[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623049":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":42,"responsibleParty":188,"collaborators":190,"id":211,"slug":26,"hasResults":212,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":26,"eligibilityCriteria":216,"healthyVolunteers":212,"sex":217,"minAge":218,"maxAge":26,"enrollmentInfo":219,"targetDuration":26,"studyType":222,"phases":223,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":244},{"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",[43,67,80,93,106,119,129,139,149,162,175],{"facility":44,"status":45,"city":46,"state":47,"zip":26,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Urology and Nephrology Center, Mansoura University","RECRUITING","Al Mansurah","Dakahlia Governorate","Egypt",{"type":50,"coordinates":51},"Point",[52,53],31.38069,31.03637,{"lat":53,"lon":52},[56,60,64],{"name":57,"role":39,"phone":58,"phoneExt":26,"email":59},"Ahmed El-Assmy, Professor of Urology","+201227112513","a_assmy@yahoo.com",{"name":61,"role":39,"phone":62,"phoneExt":26,"email":63},"Yahya H Elmorsy, MSc of Urology","+201100311999","hossam.yahya@yahoo.com",{"name":65,"role":66,"phone":26,"phoneExt":26,"email":26},"Yahya H El-morsy, MSc of Urology","PRINCIPAL_INVESTIGATOR",{"facility":68,"status":45,"city":69,"state":26,"zip":26,"country":48,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Faculty of medicine, Alexandria University","Alexandria",{"type":50,"coordinates":71},[72,73],29.91582,31.20176,{"lat":73,"lon":72},[76],{"name":77,"role":39,"phone":78,"phoneExt":26,"email":79},"Abdulrahman Zahran, Professor of Urology","+201005455351","abdelrahmanzahran@gmail.com",{"facility":81,"status":45,"city":82,"state":26,"zip":26,"country":48,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Faculty of medicine, Aswan university","Aswān",{"type":50,"coordinates":84},[85,86],32.89942,24.09082,{"lat":86,"lon":85},[89],{"name":90,"role":39,"phone":91,"phoneExt":26,"email":92},"Amr alameldeen","+201009081997","amr_uro2009@yahoo.com",{"facility":94,"status":45,"city":95,"state":26,"zip":26,"country":48,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Faculty of Medicine - Assiut University","Asyut",{"type":50,"coordinates":97},[98,99],31.18368,27.18096,{"lat":99,"lon":98},[102],{"name":103,"role":39,"phone":104,"phoneExt":26,"email":105},"Mohammed Naguib Elgendy","+201009882171","Elgendy8686@hotmail.com",{"facility":107,"status":45,"city":108,"state":26,"zip":26,"country":48,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Cairo University, faculty of medicine","Cairo",{"type":50,"coordinates":110},[111,112],31.24967,30.06263,{"lat":112,"lon":111},[115],{"name":116,"role":39,"phone":117,"phoneExt":26,"email":118},"Galal Mohammed ElShorbagy, Professor of Urology","+201003339381","Galal.mohammed1@kasralainy.edu.eg",{"facility":120,"status":45,"city":108,"state":26,"zip":26,"country":48,"cosmosGeoPoint":121,"geoPoint":123,"contacts":124},"Faculty of medicine, Ain Shams University",{"type":50,"coordinates":122},[111,112],{"lat":112,"lon":111},[125],{"name":126,"role":39,"phone":127,"phoneExt":26,"email":128},"Ashraf Satour","+201000396284","Ashrafsatour@med.asu.edu.eg",{"facility":130,"status":45,"city":108,"state":26,"zip":26,"country":48,"cosmosGeoPoint":131,"geoPoint":133,"contacts":134},"Faculty of medicine, Azhar University",{"type":50,"coordinates":132},[111,112],{"lat":112,"lon":111},[135],{"name":136,"role":39,"phone":137,"phoneExt":26,"email":138},"Mohammed ELgammal","+201000319556","gemykarter2020@gmail.com",{"facility":140,"status":45,"city":108,"state":26,"zip":26,"country":48,"cosmosGeoPoint":141,"geoPoint":143,"contacts":144},"Faculty of medicine, october 6 Univeristy",{"type":50,"coordinates":142},[111,112],{"lat":112,"lon":111},[145],{"name":146,"role":39,"phone":147,"phoneExt":26,"email":148},"Ayman Rashed, Professor of Urology","+201006023284","aymanrashed@msn.com",{"facility":150,"status":45,"city":151,"state":26,"zip":26,"country":48,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Faculty of medicine, Luxor university","Luxor",{"type":50,"coordinates":153},[154,155],32.6421,25.69893,{"lat":155,"lon":154},[158],{"name":159,"role":39,"phone":160,"phoneExt":26,"email":161},"Ahmed Altaher, Professor of Urology","+201116552455","altaher1964.aa@gmail.com",{"facility":163,"status":45,"city":164,"state":26,"zip":26,"country":48,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"faculty of medicine, Minya University","Minya",{"type":50,"coordinates":166},[167,168],30.75813,28.09193,{"lat":168,"lon":167},[171],{"name":172,"role":39,"phone":173,"phoneExt":26,"email":174},"Mohammed Hussein Qasem","+201033131812","m.hussien@mu.edu.eg",{"facility":176,"status":45,"city":177,"state":26,"zip":26,"country":48,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Faculty of medicine, Tanta University","Tanta",{"type":50,"coordinates":179},[180,181],31.00192,30.78847,{"lat":181,"lon":180},[184],{"name":185,"role":39,"phone":186,"phoneExt":26,"email":187},"Maged Ragab, Professor of Urology","+201006632607","Mmregy@gmail.com",{"type":189,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[191,193,195,197,199,201,203,205,207,209],{"name":192,"class":6},"Cairo University",{"name":194,"class":6},"Ain Shams University",{"name":196,"class":6},"Aswan University",{"name":198,"class":6},"Luxor university",{"name":200,"class":6},"Assiut University",{"name":202,"class":6},"Minia University",{"name":204,"class":6},"Alexandria University",{"name":206,"class":6},"Tanta University",{"name":208,"class":6},"October 6 University",{"name":210,"class":6},"Al-Azhar University","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":220,"type":221},500,"ESTIMATED","INTERVENTIONAL",[224],"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",[227],"Erectile Dysfunctions",[229,230,231,232,233,234],"Erectile Dysfunction","ED","Sildenafil","Tadalafil","PDE5i Non-Responders","Combination Therapy","2026-02-02",{"date":237,"type":238},"2026-02-06","ACTUAL",{"date":240,"type":238},"2025-12-01",{"date":242,"type":221},"2027-06",{"name":5,"class":6},11]