hrp0097p1-553 | Pituitary, Neuroendocrinology and Puberty | ESPE2023

A 12-month, open-label, single-arm, phase 3 trial of the efficacy and safety of triptorelin 3-month formulation in Chinese children with central precocious puberty (CPP)

Luo Xiaoping , Zhang Cai , Yang Yu , Xu Xu , Cheng Xinran , Wei Haiyan , Wang Lanying , Huang Frank , Cabri Patrick

Background: CPP is commonly treated with triptorelin, a gonadotropin-releasing hormone (GnRH) analogue. It is available as 1-month and 3-month prolonged-release (PR) formulations, but only the former is approved for CPP in China. Overseas studies have proved the efficacy and safety of triptorelin 3-month PR formulation; this study evaluated efficacy and safety in Chinese children with CPP.Methods: In this 12-month, open-...

hrp0098p1-80 | Pituitary, Neuroendocrinology and Puberty 1 | ESPE2024

A 12-month, Open-Label, Single-Arm, Phase 3 Trial of the Efficacy and Safety of Triptorelin 6-Month Formulation in Chinese Children with Central Precocious Puberty

Yu Xiao , Cheng Xinran , Xu Xu , Gong Chunxiu , Li Guimei , Yao Hui , Zhou Li , Zhong Yan , Yang Yu , Luo Feihong , Zhang Yining , Huang Frank , Shi Xiaofeng , Cabri Patrick , Luo Xiaoping

Objectives: The gonadotropin-releasing hormone (GnRH) analogue triptorelin is used to treat central precocious puberty (CPP) in 1-, 3- and 6-month prolonged-release (PR) formulations. Currently, only the 1- and 3-month formulations are approved for CPP in China. However, the 6-month formulation is available for CPP treatment in numerous countries; this study assessed the efficacy and safety of this formulation in Chinese children with CPP.<p class="abstext...