Ulipristal acetate compared with leuprorelin acetate for japanese women with symptomatic uterine fibroids: A phase 3 randomized controlled trial
Fertility and Sterility Mar 19, 2021
Osuga Y, Nakano Y, Yamauchi Y, et al. - The efficacy and safety of ulipristal acetate (UPA) for uterine fibroids (UFs) were investigated via performing a phase 3 study with leuprorelin (LEU) as a comparator. Among Asians, this is the first confirmatory trial of UPA for UFs. In this multicenter, randomized, double-blind, double-dummy, parallel-group study, researchers assigned patients to 2 arms, with 82 patients in the UPA group and 79 patients in the LEU group. Outcomes suggest that on heavy menstrual bleeding, UPA had a comparable effect to that of LEU in Japanese patients with symptomatic UFs. The UPA treatment did not link with any notable AEs, and had AEs comparable with that of AEs in the LEU group. Findings thereby establishes UPA as clinically valuable for Asians.
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