Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444639
Status:
TERMINATED
Last Update Posted:
2019-11-22
First Post:
2007-03-07
Brief Title:
Study to Assess the Non-inferiority of Pamorelin 1125mg SC Injected Versus Pamorelin 1125mg IM Injected in Patients Suffering From Advanced Prostate Cancer PAMOJECT
Sponsor:
Ipsen
Organization:
Ipsen
Study Overview
Official Title:
Phase II Multi-Centric Randomised Open-label Parallel-Group Study to Assess the Non-inferiority of Pamorelin 1125mg SC Injected Versus Pamorelin 1125mg IM Injected in Patients Suffering From Advanced Prostate Cancer
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The active ingredient of Pamorelin 1125 mg is Triptorelin Triptorelin is a substitute for a natural hormone produced in the body called Gonadotrophin-releasing hormone GnRH GnRH is a hormone secreted by hypothalamus a gland located in brain and controls the production of sex hormones eg testosterone in men in other organs in the body The growth of prostate cancer cells one of the most common cancers in men is induced by the hormone testosterone Hormonotherapy is one of treatments available to treat this type of disease by controlling the testosterone serum level Pamorelin 1125 mg is normally injected in the muscle but this type of injection is not suitable for every patient Therefore the primary purpose of this study is to assess the non-inferiority of the 12-week triptorelin formulation Pamorelin 1125 mg administered via subcutaneous SC injection as compared to Pamorelin 1125 mg administered via standard intramuscular IM injection based on the percentage of patients presenting a testosterone level 50 ngdl at week 24
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 |
|---|---|---|---|
| 2005-005058-31 | EUDRACT_NUMBER | None | None |