clinical trial · NCT05029622
A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.
Ipsen·phase3·completed·n = 66
Central Precocious PubertyTriptorelin Pamoate
brief 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).
started
Aug 10, 2021
primary completion
Aug 21, 2022
completion
Feb 13, 2023
last updated
Feb 19, 2025
official title
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.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol