Completed
PHASE2
INTERVENTIONAL
NCT01257425
Equivalence of Intramuscular (IM) Versus Subcutaneous (SC) Applications of Long Acting Pamorelin 11.25 mg
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
Triptorelin Pamoate (Pamorelin® LA 11.25 mg)
Type:
DRUG
Description:
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.
Primary Outcomes
Measure:
Area Under the Curve of Testosterone Serum Concentration Between D1 and D85 (AUC1-85d).
TimeFrame:
1, 3, 5, 8, 15, 22, 29, 57, 85 days post-dose
Description:
Area under the curve (AUC) calculated from serum testosterone concentration taken at intervals between the first administration (Day 1) of the study drug and Day 85 after dosing. From the curve describing serum testosterone concentration levels (ng/mL) over time, the AUC was calculated using numerical integration methods. This value was log-transformed to more closely meet the assumption of the statistical method.
Trial Information
NCT ID
NCT01257425
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Ipsen
Last Updated
December 15, 2025