Uterus contracting oxytocin hormon in magnetic resonance guided focused ultrasound therapy

Oxytocin in mr guided focused ultrasound treatment (MRI-HIFU) - Oxytocin-HIFU

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-005022-38-FI

Enrollment

100

Registered

2018-03-14

Start date

2018-06-13

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

women with uterine fibroids or adenomyosis MedDRA version: 20.0 Level: LLT Classification code 10016628 Term: Fibroids System Organ Class: 100000004864 MedDRA version: 20.0 Level: PT Classification code 10056268 Term: Adenomyosis System Organ Class: 10038604 - Reproductive system and breast disorders

Interventions

Trade Name: Syntocinon Product Name: Syntocinon Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: OXYTOCIN CAS Number: 50-56-6

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Generally healthy women with uterine fibroids or adenomyosis scheduled for MRI-HIFU treatment Inclusion criteria are as for MRI-HIFU treatment in general: Age > 18 years BMI =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Poor general health unsuitability for MRI-HIFU treatment known allergy to study drug

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the efficacy of oxytocin in reducing the perfusion in uterine fibroids and adenomyosis;Secondary Objective: To enchance the efficacy of MRI-HIFU tretment of uterine fibroids and adenomyosis;Primary end point(s): Decrease in perfusion of uterine fibroid or adenomyosis;Timepoint(s) of evaluation of this end point: Efficacy of treatment evaluated immediately after use of oxytocin infusion in MRI screening	—

Measure

Time frame

Main Objective: To study the efficacy of oxytocin in reducing the perfusion in uterine fibroids and adenomyosis;Secondary Objective: To enchance the efficacy of MRI-HIFU tretment of uterine fibroids and adenomyosis;Primary end point(s): Decrease in perfusion of uterine fibroid or adenomyosis;Timepoint(s) of evaluation of this end point: Efficacy of treatment evaluated immediately after use of oxytocin infusion in MRI screening

—

Secondary

Measure	Time frame
Secondary end point(s): none	—

Countries

Finland

Contacts

Public ContactKirsi Joronen

Turku University Hospital

kirsi.joronen@tyks.fi

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026