Study of Lupron Depot In The Treatment of Central Precocious Puberty
Study of Lupron Depot In The Treatment of Central Precocious Puberty
The purpose of this study is to determine if Lupron (leuprolide acetate) is safe and
 effective in treating children with Central Precocious Puberty (CPP), and to assess long term
 effects of leuprolide acetate treatment after therapy is discontinued.
This study includes a Prestudy Period; a treatment period where subjects will receive
 treatment every 4 weeks until the initiation of puberty (age 12 for males and age 11 for
 females); a follow-up period where subjects will be observed every 6 months until physical
 and laboratory observations are at pubertal levels, then every 12 months for 5 years; lastly
 a final follow-up questionnaire is given to all subjects when they are at least 18 years old.

 At the treatment visits, efficacy assessments are Tanner staging (suppression of breast
 development in females and genital development in males), gonadotropins (LH and FSH), sex
 steroids (estradiol in females and testosterone in males), ratio of bone age to chronological
 age, adult height compared to a standard population and predicted mature height, and age and
 time to regular menses in females. This protocol will also capture data from the final
 questionnaire about female reproductive status at adulthood including the presence of regular
 menses and number of pregnancies.
Inclusion Criteria:

 -  Clinical diagnosis of isosexual central precocious puberty with onset of Tanner scores
 of Stage II for breast or pubic hair earlier than age 8.0 years in girls or Stage II
 for pubic hair or genitalia earlier than 9.0 years in boys.

 -  Confirmation of diagnosis by a pubertal response to a gonadotropin-releasing hormone
 (GnRH) stimulation test (LH > 10 U/L at baseline).

 -  Chronological age less than 9.0 years in girls or less than 10.0 years in boys at time
 of first dosing.

 -  Bone age advanced at least 1 year beyond the chronological age at entry into the
 study.

 -  The condition may be idiopathic or secondary to another lesion. If secondary, therapy
 of the primary condition will have been undertaken and stabilized.

 -  No evidence of abnormal pituitary, adrenal, thyroid and gonadal function except for
 premature secretion of gonadotropins.

 Exclusion Criteria:

 -  Irradiation to the central nervous system.

 -  Prior therapy with medroxyprogesterone acetate and/or with any GnRH analog (including
 prior treatment with daily subcutaneous and depot formulations of leuprolide acetate).