Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Prostatic Hyperplasia

Treatments

Drug: Dutasteride

Study type

Interventional

Funder types

Industry

Identifiers

NCT00062790

ARI40014

Details and patient eligibility

About

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.

Sex

Male

Ages

50+ years old

Volunteers

No 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