Evidence map›Paper›PMID 39412628›Full record

Trial reportAdvances in therapy2024

A Phase 3, Open-Label, Single-Arm Trial of the Efficacy and Safety of Triptorelin 6-Month Formulation in Chinese Children with Central Precocious Puberty.

Xiao Yu, Xinran Cheng, Haiyan Wei, Xu Xu, Chunxiu Gong, Guimei Li, Hui Yao, Li Zhou, Yan Zhong, Yu Yang and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05029622 (A Phase III, Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Chinese Paediatric Participants With Central Precocious Puberty.), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05029622 phase3completednot on this map

A Phase III, Open-label, Multicentre, Single Arm Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Chinese Paediatric Participants With Central Precocious Puberty.

TypeinterventionalSponsorIpsenRan2021 to 2023Enrolled66ConditionsCentral Precocious PubertyArmsTriptorelin Pamoate
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Xiao YuDepartment of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, Hubei,, China.
Xinran ChengDepartment of Endocrinology and Metabolism, Chengdu Women's and Children's Central Hospital, Chengdu, China.
Haiyan WeiDepartment of Endocrinology and Genetic, Children's Hospital Affiliated to Zhengzhou University, Zhengzhou, China.
Xu XuDepartment of Pediatric Endocrinology, Wuxi Children's Hospital, Wuxi, China.
Chunxiu GongDepartment of Endocrinology, Genetics and Metabolism, National Center for Children's Health, Beijing Children's Hospital, Capital Medical University, Beijing, China.
Guimei LiDepartment of Pediatric Endocrinology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, China.
Hui YaoDepartment of Pediatrics, Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, China.
Li ZhouDepartment of Children's Health, Pingxiang Maternity and Child Care, Pingxiang, China.
Yan ZhongDepartment of Child Healthcare, Hunan Children's Hospital, Changsha, China.
Yu YangDepartment of Endocrinology, Metabolism, and Genetics, Children's Hospital of Nanchang University & Jiangxi Provincial Children's Hospital, Nanchang, China.
Feihong LuoDepartment of Endocrinology, Metabolism and Genetics, Children's Hospital of Fudan University, Shanghai, China.
Yining ZhangDepartment of Endocrinology, Genetics and Metabolism, The First Hospital of Jilin University, Changchun, China.
Frank HuangIpsen (Shanghai) Innovation Pharmaceutical Co., Ltd, Shanghai, China.
Xiaofeng ShiIpsen (Shanghai) Innovation Pharmaceutical Co., Ltd, Shanghai, China.
Patrick CabriIpsen, Boulogne-Billancourt, France.
Xiaoping LuoDepartment of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan, Hubei,, China. xpluo@tjh.tjmu.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThis phase 3 study assessed the efficacy, safety, and pharmacokinetics of the 6-month prolonged release (PR) formulation in Chinese children with central precocious puberty (CPP).

methodsIn this open-label study (NCT05029622), Chinese children (girls < 9 years, boys < 10 years) received two doses of triptorelin pamoate 22.5 mg (day 1 and month 6). Primary endpoint was the proportion at month 6 with luteinizing hormone (LH) suppression (stimulated peak LH ≤ 5 IU/L after gonadotropin-releasing hormone stimulation). Secondary endpoints included safety assessments, hormone level changes, and clinical parameters from baseline.

resultsOverall, 66 children completed the study (93.9% girls; median age 8.0 [range 5-9] years). At month 6, all patients had LH suppression; this was maintained at month 12 in 98.5% of patients. Mean basal and peak LH and follicle-stimulating hormone levels were suppressed throughout follow-up. All patients at months 3 to 12 had sex hormone suppression to prepubertal levels. Stable or reduced breast development was seen for 98.4% and 93.5% of girls at month 6 and 12, respectively; all boys had regression or stable genital development until month 12. Compared with baseline (9.82 cm/year), mean growth velocity was 5.88 cm/year at month 6 and 5.17 cm/year at month 12. Mean bone age/chronological age ratio decreased from 1.27 at baseline to 1.23 and 1.21 at month 6 and 12, respectively. In girls, 64.5% showed decreased uterine length at month 6 and 12 versus baseline, while 75.0% of boys showed stable testicular volume versus baseline. Thirteen patients (19.7%) had 22 drug-related treatment emergent adverse events (TEAEs); no grade ≥ 3 TEAEs were reported.

conclusionThe efficacy and safety profile of triptorelin 6-month PR in Chinese children with CPP was consistent with data previously reported in non-Chinese children with CPP, supporting this as a viable treatment option for Chinese children with CPP.

trial registrationTrial registration: ClinicalTrials.gov identifier, NCT05029622.

Indexed as

Luteinizing HormonePuberty, PrecociousTriptorelin PamoateChildChild, PreschoolChinaDelayed-Action PreparationsEast Asian PeopleFemaleFollicle Stimulating HormoneHumansMaleTreatment OutcomeDelayed-Action PreparationsFollicle Stimulating HormoneLuteinizing HormoneTriptorelin PamoateCentral precocious pubertyChinese childrenTriptorelin

Identifiers

PMID39412628
PMCPMC11550251

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.