Clinical trial NCT00062790: Effect Of Dutasteride On Intraprostatic Dihydrotestosterone (DHT) Levels
Official title: Effects of Dutasteride on Intraprostatic Dihydrotestosterone (DHT) Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostatic Hyperplasia
Keywords: Testosterone
DHT
TURP
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2003-06-17
Enrollment: 50
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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:
measure: Effect of repeat oral once daily dosing of 0.5mg dutasteride compared to placebo on prostatic tissue content of testosterone.
measure: Changes in serum DHT (dihydrotestosterone) and T (testosterone).
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: New Britain
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Trumbull
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Augusta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Niles
country: United States
facility: GSK Investigational Site
state: Illinois
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Lebanon
country: United States
facility: GSK Investigational Site
state: New Hampshire
city: Eugene
country: United States
facility: GSK Investigational Site
state: Oregon
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: