NCT07391579 Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients
| NCT ID | NCT07391579 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mansoura University |
| Condition | Erectile Dysfunctions |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 500 participants in total. It began in 2025-12-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Ahmed A Shokeir, professor of urology
STUDY CHAIR
Urology & Nephrology Center, Masnoura university, Egypt
Frequently Asked Questions
Who can join the NCT07391579 clinical trial?
This trial is open to male participants only, aged 21 Years or older, studying Erectile Dysfunctions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07391579 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07391579 currently recruiting?
Yes, NCT07391579 is actively recruiting participants. Contact the research team at ahmed.shokeir@hotmail.com for enrollment information.
Where is the NCT07391579 trial being conducted?
This trial is being conducted at Al Mansurah, Egypt, Alexandria, Egypt, Aswān, Egypt, Asyut, Egypt and 7 additional locations.
Who is sponsoring the NCT07391579 clinical trial?
NCT07391579 is sponsored by Mansoura University. The principal investigator is Ahmed A Shokeir, professor of urology at Urology & Nephrology Center, Masnoura university, Egypt. The trial plans to enroll 500 participants.