Clinical Trial

Efficacy of Intracavernosal Xeomin With Tadalafil for Mild-Moderate Erectile Dysfunction

Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
Erectile dysfunction (ED) affects approximately 30 million men in the United States and is associated with factors such as aging, smoking, diabetes, hypertension, obesity, and sedentary lifestyle. ED can also negatively impact the quality of life of patients and their partners. Treatment decisions are typically made jointly between patients and their urologists, often starting with less invasive options. Oral phosphodiesterase-5 inhibitors (PDE5 inhibitors), including sildenafil, tadalafil, and vardenafil, are commonly used as first-line therapy. While these medications improve erectile function in many patients, approximately 30-40% do not respond adequately to PDE5 inhibitor therapy alone. Patients who do not achieve sufficient benefit may require additional or more invasive treatment options.
Protocol Amendment History 4 changes
notable Primary completion pushed: 2028-06 -> 2028-09 2026-08-15
minor Completion pushed: 2028-06 -> 2028-09 2026-08-15
notable Primary completion moved earlier: 2029-06 -> 2028-06 2026-05-12
minor Completion moved earlier: 2030-06 -> 2028-06 2026-05-12
Trial Details
NCT Number NCT07537855
Lead Sponsor Northwestern University
Collaborators: Merz North America, Inc.
Conditions Erectile Dysfunction
Enrollment 30 participants
Start Date 2026-09
Primary Completion 2028-09 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-14