drugset / Trial / NCT02712320
Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg
NaSingle-groupOpen-labelTreatment
Summary
This is a safety extension of up to 12 months of additional treatment with LMIS 50 mg after the subject has completed 12 months of treatment under Protocol FP01C-13-001 and remain eligible for continued treatment with androgen deprivation therapy. Subjects participating in Protocol FP01C-13-001-EX will be followed for safety only.
Timeline
- Start
- 2016-02
- Primary completion
- 2017-05
- Completion
- 2017-12-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leuprolide | Other / unclassified | 50 mg | Subcutaneous |