[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tadalafil\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tadalafil":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":20,"type":21},260,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28],"Erectile Dysfunction","Tadalafil","RECRUITING","2026-08-16",{"date":32,"type":33},"2026-08-18","ACTUAL",{"date":35,"type":33},"2026-08-13",{"date":37,"type":21},"2027-06-30",{"name":39,"class":40},"Al-Azhar University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":41},"100648623","tamsulosin-monotherapy-versus-combination-therapy-with-tadalafil-25-mg-vs-5-mg-in-managing-male-luts-secondary-to-bph-100648623","NCT07722884","Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH","Safety and Efficacy of Tamsulosin Monotherapy Versus Combination Therapy With Tadalafil (2.5 mg vs 5 mg) in Managing Male LUTS Secondary to BPH","Inclusion Criteria:\n\n* Patients older than 45 years of age.\n* Clinical diagnosis of benign prostatic hyperplasia (BPH) and moderate to severe lower urinary tract symptoms (LUTS) \\[International Prostate Symptom Score (IPSS) ≥ 13\\].\n* Maximum flow rate (Qmax) ≤ 15 mL\u002Fs, prostate volume ≥ 30 mL by transrectal ultrasound.\n\nExclusion Criteria:\n\n* Patients taking α-blockers, beta-blockers, 5-alpha reductase inhibitors, phosphodiesterase-5 (PDE5) inhibitors, anticholinergics, or nitrates were excluded.\n* Patients with a history of prostate or bladder surgery, lower urinary tract procedures, prostate or bladder cancer, neurological conditions affecting bladder function, severe cardiovascular disease, hepatic impairment, diabetes mellitus with complications, kidney dysfunction (acute or chronic), neurogenic bladder, or congenital urinary anomalies.\n* Additionally, patients with recent myocardial infarction, unstable angina, severe heart failure, uncontrolled hypertension, Prostate-Specific Antigen (PSA)\\>4 ng\u002FmL (unless cancer ruled out), active urinary tract infection, urinary retention, and those unavailable for follow-up were also excluded from the study.","ALL","45 Years",{"count":52,"type":21},90,[54],"NA","This study aims to evaluate the short-term impact and clinical outcomes of tamsulosin monotherapy versus combination therapy with tamsulosin plus tadalafil (2.5 mg vs. 5 mg) on lower urinary tract symptoms (LUTS) severity and patient quality of life in men with benign prostatic hyperplasia (BPH). It also seeks to determine whether the lower tadalafil dose provides adequate symptom relief while minimizing adverse effects over a 12-week follow-up period.",[57,58,59,60,28,61,62],"Safety","Efficacy","Tamsulosin","Monotherapy","Lower Urinary Tract Symptoms","Benign Prostatic Hyperplasia","2026-07-20",{"date":65,"type":33},"2026-07-23",{"date":67,"type":33},"2026-07-01",{"date":69,"type":21},"2027-01-01",{"name":71,"class":40},"Ain Shams University"]