Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-04 @ 8:53 PM
Study NCT ID:
NCT03209492
Status:
COMPLETED
Last Update Posted:
2019-04-11
First Post:
2017-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"
Status:
COMPLETED
Status Verified Date:
2019-04
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 evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.
Detailed Description:
The drug being tested in this study is called Leuprorelin acetate (Leuplin PRO for Injection Kit 22.5 mg). Leuprorelin acetate is being tested to treat people who have prostate cancer.
This study will look at the safety in patients with prostate cancer receiving the drug in the routine clinical setting.
The study will enroll approximately 300 patients.
• Leuprorelin acetate
This multi-center trial will be conducted in Japan.
This study will look at the safety in patients with prostate cancer receiving the drug in the routine clinical setting.
The study will enroll approximately 300 patients.
• Leuprorelin acetate
This multi-center trial will be conducted in Japan.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| JapicCTI-163213 | REGISTRY | JapicCTI | View |