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

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

Conditions

• Erectile Dysfunctions

Interventions

DRUG

Tadalafil 5 mg & Sildenafil 100mg

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

DRUG

Sildenafil 100mg & placebo

Daily Placebo combined with on demand Sildenafil 100mg

Sponsors & Collaborators

• Cairo University

  collaborator OTHER

• Ain Shams University

  collaborator OTHER

• Aswan University

  collaborator OTHER

• Luxor university

  collaborator OTHER

• Assiut University

  collaborator OTHER

• Minia University

  collaborator OTHER

• Alexandria University

  collaborator OTHER

• Tanta University

  collaborator OTHER

• October 6 University

  collaborator OTHER

• Al-Azhar University

  collaborator OTHER

• Mansoura University

  lead OTHER

Principal Investigators

• Ahmed A Shokeir, professor of urology · Urology & Nephrology Center, Masnoura university, Egypt

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2026-12-31

Completion

2027-06-30

Countries

• Egypt

Study Locations