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A Randomized Double-Blind Clinical Study of Intracavernosal OnabotulinumtoxinA Injection in Patients With Erectile Dysfunction Refractory to Phosphodiesterase-5 Inhibitors

Study acronym: BTXDE
StatusCompleted
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
This study aims to evaluate the clinical efficacy of intracavernosal treatment with onabotulinumtoxinA (Botox) in 114 men aged 30 years or older with erectile dysfunction who have not responded to first-line oral pharmacological treatment. For this purpose, the effects of onabotulinumtoxinA are compared with those of a placebo consisting of an intracavernosal injection of physiological saline. The study is patient-blinded. Participants in the experimental group receive 100 U of onabotulinumtoxinA diluted in 1 mL of physiological saline, while participants in the control group receive 1 mL of physiological saline.
Trial Details
NCT Number NCT07834164
Lead Sponsor Clinica Universidad de Navarra, Universidad de Navarra
Conditions
(from sponsor)		 Erectile Dysfunction
Related terms Erectile Dysfunction
Enrollment 114 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov