At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 147 enrolled
Drug / intervention
Triptorelin embonate 22.5 mgdrug
Likely dose
Triptorelin embonate 22.5 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, Multicentre, Single Arm Study to Assess the Efficacy and Safety of Triptorelin 6-month Formulation Administered Subcutaneously in Participants With Locally Advanced and/or Metastatic Prostate Cancer Previously Treated and Castrated With a GnRH Analogue
In Brief
A Phase 3 clinical trial evaluating Triptorelin embonate 22.5 mg for Prostate Cancer. Completed, enrolled 147 participants across 39 sites in 7 countries.
Detailed Summary
The aim of the study is to determine if triptorelin formulated for use every 6 months (given twice during the study) is effective and safe for when given by injection under the skin for the treatment of adult males with cancer in the prostate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesBelgium, Czechia, France, Germany, Lithuania, Netherlands, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedJul 2022
Enrollment StartAug 2022
Primary CompletionJul 2024
TodayJul 2026
First PostedJul 14, 2022
Enrollment StartAug 30, 2022
Primary CompletionJul 8, 2024
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 4.0 years ago
Interventions
Triptorelin embonate 22.5 mgdrug
A prolonged release formulation of triptorelin pamoate 22.5 mg 6-month formulation in D, L-lactide-co-glycolide polymers for single subcutaneous injection on Day 1 and Day 169