PMID- 33715871
OWN - NLM
STAT- MEDLINE
DCOM- 20210805
LR  - 20210805
IS  - 1556-5653 (Electronic)
IS  - 0015-0282 (Linking)
VI  - 116
IP  - 1
DP  - 2021 Jul
TI  - Ulipristal acetate compared with leuprorelin acetate for Japanese women with 
      symptomatic uterine fibroids: a phase III randomized controlled trial.
PG  - 189-197
LID - S0015-0282(21)00044-3 [pii]
LID - 10.1016/j.fertnstert.2021.01.023 [doi]
AB  - OBJECTIVE: 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. 
      DESIGN: Multicenter, randomized, double-blind, double-dummy, parallel-group 
      study. SETTING: 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.
CI  - Copyright (c) 2021 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Osuga, Yutaka
AU  - Osuga Y
AD  - Department of Obstetrics and Gynecology, Faculty of Medicine, The University of 
      Tokyo, Tokyo, Japan.
FAU - Nakano, Yasuaki
AU  - Nakano Y
AD  - ASKA Pharmaceutical Co., Ltd., Tokyo, Japan. Electronic address: 
      nakano-y2@aska-pharma.co.jp.
FAU - Yamauchi, Yuji
AU  - Yamauchi Y
AD  - ASKA Pharmaceutical Co., Ltd., Tokyo, Japan.
FAU - Takanashi, Masaya
AU  - Takanashi M
AD  - ASKA Pharmaceutical Co., Ltd., Tokyo, Japan.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210311
PL  - United States
TA  - Fertil Steril
JT  - Fertility and sterility
JID - 0372772
RN  - 0 (Norpregnadienes)
RN  - EFY6W0M8TG (Leuprolide)
RN  - YF7V70N02B (ulipristal acetate)
SB  - IM
CIN - Fertil Steril. 2021 Jul;116(1):80. PMID: 34148594
MH  - Adult
MH  - Amenorrhea/chemically induced
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Japan
MH  - Leiomyoma/complications/diagnostic imaging/*drug therapy
MH  - Leuprolide/adverse effects/*therapeutic use
MH  - Menorrhagia/diagnosis/*drug therapy/etiology
MH  - Middle Aged
MH  - Norpregnadienes/adverse effects/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
MH  - Uterine Neoplasms/complications/diagnostic imaging/*drug therapy
OTO - NOTNLM
OT  - Leiomyoma
OT  - menorrhagia
OT  - selective progesterone receptor modulator
OT  - ulipristal acetate
OT  - uterine fibroids
EDAT- 2021/03/16 06:00
MHDA- 2021/08/06 06:00
CRDT- 2021/03/15 06:00
PHST- 2020/09/10 00:00 [received]
PHST- 2021/01/18 00:00 [revised]
PHST- 2021/01/19 00:00 [accepted]
PHST- 2021/03/16 06:00 [pubmed]
PHST- 2021/08/06 06:00 [medline]
PHST- 2021/03/15 06:00 [entrez]
AID - S0015-0282(21)00044-3 [pii]
AID - 10.1016/j.fertnstert.2021.01.023 [doi]
PST - ppublish
SO  - Fertil Steril. 2021 Jul;116(1):189-197. doi: 10.1016/j.fertnstert.2021.01.023. 
      Epub 2021 Mar 11.