Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels

Completed · Phase 4

Conditions studied: Prostatic Hyperplasia

In brief

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.

Key facts

Study ID

NCT00062790

Run by

GlaxoSmithKline

People needed

50

Starts

2003-10-01

Expected to finish

2005-07-01

Last updated by the study team

2016-09-15

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Long Beach, California, United States
• GSK Investigational Site — New Britain, Connecticut, United States
• GSK Investigational Site — Trumbull, Connecticut, United States
• GSK Investigational Site — Augusta, Georgia, United States
• GSK Investigational Site — Chicago, Illinois, United States
• GSK Investigational Site — Niles, Illinois, United States
• GSK Investigational Site — Boston, Massachusetts, United States
• GSK Investigational Site — Lebanon, New Hampshire, United States
• GSK Investigational Site — Eugene, Oregon, United States
• GSK Investigational Site — Dallas, Texas, United States
• GSK Investigational Site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.