[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623049":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":189,"collaborators":191,"id":212,"slug":213,"hasResults":214,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":26,"eligibilityCriteria":218,"healthyVolunteers":214,"sex":219,"minAge":220,"maxAge":26,"enrollmentInfo":221,"targetDuration":26,"studyType":224,"phases":225,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},{"fullName":5,"class":6},"Mansoura University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A","EXPERIMENTAL","Daily tadalafil 5 mg and on-demand sildenafil 100 mg",[13],"Drug: Tadalafil 5 mg & Sildenafil 100mg",{"label":15,"type":16,"description":17,"interventionNames":18},"Group B","PLACEBO_COMPARATOR","daily Placebo and on demand sildenafil 100 mg",[19],"Drug: Sildenafil 100mg & placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tadalafil 5 mg & Sildenafil 100mg","daily dosing of Tadalafil 5 mg combined with on demand Sildenafil 100mg",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sildenafil 100mg & placebo","Daily Placebo combined with on demand Sildenafil 100mg",[15],[32],{"name":33,"affiliation":34,"role":35},"Ahmed A Shokeir, professor of urology","Urology & Nephrology Center, Masnoura university, Egypt","STUDY_CHAIR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Ahmed A Shokeir+2, professor of Urology","CONTACT","+201121102929","ahmed.shokeir@hotmail.com",[43,68,81,94,107,120,130,140,150,163,176],{"facility":44,"status":45,"city":46,"state":47,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Urology and Nephrology Center, Mansoura University","RECRUITING","Al Mansurah","Dakahlia Governorate","Egypt","EG",{"type":51,"coordinates":52},"Point",[53,54],31.38069,31.03637,{"lat":54,"lon":53},[57,61,65],{"name":58,"role":39,"phone":59,"phoneExt":26,"email":60},"Ahmed El-Assmy, Professor of Urology","+201227112513","a_assmy@yahoo.com",{"name":62,"role":39,"phone":63,"phoneExt":26,"email":64},"Yahya H Elmorsy, MSc of Urology","+201100311999","hossam.yahya@yahoo.com",{"name":66,"role":67,"phone":26,"phoneExt":26,"email":26},"Yahya H El-morsy, MSc of Urology","PRINCIPAL_INVESTIGATOR",{"facility":69,"status":45,"city":70,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Faculty of medicine, Alexandria University","Alexandria",{"type":51,"coordinates":72},[73,74],29.91582,31.20176,{"lat":74,"lon":73},[77],{"name":78,"role":39,"phone":79,"phoneExt":26,"email":80},"Abdulrahman Zahran, Professor of Urology","+201005455351","abdelrahmanzahran@gmail.com",{"facility":82,"status":45,"city":83,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Faculty of medicine, Aswan university","Aswān",{"type":51,"coordinates":85},[86,87],32.89942,24.09082,{"lat":87,"lon":86},[90],{"name":91,"role":39,"phone":92,"phoneExt":26,"email":93},"Amr alameldeen","+201009081997","amr_uro2009@yahoo.com",{"facility":95,"status":45,"city":96,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Faculty of Medicine - Assiut University","Asyut",{"type":51,"coordinates":98},[99,100],31.18368,27.18096,{"lat":100,"lon":99},[103],{"name":104,"role":39,"phone":105,"phoneExt":26,"email":106},"Mohammed Naguib Elgendy","+201009882171","Elgendy8686@hotmail.com",{"facility":108,"status":45,"city":109,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Cairo University, faculty of medicine","Cairo",{"type":51,"coordinates":111},[112,113],31.24967,30.06263,{"lat":113,"lon":112},[116],{"name":117,"role":39,"phone":118,"phoneExt":26,"email":119},"Galal Mohammed ElShorbagy, Professor of Urology","+201003339381","Galal.mohammed1@kasralainy.edu.eg",{"facility":121,"status":45,"city":109,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":122,"geoPoint":124,"contacts":125},"Faculty of medicine, Ain Shams University",{"type":51,"coordinates":123},[112,113],{"lat":113,"lon":112},[126],{"name":127,"role":39,"phone":128,"phoneExt":26,"email":129},"Ashraf Satour","+201000396284","Ashrafsatour@med.asu.edu.eg",{"facility":131,"status":45,"city":109,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":132,"geoPoint":134,"contacts":135},"Faculty of medicine, Azhar University",{"type":51,"coordinates":133},[112,113],{"lat":113,"lon":112},[136],{"name":137,"role":39,"phone":138,"phoneExt":26,"email":139},"Mohammed ELgammal","+201000319556","gemykarter2020@gmail.com",{"facility":141,"status":45,"city":109,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":142,"geoPoint":144,"contacts":145},"Faculty of medicine, october 6 Univeristy",{"type":51,"coordinates":143},[112,113],{"lat":113,"lon":112},[146],{"name":147,"role":39,"phone":148,"phoneExt":26,"email":149},"Ayman Rashed, Professor of Urology","+201006023284","aymanrashed@msn.com",{"facility":151,"status":45,"city":152,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Faculty of medicine, Luxor university","Luxor",{"type":51,"coordinates":154},[155,156],32.6421,25.69893,{"lat":156,"lon":155},[159],{"name":160,"role":39,"phone":161,"phoneExt":26,"email":162},"Ahmed Altaher, Professor of Urology","+201116552455","altaher1964.aa@gmail.com",{"facility":164,"status":45,"city":165,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"faculty of medicine, Minya University","Minya",{"type":51,"coordinates":167},[168,169],30.75813,28.09193,{"lat":169,"lon":168},[172],{"name":173,"role":39,"phone":174,"phoneExt":26,"email":175},"Mohammed Hussein Qasem","+201033131812","m.hussien@mu.edu.eg",{"facility":177,"status":45,"city":178,"state":26,"zip":26,"country":48,"countryCode":49,"cosmosGeoPoint":179,"geoPoint":183,"contacts":184},"Faculty of medicine, Tanta University","Tanta",{"type":51,"coordinates":180},[181,182],31.00192,30.78847,{"lat":182,"lon":181},[185],{"name":186,"role":39,"phone":187,"phoneExt":26,"email":188},"Maged Ragab, Professor of Urology","+201006632607","Mmregy@gmail.com",{"type":190,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[192,194,196,198,200,202,204,206,208,210],{"name":193,"class":6},"Cairo University",{"name":195,"class":6},"Ain Shams University",{"name":197,"class":6},"Aswan University",{"name":199,"class":6},"Luxor university",{"name":201,"class":6},"Assiut University",{"name":203,"class":6},"Minia University",{"name":205,"class":6},"Alexandria University",{"name":207,"class":6},"Tanta University",{"name":209,"class":6},"October 6 University",{"name":211,"class":6},"Al-Azhar University","100623049","phase-4-daily-tadalafil-5-mg-combined-with-on-demand-sildenafil-100-mg-for-treatment-of-erectile-dysfunction-in-pde-5i-non-responder-patients-100623049",false,"NCT07391579","Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients","Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients: A Multicenter Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n* Sexually active male.\n* History of ED for ≥6 months.\n* Erectile function domain of IIEF-15 score \\\u003C17.\n* Documented failure to respond to PDE-5I \\[definition of non-responder patients are patients with ED who don't respond to maximum dose of PDE-5I on ≥4 occasions in spite of accurate timing and good sexual stimulation\\].\n* Stable sexual relationship ≥ 6 months.\n\nExclusion Criteria:\n\n* Penile anatomical deformities or Peyronie's disease.\n* Pelvic surgery or radiation.\n* Active malignancy or severe systemic illness.\n* Previous penile surgery of any kind, such as penile prosthesis, penile lengthening, penile cancer surgery, penile plication or grafting.\n* Contraindication to PDE5i (High risk cardiac patients, patients on nitrates, hypotension).\n* Using other treatments for ED e.g., Intra-cavernoasl prostaglandin injection therapy.","MALE","21 Years",{"count":222,"type":223},500,"ESTIMATED","INTERVENTIONAL",[226],"PHASE4","The goal of this clinical trial is to evaluate whether daily dosing with tadalafil 5 mg combined with on-demand sildenafil 100 mg can improve erectile function in men with erectile dysfunction (ED) who do not respond to PDE5 inhibitor alone.\n\nThe main questions it aims to answer are:\n\n* Does the combination of daily tadalafil and on-demand sildenafil lead to a greater improvement in erectile function (measured by the IIEF-EF domain) compared with on-demand sildenafil alone?\n* Is the combination therapy safe and well tolerated in this patient population?\n\nResearchers will compare:\n\n* Group A: Daily tadalafil 5 mg plus on-demand sildenafil 100 mg\n* Group B: Daily placebo plus on-demand sildenafil 100 mg\n\nto determine whether the combination regimen provides superior improvement in erectile function and patient satisfaction.\n\nParticipants will:\n\n* Undergo baseline assessment including medical history, physical examination, and laboratory tests.\n* Be randomly assigned to one of the two treatment groups.\n* Take the assigned medications for 12 weeks.\n* Complete follow-up evaluations at 4, 8, and 12 weeks, including:\n\nInternational Index of Erectile Function (IIEF-15) questionnaire Erection Hardness Score (EHS) assessment Reporting of any adverse effects",[229],"Erectile Dysfunctions",[231,232,233,234,235,236],"Erectile Dysfunction","ED","Sildenafil","Tadalafil","PDE5i Non-Responders","Combination Therapy","2026-02-02",{"date":239,"type":240},"2026-02-06","ACTUAL",{"date":242,"type":240},"2025-12-01",{"date":244,"type":223},"2027-06",{"name":5,"class":6},11]