NCT00667446

Safety Extension Study Of Leuprolide Acetate (Lupron Depot) In The Treatment Of Central Precocious Puberty

A 36 Month, Multi-Center, Open-Label Extension Study to Evaluate the Safety of Leuprolide Acetate 11.25 mg and 30 mg Formulations in Children With Central Precocious Puberty

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this extension study is to determine if leuprolide acetate (11.25 mg and 30 mg) is safe in treating children with Central Precocious Puberty over a longer period of time (36 months).

Detailed description

This study includes a 36-month Study Drug Treatment Period (3-month treatment cycles), and a Safety Follow-up Period (12 weeks following the Month 36 visit). Participants will receive a total of twelve injections of the same treatment they received in the lead-in study, L-CP07-167 (NCT00635817) either leuprolide acetate 11.25 mg or 30 mg depot formulation. Each injection will be administered 3 months apart for up to 36 months of treatment. Study visits will occur on Day 1, Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30 and 33 (1st through the 12th leuprolide acetate depot injections, respectively), Month 36, and 12 weeks later for the Safety Follow-up Visit.

Conditions

• Precocious
• Leuprolide Acetate
• Luteinizing Hormone (LH)
• Gonadotrophin-releasing Hormone Agonist (GnRHa)
• Tanner Staging
• Depot Formulation
• Suppression of LH
• Central Precocious Puberty (CPP)
• Gonadotrophin-releasing Hormone (GnRH)
• Lupron
• GnRH Analog
• Pediatrics Central Precocious Puberty

Interventions

Type	Name	Description
DRUG	Leuprolide Acetate 3 Month Depot

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-10-01
• Completion: 2013-01-01
• First posted: 2008-04-28
• Last updated: 2014-01-09
• Results posted: 2013-12-10

Locations

20 sites across 2 countries: United States, Puerto Rico