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PHASE II MULTI-CENTRIC, RANDOMISED, OPEN-LABEL, PARALLEL-GROUP STUDY TO ASSESS THE NON-INFERIORITY OF PAMORELIN® 11,25MG SC INJECTED VERSUS PAMORELIN® 11,25MG IM INJECTED IN PATIENTS SUFFERING FROM AD...

Update Il y a 4 ans
Reference: EUCTR2005-005058-31

PHASE II MULTI-CENTRIC, RANDOMISED, OPEN-LABEL, PARALLEL-GROUP 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

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Extract

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.

Inclusion criteria

  • Patients with advanced (locally or metastatic) prostate cancer scheduled to receive an LHRH analogue as androgen deprivation therapy

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