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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00660010
Study type Interventional
Source Abbott
Contact
Status Completed
Phase Phase 3
Start date January 1991
Completion date April 2009

See also
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Completed NCT00635817 - A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty Phase 3
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Completed NCT00494169 - Investigation of the Genetic Causes of Kallmann Syndrome and Reproductive Disorders
Recruiting NCT04884620 - The 3rd COPENHAGEN Puberty Study
Active, not recruiting NCT03628937 - The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls N/A
Enrolling by invitation NCT02790112 - Long-term Outcome of GnRH Analogues Treatment of Children With Idiopathic Central Precocious Puberty N/A