Daily Tadalafil as Adjunctive Therapy Versus Monotherapy for PDE5 Inhibitor-Resistant Erectile Dy… (NCT07753720) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Daily Tadalafil as Adjunctive Therapy Versus Monotherapy for PDE5 Inhibitor-Resistant Erectile Dysfunction
Egypt260 participantsStarted 2026-08-10
Plain-language summary
This randomized trial will compare daily tadalafil 5 mg as adjunct therapy versus monotherapy in men with on-demand PDE5 inhibitor-resistant erectile dysfunction. The study will evaluate changes in erectile function, treatment satisfaction, partner satisfaction, and safety over 12 weeks.
Who can participate
Age range
18 Years – 70 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
* Age: 18 to 70 years.
* Diagnosis: Erectile dysfunction for at least 6 months.
* PDE5 inhibitor resistance: History of on-demand PDE5 inhibitor use for at least 3 months with inadequate response, defined as:
* International Index of Erectile Function-Erectile Function score less than 26 despite optimal dosing.
* Self-reported inability to achieve or maintain an erection sufficient for satisfactory sexual intercourse in at least 50% of attempts.
* Confirmed proper medication use with at least 4 to 8 attempts with adequate sexual stimulation.
* Stable relationship: Sexually active with a female partner for at least 6 months.
* Informed consent: Willing and able to provide written informed consent.
Exclusion Criteria
* Current use of nitrates.
* Unstable cardiovascular disease, including recent myocardial infarction within 6 months, unstable angina, or severe heart failure.
* Uncontrolled hypertension greater than 180 over 110 mmHg or severe hypotension less than 90 over 50 mmHg.
* Severe hepatic impairment, Child-Pugh class C, or renal impairment with estimated glomerular filtration rate less than 30 mL per minute per 1.73 m².
* Untreated hypogonadism, total testosterone less than 250 ng/dL.
* Severe penile anatomic deformity or prior penile prosthesis.
* History of priapism.
* Severe untreated depression.
* Pelvic surgery or radiation within 6 months.
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-Erectile Function score from baseline to week 12.