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RECRUITING
NCT07753720
PHASE4

Daily Tadalafil as Adjunctive Therapy Versus Monotherapy for PDE5 Inhibitor-Resistant Erectile Dysfunction

Sponsor: Al-Azhar University

View on ClinicalTrials.gov

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.

Official title: Efficacy of Daily 5-mg Tadalafil as Adjunctive Therapy Versus Monotherapy in Men With On-Demand PDE5 Inhibitor-Resistant Erectile Dysfunction: A Prospective Randomized Trial

Key Details

Gender

MALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2026-08-13

Completion Date

2027-06-30

Last Updated

2026-09-01

Healthy Volunteers

No

Interventions

DRUG

Tadalafil; Current on-demand PDE5 inhibitor

Tadalafil 5 mg orally once daily for 12 weeks plus the participant's current effective on-demand PDE5 inhibitor, taken 1-2 hours before sexual activity, with a maximum of once daily.

DRUG

Tadalafil 5 mg

Tadalafil 5 mg orally once daily for 12 weeks.

Locations (1)

Department of Urology, Al-Hussein and Sayed Galal University Hospitals, Al-Azhar University

Cairo, Egypt