Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415246
Status:
TERMINATED
Last Update Posted:
2019-11-22
First Post:
2006-12-21
Brief Title:
Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer
Sponsor:
Ipsen
Organization:
Ipsen
Study Overview
Official Title:
A Phase III Single Arm Multicentre Study to Evaluate the Efficacy and Safety of a Subcutaneous Four Months Sustained-release Formulation of Triptorelin a Gonadotrophin Releasing Hormone Analogue in Patients With Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The preliminary data do not support the expected sustainable blood levels of triptorelin for a duration of 4 months in all patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To identify the proportion of patients remaining medically castrated testosterone level 50 ngdL on Day 240 following two administrations of a 4-month sustained-release SR formulation of triptorelin
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-001511-30 | EUDRACT_NUMBER | None | None |