FibroidPhase 4NCT03937401
Oxytocin in MRI-HIFU
A Phase 4 study testing Oxytocin in people with Fibroid and Adenomyosis, run by Turku University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibroid, Adenomyosis
- What is being tested?
- Oxytocin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- 1 Feb 2019to 1 Jan 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients undergoing MRI-HIFU -treatment
- Patients assessed for suitability to MRI-HIFU treatment
- willingness to participate in trial
Who cannot join
- Known allergy to Syntocinon/oxytocin
- Elevated blood pressure
- ischemic heart disease
- Long QT- interval
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Oxytocin in MRI-HIFU Treatment
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.
- Conditions
- Fibroid, Adenomyosis
- Being tested
- Oxytocin
- Keywords
- oxytocin, MRI-HIFU, fibroid, adenomyosis
- Medical subject headings
- Leiomyoma, Adenomyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called MRI-HIFU
Oxytocin infusion during MRI-HIFU treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with oxytocin during MRI-HIFU | Experimental | Not described Receives: Drug: Oxytocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
NPV
non perfused volume (percentage of fibroid destroyed)
Measured: up to one year
duration of MRI-HIFU
duration of MRI-HIFU treatment
Measured: up to one year
UFS-Qol
Uterine fibroid symptom severity and quality of life (patient quality of life questionnaire)
Measured: 12 months after HIFU treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Feb 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FibroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937401
- Sponsor's protocol ID
- T366/2017
- Status last verified
- May 2019
- First submitted
- 26 Apr 2019
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Publications
Otonkoski S, Viitala A, Komar G, Sainio T, Yanovskiy A, Blanco Sequieros R, Perheentupa A, Joronen K. Magnetic resonance guided high intensity focused ultrasound (MR-HIFU) effectively reduces fibroid-related symptoms and improves quality of life-A prospective single-centre 12-month follow-up study. Acta Obstet Gynecol Scand. 2025 Jun;104(6):1172-1180. doi: 10.1111/aogs.15086. Epub 2025 Apr 29.
PubMed 40302212Otonkoski S, Sainio T, Komar G, Suomi V, Saunavaara J, Blanco Sequeiros R, Perheentupa A, Joronen K. Oxytocin selectively reduces blood flow in uterine fibroids without an effect on myometrial blood flow: a dynamic contrast enhanced MRI evaluation. Int J Hyperthermia. 2020;37(1):1293-1300. doi: 10.1080/02656736.2020.1846792.
PubMed 33207939
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Oxytocin in MRI-HIFU Treatment
- ClinicalTrials.gov ID
- NCT03937401
- Acronym / sponsor ID
- T366/2017
- Conditions
- Fibroid, Adenomyosis
- Keywords
- oxytocin, MRI-HIFU, fibroid, adenomyosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with oxytocin during MRI-HIFU | Experimental | Drug: Oxytocin |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients undergoing MRI-HIFU -treatment
- Patients assessed for suitability to MRI-HIFU treatment
- willingness to participate in trial
Key exclusion criteria (4 listed)
- Known allergy to Syntocinon/oxytocin
- Elevated blood pressure
- ischemic heart disease
- Long QT- interval
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: MRI-HIFUOxytocin infusion during MRI-HIFU treatment | Drug | Patients treated with oxytocin during MRI-HIFU |
Primary outcome
NPV
Time frame: up to one year
non perfused volume (percentage of fibroid destroyed)
duration of MRI-HIFU
Time frame: up to one year
duration of MRI-HIFU treatment
UFS-Qol
Time frame: 12 months after HIFU treatment
Uterine fibroid symptom severity and quality of life (patient quality of life questionnaire)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2019.
- Derived from this study: PubMed 40302212Otonkoski S, Viitala A, Komar G, Sainio T, Yanovskiy A, Blanco Sequieros R, Perheentupa A, Joronen K. Magnetic resonance guided high intensity focused ultrasound (MR-HIFU) effectively reduces fibroid-related symptoms and improves quality of life-A prospective single-centre 12-month follow-up study. Acta Obstet Gynecol Scand. 2025 Jun;104(6):1172-1180. doi: 10.1111/aogs.15086. Epub 2025 Apr 29.
- Derived from this study: PubMed 33207939Otonkoski S, Sainio T, Komar G, Suomi V, Saunavaara J, Blanco Sequeiros R, Perheentupa A, Joronen K. Oxytocin selectively reduces blood flow in uterine fibroids without an effect on myometrial blood flow: a dynamic contrast enhanced MRI evaluation. Int J Hyperthermia. 2020;37(1):1293-1300. doi: 10.1080/02656736.2020.1846792.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin in people with Fibroid and Adenomyosis, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NPV (time frame: up to one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03937401, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2019.