At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 109 enrolled
Drug / intervention
Triptorelin Pamoate (Pamorelin® LA 11.25 mg)drug
Likely dose
Triptorelin Pamoate (Pamorelin® LA 11.25 mg)from 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, Multicentre, Open, Prospective, Randomised, Parallel-Group, Pharmacodynamic Equivalence Study on Intramuscular Versus Subcutaneous Applications of Triptorelin Pamoate (Pamorelin® LA 11.25 mg) in Patients With Advanced Prostate Cancer
In Brief
A Phase 2 clinical trial evaluating Triptorelin Pamoate (Pamorelin® LA 11.25 mg) for Prostate Cancer. Completed, enrolled 109 participants across 22 sites.
Detailed Summary
The purpose of this study is to demonstrate the pharmacodynamic equivalence of triptorelin pamoate (Pamorelin® LA 11.25 mg), applied either IM or SC, in terms of the area under the curve \[AUC1-85day\] for serum testosterone in patients with advanced prostate cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesGermany
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2010
First PostedDec 2010
Primary CompletionFeb 2012
Study CompletionMay 2012
TodayJul 2026
First PostedDec 9, 2010
Enrollment StartDec 1, 2010
Primary CompletionFeb 1, 2012
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.6 years ago
Interventions
Triptorelin Pamoate (Pamorelin® LA 11.25 mg)drug
Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85. Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85.