RecruitingPhase 4NCT07391579

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

Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients: A Multicenter Randomized, Double-Blind, Placebo-Controlled Trial


Sponsor

Mansoura University

Enrollment

500 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: MALEMin Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Sildenafil 100mg & placebo and a drug called Tadalafil 5 mg & Sildenafil 100mg for people with erectile dysfunctions. The study is currently recruiting participants at 11 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTadalafil 5 mg & Sildenafil 100mg

daily dosing of Tadalafil 5 mg combined with on demand Sildenafil 100mg

DRUGSildenafil 100mg & placebo

Daily Placebo combined with on demand Sildenafil 100mg


Locations(11)

Urology and Nephrology Center, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Faculty of medicine, Alexandria University

Alexandria, Egypt

Faculty of medicine, Aswan university

Aswān, 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

Faculty of medicine, Luxor university

Luxor, Egypt

faculty of medicine, Minya University

Minya, Egypt

Faculty of medicine, Tanta University

Tanta, Egypt

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NCT07391579


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