Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunct… (NCT07391579) | Clinical Trial Compass
RecruitingPhase 4
Daily Tadalafil 5 mg Combined With On-Demand Sildenafil 100 mg for Treatment of Erectile Dysfunction in PDE-5I Non Responder Patients
Egypt500 participantsStarted 2025-12-01
Plain-language 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
Who can participate
Age range
21 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in International Index of Erectile Function-5 (IIEF-5) total score
Timeframe: from baseline to 12 weeks after starting treatment