Ulipristal Acetate Versus GnRH Analogue Treatment Before Hysteroscopic Resection of Uterine Leiomyoma

What Was Tested

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

The uterine leiomyoma is the most common female benign disease.

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

The registry classes the interventions as drug.

More on the Plan

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

Moreover, it controlled bleeding faster than GnRH agonists, with median times to amenorrhea of 5-7 days in patients receiving UPA compared to 21 days in patients receiving a GnRH agonist.

Who Took Part

Enrollment: 146 planned participants were the target.

It was open to women only aged from 18 years up to 55 years.

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

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

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: care provider, 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

The main thing measured (primary outcome): Uterine bleeding assessed by pictorial blood-loss assessment chart (PBAC) (time frame: 90 days after the beginning of the treatment).

It also tracked 4 secondary outcomes, for example Feasibility of myoma hysteroscopic resection (VAS score), Operative time, Haemoglobin concentration and Fluid absorption.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Leuprolide in 146 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.