PMID- 34941067
OWN - NLM
STAT- MEDLINE
DCOM- 20220126
LR  - 20230103
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Print)
IS  - 0025-7974 (Linking)
VI  - 100
IP  - 51
DP  - 2021 Dec 23
TI  - An open label, multicenter clinical trial that investigated the efficacy and 
      safety of leuprorelin treatment of central precocious puberty in Chinese 
      children.
PG  - e28158
LID - 10.1097/MD.0000000000028158 [doi]
LID - e28158
AB  - BACKGROUND: Leuprorelin is an analog of gonadotropin-releasing hormone that is 
      used for the therapy of central precocious puberty (CPP). The aims of this 
      prospective, open label, multicenter clinical trial were to establish its 
      efficacy and safety during long-term use. METHODS: Patients, who were all 
      children, were treated with 1.88 to 3.75 mg leuprorelin subcutaneously once every 
      4 weeks for a total of 96 weeks between 2015 and 2018. The primary endpoint was 
      the rate of occurrence of adverse events (AEs) and the secondary endpoint was no 
      progression in the Tanner stage or regression by week 96 compared to baseline. 
      RESULTS: A total of 307 CPP patients, 305 (99.3%) females and 2 males (0.7%), 
      completed the 96-weeks of treatment. Due to limited data for male patients, they 
      are not discussed in the efficacy results. Treatment-emergent AEs (TEAEs) were 
      reported for 252 (82.1%) patients, mostly (79.5%) being mild or moderate and only 
      33 (10.7%) of patients experienced TEAEs related to leuprorelin therapy. The most 
      frequent (>2%) drug-related TEAEs were injection site induration (4.6%, 14/307) 
      and vaginal bleeding (2.3%, 7/305). After treatment, 83.5% of patients had 
      regression or no progression in the Tanner stage (95% confidence interval: 
      78.68%, 87.62%) and the majority had decreased gonadotropin-releasing 
      hormone-stimulated peak luteinizing hormone and follicle-stimulating hormone 
      concentrations, as well as reduced sex hormone concentrations and a reduction in 
      the bone age/chronological age ratio compared to baseline. CONCLUSIONS: The trial 
      revealed that CPP was effectively treated in most patients who received 
      leuprorelin for nearly 2 years. Any drug-related AEs were reported with low 
      incidence (<5%) and were consistent with the known safety profile of leuprorelin. 
      TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov (registration 
      number: NCT02427958).
CI  - Copyright (c) 2021 the Author(s). Published by Wolters Kluwer Health, Inc.
FAU - Luo, Xiaoping
AU  - Luo X
AUID- ORCID: 0000-0002-3748-4817
AD  - Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science & Technology, Wuhan, China.
FAU - Hou, Ling
AU  - Hou L
AD  - Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong 
      University of Science & Technology, Wuhan, China.
FAU - Zhong, Yan
AU  - Zhong Y
AD  - Department of Child Healthcare, Hunan Children's Hospital, Changsha, China.
FAU - You, Cheng
AU  - You C
AD  - Department of Child Healthcare, Hunan Children's Hospital, Changsha, China.
FAU - Yang, Yu
AU  - Yang Y
AD  - Department of Endocrinology, Metabolism and Genetics, The Affiliated Children's 
      Hospital of Nanchang University, Jiangxi Provincial Children's Hospital, 
      Nanchang, China.
FAU - Wu, Xian
AU  - Wu X
AD  - Department of Endocrinology, Metabolism and Genetics, The Affiliated Children's 
      Hospital of Nanchang University, Jiangxi Provincial Children's Hospital, 
      Nanchang, China.
FAU - Li, Pin
AU  - Li P
AD  - Department of Endocrinology, Shanghai Children's Hospital, Shanghai Jiao Tong 
      University, Shanghai, China.
FAU - Zhou, Shasha
AU  - Zhou S
AD  - Department of Endocrinology, Shanghai Children's Hospital, Shanghai Jiao Tong 
      University, Shanghai, China.
FAU - Qiu, Wenjuan
AU  - Qiu W
AD  - Shanghai Institute for Pediatric Research, Xinhua Hospital Affiliated to Shanghai 
      Jiao Tong University, School of Medicine, Shanghai, China.
FAU - Zhang, Huiwen
AU  - Zhang H
AD  - Shanghai Institute for Pediatric Research, Xinhua Hospital Affiliated to Shanghai 
      Jiao Tong University, School of Medicine, Shanghai, China.
FAU - Liu, Ying
AU  - Liu Y
AD  - Department of Endocrinology, Children's Hospital of Capital Institute of 
      Pediatrics, Beijing, China.
FAU - Qian, Ye
AU  - Qian Y
AD  - Department of Endocrinology, Children's Hospital of Capital Institute of 
      Pediatrics, Beijing, China.
FAU - Luo, Feihong
AU  - Luo F
AD  - Department of Endocrinology, Metabolism and Genetics, Children's Hospital of 
      Fudan University, Shanghai, China.
FAU - Cheng, Ruoqian
AU  - Cheng R
AD  - Department of Endocrinology, Metabolism and Genetics, Children's Hospital of 
      Fudan University, Shanghai, China.
FAU - Hu, Yuhua
AU  - Hu Y
AD  - Department of Pediatrics, Jiangsu Province Hospital, Nanjing, China.
FAU - Gong, Haihong
AU  - Gong H
AD  - Department of Pediatrics, Jiangsu Province Hospital, Nanjing, China.
FAU - Wang, Qing
AU  - Wang Q
AD  - Department of Pediatrics, Affiliated Hospital of Jiangnan University, Wuxi, 
      China.
FAU - Xu, Zhuangjian
AU  - Xu Z
AD  - Department of Pediatrics, Affiliated Hospital of Jiangnan University, Wuxi, 
      China.
FAU - Du, Hongwei
AU  - Du H
AD  - Department of Pediatric Endocrinology, The First Bethune Hospital of Jilin 
      University, Changchun, China.
FAU - Lu, Feiyu
AU  - Lu F
AD  - Department of Pediatric Endocrinology, The First Bethune Hospital of Jilin 
      University, Changchun, China.
FAU - Fu, Junfen
AU  - Fu J
AD  - Department of Endocrinology, The Children's Hospital of Zhejiang University 
      School of Medicine, National Clinical Research Center for Child Health, Hangzhou, 
      China.
FAU - Chen, Xuefeng
AU  - Chen X
AD  - Department of Endocrinology, The Children's Hospital of Zhejiang University 
      School of Medicine, National Clinical Research Center for Child Health, Hangzhou, 
      China.
FAU - Wang, Winston
AU  - Wang W
AD  - Takeda Development Center Asia, Shanghai, China.
FAU - Guo, Ziheng
AU  - Guo Z
AD  - Takeda Medical Affairs, Takeda (China) International Trading Co., Ltd, Shanghai, 
      China.
LA  - eng
SI  - ClinicalTrials.gov/NCT02427958
GR  - Not applicable/Takeda Development Center Asia, Pte. Limited/
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 33515-09-2 (Gonadotropin-Releasing Hormone)
RN  - 9002-68-0 (Follicle Stimulating Hormone)
RN  - EFY6W0M8TG (Leuprolide)
SB  - IM
MH  - Child
MH  - China
MH  - Female
MH  - Follicle Stimulating Hormone
MH  - Gonadotropin-Releasing Hormone
MH  - Humans
MH  - Leuprolide/adverse effects/*therapeutic use
MH  - Male
MH  - Prospective Studies
MH  - Puberty, Precocious/*drug therapy
PMC - PMC8702188
COIS- All remaining authors declare that there are no conflicts of interest that could 
      be perceived as prejudicing the impartiality of the research reported.
EDAT- 2021/12/24 06:00
MHDA- 2022/01/27 06:00
PMCR- 2021/12/23
CRDT- 2021/12/23 14:07
PHST- 2021/03/22 00:00 [received]
PHST- 2021/11/18 00:00 [accepted]
PHST- 2021/12/23 14:07 [entrez]
PHST- 2021/12/24 06:00 [pubmed]
PHST- 2022/01/27 06:00 [medline]
PHST- 2021/12/23 00:00 [pmc-release]
AID - 00005792-202112230-00043 [pii]
AID - MD-D-21-02286 [pii]
AID - 10.1097/MD.0000000000028158 [doi]
PST - ppublish
SO  - Medicine (Baltimore). 2021 Dec 23;100(51):e28158. doi: 
      10.1097/MD.0000000000028158.