Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056654
Status:
COMPLETED
Last Update Posted:
2008-09-17
First Post:
2003-03-20
Brief Title:
Study of a 6-Month Sustained-Release Formulation of Leuprolide Acetate in Prostate Cancer
Sponsor:
Abbott
Organization:
Abbott
Study Overview
Official Title:
Pharmacokinetic Safety and Efficacy Study of a Six-Month Depot Formulation of Leuprolide in Subjects With Prostatic Carcinoma
Status:
COMPLETED
Status Verified Date:
2008-09
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 purpose of the study is to determine if a new sustained-release 45 mg depot formulation of leuprolide acetate will reduce serum testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma
Detailed Description:
The primary purpose of the study is to determine if a new sustained-release 45 mg depot formulation of leuprolide acetate administered once every 26 weeks for 1 year will lower testosterone levels to and maintain them at medically castrate levels in subjects with prostatic adenocarcinoma This study will also evaluate the pharmacokinetic profile of the 45 mg formulation and assess the safety of this formulation
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