NCT00194675

TRADE-Testosterone Replacement and Dutasteride Effectiveness

Testosterone Replacement and Dutasteride Effectiveness (TRADE)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to determine whether the combination of the male hormone testosterone \[T\] in gel form and the oral drug dutasteride \[D\], used to shrink large prostate glands can safely reduce the size of the prostate gland and symptoms of prostate enlargement (called benign prostatic hyperplasia \[BPH\]) compared to T treatment alone in men with low testosterone (called hypogonadism).

Detailed description

The primary aim of this study is to determine whether correction of hypogonadism using a combination of testosterone and dutasteride spares subjects from increases in prostate size and symptoms of BPH which may be associated with T alone. We will also determine the effects of changes in serum T and dihydrotestosterone (DHT) on both the hormonal milieu and genetic program within the prostate gland itself. The technology employed will allow us to determine which genes are androgen responsive within each prostate tissue compartment. Together, these data may determine whether the combination of testosterone and dutasteride safely corrects the symptoms of BPH and hypogonadism and minimizes growth stimulus to the prostate at the genetic level. We will also assess the effects of the combination of T and dutasteride on cognitive function. This is a six-month, double-blind, randomized, placebo-controlled, single-site study of older hypogonadal men with mild to moderate BPH. Within each treatment group, a sub-group of subjects will undergo additional procedures as part of a Prostate Biopsy sub-study to obtain prostate tissue for hormonal and genetic analyses. Selection of subjects will be based on clinical indication and/or willingness to undergo prostate biopsies.

Conditions

• Hypogonadism
• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Dutasteride	Dutasteride 0.5 mg orally daily
DRUG	Testosterone gel	Testosterone gel 7.5 g daily topical
DRUG	Placebo dutasteride	placebo dutasteride orally daily

Timeline

• Start date: 2005-03-01
• Primary completion: 2010-04-01
• Completion: 2010-12-01
• First posted: 2005-09-19
• Last updated: 2017-12-05
• Results posted: 2012-08-20

Locations

1 site across 1 country: United States