NCT05458856

Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Ipsen · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Triptorelin embonate 22.5 mg	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

Timeline

• Start date: 2022-08-30
• Primary completion: 2024-07-08
• Completion: 2024-07-08
• First posted: 2022-07-14
• Last updated: 2025-07-25
• Results posted: 2025-07-23

Locations

39 sites across 7 countries: Belgium, Czechia, France, Germany, Lithuania, Netherlands, Spain

Regulatory

• FDA-regulated drug study