Puberty, Precocious Clinical Trial
Official title:
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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