N/A
Completed N=312
Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
Premenopausal Breast Cancer
Source: ClinicalTrials.gov NCT03209518 ↗
Enrolled (actual)
312
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Percentage of Participants Who Had One or More Adverse Events — 6.45 Percentage of Participants
Summary
The purpose of this survey is to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Had One or More Adverse Events |
6.45 | — |
| SECONDARY Percentage of Participants Who Had One or More Adverse Reactions |
5.48 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with premenopausal breast cancer will be included.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03209518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.