NCT00635817

A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty

A Phase 3, Randomized, Multi-Center, Open-Label Study to Evaluate the Efficacy and Safety of Leuprolide Acetate 11.25 and 30 mg Formulations in Children With Central Precocious Puberty

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 2 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if 11.25 and 30 mg formulations of leuprolide are effective in treating children with Central Precocious Puberty (CPP).

Detailed description

Study Design: A total of 80 children with confirmed CPP were planned to be enrolled and randomized in a 1:1 ratio to receive 2 injections of either leuprolide acetate 11.25 mg or 30 mg depot formulation, each injection administered 3 mo apart (6 mo of treatment): This study includes a 4-week Screening Period, two 3-mo treatment cycles, and a posttreatment follow-up period (12 weeks following the Mo 6 visit). Study visits will occur at Screening, Day 1, Week 2 (only for subjects participating in the pharmacokinetic subset), Mo 1, 2, 3, Mo 6/Early Termination, and 12 weeks later, for the Posttreatment Follow-up Visit. This study was conducted at 18 sites in the United States and 4 sites in Puerto Rico.

Conditions

• Puberty, Precocious

Interventions

Type	Name	Description
DRUG	Leuprolide acetate 11.25 mg	Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart.
DRUG	Leuprolide acetate 30 mg	Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart.

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-01-01
• Completion: 2010-06-01
• First posted: 2008-03-14
• Last updated: 2011-11-02
• Results posted: 2011-02-09

Locations

25 sites across 2 countries: United States, Puerto Rico