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NCT00062790 Clinical Trial

Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

Prostatic Hyperplasia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00062790
Other study ID # ARI40014
Secondary ID
Status Completed
Phase Phase 4
First received June 16, 2003
Last updated September 13, 2016
Start date October 2003
Est. completion date July 2005

Study information
Verified date September 2016
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 50 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Dutasteride

Locations
Country Name City State
United States GSK Investigational Site Augusta Georgia
United States GSK Investigational Site Boston Massachusetts
United States GSK Investigational Site Chicago Illinois
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Eugene Oregon
United States GSK Investigational Site Lebanon New Hampshire
United States GSK Investigational Site Long Beach California
United States GSK Investigational Site New Britain Connecticut
United States GSK Investigational Site Niles Illinois
United States GSK Investigational Site Richmond Virginia
United States GSK Investigational Site Trumbull Connecticut

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on prostatic tissue content of testosterone.
Secondary Changes in serum DHT (dihydrotestosterone) and T (testosterone).
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