Completed
PHASE3
INTERVENTIONAL
NCT00751790
Efficacy and Safety of a Triptorelin 6-month Formulation in Patients With Advanced Prostate Cancer
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
Efficacy and safety of a triptorelin 6-month formulation in patients with advanced prostate cancer. It was assumed that during the study treatment \>90% of the patients would achieve and maintain castrate levels of serum testosterone.
Detailed Description
Efficacy of triptorelin treatment on gonadotropin (LH) stimulation from hypophysis, as well as on the PSA (prostate specific antigen) levels and safety laboratory parameters. The triptorelin pharmacokinetics and testosterone pharmacodynamics were assessed in a subset of 15 patients.
Interventions
Name:
triptorelin embonate (INN)
Type:
DRUG
Description:
Triptorelin embonate 22.5 mg 6 month formulation to be injected every 24 weeks
Primary Outcomes
Measure:
Achievement of Castration and Maintenance of Castration
TimeFrame:
at Day 29
Description:
Percentage of patients achieving castrate testosterone levels (≤1.735 nmol/L) by Day 29 (28 days after study drug injection) and percentage of patients maintaining castrate testosterone levels from Month 2 to end of Month 12 (Week 48).
Trial Information
NCT ID
NCT00751790
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Debiopharm International SA
Last Updated
December 15, 2025