[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100443321":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":42,"locations":28,"responsibleParty":48,"collaborators":28,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":28,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":28,"enrollmentInfo":59,"targetDuration":28,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":71,"whyStopped":28,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":28},{"fullName":5,"class":6},"EMS","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"TORONTO 20 + 30\u002F60","EXPERIMENTAL","The study is double-dummy. The patient must take 2 tablets before the sexual intercourse, as follows:\n\n1 tablet of Toronto association, oral;\n\n1 tablet of tadalafil placebo, oral.",[13,14],"Drug: Toronto association","Other: Tadalafil placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"TADALAFIL","ACTIVE_COMPARATOR","The study is double-dummy. The patient must take 2 tablets before the sexual intercourse, as follows:\n\n1 tablet of tadalafil , oral;\n\n1 tablet of Toronto association placebo, oral.",[20,21],"Drug: Tadalafil","Other: Toronto association placebo",[23,29,33,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Toronto association","Toronto association coated tablet, 20 mg + 30 mg or 20 mg + 60 mg, oral, 2 hours before the sexual intercourse.",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Tadalafil","Tadalafil coated tablet, 20 mg, oral, 2 hours before the sexual intercourse.",[16],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"OTHER","Tadalafil placebo","Tadalafil placebo coated tablet, oral, 2 hours before the sexual intercourse.",[9],{"type":34,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Toronto association placebo","Toronto association placebo coated tablet, oral, 2 hours before the sexual intercourse.",[16],[43],{"name":44,"role":45,"phone":46,"phoneExt":28,"email":47},"Arthur M Kummer, MD","CONTACT","+551938879851","pesquisa.clinica@ncfarma.com.br",{"type":49,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100443321","phase-3-efficacy-and-safety-of-toronto-association-in-the-treatment-of-erectile-dysfunction-and-premature-ejaculation-100443321",false,"NCT05052879","Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation","National, Multicenter, Randomized, Double-blind, Double-dummy, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Toronto Association in the Treatment of Erectile Dysfunction and Premature Ejaculation","Inclusion Criteria:\n\n* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;\n* Male participants, with age greater than or equal to 18 years;\n* Heterosexual, sexually active participants in a stable and monogamous relationship for at least 6 months before screening and who plan to maintain this relationship throughout the study period;\n* Participants with erectile dysfunction, in stable and effective treatment with PDE-5 inhibitors;\n* Participants diagnosed with premature ejaculation;\n* Participants with IELT ≤ 2 minutes;\n* Participants with score ≥ 25 points in the erectile function questionnaire;\n* Participants (or partners) who use at least one contraceptive method.\n\nExclusion Criteria:\n\n* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;\n* Participation in a clinical trial in the year prior to this study;\n* Known hypersensitivity to any of the formula compounds;\n* Participants with cardiovascular disease for whom sexual activity is inadvisable\n* History or current experience of surgical interventions or radiotherapy in the pelvic region, neurological conditions, trauma or infections that are associated with the symptoms premature ejaculation;\n* Diagnosis of other diseases or conditions in the urinary tract;\n* Participants with conditions that may predispose them to priapism;\n* History of severe psychiatric or psychosocial disorders;\n* Participant whose partner has clinically important sexual dysfunctions.","MALE","18 Years",{"count":60,"type":61},232,"ESTIMATED","INTERVENTIONAL",[64],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of Toronto association in the treatment of both sexual dysfunction: erectile dysfunction and premature ejaculation.",[67,68],"Erectile Dysfunction","Premature Ejaculation",[70,68],"Erectile dysfunction","NOT_YET_RECRUITING","2023-04-11",{"date":74,"type":75},"2023-04-12","ACTUAL",{"date":77,"type":61},"2024-07",{"date":79,"type":61},"2026-08",{"name":5,"class":6}]