Novel MRI Strategies as a Non-invasive Biomarker in Women With Uterine Fibroids

What Was Tested

The trial (phase 4) is built around Goserelin and Cetrorelix.

Associated heavy menstrual bleeding is often an indication for surgery.

At present there are no long-term medical treatments for fibroids.

It had three arms (groups): 1 (active comparator), 2 (active comparator) and 3 (no intervention).

GnRH analogue-Zoladex.

GnRH antagonist plus GnRH analogue.

The registry classes the interventions as drug.

Who Took Part

The registry lists 30 actual participants took part.

It was open to women only aged from 18 years with no upper age limit.

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

Examples of who could join: Scheduled for hysterectomy with a fibroid uterus. At least one intramural non-pedunculated, submucosal or subserous fibroid(\>2cm) or multiple small fibroids (uterine volume\>200cm3). Ability to understand and willingness to sign consent form. Normal smear within 3 years.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: pregnant or lactating; contra indication to mri; unable to tolerate supine position.

How the Study Was Run

It was run as a randomized, single-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Goserelin and who got the comparison, which limits bias.

Everyone knew when Goserelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-12 with completion listed for 2010-09.

It ran at 1 site in United Kingdom.

What Was Measured

Researchers chose this as the main measure: Uterine and fibroid volume (time frame: 2010).

It also tracked 1 secondary outcome, for example Uterine vascular perfusion, vasculature and extracellular matrix (ECM)content of fibroids.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Goserelin and Cetrorelix in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Goserelin compound page and the Cetrorelix compound page, all human trials.