Study of Leuprolide Acetate Injectable Suspension in the Treatment of Central Precocious Puberty

Inclusion Criteria: * Females age 2 to 8 years (inclusive) or males age 2 to 9 years (inclusive) * Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP * Pubertal-type LH response following an abbreviated GnRHa stimulation test before treatment initiation * Clinical evidence of puberty, defined as Tanner stage ≥ 2 for breast development in females or testicular volume ≥ 4 mL in males * Difference between bone age (Greulich and Pyle method) and chronological age ≥ 1 year Exclusion Criteria: * Gonadotropin-independent (peripheral) precocious puberty * Prior or current GnRH treatment for CPP * Prior or current therapy with medroxyprogesterone acetate, growth hormone or insulin-like growth factor-1 (IGF-1) * Diagnosis of short stature (ie, 2.25 standard deviations (SD) below the mean height for age) * Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions * Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study