Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels - Full Text View

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 IV

Drug Information available for:

Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Dutasteride Stanolone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacokinetics/Dynamics Study

Official Title:	Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels

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

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
	Niles, Illinois, United States, 60714
	GSK Investigational Site
	Chicago, Illinois, United States, 60612

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

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ARI40014
First Received:	June 16, 2003
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00062790
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

DHT

TURP

Testosterone

Study placed in the following topic categories:

Dutasteride

Testosterone

Hyperplasia

Prostatic Diseases

Prostatic Hyperplasia

Dihydrotestosterone

Methyltestosterone

Genital Diseases, Male

Testosterone 17 beta-cypionate

Additional relevant MeSH terms:

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Enzyme Inhibitors

Hormones

Pharmacologic Actions

Androgens

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00062790