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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age21+
SponsorMansoura University

About this trial

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

Eligibility criteria

Qualifiers

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].

Disqualifiers

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.

Trial design

Treatments tested in this trial

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

Treatment groups

500 Participants
are divided into 2 treatment groups

Sponsors and collaborators

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