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

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Erectile Dysfunctions

In brief

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

Key facts

Study ID

NCT07391579

Run by

Mansoura University

People needed

500

Starts

2025-12-01

Expected to finish

2027-06-01

Last updated by the study team

2026-02-06

Who can join

Age: 21 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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].
• Stable sexual relationship ≥ 6 months.

You may not qualify if…

• 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.

Where it is running

• Urology and Nephrology Center, Mansoura University — Al Mansurah, Dakahlia Governorate, Egypt (enrolling)
• Faculty of medicine, Alexandria University — Alexandria, Egypt (enrolling)
• Faculty of medicine, Aswan university — Aswān, Egypt (enrolling)
• Faculty of Medicine - Assiut University — Asyut, Egypt (enrolling)
• Cairo University, faculty of medicine — Cairo, Egypt (enrolling)
• Faculty of medicine, Ain Shams University — Cairo, Egypt (enrolling)
• Faculty of medicine, Azhar University — Cairo, Egypt (enrolling)
• Faculty of medicine, october 6 Univeristy — Cairo, Egypt (enrolling)
• Faculty of medicine, Luxor university — Luxor, Egypt (enrolling)
• faculty of medicine, Minya University — Minya, Egypt (enrolling)
• Faculty of medicine, Tanta University — Tanta, Egypt (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.