A Randomized, Open-label, Parallel-group Study, to Assess the Pharmocodynamic Effect on Dihydrotestosterone Regulated Gene Expression, Longitudinally and in a Dose Dependent Manner, of 0.5mg and 3.5mg Dutasteride Administered Orally Once Daily, for One Year in Men With Symptomatic Benign Prostatic Hyperplasia and During a Two Month Period Between Baseline and Radical Prostatectomy in Men With Biopsy-proven, Clinically Localized Prostate Cancer

Trial Profile

A Randomized, Open-label, Parallel-group Study, to Assess the Pharmocodynamic Effect on Dihydrotestosterone Regulated Gene Expression, Longitudinally and in a Dose Dependent Manner, of 0.5mg and 3.5mg Dutasteride Administered Orally Once Daily, for One Year in Men With Symptomatic Benign Prostatic Hyperplasia and During a Two Month Period Between Baseline and Radical Prostatectomy in Men With Biopsy-proven, Clinically Localized Prostate Cancer

Completed
Phase of Trial: Phase IV

Latest Information Update: 23 Jan 2017

At a glance

  • Drugs Dutasteride (Primary)
  • Indications Benign prostatic hyperplasia; Prostate cancer
  • Focus Pharmacodynamics
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 21 Mar 2009 Results presented at EAU
    • 12 Oct 2008 Trial phase changed from II/III to IV as reported by ClinicalTrials.gov.
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