Contraception Clinical Trial
Official title:
The Effects of Testosterone on Prostate Tissue in Normal Men (ACYP-1)
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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