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

NCT07834164 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: BTXDE
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• BOTOX efficacy

  Check if intracavernosal injections of onabotulinum toxin A improve erectile dysfunction in refractory patients to oral medication using questionnaires.

  6 months

Study Arms (2)

OnabotulinumtoxinA (Botox) 100 U

EXPERIMENTAL

Participants receive an intracavernosal injection of 100 U of onabotulinumtoxinA (Botox) diluted in 1 mL of physiological saline.

Drug: OnabotulinumtoxinA (Botox ®) Injections

Placebo (Normal Saline)

PLACEBO COMPARATOR

Participants receive an intracavernosal injection of 1 mL of physiological saline as placebo.

Drug: Saline (0.9% NaCl)

Interventions

OnabotulinumtoxinA (Botox ®) Injections DRUG

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

OnabotulinumtoxinA (Botox) 100 U

Saline (0.9% NaCl) DRUG

1 mL of physiological saline, administered by intracavernosal injection

Placebo (Normal Saline)

Eligibility Criteria

• Age: 30 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with erectile dysfunction (ED) with an inadequate response to phosphodiesterase type 5 inhibitors (PDE5 inhibitors) or to intracavernosal injections with Caverject or Bimix/Trimix (IIEF-15 questionnaire score ≤12).
• Patients aged 30 years or older.
• Patients who have provided informed consent to participate in the study.
• Patients who, in the investigator's opinion, are able to comply with all clinical trial requirements.
• Patients who agree to attend follow-up visits and undergo the required assessments.

You may not qualify if:

• Severe infections or diseases, or hepatic, renal, or bone marrow insufficiency, that, in the investigator's opinion, contraindicate participation in the study.
• Known hypersensitivity to onabotulinumtoxinA (BoNT-A).
• Patients who do not consent to participate in the study.
• Patients younger than 30 years.
• Patients who underwent robotic radical prostatectomy less than 6 months prior to study enrollment.
• Patients with a known history of neurogenic injury.
• Patients with a history of radiation therapy.
• Patients with a known psychiatric disorder.
• Patients with anatomical abnormalities of the penis.
• Patients who do not agree to, or are unable to commit to, attending the scheduled follow-up visits.

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Botulinum Toxins, Type A; Injections; Sodium Chloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 22, 2026
• Study Start: November 25, 2024
• Primary Completion: June 12, 2026
• Study Completion: July 2, 2026
• Last Updated: September 22, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)