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Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00062790
First received: June 16, 2003
Last updated: October 1, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Benign Prostatic Hyperplasia
 Drug: Dutasteride
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels

Resource links provided by NLM:

Drug Information available for: Dutasteride
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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:
  • 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).

Estimated Enrollment: 50
Study Start Date: October 2003
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Dutasteride
    Other Name: Dutasteride
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00062790

Locations
United States, California
GSK Investigational Site
Long Beach, California, United States, 90806
United States, Connecticut
GSK Investigational Site
New Britain, Connecticut, United States, 06052
GSK Investigational Site
Trumbull, Connecticut, United States, 06611
United States, Georgia
GSK Investigational Site
Augusta, Georgia, United States, 30912
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
GSK Investigational Site
Niles, Illinois, United States, 60714
United States, New Hampshire
GSK Investigational Site
Lebanon, New Hampshire, United States, 03756
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401-8122
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75235
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00062790     History of Changes
Other Study ID Numbers: ARI40014
Study First Received: June 16, 2003
Last Updated: October 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
DHT
TURP
Testosterone

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes
Dihydrotestosterone
Dutasteride
Androgens
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013