Overview
Sponsor-declared trial summary
Spermatocele
To compare 2ml Aetoxysclerol 30mg/ml vs. a combination of 2ml Aetoxysclerol 30mg/ml and25ml of ethanol 99.5% regarding symptom score 3 months from treatment and re-treatment rate from hydro or spermatoceles. and Pain during treatment with no local anesthesia (standard of care), spermatic chord bloc or instillation …
Key facts
- Sponsor
- Region Jamtland Harjedalen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12]
- Trial duration
- 5 May 2025 → ongoing
- Decision date (initial)
- 2024-11-06
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Region Jämtland/Härjedalen · Visare Norr
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To compare
2ml Aetoxysclerol 30mg/ml vs. a combination of 2ml Aetoxysclerol 30mg/ml and25ml of ethanol 99.5% regarding symptom score 3 months from treatment and re-treatment rate from hydro or spermatoceles.
and
Pain during treatment with no local anesthesia (standard of care), spermatic chord bloc or instillation anesthesia
Secondary objectives 4
- To compare complication rates from 2ml Aetoxysclerol 30mg/ml vs. a combination of 2ml Aetoxysclerol 30mg/ml and 25ml of ethanol 99.5%.
- Retreatment for hydro or spermatocele on the treated side within 5 years form treatment
- Symptom score, on the treated side, 24 months from treatment hydro or spermatoceles.
- Pain score 1 day from treatment
Conditions and MedDRA coding
Spermatocele
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10041490 | Spermatocele | 100000004872 |
| 20.0 | PT | 10020488 | Hydrocele | 100000004850 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Hydro or spermatocele
- Informed consent
- Inconveniance at least corresponding to symptoms that can not be ignored but does not affect activities of daily life
- Age ≥ 30år
- Hydro or spermatocele at least 50ml (assesed by orchidometry)
Exclusion criteria 2
- Paternity wish
- Hydro or spermatocele deemed not drainable
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 9
- Symptoms from the treated side 3 months from treatment
- Pain according to numeric rating scale (0-10) during treatement
- Anti-coaculant therapy not suitable to suspend before treatment
- Allergy to ethanol, Aethoxysclerol or ant local anaestethics used in the study
- Mental disability, reluctance of the patient or language barriers making the purpose of participating in the study difficult to grasp
- Current or just finished participation in another clinical pharmacological study
- Prior participation in the study at hand
- Treatment with immuno-stimulating drugs
- Hydro or spermatocele not able to be evacuated percutaneously
Secondary endpoints 4
- Complications 30 days from treatement
- Retreatement on the treated side
- Symptoms from the treated side 24 months from treatment
- Pain according to numeric rating scale (0-10) 1 day after treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
Ropivacain Sintetica 7,5 mg/ml Injektionslösung
PRD1961841 · Product
- Active substance
- Ropivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 187.5 mg milligram(s)
- Max total dose
- 187.5 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB09 — ROPIVACAINE
- Marketing authorisation
- 1-31355
- MA holder
- SINTETICA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB11947MIG · Substance
- Active substance
- Ethanol, Anhydrous
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- LOCAL INJECTION
- Max daily dose
- 25 ml millilitre(s)
- Max total dose
- 25 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
- Yes
- Modification description
- Diluted to 70%v/v by addition of 30ml sterile water to 70ml anhydrous ethanol 99.5%
Mepivacaine Accord 10 mg/ml injektionsvätska, lösning
PRD4194248 · Product
- Active substance
- Mepivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 250 mg milligram(s)
- Max total dose
- 250 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB03 — MEPIVACAINE
- Marketing authorisation
- 52935
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Lidocaine Accord 10 mg/ml injektionsvätska, lösning
PRD3009771 · Product
- Active substance
- Lidocaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 250 mg milligram(s)
- Max total dose
- 250 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB02 — LIDOCAINE
- Marketing authorisation
- 51169
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bupivacaine Baxter 5 mg/ml injektionsvätska, lösning
PRD9053661 · Product
- Active substance
- Bupivacaine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFILTRATION
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N01BB01 — BUPIVACAINE
- Marketing authorisation
- 51796
- MA holder
- BAXTER HOLDING B.V.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
Aethoxysklerol 30 mg/ml injektionsvätska, lösning
PRD633491 · Product
- Active substance
- Lauromacrogol 400
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- OTHER USE
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 60 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C05BB02 — POLIDOCANOL
- Marketing authorisation
- 9613
- MA holder
- CHEMISCHE FABRIK KREUSSLER & CO. GMBH
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Jamtland Harjedalen
- Sponsor organisation
- Region Jamtland Harjedalen
- Address
- Kyrkgatan 12
- City
- Ostersund
- Postcode
- 831 50
- Country
- Sweden
Scientific contact point
- Organisation
- Region Jamtland Harjedalen
- Contact name
- Karl-Johan Lundström
Public contact point
- Organisation
- Region Jamtland Harjedalen
- Contact name
- Karl-Johan Lundström
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruiting | 300 | 3 |
| 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 |
|---|---|---|---|---|---|
| Sweden | 2024-11-26 | 2024-11-26 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-78031
- Halt date
- 2024-12-18
- Planned restart
- 2025-04-08
- Member states concerned
- Sweden
- Publication date
- 2025-04-07
- Reason
- Sponsor decision
- Explanation
- Due to unexpectely high rate of adverse events (not serious) the benefit-risk balance has changed. Before restart of trial the lower changed doses has been approved by the reporting member state (SM 1).
This temporary halt is the same as previous but we have to do this due to technical reasons ie the restart button is inactive. - Follow-up measures
- All patients treated has been followed to resolution. During this period no recruitment has been done.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Temporary halt TH-63689
- Halt date
- 2024-12-18
- Planned restart
- 2025-03-29
- Member states concerned
- Sweden
- Publication date
- 2025-03-28
- Reason
- Sponsor decision
- Explanation
- Due to unexpectely high rate of adverse events (not serious) the benefit-risk balance has changed. Before restart of trial the lower changed doses needs to be approved by the authorities.
- Follow-up measures
- Clinical follow-up according to clinical routine is performed until resolution of adverse event.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Provningsprotokoll_HydoAlcScler_2022-502284-38-00 | 2.1 |
| Recruitment arrangements (for publication) | Rekrytering-och-samtyckesprocess_2022-502284-38-00 | 1 |
| Subject information and informed consent form (for publication) | Forsokspersonsinformation_2022-502284-38-00 | 2.1 |
| Summary of Product Characteristics (SmPC) (for publication) | Aetoxysclerol | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Bupivacain | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Etanol Anhydrous | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Lidocain-2 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Mepivacain_SPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Ropivacain-2 | 1 |
| Synopsis of the protocol (for publication) | Synopsis2022-502284-38-00 | 2.1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-19 | Sweden | Acceptable 2024-11-06
|
2024-11-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-27 | Sweden | Acceptable 2025-03-18
|
2025-03-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-07 | Sweden | Acceptable 2025-04-29
|
2025-04-29 |