Daily Tadalafil as Adjunctive Therapy Versus Monotherapy for PDE5 Inhibitor-Resistant Erectile Dysfunction
NCT07753720 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 260
Last updated 2026-08-07
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.
Conditions
- Erectile Dysfunction
- Tadalafil
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.
Sponsors & Collaborators
-
Al-Azhar University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-30
- Primary Completion
- 2027-06-30
- Completion
- 2027-06-30
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