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

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 impairment (bilirubin \>1.5 x ULN or alanine aminotransferase (ALT)/aspartate transaminase (AST) \>3 x ULN)
• •Any other condition or chronic illness or treatment possibly interfering with growth or other study endpoints (e.g. chronic steroid use except topical steroids, renal failure, diabetes, moderate to severe scoliosis)
• •Prior or current therapy with a GnRH agonist (GnRHa), medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1)
• •Diagnosis of short stature, i.e. \>2.25 standard deviation (SD) below the mean height for age
• •Major medical or psychiatric illness that could interfere with study visits
• •Known hypersensitivity to any of the test materials or related compounds
• •Use of anticoagulants (heparin and coumarin derivatives) within the 2 weeks prior to the Screening visit.