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COMPLETED
NCT07834164
PHASE2

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

Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

MALE

Age Range

30 Years - Any

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2024-11-25

Completion Date

2026-07-02

Last Updated

2026-09-22

Healthy Volunteers

Yes

Interventions

DRUG

OnabotulinumtoxinA (Botox ®) Injections

OnabotulinumtoxinA 100 U diluted in 1 mL of physiological saline, administered by intracavernosal injection

DRUG

Saline (0.9% NaCl)

1 mL of physiological saline, administered by intracavernosal injection

Locations (1)

Clinica Universidad de Navarra

Pamplona, Navarre, Spain