NCT07537855

Efficacy of Intracavernosal Xeomin With Tadalafil for Mild-Moderate Erectile Dysfunction: A Randomized Crossover Pilot Study

Clinical Efficacy of Intracavernosal Xeomin as an Adjunctive Therapy to on Demand Tadalafil 20 mg for the Treatment of Mild to Moderate Erectile Dysfunction: A Randomized Crossover Pilot Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Erectile Dysfunction

Interventions

Type	Name	Description
DRUG	IncobotulinumtoxinA (100 Units)	Intracavernosal Xeomin
OTHER	Placebo	Placebo

Timeline

• Start date: 2026-06-01
• Primary completion: 2029-06-01
• Completion: 2030-06-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Regulatory

• FDA-regulated drug study