Linzagolix versus leuprorelin in Japanese women with uterine leiomyomas: a phase 3, randomized, active-controlled, non-inferiority trial

What Was Tested

The paper reports a study of Leuprolide, published as a randomized controlled trial.

Who Took Part

The study group was 287 patients.

PubMed indexes the participants as adults and middle-aged adults, women only.

Patients were randomized using an interactive web response system, stratified by the presence of pain symptoms.

Eligible patients were premenopausal women (aged ≥20 years) with uterine leiomyomas and HMB.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled, multicenter and parallel-group study.

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

Neither the patients nor the staff measuring them knew who was on Leuprolide, so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with Leuprolide could be set against what happens without it.

More than one site took part, so the patients came from several places.

The timeline in the abstract includes 24 weeks.

Key assessments throughout the treatment period included menstrual bleeding (measured using the Pictorial Blood Loss Assessment Chart [PBAC]), pain (measured using a numeric rating scale), blood haemoglobin, myoma and uterine volumes (measured by transvaginal ultrasound), patient-reported symptom severity and quality of life, plasma oestradiol, adverse events (AEs), and BMD.

At the end of treatment, patients entered a follow-up period of up to 24 weeks, during which plasma oestradiol, BMD, and menstrual recovery were assessed.

What Was Measured

Topics PubMed links to this paper include Antineoplastic Agents, Hormonal, Gonadotropin-Releasing Hormone, Japan, Leiomyoma, Leuprolide, Menorrhagia and Uterine Neoplasms.

The authors tagged it with the keywords gonadotropin-releasing hormone receptor antagonist, heavy menstrual bleeding, linzagolix, randomized controlled trial and uterine leiomyomas.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Leuprolide in 287 patients over 24 weeks.

The abstract goes on to report its results in about 12 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2026 (Human reproduction (Oxford, England)), a journal based in England.

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