[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536406":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":46,"collaborators":24,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":57,"maxAge":24,"enrollmentInfo":58,"targetDuration":24,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":24,"overallStatus":68,"whyStopped":24,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"EMS","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DTT106","EXPERIMENTAL","1 hard capsule once a day, consistently 30 minutes after the same meal each day",[13],"Drug: DTT106",{"label":15,"type":16,"description":11,"interventionNames":17},"dutasteride and tamsulosin","ACTIVE_COMPARATOR",[18],"Drug: Dutasteride-Tamsulosin",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","oral route",[9],null,{"type":21,"name":26,"description":22,"armGroupLabels":27,"otherNames":24},"Dutasteride-Tamsulosin",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Cassiano Berto","CONTACT","+551938877724","pesquisa.clinica@ncfarma.com.br",[35],{"facility":5,"status":24,"city":36,"state":37,"zip":24,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":24},"Hortolândia","São Paulo","Brazil","BR",{"type":41,"coordinates":42},"Point",[43,44],-47.22,-22.85833,{"lat":44,"lon":43},{"type":47,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100536406","phase-3-efficacy-and-safety-of-the-dtt106-in-the-treatment-of-erectile-dysfunction-associated-with-benign-prostatic-hyperplasia-100536406",false,"NCT06264414","Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia","Phase III, Multicenter, Randomized, Double-blind Clinical Trial to Assess the Efficacy and Safety of the DTT106 in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia","AUSTRÁLIA","Inclusion Criteria:\n\n* men aged 40 years and older.\n* Sexually active men, with a defined partner, who have engaged in an average of 1 attempt at sexual intercourse per week in the last month.\n* Participants under stable treatment with dutasteride + tamsulosin combination therapy.\n* Diagnosis of erectile dysfunction, according to criteria established by the Guideline of the Brazilian Society of Urology and the American Society of Urology (2017);\n* Erectile Function domain score of IIEF ≤ 25 and ≥ 6 points at the time of screening.\n\nExclusion Criteria:\n\n* Any clinical or physical observation noted during evaluation by the investigating physician, or any laboratory condition, which is interpreted as posing a risk to participation in the clinical trial;\n* Presence of uncontrolled chronic diseases;\n* History of alcohol or illicit drug use disorder within the past 2 years;\n* Men who are planning to impregnate their partners, or fertile men who are not using a reliable contraceptive method;\n* Known allergy or hypersensitivity to the components of the medicinal products used during the clinical trial;\n* History of pelvic surgery, prostatectomy, radiation therapy, penile implant placement surgery, urinary tract trauma, or invasive procedures for BPH treatment.\n* Diagnosis of other diseases or conditions in the urinary tract, including, but not limited to: cancer, neurogenic bladder, urinary incontinence, recurrent infection, urethral stenosis, bacterial prostatitis.\n* Clinical evidence of prostate cancer;\n* Severe renal failure;\n* Severe liver failure;\n* Hypogonadism (supported by values below normal, as established by the local laboratory, for total testosterone) or absent libido (sex drive);\n* Severe psychiatric or psychosocial disorders;\n* Primary erectile dysfunction;\n* Polyneuropathy, neurodegenerative diseases, spinal cord trauma or injury, tumors in the central nervous system, or other conditions that may affect erections;\n* History of orthostatic hypotension.\n* Expected to undergo cataract or glaucoma surgery;\n* Concomitant use of any form of organic nitrate;\n* Concomitant use of guanylate cyclase stimulators such as riociguat;\n* Anatomical deformation of the penis that can significantly impair erection, including, but not limited to: angulation, cavernous fibrosis, and Peyronie's disease.\n* Conditions that may predispose to priapism, including but not limited to: sickle cell anemia, multiple myeloma, leukemia;\n* Prior diagnosis of pulmonary hypertension;\n* Presence of anterior ischemic optic neuropathy, or degenerative diseases of the retina, including retinitis pigmentosa;\n* Diagnosis of dysautonomia.\n* Cardiovascular disease for which sexual activity is inadvisable, including but not limited to: Myocardial infarction in the last 90 days; Unstable angina or angina that occurs during sexual intercourse; Class 2 or higher heart failure according to the New York Heart Association in the last 6 months; Arrhythmias not controlled; Hypotension (\\\u003C 90\u002F50 mmHg) or uncontrolled hypertension; Stroke in the last six months.\n* Diabetics with HbA1c greater than or equal to 10%, or with a history of retinopathy and\u002For neuropathy;\n* Use of prohibited medications as per the protocol;\n* Erectile dysfunction that has not responded to phosphodiesterase inhibitors type 5 (including but not limited to: sildenafil, tadalafil, vardenafil) at the time of screening.\n* Participation in clinical trial protocols within the last 12 (twelve) months.","MALE","40 Years",{"count":59,"type":60},262,"ESTIMATED","INTERVENTIONAL",[63],"PHASE3","The purpose of this study is to assess the safety and efficacy of the DTT106 in the treatment of erectile dysfunction associated with benign prostatic hyperplasia",[66,67],"Prostatic Hyperplasia, Benign","Erectile Dysfunction","NOT_YET_RECRUITING","2024-02-16",{"date":71,"type":72},"2024-02-20","ACTUAL",{"date":74,"type":60},"2025-02",{"date":76,"type":60},"2027-07",{"name":5,"class":6},1]