Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.

Inclusion Criteria: * Onset of development of secondary sex characteristics before 8 and 9 years in girls and boys, respectively breast development in girls or testicular enlargement in boys according to the Tanner method: Stage II * Pubertal response of LH to GnRH stimulation test (stimulated peak LH ≥5 IU/L) * Difference between bone age (BA) (according to Greulich and Pyle method) and chronological age (CA) \>1 year * Girls with Tanner staging ≥2 for breast development and enlarged uterine length and several follicles with diameter \>4 mm in the ovary at Screening visit; boys who have testicular volume ≥4 mL at Screening visit * Age \< 9 years old for girls and \< 10 years old for boys at initiation of triptorelin treatment * Weight at least 20 kg * Subjects will qualify for the extension phase if they sign the corresponding specific consent form, are still benefiting from treatment at the end the primary study and have not experienced any unacceptable safety issues. Exclusion Criteria: * Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion * Non-progressing isolated premature thelarche * Presence of an unstable intracranial tumour or an intracranial tumour requiring neurosurgery or cerebral irradiation. Participants with hamartomas not requiring surgery are eligible * Evidence of renal (creatinine \>1.5 x upper limit of normal (ULN)) or hepatic impairmen…