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Clinical Trials in Egypt / NCT07391579
Recruiting Phase 4

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

NCT07391579 · tracked via the Priya Life Science Egypt tracker
Sponsor
Mansoura University
Phase
Phase 4
Started
2025-12-01
Last updated
2026-02-06

Condition(s) studied

Erectile Dysfunctions

Investigational drug(s) / intervention(s)

Tadalafil 5 mg & Sildenafil 100mgSildenafil 100mg & placebo

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

Sildenafil 100mg & placebo: Daily Placebo combined with on demand Sildenafil 100mg

Study 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
MALE
Min age
21 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Change in International Index of Erectile Function-5 (IIEF-5) total score — from baseline to 12 weeks after starting treatment
    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.

Trial sites (11)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07391579 on ClinicalTrials.gov ↗ ← All trials in Egypt