Conditions: Hypogonadism Benign Prostatic Hyperplasia
Keywords: androgen deficiency testosterone Benign Prostatic Hyperplasia hypogonadism prostate BPH
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 53
Healthy volunteers: yes

Brief 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.

Arms:
arm 1: Testosterone 1% gel 7.5 topical daily + placebo dutasteride orally daily arm 2: Testosterone 1% gel 7.5 topical daily + dutasteride 0.5 mg orally daily

Interventions: intervention 1: Dutasteride intervention 2: Testosterone gel intervention 3: Placebo dutasteride
Intervention descriptions: intervention 1: Dutasteride 0.5 mg orally daily intervention 2: Testosterone gel 7.5 g daily topical intervention 3: placebo dutasteride orally daily

Protocol document: