Clinical trial · Observational
Special Drug Use Surveillance of Leuprorelin for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
Special Drug Use Surveillance of Leuplin PRO for Injection Kit 22.5 mg in "Premenopausal Breast Cancer"
NCT03209518CI-TRIAL-00041406completedResults 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 to evaluate the safety in patients with premenopausal breast cancer receiving Leuprorelin in the routine clinical setting.
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 |
|---|---|---|---|
| Premenopausal Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuprorelin acetate | Drug | Leuprolide | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Leuprorelin acetate
- description
- Usually, for adults, 22.5 mg of Leuprorelin acetate was subcutaneously administered once every 24 weeks. Refer to the Precautions section of the package insert. Participants received Leuprorelin as part of routine medical care.
- interventionNames
- Drug: Leuprorelin acetate
Primary outcomes (1)
- measure
- Percentage of Participants Who Had One or More Adverse Events
- timeFrame
- Up to Week 24
Secondary outcomes (1)
- measure
- Percentage of Participants Who Had One or More Adverse Reactions
- timeFrame
- Up to Week 24
- description
- Adverse drug reaction refers to adverse events related to the administered drug.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.