Status:
NOT_YET_RECRUITING
Combination Therapy of Tadalafil 2.5mg Plus Sildenafil 25mg Versus Tadalafil 5 mg Monotherapy for Treatment of Erectile Dysfunction: A Randomized, Placebo-Controlled Double-Blinded Cross-Over Study
Lead Sponsor:
Assiut University
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18-60 years
Phase:
PHASE3
Brief Summary
Erectile dysfunction (ED) is characterized by the persistent inability to attain or sustain an erection adequate for satisfactory sexual intercourse. As one of the most common male sexual health disor...
Eligibility Criteria
Inclusion
- -Men aged 18-70 years with a clinical diagnosis of erectile dysfunction (ED) for ≥3 months.
- International Index of Erectile Function (IIEF-5) score ≤21.
- Stable sexual relationship for ≥3 months.
- Willingness to adhere to the study protocol and provide informed consent.
- No prior use of PDE5 inhibitors within 4 weeks before enrollment.
Exclusion
- -Severe cardiovascular disease (uncontrolled hypertension, recent MI/stroke).
- Hypersensitivity to tadalafil, sildenafil, or any PDE5 inhibitor.
- Severe hepatic/renal impairment (e.g., CrCl \<30 mL/min, Child-Pugh C).
- Concomitant use of nitrates, strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole).
- History of priapism, penile deformities, or radical prostatectomy.
- Major psychiatric disorders affecting compliance.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT07177326
Start Date
October 1 2025
End Date
December 1 2026
Last Update
September 24 2025
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