Ignite Creation Date:
2024-05-05 @ 7:14 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00635817
Status:
COMPLETED
Last Update Posted:
2011-11-02
First Post:
2008-03-07
Brief Title:
A Study of Leuprolide 1125 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
A Phase 3 Randomized Multi-Center Open-Label Study to Evaluate the Efficacy and Safety of Leuprolide Acetate 1125 and 30 mg Formulations in Children With Central Precocious Puberty
Status:
COMPLETED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if 1125 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 11 ratio to receive 2 injections of either leuprolide acetate 1125 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 6Early 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
A total of 80 children with confirmed CPP were planned to be enrolled and randomized in a 11 ratio to receive 2 injections of either leuprolide acetate 1125 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 6Early 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None