Pharmacokinetic Study of Leuprolide Acetate Injectable Suspension in the Treatment of 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