At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 51 enrolled
Drug / intervention
leuprolide acetate FluidCrystal® injection depot +1 moredrug
Likely dose
Not stated in 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.
A Phase II, Open Label, Active Control, Multi-National, Multi-Centre, Randomized, Parallel Group Study Assessing Pharmacokinetics, Pharmacodynamics, Efficacy and Safety of CAM2032 (Leuprolide Acetate FluidCrystal® Injection Depot Once Monthly) After Repeat Doses of 3.75 mg and 7.5 mg of Leuprolide Acetate vs. Eligard® 7.5 mg in Patients With Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating leuprolide acetate FluidCrystal® injection depot and leuprolide acetate for Prostate Cancer. Completed, enrolled 51 participants across 7 sites in 2 countries.
Detailed Summary
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, efficacy and safety of CAM2032 versus Eligard, in patients with prostate cancer. All patients will receive leuprolide acetate administered subcutaneously once monthly during 3 months.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesFinland, Hungary
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartSep 2014
Primary CompletionNov 2015
Study CompletionMar 2016
TodayJul 2026
First PostedAug 8, 2014
Enrollment StartSep 1, 2014
Primary CompletionNov 1, 2015
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.9 years ago
Interventions
leuprolide acetate FluidCrystal® injection depotdrug
leuprolide acetatedrug