Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty

Exclusion Criteria

• •Incomplete precocious puberty, peripheral precocious puberty or evidence of any abnormal pituitary, hypothalamic, adrenal, thyroid and gonadal function (other than premature secretion of gonadotropins) not adequately controlled, unstable intracranial tumors except hamartoma.
• •Bone age ≥14 years for girls and ≥15 years for boys (based on the Month 6 lead in study, L-CP07-167, radiographic results).
• •Has an abnormal laboratory value suggesting a clinically significant underlying disease or condition.
• •Chronic illness requiring treatment that may interfere with growth, ie, chronic steroid use, renal failure, moderate to severe scoliosis.
• •Current therapy with medroxyprogesterone acetate.
• •Current therapy with growth hormone.
• •Current therapy with insulin-like growth factor-1 (IGF-1).
• •Current use of an estrogen preparation.
• •Any concomitant medical condition that, in the opinion of the investigator, may expose a subject to an unacceptable level of safety risk or that affects subject compliance.
• •Subject has a positive pregnancy test.