Ulipristal Acetate Versus GnRH Analogue and Myometrial Preservation

What Was Tested

In this phase 4 trial, researchers set out to test Leuprolide.

Type II (G2) fibroids often require more surgeries due to their particular position in the myometrium.

Surgery, moreover, should always be tailored, particularly in patients wishing to conceive, to preserve the integrity of the myometrium.

It had two arms (groups): Ulipristal acetate (experimental) and Leuprolile acetate (active comparator).

Women will be treated with an injection IM on leuprolide acetate 11,25 in the luteal phase repeated 3 months later.

The registry classes the interventions as drug.

More on the Plan

Uterine leiomyoma is the most common benign tumor of the female genital tract.

In this particular population, indeed, the possibility of avoiding any kind of uterine surgery should always be exploited.

Up to now, hysteroscopic resection of submucosal fibroids is considered the gold standard for symptomatic patients, since no medication has been able to restore uterine cavity in a permanent manner.

No sub-analysis have been conducted on submucosal fibroids, but is of interest to underline that, when myomas regress so much that they no longer distort the uterine cavity, surgery may not be required.

Who Took Part

110 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

As a double-blind Leuprolide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2015-02 with completion listed for 2017-09.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Proportion of restored uterine cavity 1 year after enrollment (time frame: 1 year after treatment).

It also tracked 3 secondary outcomes, for example Time to pregnancy, Live birth rate and Proportion of patients needing surgery after UPA or GnRH-a.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 110 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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