[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100470069":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":70,"collaborators":44,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":74,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":44,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":52,"whyStopped":44,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Clinical Academic Center (2CA-Braga)","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control arm","ACTIVE_COMPARATOR","tamsulosin 0.4mg (once a day) for 6 months.",[13],"Drug: Tamsulosin",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental arm","EXPERIMENTAL","5-hidroxitriptophan 100 mg (3 times a day) for 6 months.",[19],"Drug: 5-hidroxitriptophan",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tamsulosin","Oral medication, once a day for 6 months.",[9],[27],"Omnic",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"5-hidroxitriptophan","Oral medication, 3 times a day for 6 months.",[15],[33],"Cincofarm",[35],{"name":36,"affiliation":37,"role":38},"Emanuel Dias","Hospital de Braga","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Mónica Gonçalves","CONTACT","+351 253 027 249",null,"2ca@ccabraga.org",{"name":47,"role":42,"phone":43,"phoneExt":44,"email":48},"Rosana Magalhães","cro@ccabraga.org",[50],{"facility":51,"status":52,"city":53,"state":44,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Clinical Academic Center - Braga, Association (2CA-Braga)","RECRUITING","Braga","4710-243","Portugal","PT",{"type":58,"coordinates":59},"Point",[60,61],-8.42311,41.5514,{"lat":61,"lon":60},[64,66,69],{"name":36,"role":42,"phone":43,"phoneExt":44,"email":65},"emanueldias@med.uminho.pt",{"name":67,"role":42,"phone":43,"phoneExt":44,"email":68},"Joana Sousa","coordenacao@ccabraga.org",{"name":36,"role":42,"phone":44,"phoneExt":44,"email":44},{"type":71,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100470069","phase-2-proof-of-concept-study-to-evaluate-the-safety-and-efficacy-of-tryptophan-in-patients-with-bph-100470069",false,"NCT05401032","Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH.","TryptoBPH - Proof-of-concept Study to Evaluate the Safety and Efficacy of Tryptophan in Patients with BPH","TryptoBPH","Inclusion Criteria:\n\n* Written informed consent;\n* Male patients with BPH for which tamsulosin is the therapeutic option per SoC;\n* Aged ≥50 and less than 75 years old;\n* With prostate volume ≥30 cm3 by TRUS;\n* Diagnosed with LUTS defined by a stable IPSS total score ≥13 points.\n\nExclusion Criteria:\n\n* Patients with post-void bladder residual volume ≥250 ml;\n* Patients with intravesical obstruction from any cause other than BPH;\n* History of any procedure considered an intervention for BPH;\n* Patients with active urinary tract infection;\n* History of recurrent urinary tract infections;\n* Current prostatitis or diagnosis of chronic prostatitis;\n* History of prostate or invasive bladder cancer;\n* Use of 5 α-reductase inhibitors within 6 months;\n* Phytotherapy within 2 weeks before entry;\n* Use of serotonin reuptake inhibitors or monoamine oxidase inhibitors;\n* Patients with acute or chronic kidney failure;\n* Patients with diagnosed or suspicion of intolerance to lactose;\n* Patients submitted to general anesthesia in the past 4 weeks;\n* Known intellectual disability that may hampers giving informed consent and would make the patient inappropriate for entry into this study, in the judgment of the investigator.","MALE","50 Years","74 Years",{"count":84,"type":85},70,"ESTIMATED","INTERVENTIONAL",[88],"PHASE2","Benign prostatic hyperplasia (BPH) is one of the most prevalent human diseases and a major cause of lower urinary tract symptoms (LUTS). Some men respond to current medical treatment (mainly α-1 adrenoreceptor antagonists and 5 α-reductase inhibitors), but a large proportion of patients continues to need a surgical procedure to treat resistant LUTS or even more serious complications of BPH, creating the emerging necessity for novel pharmacological therapies.\n\nOxitriptan may have a possible positive effect on BPH associated symptoms with probably no impact in sexual function (which is a common side effect of the current drugs for BPH associated symptoms). Also, improvement in symptoms could be higher than that of current drugs used for this condition.\n\nThis is a single-center parallel group, randomized clinical trial. The study will take place in Hospital de Braga (Urology department). Eligible patients will be randomized to receive tamsulosin 0.4mg (once a day, q.d.) or 5-HTP (5-hidroxitriptophan) 100mg (three times a day, t.i.d.), for 6 months.",[91,92],"BPH","LUTS(Lower Urinary Tract Symptoms)",[91,94,95,96,23],"LUTS","5-HTP","Oxitriptan","2025-01-03",{"date":99,"type":100},"2025-01-06","ACTUAL",{"date":102,"type":100},"2024-12-20",{"date":104,"type":85},"2026-12-31",{"name":5,"class":6},1]