Daily Tadalafil as Adjunctive Therapy Versus Monotherapy for PDE5 Inhibitor-Resistant Erectile Dysfunction
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexMale
Age18-70
SponsorAl-Azhar University
About this trial
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.
Eligibility criteria
Qualifiers
Age: 18 to 70 years.
Diagnosis: Erectile dysfunction for at least 6 months.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Tadalafil; Current on-demand PDE5 inhibitor
- Tadalafil 5 mg
Treatment groups
260 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov