At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 30 enrolled
Drug / intervention
LMIS 50 mgdrug
Likely dose
LMIS 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label, Single-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma - SAFETY EXTENSION
In Brief
A Phase 3 clinical trial evaluating LMIS 50 mg for Prostatic Neoplasms. Completed, enrolled 30 participants across 7 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms
CountriesUnited States
CollaboratorsQPS-Qualitix
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
First PostedMar 2016
Primary CompletionMay 2017
Study CompletionDec 2017
TodayJul 2026
First PostedMar 18, 2016
Enrollment StartFeb 1, 2016
Primary CompletionMay 1, 2017
Study CompletionDec 19, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.3 years ago
Interventions
LMIS 50 mgdrug
Subcutaneous injection of 50 mg Leuprolide Mesylate