Erectile DysfunctionPhase 2BTXDENCT07834164
A Randomized Double-Blind Clinical Study of Intracavernosal OnabotulinumtoxinA Injection in Patients With Erectile Dysfunction Refractory to Phosphodiesterase-5 Inhibitors
A Phase 2 study testing OnabotulinumtoxinA (Botox ®) Injections and Saline (0.9% NaCl) in people with Erectile Dysfunction, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Erectile Dysfunction
- What is being tested?
- OnabotulinumtoxinA (Botox ®) Injections and Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 25 Nov 2024to 2 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- OnabotulinumtoxinA (Botox ®) Injections, Saline (0.9% NaCl)
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnabotulinumtoxinA (Botox ®) InjectionsDrug
OnabotulinumtoxinA 100 U diluted in 1 mL of physiological saline, administered by intracavernosal injection
Saline (0.9% NaCl)Drug
1 mL of physiological saline, administered by intracavernosal injection
| Study group | Role | What they receive |
|---|---|---|
| OnabotulinumtoxinA (Botox) 100 U | Experimental | Participants receive an intracavernosal injection of 100 U of onabotulinumtoxinA (Botox) diluted in 1 mL of physiological saline. Receives: Drug: OnabotulinumtoxinA (Botox ®) Injections |
| Placebo (Normal Saline) | Placebo comparator | Participants receive an intracavernosal injection of 1 mL of physiological saline as placebo. Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOTOX efficacy
Check if intracavernosal injections of onabotulinum toxin A improve erectile dysfunction in refractory patients to oral medication using questionnaires.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start25 Nov 2024
- Primary completion12 Jun 2026
- Study completion2 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834164
- Sponsor's protocol ID
- BTXDE
- Acronym
- BTXDE
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-Blind Clinical Study of Intracavernosal OnabotulinumtoxinA Injection in Patients With Erectile Dysfunction Refractory to Phosphodiesterase-5 Inhibitors
- ClinicalTrials.gov ID
- NCT07834164
- Acronym / sponsor ID
- BTXDE / BTXDE
- Conditions
- Erectile Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OnabotulinumtoxinA (Botox) 100 U | Experimental | Drug: OnabotulinumtoxinA (Botox ®) InjectionsParticipants receive an intracavernosal injection of 100 U of onabotulinumtoxinA (Botox) diluted in 1 mL of physiological saline. |
| Placebo (Normal Saline) | Placebo comparator | Drug: Saline (0.9% NaCl)Participants receive an intracavernosal injection of 1 mL of physiological saline as placebo. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OnabotulinumtoxinA (Botox ®) InjectionsOnabotulinumtoxinA 100 U diluted in 1 mL of physiological saline, administered by intracavernosal injection | Drug | OnabotulinumtoxinA (Botox) 100 U |
| Saline (0.9% NaCl)1 mL of physiological saline, administered by intracavernosal injection | Drug | Placebo (Normal Saline) |
Primary outcome
BOTOX efficacy
Time frame: 6 months
Check if intracavernosal injections of onabotulinum toxin A improve erectile dysfunction in refractory patients to oral medication using questionnaires.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OnabotulinumtoxinA (Botox ®) Injections and Saline (0.9% NaCl) in people with Erectile Dysfunction, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOTOX efficacy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.