NCT00660010

Study of Lupron Depot In The Treatment of Central Precocious Puberty

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Puberty, Precocious

Interventions

Type	Name	Description
DRUG	Lupron (leuprolide acetate)	Leuprolide acetate was administered monthly by intramuscular injection starting at 300 mcg/kg with adjustments of 3.75 mg upward, at subsequent clinic visits based on physical and laboratory parameters. Dosing continued until NDA was approved, or until subject no longer required leuprolide acetate to treat CPP.

Timeline

• Start date: 1991-01-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-04-17
• Last updated: 2011-04-12
• Results posted: 2010-07-20

Locations

9 sites across 1 country: United States