Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00062790

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Prostatic Hyperplasia	Drug: Dutasteride	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels

Study Start Date :

Oct 1, 2003

Actual Study Completion Date :

Jul 1, 2005

Outcome Measures

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). []

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Long Beach	California	United States	90806
2	GSK Investigational Site	New Britain	Connecticut	United States	06052
3	GSK Investigational Site	Trumbull	Connecticut	United States	06611
4	GSK Investigational Site	Augusta	Georgia	United States	30912
5	GSK Investigational Site	Chicago	Illinois	United States	60612
6	GSK Investigational Site	Niles	Illinois	United States	60714
7	GSK Investigational Site	Boston	Massachusetts	United States	02114-3139
8	GSK Investigational Site	Lebanon	New Hampshire	United States	03756
9	GSK Investigational Site	Eugene	Oregon	United States	97401-8122
10	GSK Investigational Site	Dallas	Texas	United States	75235
11	GSK Investigational Site	Richmond	Virginia	United States	23249