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Triptorelin

Decapeptyl, Trelstar, Gonapeptyl, Pamorelin

Quick Stats
Studies 178
Trials 100
Terminated PHASE2 INTERVENTIONAL NCT00444639

Study to Assess the Non-inferiority of Pamorelin® 11,25mg SC Injected Versus Pamorelin® 11,25mg IM Injected in Patients Suffering From Advanced Prostate Cancer (PAMOJECT)

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The active ingredient of Pamorelin® 11,25 mg is Triptorelin. Triptorelin is a substitute for a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH). GnRH is a hormone secreted by hypothalamus (a gland located in brain) and controls the production of sex hormones (eg testosterone in men) in other organs in the body. The growth of prostate cancer cells, one of the most common cancers in men, is induced by the hormone testosterone. Hormonotherapy is one of treatments available to treat this type of disease by controlling the testosterone serum level. Pamorelin® 11,25 mg is normally injected in the muscle but this type of injection is not suitable for every patient. Therefore the primary purpose of this study is to assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via standard intramuscular (IM) injection based on the percentage of patients presenting a testosterone level ≤ 50 ng/dl at week 24.

Interventions

Name: Triptorelin (Decapeptyl®)
Type: DRUG
Description: Two injections of 11.25mg given every 12 weeks

Primary Outcomes

Measure: Percentage of patients achieving a plasma testosterone level ≤ 50 ng/dl (1,7 nmol/l).
TimeFrame: Week 24
Description:

Trial Information

NCT ID

NCT00444639

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Ipsen

Last Updated

December 15, 2025