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A Phase 3, Multi-Center, Open-Label, Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Two 6-Month Leuprolide Formulations, in Subjects With Prostatic Adenocarcinoma.

Trial Profile

A Phase 3, Multi-Center, Open-Label, Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of Two 6-Month Leuprolide Formulations, in Subjects With Prostatic Adenocarcinoma.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Leuprorelin (Primary)
  • Indications Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Abbott Laboratories; TAP Pharmaceuticals
  • Most Recent Events

    • 13 May 2010 Additional trial identifier 1B-08-2 identified as reported by University of Southern California Norris Comprehensive Cancer Center record.
    • 13 May 2010 New source identified and integrated (University of Southern California Norris Comprehensive Cancer Center record no. 1B-08-2).
    • 11 Mar 2010 Based on the results of this study, the US FDA has accepted for review a supplemental New Drug Application of a 6-month 45mg formulation of leuprorelin for the treatment of advanced prostate cancer, according to an Abbott Laboratories media release.
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