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 medical history, physical examination, and laboratory tests. * Be randomly assigned to one of the two treatment groups. * Take the assigned medications for 12 weeks. * Complete follow-up evaluations at 4, 8, and 12 weeks, including:
International Index of Erectile Function (IIEF-15) questionnaire Erection Hardness Score (EHS) assessment Reporting of any adverse effects
Sexually active male.
History of ED for ≥6 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 ≥4 occasions in spite of accurate timing and good sexual stimulation].
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.
Parallel
Tadalafil 5 mg & Sildenafil 100mg
Drugdaily dosing of Tadalafil 5 mg combined with on demand Sildenafil 100mg
Sildenafil 100mg & placebo
DrugDaily Placebo combined with on demand Sildenafil 100mg
Change in International Index of Erectile Function-5 (IIEF-5) total score
The IIEF-5 is a validated 5-item questionnaire assessing erectile function, with total scores ranging from 5 to 25; higher scores indicate better erectile function.
Change in Erection Hardness Score (EHS), assessed using the validated 4-point Erection Hardness Scale
The Erection Hardness Score (EHS) is a validated 4-point scale assessing penile rigidity, with higher scores indicating better erectile hardness.
Change in International Index of Erectile Function (IIEF-15) total score
The International Index of Erectile Function (IIEF-15) is a validated 15-item questionnaire assessing erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction, with total scores ranging from 5 to 75; higher scores indicate better sexual function.
Incidence and severity of adverse events graded according to CTCAE version 5.0
Adverse events will be recorded at each follow-up visit and classified by type, severity, and relationship to the intervention. Severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Click on the lead sponsor to view all of their trials.
Mansoura University
Lead sponsor
Cairo University
Collaborator
Ain Shams University
Collaborator
Aswan University
Collaborator
Luxor university
Collaborator
Assiut University
Collaborator
Minia University
Collaborator
Alexandria University
Collaborator
Tanta University
Collaborator
October 6 University
Collaborator
Al-Azhar University
Collaborator
