deltatrials
Completed PHASE4 NCT00375765

Effects On Dihydrotestosterone Regulated Gene Expression In Benign Prostatic Hyperplasia Or Prostate Cancer

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

Sponsor: GlaxoSmithKline

Conditions Benign Prostatic Hyperplasia Prostate Cancer
Interventions Dutasteride
Updated 6 times since 2017 Last updated: Jan 17, 2017 Started: Apr 30, 2005 Primary completion: Jul 31, 2007 Completion: Jul 31, 2007

This PHASE4 trial investigates Benign Prostatic Hyperplasia and Prostate Cancer and is currently completed. GlaxoSmithKline leads this study, which shows 6 recorded versions since 2005 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Change History

6 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE4

▶ Show 1 earlier version

  1. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE4

    First recorded

Apr 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • GlaxoSmithKline
Data source: GlaxoSmithKline

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

  • • Nijmegen, Netherlands