Clinical trial • Phase IV • Other

Toxin type A complex of Clostridium botulinum (botulinum toxin A complex) for Erectile dysfunction

Phase IV trial of Toxin type A complex of Clostridium botulinum (botulinum toxin A complex) for Erectile dysfunction.

Overview

Trial Therapeutic Area
Other
Trial Disease
Erectile dysfunction
Trial Stage
Phase IV
Drug Modality
Peptide/protein/enzyme|Small molecule

Key dates

Initial CTIS Submission Date
14-06-2024
First CTIS Authorization Date
20-09-2024

Trial design

Randomised, placebo: sodium chloride solution 0.9% (local injection), max total amount 1 ml; test: botulinum toxin (onabotulinumtoxin a) (local injection), max total amount 1 ml. specific dosing schedule not fully specified in part i/ii documents; secondary objectives reference six-monthly hospital administration for bont-a.-controlled Phase IV trial across 2 sites in Spain.

Randomised
Yes
Comparator
Placebo: SODIUM CHLORIDE SOLUTION 0.9% (local injection), max total amount 1 ml; Test: BOTULINUM TOXIN (Onabotulinumtoxin A) (local injection), max total amount 1 ml. Specific dosing schedule not fully specified in Part I/II documents; secondary objectives reference six-monthly hospital administration for BoNT-A.
Target Sample Size
114
Trial Duration For Participant
730

Eligibility

Recruits 114 Vulnerable population not selected. Consent requirement: "The patient, or his or her representative, has given consent to participate in the study." No assent process or age-specific consent documents are specified..

Vulnerable Population
Vulnerable population not selected. Consent requirement: "The patient, or his or her representative, has given consent to participate in the study." No assent process or age-specific consent documents are specified.

Inclusion criteria

  • {"criterion_text":"-Patients diagnosed with ED with insufficient response to IPDE5 or intracavernous injections with Caverject or Bimix/Trimix (IIEF-15 questionnaire score ≤ 12)."}
  • {"criterion_text":"-The patient is over 30 years old"}
  • {"criterion_text":"-The patient, or his or her representative, has given consent to participate in the study."}
  • {"criterion_text":"-The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial."}
  • {"criterion_text":"-Patient must commit to attending follow-up appointments and undergoing the appropriate tests."}

Exclusion criteria

  • {"criterion_text":"-Patients who do not accept informed consent"}
  • {"criterion_text":"-Patients who do not accept or cannot commit to attending the follow-up sessions."}
  • {"criterion_text":"-Patients under 30 years of age."}
  • {"criterion_text":"-Known hypersensitivity to BoNT-A"}
  • {"criterion_text":"-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."}
  • {"criterion_text":"-Patients with robotic radical prostatectomy less than 6 months ago"}
  • {"criterion_text":"-Patients with a history of known neurogenic damage"}
  • {"criterion_text":"-Patients with a history of radiotherapy treatment"}
  • {"criterion_text":"-Patients with known psychiatric disorder"}
  • {"criterion_text":"-Patients with anatomical abnormalities in the penis."}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Subjective perception of rigidity","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
114
Recruitment Window Months
24
Consent Approach
The patient, or his or her representative, has given consent to participate in the study. A subject information and informed consent form is listed among the trial documents ('L1_SIS and ICF all subjets'). Translations of trial titles into Spanish are present. No detailed assent procedure or age-specific consent documents are specified in the available data.

Geography

Total Number Of Sites
2
Total Number Of Participants
114

Spain

Earliest CTIS Part Ii Submission Date
02-09-2024
Latest Decision Or Authorization Date
29-12-2025
Processing Time Days
483
Number Of Sites
2
Number Of Participants
114

Sites

Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Urología
Principal Investigator Name
José Enrique Robles García
Principal Investigator Email
jerobles@unav.es
Contact Person Name
José Enrique Robles García
Contact Person Email
jerobles@unav.es
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Urología
Principal Investigator Name
José Enrique Robles García
Principal Investigator Email
jrobles@unav.es
Contact Person Name
José Enrique Robles García
Contact Person Email
jrobles@unav.es

Sponsor

Primary sponsor

Full Name
Clinica Universidad De Navarra
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Spain

Investigational products

Investigational Product Name
BOTULINUM TOXIN
Active Substance
Toxin type A complex of Clostridium botulinum (botulinum toxin A complex)
Modality
Peptide/protein/enzyme
Routes Of Administration
LOCAL INJECTION
Route
LOCAL INJECTION
Frequency
Six-monthly administration in hospital (as referenced in secondary objectives)
Maximum Dose
1 ml
Investigational Product Name
SODIUM CHLORIDE SOLUTION 0.9%
Active Substance
SODIUM CHLORIDE SOLUTION 0.9%
Modality
Small molecule
Routes Of Administration
LOCAL INJECTION
Route
LOCAL INJECTION
Maximum Dose
1 ml

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