Actively Recruiting
Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients
Led by Mansoura University · Updated on 2026-02-06
500
Participants Needed
11
Research Sites
78 weeks
Total Duration
On this page
Sponsors
M
Mansoura University
Lead Sponsor
C
Cairo University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sexually active male
- History of erectile dysfunction for at least 6 months
- Erectile function domain score of IIEF-15 less than 17
- Documented failure to respond to PDE-5 inhibitors despite proper use on 4 or more occasions
- Stable sexual relationship for 6 months or longer
You will not qualify if you...
- Penile anatomical deformities or Peyronie's disease
- History of pelvic surgery or radiation
- Active cancer or severe systemic illness
- Previous penile surgeries such as prosthesis, lengthening, cancer surgery, plication, or grafting
- Contraindications to PDE5 inhibitors including high-risk heart conditions, nitrate use, or low blood pressure
- Use of other erectile dysfunction treatments like intra-cavernosal prostaglandin injections
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 11 locations
1
Urology and Nephrology Center, Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
Actively Recruiting
2
Faculty of medicine, Alexandria University
Alexandria, Egypt
Actively Recruiting
3
Faculty of medicine, Aswan university
Aswān, Egypt
Actively Recruiting
4
Faculty of Medicine - Assiut University
Asyut, Egypt
Actively Recruiting
5
Cairo University, faculty of medicine
Cairo, Egypt
Actively Recruiting
6
Faculty of medicine, Ain Shams University
Cairo, Egypt
Actively Recruiting
7
Faculty of medicine, Azhar University
Cairo, Egypt
Actively Recruiting
8
Faculty of medicine, october 6 Univeristy
Cairo, Egypt
Actively Recruiting
9
Faculty of medicine, Luxor university
Luxor, Egypt
Actively Recruiting
10
faculty of medicine, Minya University
Minya, Egypt
Actively Recruiting
11
Faculty of medicine, Tanta University
Tanta, Egypt
Actively Recruiting
Research Team
A
Ahmed A Shokeir+2, professor of Urology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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