Conditions: Puberty, Precocious
Keywords: CPP central precocious puberty pediatrics suppression of luteinizing hormone Lupron leuprolide acetate depot formulation GnRHa GnRH agonist GnRH analog luteinizing hormone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 84
Healthy volunteers: no

Brief 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.

Arms:
arm 1: There are 2 arms that received leuprolide acetate 11.25 mg. Subjects who are treatment naive to leuprolide acetate are designated to be in Arm A and subjects who have previously been treated with leuprolide acetate are designated to be in Arm B. arm 2: There are 2 arms that received leuprolide acetate 30 mg. Subjects who are treatment naive to leuprolide acetate are designated to be in Arm C and subjects who have previously been treated with leuprolide acetate are designated to be in Arm D.

Interventions: intervention 1: Leuprolide acetate 11.25 mg intervention 2: Leuprolide acetate 30 mg
Intervention descriptions: intervention 1: Two intramuscular injections of leuprolide acetate for depot suspension 11.25 mg administered 3 mo apart. intervention 2: Two intramuscular injections of leuprolide acetate for depot suspension 30 mg administered 3 mo apart.

Protocol document: