Special drug use surveillance of Leuprorelin for Injection Kit 22.5 mg in Premenopausal breast cancer
Not Applicable
Completed
- Conditions
- Premenopausal breast cancer
- Registration Number
- JPRN-jRCT1080223148
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
These results suggest that there are no new safety concerns about Leuplin PRO associated with its characteristics (e.g., increased amount administered per dose, different time-course of serum drug concentrations) compared with Leuplin SR. Please refer to Conclusions in "Adverse Events" section for the details.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 312
Inclusion Criteria
Participants with premenopausal breast cancer will be included.
Exclusion Criteria
Participants who meet any of the following criteria will not be included.
Participants with a history of hypersensitivity to any ingredients of Leuplin PRO, synthesized LH-RH, or LH-RH analogues
Pregnant or potentially pregnant participants and breastfeeding participants
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Percentage of Participants Who Had One or More Adverse Events<br>Time Frame: Up to Week 24
- Secondary Outcome Measures
Name Time Method safety<br>Percentage of Participants Who Had One or More Adverse Reactions<br>Time Frame: Up to Week 24