[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650886":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":25,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Al-Azhar University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Adjunct Therapy","EXPERIMENTAL","Participants will receive tadalafil 5 mg orally once daily for 12 weeks plus their current effective on-demand PDE5 inhibitor, taken 1-2 hours before sexual activity, with a maximum of once daily.",[13,14],"Drug: Tadalafil; Current on-demand PDE5 inhibitor","Drug: Tadalafil 5 mg",{"label":16,"type":10,"description":17,"interventionNames":18},"Monotherapy","Participants will receive tadalafil 5 mg orally once daily for 12 weeks.",[14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Tadalafil; Current on-demand PDE5 inhibitor","Tadalafil 5 mg orally once daily for 12 weeks plus the participant's current effective on-demand PDE5 inhibitor, taken 1-2 hours before sexual activity, with a maximum of once daily.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Tadalafil 5 mg","Tadalafil 5 mg orally once daily for 12 weeks.",[9,16],[31],{"name":32,"affiliation":33,"role":34},"Abul-fotouh Ahmed","Department of Urology, Faculty of Medicine, Al-Azhar University, Cairo, Egypt","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Abul-fotouh Ahmed, MD","CONTACT","+201001066756","abulfotouhahmed@yahoo.com",[42],{"facility":43,"status":44,"city":45,"state":25,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University","RECRUITING","Cairo","Egypt","EG",{"type":49,"coordinates":50},"Point",[51,52],31.24967,30.06263,{"lat":52,"lon":51},[55,56],{"name":32,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":57,"role":58,"phone":25,"phoneExt":25,"email":25},"Taha G El-Desouky","SUB_INVESTIGATOR",{"type":34,"investigatorFullName":32,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Principal Investigator","100650886","daily-tadalafil-as-adjunctive-therapy-versus-monotherapy-for-pde5-inhibitor-resistant-erectile-dysfunction-100650886",false,"NCT07753720","Daily Tadalafil as Adjunctive Therapy Versus Monotherapy for PDE5 Inhibitor-Resistant Erectile Dysfunction","Efficacy of Daily 5-mg Tadalafil as Adjunctive Therapy Versus Monotherapy in Men With On-Demand PDE5 Inhibitor-Resistant Erectile Dysfunction: A Prospective Randomized Trial","Inclusion Criteria\n\n* Age: 18 to 70 years.\n* Diagnosis: Erectile dysfunction for at least 6 months.\n* PDE5 inhibitor resistance: History of on-demand PDE5 inhibitor use for at least 3 months with inadequate response, defined as:\n* International Index of Erectile Function-Erectile Function score less than 26 despite optimal dosing.\n* Self-reported inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse in at least 50% of attempts.\n* Confirmed proper medication use with at least 4 to 8 attempts with adequate sexual stimulation.\n* Stable relationship: Sexually active with a female partner for at least 6 months.\n* Informed consent: Willing and able to provide written informed consent.\n\nExclusion Criteria\n\n* Current use of nitrates.\n* Unstable cardiovascular disease, including recent myocardial infarction within 6 months, unstable angina, or severe heart failure.\n* Uncontrolled hypertension greater than 180 over 110 mmHg or severe hypotension less than 90 over 50 mmHg.\n* Severe hepatic impairment, Child-Pugh class C, or renal impairment with estimated glomerular filtration rate less than 30 mL per minute per 1.73 m².\n* Untreated hypogonadism, total testosterone less than 250 ng\u002FdL.\n* Severe penile anatomic deformity or prior penile prosthesis.\n* History of priapism.\n* Severe untreated depression.\n* Pelvic surgery or radiation within 6 months.","MALE","18 Years","70 Years",{"count":72,"type":73},260,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","This randomized trial will compare daily tadalafil 5 mg as adjunct therapy versus monotherapy in men with on-demand PDE5 inhibitor-resistant erectile dysfunction. The study will evaluate changes in erectile function, treatment satisfaction, partner satisfaction, and safety over 12 weeks.",[79,80],"Erectile Dysfunction","Tadalafil","2026-08-16",{"date":83,"type":84},"2026-08-18","ACTUAL",{"date":86,"type":84},"2026-08-13",{"date":88,"type":73},"2027-06-30",{"name":5,"class":6},1]