Completed
PHASE3
INTERVENTIONAL
NCT01715129
Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate Cancer
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when administered by subcutaneous route.
Interventions
Name:
Triptorelin Pamoate 11.25mg
Type:
DRUG
Description:
Primary Outcomes
Measure:
Percentage of Subjects Demonstrating Castration at Day 29 and Maintaining Castration at Day 183
TimeFrame:
At Day 29 and 183
Description:
Percentage of subjects castrated (i.e. with serum testosterone \<50 ng/dL or 1.735 nmol/L, using the LC-MS/MS method and missing data imputed by immunoassay method (at time points when LC-MS/MS data was planned to be available only) and the proportion with castration maintained at Day 183 (after receiving 2 S.C. administrations of triptorelin pamoate, three months apart); they were calculated along with their respective 95% confidence intervals (CI) using exact methods on the ITT population at Day 29 and on the initially castrated (IC) population at Day 183
Trial Information
NCT ID
NCT01715129
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Ipsen
Last Updated
December 15, 2025