Clinical trial · Observational
Leuplin SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"
Leuprorelin Acetate SR 11.25 mg Injection Kit Specified Drug-use Survey "Long-term Use Survey in Prostate Cancer Patients (96 Weeks)"
NCT02167893CI-TRIAL-00026672completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this survey is designed to evaluate the efficacy and safety of long-term use (96 weeks) of leuprorelin acetate SR 11.25 milligram (mg) injection kit (Leuplin SR 11.25 mg injection kit) in prostate cancer participants in daily medical practice.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuprorelin acetate | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Subcutaneous administration of leuprorelin acetate
- description
- Subcutaneous administration of leuprorelin acetate once every 12 weeks as daily medicinal practice.
- interventionNames
- Drug: Leuprorelin acetate
Primary outcomes (2)
- measure
- Number of Participants Reporting One or More Adverse Drug Reactions
- timeFrame
- Baseline up to Week 96
- description
- Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.
- measure
- Number of Participants Reporting One or More Serious Adverse Drug Reactions
- timeFrame
- Baseline up to Week 96
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: Prostate cancer participants who meet all the following criteria: 1. Participants for whom prostate cancer was initially diagnosed on or after January 1, 2005 2. Participants with no prior history of treatment with Leuplin SR 11.25 mg Injection Kit (as an exception, participants with prior history of treatment with Leuplin 3.75 mg Injection Kit may be enrolled in the survey ) 3. Participants with prostate-specific antigen (PSA) level determined at baseline or within 3 months prior to the start of treatment with Leuplin SR 11.25 mg Injection Kit Exclusion Criteria: \-
References
Publications (0)
Data not yet available
No reference posted for this study.