高级检索
当前位置: 首页 > 详情页

Efficacy and Safety of Triptorelin 3-Month Formulation in Chinese Children with Central Precocious Puberty: A Phase 3, Open-Label, Single-Arm Study

文献详情

资源类型:
WOS体系:
Pubmed体系:

收录情况: ◇ SCIE

单位: [1]Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [2]Department of Endocrinology, Metabolism, and Genetics, Children’s Hospital of Nanchang University and Jiangxi Provincial Children’s Hospital, Nanchang, China [3]Department of Pediatric Endocrinology, Wuxi Children’s Hospital, Wuxi, China [4]Department of Endocrinology and Metabolism, Chengdu Women’s and Children’s Central Hospital, Chengdu, China [5]Department of Endocrinology, Metabolism and Genetics, Henan Children’s Hospital, Children’s Hospital Affiliated to Zhengzhou University, Zhengzhou, China [6]Department of Child Health Care, Tangshan Maternal and Child Health Hospital, Tangshan, China [7]Ipsen (Shanghai) Innovation Pharmaceutical Co., Ltd., Shanghai, China [8]Ipsen, Boulogne-Billancourt, France
出处:
ISSN:

摘要:
Triptorelin is available as 1- and 3-month prolonged-release (PR) formulations; at the time of the study, only the former was approved for central precocious puberty (CPP) in China. This study assessed the efficacy and safety of the triptorelin 3-month PR formulation in Chinese children with CPP.In this 12-month, prospective, open-label, multicentre, single-arm study (NCT04736602), Chinese children (mean age [standard deviation (SD)], 7.6 ± 0.8 years) with CPP received triptorelin pamoate 15 mg on day 1 and at months 3, 6 and 9. The primary endpoint was the proportion with luteinizing hormone (LH) suppression (stimulated peak LH ≤ 3 IU/L after gonadotropin-releasing hormone [GnRH] stimulation) at month 3. Secondary endpoints included changes from baseline in hormone levels and clinical parameters, as well as safety assessments.Overall, 32 children were enrolled, including three boys. LH suppression to prepubertal levels (≤ 3 IU/L) after GnRH stimulation was observed in 100%, 93.5% and 93.5% of participants at months 3, 6 and 12, respectively. Basal and peak LH and follicle-stimulating hormone levels were substantially suppressed at months 3, 6 and 12, and most participants showed sex hormone suppression. At months 6 and 12 respectively 92.9% and 89.3% of girls had stable breast development, and all boys had stable genital development. There was a decrease in mean growth velocity from baseline (8.96 cm/year) to months 3, 6 and 12 (8.07, 5.24 and 6.94 cm/year, respectively). The mean difference between bone and chronological age decreased from baseline (2.85 years) to month 12 (2.39 years). In girls, uterine length was stable or reduced at month 12; in boys, testicular volume was reduced. Triptorelin was well tolerated.The triptorelin 3-month PR formulation demonstrated similar efficacy to that previously reported in non-Chinese patients with CPP and had an acceptable safety profile. This supports triptorelin 3-month PR as a viable option for Chinese children with CPP.© 2023. The Author(s).

语种:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2022]版:
大类 | 3 区 医学
小类 | 3 区 医学:研究与实验 3 区 药学
最新[2025]版:
大类 | 3 区 医学
小类 | 2 区 药学 3 区 医学:研究与实验
JCR分区:
出版当年[2021]版:
Q2 PHARMACOLOGY & PHARMACY Q3 MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版:
Q2 MEDICINE, RESEARCH & EXPERIMENTAL Q2 PHARMACOLOGY & PHARMACY

影响因子: 最新[2023版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者:
第一作者单位: [1]Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
通讯作者:
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:590 今日访问量:0 总访问量:442 更新日期:2025-06-01 建议使用谷歌、火狐浏览器 常见问题

版权所有:重庆聚合科技有限公司 渝ICP备12007440号-3 地址:重庆市两江新区泰山大道西段8号坤恩国际商务中心16层(401121)