drugset / Trial / NCT02712320

Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg

NCT02712320

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

EvaluationDrugModalityDoseRoute
Subject Leuprolide Other / unclassified 50 mg Subcutaneous

Indications