With Benign Prostatic Hyperplasia","Randomized Clinical Trial to Evaluate the Safety and Efficacy of Product DNN.65.21.005 in Alleviating Lower Urinary Tract Symptoms in Patients With Benign Prostatic Hyperplasia","NICCOLO","Inclusion Criteria:\n\n* Male participants aged 50 years and older.\n* Ability to understand the study and provide informed consent, documented by signing the Informed Consent Form (ICF).\n* Participants presenting lower urinary tract symptoms (LUTS) associated with prostate enlargement, without neurological or infectious causes.\n\nExclusion Criteria:\n\n* History or evidence of prostate cancer.\n* Urinary retention ≥100 mL, as assessed by abdominal prostate ultrasound.\n* Previous diagnosis of Parkinson's disease or other neurological disorders that may lead to neurogenic bladder.\n* Use of herbal treatments for prostate enlargement within 14 days prior to the screening visit.\n* Current use or use of alpha-blocker medications within 7 days prior to the start of study treatment.\n* Current use or use of 5-alpha reductase inhibitors (5ARIs) within 180 days prior to the start of study treatment.\n* Use of any prohibited medications within the timeframe specified in the study protocol.\n* Any clinical findings or observations (clinical or physical evaluation) that, in the investigator's judgment, pose a risk to participation in the study.","MALE","50 Years",{"count":39,"type":40},218,"ESTIMATED","INTERVENTIONAL",[43],"PHASE3","To evaluate the safety and efficacy of DNN.65.21.005 versus Combodart® in the treatment of benign prostatic hyperplasia",[46],"Prostatic Hyperplasia, Benign","NOT_YET_RECRUITING","2025-11-26",{"date":50,"type":51},"2025-12-08","ACTUAL",{"date":53,"type":40},"2026-01",{"date":55,"type":40},"2027-04",{"name":5,"class":6}]