Actively Recruiting
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
Led by Mansoura University · Updated on 2026-02-06
500
Participants Needed
11
Research Sites
26 weeks
Total Duration
On this page
Sponsors
M
Mansoura University
Lead Sponsor
C
Cairo University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether combining daily tadalafil 5 mg with on-demand sildenafil 100 mg improves erectile function in men with erectile dysfunction (ED) who do not respond to PDE5 inhibitors alone. This Phase 4 clinical trial aims to see if this combination leads to greater improvement in erectile function compared to on-demand sildenafil alone, while also assessing safety and tolerability in this patient group. Participants will be randomly assigned to one of two groups: one receiving daily tadalafil 5 mg plus on-demand sildenafil 100 mg, and the other receiving daily placebo plus on-demand sildenafil 100 mg. The treatment period lasts 12 weeks, during which participants take the assigned medications. Follow-up assessments occur at 4, 8, and 12 weeks. This study uses a quadruple-blind design to ensure unbiased results. During the study, participants undergo baseline assessments including medical history, physical exams, and lab tests. They complete questionnaires like the International Index of Erectile Function (IIEF-15) and the Erection Hardness Score (EHS) at baseline and follow-up visits. Researchers monitor changes in erectile function scores, patient satisfaction, and any adverse effects throughout the 12-week treatment. The main outcome is the change in IIEF-5 score from baseline to 12 weeks.
CONDITIONS
Brief 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 6 months or more
- Erectile function domain of IIEF-15 score less than 17
- Documented failure to respond to PDE-5 inhibitors despite maximum dose on at least 4 occasions
- Stable sexual relationship lasting 6 months or longer
You will not qualify if you...
- Penile anatomical deformities or Peyronie's disease
- Pelvic surgery or radiation
- Active malignancy or severe systemic illness
- Previous penile surgery such as prosthesis, lengthening, cancer surgery, plication, or grafting
- Contraindication to PDE5 inhibitors (including high risk cardiac patients, patients on nitrates, hypotension)
- Use of other erectile dysfunction treatments like intra-cavernosal prostaglandin injection therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants receive daily Tadalafil 5 mg combined with on-demand Sildenafil 100 mg or daily placebo combined with on-demand Sildenafil 100 mg for erectile dysfunction.
Weekly visits for up to 12 weeks
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here