Daily Tadalafil as Adjunctive Therapy Versus Monotherapy for PDE5 Inhibitor-Resistant Erectile Dysfunction
Starting soon · Phase 4
Conditions studied: Erectile Dysfunction, Tadalafil
In brief
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.
Key facts
- Study ID
- NCT07753720
- Run by
- Al-Azhar University
- People needed
- 260
- Starts
- 2026-07-30
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-08-10
Who can join
Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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