Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

September 13, 2016 updated by: GlaxoSmithKline

Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels

This study is being done to determine how much certain hormone levels in the prostate decrease when a patient takes dutasteride 0.5mg daily for 3 months prior to TURP. Male patients at least 50 years old willing to take either dutasteride or a placebo (dummy pill) once daily by mouth for 3 months prior to having a surgery to reduce the size of their prostate. During the surgery, very small pieces of the prostate that are removed will be tested to see how much dihydrotestosterone and testosterone (male hormones) are in the tissue.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • GSK Investigational Site
    • Connecticut
      • New Britain, Connecticut, United States, 06052
        • GSK Investigational Site
      • Trumbull, Connecticut, United States, 06611
        • GSK Investigational Site
    • Georgia
      • Augusta, Georgia, United States, 30912
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • GSK Investigational Site
      • Niles, Illinois, United States, 60714
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114-3139
        • GSK Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401-8122
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75235
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23249
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria:

  • Diagnosed with benign prostatic hyperplasia
  • Must be scheduled to have a transurethral resection of the prostate (prostate surgery) and be able to wait 3 months to have the procedure.
  • PSA (prostate specific antigen) level must be between 1.5 and 15 ng/ml.

Exclusion criteria:

  • Prostate cancer.
  • Use of saw palmetto or other over the counter treatments for prostate health chemically related to the study medication.
  • Previous finasteride use or other investigational 5ARI within 6 months prior to screening.
  • History of chronic UTIs (urinary tract infections)
  • Presence of acute bacterial prostatitis at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effect of repeat oral daily dosing of 0.5mg dutasteride compared to placebo on prostate tissue content of DHT in patients treated for 3 months prior to transurethral resection of the prostate (TURP).

Secondary Outcome Measures

Outcome Measure
Effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on prostatic tissue content of testosterone.
Changes in serum DHT (dihydrotestosterone) and T (testosterone).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

June 16, 2003

First Submitted That Met QC Criteria

June 16, 2003

First Posted (Estimate)

June 17, 2003

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARI40014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Annotated Case Report Form
    Information identifier: ARI40014
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Clinical Study Report
    Information identifier: ARI40014
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistical Analysis Plan
    Information identifier: ARI40014
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: ARI40014
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Study Protocol
    Information identifier: ARI40014
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Dataset Specification
    Information identifier: ARI40014
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Individual Participant Data Set
    Information identifier: ARI40014
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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