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Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients

RecruitingPhase 4Ages 21 Years - anyMaleMansoura University
NCT07391579 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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. The main questions it aims to answer are: * 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? * Is the combination therapy safe and well tolerated in this patient population? Researchers will compare: * Group A: Daily tadalafil 5 mg plus on-demand sildenafil 100 mg * Group B: Daily placebo plus on-demand sildenafil 100 mg to determine whether the combination regimen provides superior improvement in erectile function and patient satisfaction. Participants will: * Undergo baseline assessment including medic

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Sexually active male. * History of ED for โ‰ฅ6 months. * Erectile function domain of IIEF-15 score \<17. * Documented failure to respond to PDE-5I \[definition of non-responder patients are patients with ED who don't respond to maximum dose of PDE-5I on โ‰ฅ4 occasions in spite of accurate timing and good sexual stimulation\]. * Stable sexual relationship โ‰ฅ 6 months. Exclusion Criteria: * Penile anatomical deformities or Peyronie's disease. * Pelvic surgery or radiation. * Active malignancy or severe systemic illness. * Previous penile surgery of any kind, such as penile prosthesis, penile lengthening, penile cancer surgery, penile plication or grafting. * Contraindication to PDE5i (High risk cardiac patients, patients on nitrates, hypotension). * Using other treatments for ED e.g., Intra-cavernoasl prostaglandin injection therapy.
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What it tests

  • Tadalafil 5 mg & Sildenafil 100mg
  • Sildenafil 100mg & placebo
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Where

11 sites
Urology and Nephrology Center, Mansoura University
Al Mansurah, Egypt
Faculty of medicine, Alexandria University
Alexandria, Egypt
Faculty of medicine, Aswan university
Aswฤn, Egypt
Faculty of Medicine - Assiut University
Asyut, Egypt
Cairo University, faculty of medicine
Cairo, Egypt
Faculty of medicine, Ain Shams University
Cairo, Egypt
Faculty of medicine, Azhar University
Cairo, Egypt
Faculty of medicine, october 6 Univeristy
Cairo, Egypt

โ€ฆand 3 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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