At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 144 enrolled
Drug / intervention
Leuprolide Mesylatedrug
Likely dose
Leuprolide Mesylate 25mgfrom 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 Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects With Prostate Cancer
In Brief
A Phase 3 clinical trial evaluating Leuprolide Mesylate for Prostatic Neoplasms. Completed, enrolled 144 participants across 21 sites in 5 countries.
Detailed Summary
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with prostate cancer, when administered as two injections twelve weeks apart.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms
CountriesCzechia, Lithuania, Slovakia, South Korea, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedAug 2017
Enrollment StartSep 2017
Primary CompletionNov 2018
Study CompletionFeb 2019
TodayJul 2026
First PostedAug 25, 2017
Enrollment StartSep 26, 2017
Primary CompletionNov 19, 2018
Study CompletionFeb 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.9 years ago
Interventions
Leuprolide Mesylatedrug
Subcutaneous injection of 25mg Leuprolide Mesylate