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

An Open-label, Single Arm, Multicenter Study on the Efficacy, Safety, and Pharmacokinetics of Leuprolide Acetate 45 mg for Injectable Suspension Controlled Release in Subjects With Central (Gonadotropin-Dependent) Precocious Puberty

This study determines the effectiveness of leuprolide acetate 45 mg for injectable suspension for treatment of children with Central Precocious Puberty.

Leuprolide acetate is a GnRH agonist that inhibits pituitary gonadotropin secretion by binding to the GnRH receptors and blocking downstream hormone synthesis. The steady decrease in hormone synthesis (LH and FSH) leads to a suppression of testicular and ovarian steroidogenesis. In children with CPP, this steady decrease in hormone synthesis disrupts the progression of 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