N/A
Completed N=333
Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg for "Prostate Cancer"
Source: ClinicalTrials.gov NCT03209492 ↗Enrolled (actual)
333
Serious AEs
1.2%
Results posted
Apr 2019
Primary outcomePrimary: Percentage of Participants Who Had One or More Adverse Events — 4.27 Percentage of Participants
Summary
The purpose of this study is to evaluate the safety in patients with prostate cancer receiving the drug in the routine clinical setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Had One or More Adverse Events |
4.27 | — |
| SECONDARY Percentage of Participants Who Had One or More Adverse Reactions |
2.74 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with prostate cancer will be included.
Exclusion Criteria
- Participants with previous history of hypersensitivity to any of the ingredients of the drug or synthetic LH-RH or LH-RH derivatives
Data sourced from ClinicalTrials.gov (NCT03209492). 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.