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

Tracking Information

First Received Date ^ICMJE

June 16, 2003

Last Updated Date

October 13, 2008

Start Date ^ICMJE

October 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00062790 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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).

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

Official Title ^ICMJE

Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Benign Prostatic Hyperplasia

Intervention ^ICMJE

Drug: Dutasteride

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00062790

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

ARI40014

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP