Viewing Study NCT00128531



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Last Modification Date: 2024-10-26 @ 9:13 AM
Study NCT ID: NCT00128531
Status: COMPLETED
Last Update Posted: 2007-11-14
First Post: 2005-08-08

Brief Title: Leuprolide Acetate 375 mg Depot to Treat Prostate Cancer
Sponsor: GP-Pharm
Organization: GP-Pharm

Study Overview

Official Title: Efficacy and Safety of a New Leuprolide Acetate 375 mg Depot Formulation GP-Pharm SA When Given as Palliative Treatment to Prostate Cancer Patients
Status: COMPLETED
Status Verified Date: 2007-11
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 look at the efficacy and safety of leuprolide acetate in patients with prostate cancer
Detailed Description: Other assessments include evaluation of main leuprolide PK parameters in 12 subjects after administration of 3 doses

Study Design

This will be a multi-center open-label fixed investigation of six monthly dosages of leuprolide acetate 375 mg administered to patients with histologically proven carcinoma of prostate who might benefit from medical androgen deprivation therapy

A total of 120 male patients will receive a single im injection of leuprolide acetate 375 mg initially on study day 0 after baseline assessment and then monthly ie every 28 days for five months

12 of the patients will also have plasma leuprolide levels measured for PK analysis during the first 3 injection periods PK group These patients will belong to pre-defined study sites

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