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

This phase 3 study evaluated the efficacy and safety of a 6-month prolonged release formulation of triptorelin in 66 Chinese children with central precocious puberty (CPP). The study found that after two doses of triptorelin pamoate 22.5 mg, administered on day 1 and month 6, all patients achieved luteinizing hormone (LH) suppression at month 6, with 98.5% maintaining suppression at month 12. The treatment effectively suppressed sex hormone levels to prepubertal levels, slowed the development of sexual characteristics, and reduced growth velocity. The mean bone age/chronological age ratio decreased, and no severe treatment-related adverse events were reported. The study supports the use of 6-monthly triptorelin as a viable treatment option for Chinese children with CPP, consistent with findings in non-Chinese populations.