Overview
Sponsor-declared trial summary
Erectile dysfunction
To test the therapeutic efficacy of intracavernous injections (ICI) of Onabotulinumtoxin A (BoNT-A) in the treatment of erectile dysfunction (ED)
Key facts
- Sponsor
- Clinica Universidad De Navarra
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 31 Oct 2024 → ongoing
- Decision date (initial)
- 2024-09-20
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Clínica Universidad de Navarra
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To test the therapeutic efficacy of intracavernous injections (ICI) of Onabotulinumtoxin A (BoNT-A) in the treatment of erectile dysfunction (ED)
Secondary objectives 4
- To check the best therapeutic secondary adherence to its six-monthly administration in hospital by comparatively analyzing through the clinical history the patient's preferences between daily or on-demand consumption of oral/intracavernosal mediation vs six-monthly intracavernosal hospital administration.
- To rule out the presence of relevant adverse effects derived from this procedure.
- To assess the duration of the treatment effect.
- To define the profile of candidates for this treatment.
Conditions and MedDRA coding
Erectile dysfunction
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patients diagnosed with ED with insufficient response to IPDE5 or intracavernous injections with Caverject or Bimix/Trimix (IIEF-15 questionnaire score ≤ 12).
- The patient is over 30 years old
- The patient, or his or her representative, has given consent to participate in the study.
- The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
- Patient must commit to attending follow-up appointments and undergoing the appropriate tests.
Exclusion criteria 10
- Patients who do not accept informed consent
- Patients under 30 years of age.
- Known hypersensitivity to BoNT-A
- Serious infections or diseases or hepatic, renal or spinal cord failure that discourage the patient's participation in the study, according to the researcher's criteria.
- Patients with robotic radical prostatectomy less than 6 months ago
- Patients with a history of known neurogenic damage
- Patients with a history of radiotherapy treatment
- Patients with known psychiatric disorder
- Patients with anatomical abnormalities in the penis.
- Patients who do not accept or cannot commit to attending the follow-up sessions.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Subjective perception of rigidity
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
—
SCP1061961 · ATC
- Route of administration
- LOCAL INJECTION
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB20079 · Substance
- Active substance
- Sodium Chloride Solution 0.9%
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- LOCAL INJECTION
- Max daily dose
- 1 ml millilitre(s)
- Max total dose
- 1 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Clinica Universidad De Navarra
- Sponsor organisation
- Clinica Universidad De Navarra
- Address
- Avenue Pio XII 36
- City
- Pamplona
- Postcode
- 31008
- Country
- Spain
Scientific contact point
- Organisation
- Clinica Universidad De Navarra
- Contact name
- José Enrique Robles García
Public contact point
- Organisation
- Clinica Universidad De Navarra
- Contact name
- José Enrique Robles García
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 114 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2024-10-31 | 2024-11-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_v2 | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF all subjets | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF all subjets_reviewed | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Botox | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-14 | Spain | Acceptable 2024-08-29
|
2024-09-20 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-06 | Spain | Acceptable 2024-08-29
|
2024-11-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-25 | Spain | Acceptable | 2025-12-29 |