A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.

Summary

The purpose of the protocol is to assess the efficacy of the triptorelin 6 month PR (Prolonged Release) formulation in suppressing LH (Luteinising hormone) levels to prepubertal levels (defined as a peak LH ≤5 IU/L) after i.v. GnRH (Gonadotropin-releasing Hormone) stimulation at Month 6 (Day 169) in Chinese children with CPP (Central Precocious Puberty).

Timeline

Start

2021-08-10

Primary completion

2022-08-21

Completion

2023-02-13

Publications

• Yu X, Cheng X, Wei H, Xu X, Gong C, Li G, Yao H, Zhou L, Zhong Y, Yang Y, Luo F, Zhang Y, Huang F, Shi X, Cabri P, Luo X. 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. Adv Ther. 2024 Dec;41(12):4537-4556. doi: 10.1007/s12325-024-02991-x. Epub 2024 Oct 16.

Drugs

Indications