Efficacy and Safety of Leuprolide Acetate 45 mg in Subjects With Central Precocious Puberty

Inclusion criteria

• Pubertal-type LH response following an abbreviated GnRH stimulation test before treatment initiation > 5 IU/L
• A subject manifested with central precocious puberty according to the following criteria Age : Boy (4 years of age or older ~ under 9 years of age) Girl (4 years of age or older ~ under 8 years of age) Tanner Stage : Level 2 or higher
• Based on baseline visit (Day 0), those under the age of 10 for boys and those under the age of 9 for girls
• Confirmed diagnosis of CPP within 12 months of Baseline Visit (Day 0) but have not received prior GnRH agonist treatment for CPP
• Children with a body weight of more than 20 kg at screening
• Children have a bone age that is ≥1 year older than their chronological age at screening
• A signed written consent form by a legal representative who has been informed about this study

Exclusion criteria

• Gonadotropin-independent (peripheral) precocious puberty: extra pituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroid secretion
• Prior or current GnRH treatment for CPP
• Non-progressing isolated premature thelarche
• Presence of an unstable intracranial tumor or an intracranial tumor requiring neurosurgery or cerebral irradiation. Subjects with hamartomas not requiring surgery are eligible.
• Prior (within 12 weeks of Screening) use of medications

• Hormonal agonists (Estrogen, Progesterone, FSH, LH, Testosterone etc.)
• Hormonal antagonists (Anti-Estrogen agents, Anti-Androgen agents)
• Steroid use (except for mild topical steroids, oral steroids are allowed within 30 days)
• Herbal Medicines
• Prior or current therapy with growth hormone
• Major medical or psychiatric illness that could interfere with study visits
• Diagnosis of short stature (i.e. 2 standard deviations (SD) below the mean height for age or 3rd percentile for age)
• Pregnant or likely pregnant women (Positive urine pregnancy test), nursing women
• Known hypersensitivity to GnRH or related compounds
• 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
• Any other condition(s) which could significantly interfere with Protocol compliance
• Treatment with an investigational product within 5 half-lives of that product in prior clinical studies before the baseline visit (Day 0)
• Known history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
• Prior (within 6 months of Baseline (Day 0)) or current use of medications that, per investigator opinion, have been associated with seizures or convulsions