Clinical trial • Phase III • Other

LAUROMACROGOL 400 for Spermatocele|Hydrocele

Phase III trial of LAUROMACROGOL 400 for Spermatocele|Hydrocele.

Overview

Trial Therapeutic Area
Other
Trial Disease
Spermatocele|Hydrocele
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
19-08-2024
First CTIS Authorization Date
06-11-2024

Trial design

Randomised, open-label, arm a: 2 ml aethoxysclerol (30 mg/ml). arm b: combination of 2 ml aethoxysclerol (30 mg/ml) + 25 ml ethanol 99.5%; with or without local anesthesia as stated in trial title.-controlled Phase III trial across 3 sites in Sweden.

Randomised
Yes
Open Label
Yes
Comparator
Arm A: 2 ml Aethoxysclerol (30 mg/ml). Arm B: combination of 2 ml Aethoxysclerol (30 mg/ml) + 25 ml ethanol 99.5%; with or without local anesthesia as stated in trial title.
Target Sample Size
300
Trial Duration For Participant
1825

Eligibility

Recruits 300 No vulnerable population selected; informed consent required from participants. No assent procedures or additional consent handling for minors described..

Vulnerable Population
No vulnerable population selected; informed consent required from participants. No assent procedures or additional consent handling for minors described.

Inclusion criteria

  • {"criterion_text":"-Hydro or spermatocele"}
  • {"criterion_text":"-Informed consent"}
  • {"criterion_text":"-Inconveniance at least corresponding to symptoms that can not be ignored but does not affect activities of daily life"}
  • {"criterion_text":"-Age ≥ 30år"}
  • {"criterion_text":"-Hydro or spermatocele at least 50ml (assesed by orchidometry)"}

Exclusion criteria

  • {"criterion_text":"-Paternity wish"}
  • {"criterion_text":"-Hydro or spermatocele deemed not drainable"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-Symptoms from the treated side 3 months from treatment","definition_or_measurement_approach":"Symptom score at 3 months from treatment (as specified in main objective: symptom score 3 months)"}
  • {"endpoint_text":"-Pain according to numeric rating scale (0-10) during treatement","definition_or_measurement_approach":"Pain measured using numeric rating scale (0-10) during treatment"}
  • {"endpoint_text":"-Anti-coaculant therapy not suitable to suspend before treatment","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Allergy to ethanol, Aethoxysclerol or ant local anaestethics used in the study","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Mental disability, reluctance of the patient or language barriers making the purpose of participating in the study difficult to grasp","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Current or just finished participation in another clinical pharmacological study","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Prior participation in the study at hand","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Treatment with immuno-stimulating drugs","definition_or_measurement_approach":""}
  • {"endpoint_text":"-Hydro or spermatocele not able to be evacuated percutaneously","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"-Complications 30 days from treatement","definition_or_measurement_approach":"Complication rate assessed within 30 days from treatment"}
  • {"endpoint_text":"-Retreatement on the treated side","definition_or_measurement_approach":"Retreatment for hydro or spermatocele on the treated side (secondary objective specifies retreatment within 5 years)"}
  • {"endpoint_text":"-Symptoms from the treated side 24 months from treatment","definition_or_measurement_approach":"Symptom score at 24 months from treatment"}
  • {"endpoint_text":"-Pain according to numeric rating scale (0-10) 1 day after treatment","definition_or_measurement_approach":"Pain measured using numeric rating scale (0-10) at 1 day after treatment"}

Recruitment

Planned Sample Size
300
Recruitment Window Months
54
Consent Approach
Informed consent is required from each participant. A subject information and informed consent form document is listed ('Forsokspersonsinformation_2022-502284-38-00'), but languages and age-specific consent/assent procedures are not specified. No assent for minors is described and minors are excluded by age criteria.

Geography

Total Number Of Sites
3
Total Number Of Participants
300

Sweden

Earliest CTIS Part Ii Submission Date
17-10-2024
Latest Decision Or Authorization Date
18-03-2025
Processing Time Days
152
Number Of Sites
3
Number Of Participants
300

Sites

Site Name
Region Vaesternorrland
Department Name
Kirurgklinik
Principal Investigator Name
Johan Styrke
Principal Investigator Email
johan.styrke@rvn.se
Contact Person Name
Johan Styrke
Contact Person Email
johan.styrke@rvn.se
Site Name
C-Medical Borlänge
Department Name
C-Medical
Principal Investigator Name
Karl-Johan Lundström
Principal Investigator Email
karl-johan.lundstrom@regionjh.se
Contact Person Name
Karl-Johan Lundström
Site Name
Region Jaemtland Haerjedalen
Department Name
Kirurgklinik
Principal Investigator Name
Karl-Johan Lundström
Principal Investigator Email
karl-johan.lundstrom@regionjh.se
Contact Person Name
Karl-Johan Lundström

Sponsor

Primary sponsor

Full Name
Region Jamtland Harjedalen
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
Aethoxysklerol 30 mg/ml injektionsvätska, lösning
Active Substance
LAUROMACROGOL 400
Modality
Small molecule
Routes Of Administration
OTHER USE
Route
OTHER USE
Authorisation Status
Authorised
Starting Dose
2 ml of 30 mg/ml (as per trial title)
Dose Levels
2 ml (30 mg/ml)
Frequency
Single treatment (per protocol title)
Maximum Dose
60 mg
Investigational Product Name
ETHANOL, ANHYDROUS
Active Substance
ETHANOL, ANHYDROUS
Modality
Small molecule
Routes Of Administration
LOCAL INJECTION
Route
LOCAL INJECTION
Starting Dose
25 ml of ethanol 99.5% (as per trial title)
Dose Levels
25 ml (99.5% ethanol)
Frequency
Single treatment (per protocol title)
Maximum Dose
25 ml
Investigational Product Name
Ropivacain Sintetica 7,5 mg/ml Injektionslösung
Active Substance
ROPIVACAINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INFILTRATION
Route
INFILTRATION
Authorisation Status
Authorised
Dose Levels
max total dose 187.5 mg (product data)
Maximum Dose
187.5 mg
Investigational Product Name
Bupivacaine Baxter 5 mg/ml injektionsvätska, lösning
Active Substance
BUPIVACAINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INFILTRATION
Route
INFILTRATION
Authorisation Status
Authorised
Dose Levels
max total dose 125 mg (product data)
Maximum Dose
125 mg
Investigational Product Name
Mepivacaine Accord 10 mg/ml injektionsvätska, lösning
Active Substance
MEPIVACAINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INFILTRATION
Route
INFILTRATION
Authorisation Status
Authorised
Dose Levels
max total dose 250 mg (product data)
Maximum Dose
250 mg
Investigational Product Name
Lidocaine Accord 10 mg/ml injektionsvätska, lösning
Active Substance
LIDOCAINE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INFILTRATION
Route
INFILTRATION
Authorisation Status
Authorised
Dose Levels
max total dose 250 mg (product data)
Maximum Dose
250 mg
Combination Treatment
Yes

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