Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT03936218
Status:
COMPLETED
Last Update Posted:
2025-04-17
First Post:
2019-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Goserelin 10.8mg Injection in Treatment of Advanced Prostate Cancer
Sponsor:
Eurofarma Laboratorios S.A.
Organization:
Study Overview
Official Title:
A Two Arm, Multi Centric, Randomised, Open Label, Parallel Study to Compare Pharmacodynamics of Subcutaneous Goserelin 10.8mg Injection (Sponsor) With ZOLADEX® 10.8mg Injection (AstraZeneca) in Patients With Advanced Prostate Cancer
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:
A two arm, multi centric, randomized, open label, parallel, two doses pharmacodynamics study in patients with advanced prostate cancer.
Detailed Description:
A phase III, two arm, multi centric, randomized, open label, parallel, two doses pharmacodynamics study in patients with advanced prostate cancer. Each patient will have 25 visits total. Total duration of the study will be 183 days (including up to 14 days of screening).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
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?: