Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT03209518
Status:
COMPLETED
Last Update Posted:
2019-11-01
First Post:
2017-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
Status:
COMPLETED
Status Verified Date:
2019-10
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 survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.
Detailed Description:
The drug being tested in this survey is called Leuprorelin for Injection Kit 22.5 mg. Leuprorelin is being tested to treat people who have premenopausal breast cancer.
This survey will look at the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting.
The survey will enroll approximately 300 patients.
\- Leuprorelin
This multi-center survey will be conducted in Japan.
This survey will look at the safety in patients with premenopausal breast cancer receiving the drug in the routine clinical setting.
The survey will enroll approximately 300 patients.
\- Leuprorelin
This multi-center survey 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-163203 | REGISTRY | JapicCTI | View |