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NCT03937401 Clinical Trial

Oxytocin in MRI-HIFU

Adenomyosis Clinical Trial

Official title:
Use of Oxytocin in MRI-HIFU Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03937401
Other study ID # T366/2017
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date February 1, 2019
Est. completion date January 1, 2021

Study information
Verified date May 2019
Source Turku University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Capability of oxytocin in improving the efficacy of MRI-HIFU is studied. Patients undergoing MRI-HIFU treatment are given oxytocin during treatment and the efficacy of the treatment will be analysed by patient reported symptom questionnaires and imaging data.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 100
Est. completion date January 1, 2021
Est. primary completion date December 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Patients undergoing MRI-HIFU -treatment

- Patients assessed for suitability to MRI-HIFU treatment

- willingness to participate in trial

Exclusion Criteria:

- Known allergy to Syntocinon/oxytocin

- Elevated blood pressure

- ischemic heart disease

- Long QT- interval

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oxytocin
Oxytocin infusion during MRI-HIFU treatment

Locations
Country Name City State
Finland Turku University Hospital Turku

Sponsors (1)
Lead Sponsor Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary NPV non perfused volume (percentage of fibroid destroyed) up to one year
Primary duration of MRI-HIFU duration of MRI-HIFU treatment up to one year
Primary UFS-Qol Uterine fibroid symptom severity and quality of life (patient quality of life questionnaire) 12 months after HIFU treatment
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