Ignite Creation Date:
2024-05-06 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03695237
Status:
COMPLETED
Last Update Posted:
2024-05-29
First Post:
2018-10-02
Brief Title:
A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty CPP
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 3 Multicenter Open-Label Two-Part Study to Evaluate the Safety Efficacy Pharmacokinetics and Pharmacodynamics of Leuprolide Acetate 45 mg 6-Month Depot Formulation in Children With Central Precocious Puberty CPP
Status:
COMPLETED
Status Verified Date:
2024-05
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 primary objective of the study is to assess the safety and efficacy of a leuprolide acetate LA 45 mg 6-month depot formulation for the treatment of CPP in children who are either naïve to treatment with a gonadotropin-releasing hormone agonist GnRHa or who have been previously treated with a GnRHa
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None