At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 137 enrolled
Drug / intervention
Leuprolide Mesylatedrug
Likely dose
Leuprolide Mesylate 50mgfrom 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-Labeled, Singled-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma
In Brief
A Phase 3 clinical trial evaluating Leuprolide Mesylate for Prostatic Neoplasms. Completed, enrolled 137 participants across 29 sites in 8 countries.
Detailed Summary
The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with advanced prostate carcinoma, when administered as two injections six months apart.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms
CountriesAustria, Czechia, Germany, Lithuania, Poland, Slovakia, Taiwan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartAug 2014
First PostedSep 2014
Primary CompletionAug 2016
Study CompletionJan 2017
TodayJul 2026
First PostedSep 9, 2014
Enrollment StartAug 1, 2014
Primary CompletionAug 30, 2016
Study CompletionJan 5, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.8 years ago
Interventions
Leuprolide Mesylatedrug
Subcutaneous injection of 50mg Leuprolide Mesylate