F&S reports
Linzagolix for Japanese women with uterine fibroids: a randomized, double-blind, placebo-controlled, phase 3 trial
By Harada T, Osuga Y, Takahashi H and 3 others.
Abstract
Objective
To evaluate the efficacy, safety, and pharmacodynamics of linzagolix, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, in patients with heavy menstrual bleeding (HMB) and pain because of uterine fibroids.
Design
Phase 3, multicenter, placebo-controlled, randomized, double-blind, parallel-group, confirmatory study (NCT05445167). Subjects: Premenopausal Japanese women with HMB and moderate-to-severe pain because of uterine fibroids.
Intervention
Patients were randomized 1:1 to once-daily linzagolix 200 mg (n = 48) or placebo (n = 41) for 12 weeks.
Main outcome measures
The primary endpoints were the proportion of patients with a total pictorial blood loss assessment chart (PBAC) score <10 from week 6-12, and the proportion of patients with a maximum numeric rating scale (NRS) score ≤1 during the 28 days before the end of treatment. Secondary endpoints included time to a total PBAC score <10 or maximum NRS score ≤1, analgesic use, blood hemoglobin, myoma and uterine volumes, patient-reported symptom severity and quality of life, and plasma estradiol levels. Safety endpoints included adverse events (AEs) and time to menstrual recovery.