NCT00161486

The Effects of Testosterone on Prostate Tissue (ACYP-1)

The Effects of Testosterone on Prostate Tissue in Normal Men (ACYP-1)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to understand the effects of testosterone on the prostate. This knowledge will be used to help in the development of a safe male hormonal contraceptive and may impact the development of androgen replacement therapy in older men.

Detailed description

We will be administering two drugs: Testim (testosterone gel) and Acyline. Acyline is an experimental drug. We want to see their effects on levels of hormones in the blood and prostate. In addition, we will be examining the effects of these drugs on the expression of genes within the prostate. Acyline suppresses LH and FSH, which are hormones made by the pituitary gland, thus blocking the signal from the brain that causes the testes to make testosterone. Therefore, Acyline blocks testosterone production. In preliminary studies, a single injection of Acyline reversibly lowered the FSH, LH and testosterone levels in the blood for approximately 15 days. Prolonged low levels of LH and FSH cause suppression of sperm production in normal men. However, men may experience some side effects from the low levels of testosterone caused by acyline, thus exogenous testosterone is required to sustain normal male androgen and organ effects without suppressing spermatogenesis. This combination of drugs is a promising male contraceptive regimen. In addition, millions of older men are using testosterone replacement to treat male "andropause"; low level testosterone associated with aging. However, the effect of testosterone on the prostate is unknown. Studies examining the effect of testosterone on the prostate are needed.

Conditions

• Hypogonadism
• Contraception

Interventions

Type	Name	Description
DRUG	Testosterone gel	Testosterone gel 100 mg daily for 4 weeks
DRUG	Acyline	Acyline 300 μg/kg every two weeks (2 doses) for 4 weeks
DRUG	Placebo acyline	Placebo acyline injections every two weeks (2 doses)
DRUG	Placebo Testosterone gel	placebo testosterone gel daily for 4 weeks

Timeline

• Start date: 2004-07-01
• Primary completion: 2004-11-01
• Completion: 2004-11-01
• First posted: 2005-09-12
• Last updated: 2008-09-19

Locations

1 site across 1 country: United States