Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

GlaxoSmithKline50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Prostatic Hyperplasia

Interventions

DutasterideDRUG

Eligibility

Sex: MALEMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (11)

GSK Investigational Site

Long Beach, California, United States

GSK Investigational Site

New Britain, Connecticut, United States

GSK Investigational Site

Trumbull, Connecticut, United States

Outcomes

Primary Outcomes

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 Outcomes

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).

Data from ClinicalTrials.gov

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