Department of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan.
ASKA Pharmaceutical Co., Ltd., Tokyo, Japan.
Fertil Steril. 2021 Jul;116(1):189-197. doi: 10.1016/j.fertnstert.2021.01.023. Epub 2021 Mar 11.
To evaluate the efficacy and safety of ulipristal acetate (UPA) for uterine fibroids (UFs), a phase III study was conducted with leuprorelin (LEU) as a comparator. This is the first confirmatory trial of UPA for UFs among Asians.
Multicenter, randomized, double-blind, double-dummy, parallel-group study.
Thirty-two sites in Japan.
PATIENT(S): Patients were assigned to 2 arms, with 82 patients in the UPA group and 79 patients in the LEU group.
INTERVENTION(S): In the UPA group, 10 mg of UPA was orally administered once a day for 12 weeks. In the LEU group, 1.88 mg or 3.75 mg of LEU was subcutaneously administered at weeks 0, 4, and 8.
MAIN OUTCOME MEASURE(S): The primary endpoint was the percentage of patients with amenorrhea for 35 days. For safety evaluation, adverse events (AEs) were recorded.
RESULT(S): The percentage of patients with amenorrhea for 35 days was 87.0% in the UPA group and 81.8% in the LEU group, and the efficacy of UPA for causing amenorrhea for 35 days was confirmed to be noninferior to that of LEU. AEs occurred in 78.0% of the patients in the UPA group and 88.8% of the patients in the LEU group.
CONCLUSION(S): The effect of UPA on heavy menstrual bleeding was shown to be comparable with that of LEU in Japanese patients with symptomatic UFs. No notable AEs occurred because of the UPA treatment, and the incidence of AEs in the UPA group was comparable with that of AEs in the LEU group. This result demonstrates the clinical utility of UPA for Asians.
评估醋酸乌利司他（UPA）治疗子宫肌瘤（UFs）的疗效和安全性，该研究是一项与亮丙瑞林（LEU）进行比较的 III 期研究。这是亚洲首例关于 UPA 治疗 UFs 的确证性试验。
多中心、随机、双盲、双模拟、平行组研究。
日本 32 个研究中心。
患者被分配到 2 个治疗组，UPA 组 82 例，LEU 组 79 例。
在 UPA 组中，患者每天口服 UPA 10 mg，持续 12 周。在 LEU 组中，患者在第 0、4 和 8 周分别接受 1.88 mg 或 3.75 mg 的 LEU 皮下注射。
主要终点是闭经 35 天的患者比例。为了进行安全性评估，记录了不良事件（AEs）。
UPA 组闭经 35 天的患者比例为 87.0%，LEU 组为 81.8%，证明 UPA 引起闭经 35 天的疗效不劣于 LEU。UPA 组 78.0%的患者和 LEU 组 88.8%的患者出现 AEs。
在日本有症状的 UF 患者中，与 LEU 相比，UPA 治疗对月经过多的疗效相当。由于 UPA 治疗没有出现明显的 AEs，且 UPA 组 AEs 的发生率与 LEU 组相当，因此证明了 UPA 对亚洲人群的临床应用价值。
