Treatment of Uterine Fibroids With Magnetic Resonance Guided High Intensity Focused Ultrasound

What Was Tested

In this phase 3 trial, researchers set out to test Leuprolide.

It had two arms (groups): Fibroid dimension < 8 cm (experimental) and Fibroid dimension > 8 cm (experimental).

The registry classes the interventions as device and drug.

More on the Plan

Uterine fibroids are benign smooth muscle tumours of the muscular wall of the uterus that affect 40 per cent of women.

While the majority of fibroids are asymptomatic, fibroids may cause menorrhagia, bulk symptoms (i.e. ureteric obstruction, urinary frequency and urgency, bowel dysfunction), pain and in certain instances infertility.

Magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) treatment of fibroids is an established method for symptom alleviation with over 3000 women receiving treatment worldwide.

MR-HIFU it is not currently being used for the treatment of symptomatic fibroids in Canada.

Who Took Part

It was open to women only aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women aged 18 to 50 years. Pre or perimenopausal. Uterine size \<24 weeks. Transformed symptom severity score ≥40. Willing to attend all study visits.

The full record lists 20 inclusion and 11 exclusion criteria; among the exclusions: other pelvic disease (endometriosis, ovarian tumor, acute pelvic disease, other mass); positive pregnancy test; abnormal uterine bleeding (participant can be included if an endometrial biopsy confirms no hyperplasia or malignancy in the past 6 months).

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Leuprolide study did not mask who received what.

It started in 2018-01-18 with completion listed for 2018-01-18.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in uterine fibroid symptom severity scale (time frame: 3, 6, and 12 months).

It also tracked 8 secondary outcomes, for example Change in short form McGill pain questionnaire, Change in pictorial blood loss assessment chart, Participant use of alternative therapies for treatment of fibroids, MR Imaging to assess change in fibroid volume, MR Imaging to assess change in perfusion and Ultrasound imaging to assess change in fibroid volume.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Leuprolide in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.