Effect of Dihydrotestosterone (DHT) on Prostate Tissue [Short Title: DHT-3]
Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
Summary
The purpose of this research study is to understand the effects of a male hormone normally
made in the body called Dihydrotestosterone (DHT) on the prostate gland that is located under
the bladder. The knowledge gained from this study may be used to help in the future to
develop a safe male hormonal contraceptive to prevent pregnancy, in the safe treatment of low
male hormone levels in men, and in the treatment and prevention of diseases of the prostate.
The investigators will be giving DHT in a gel form, to be applied to the skin, or a placebo
gel (with no active drug in it). The investigators want to see the effects of DHT on levels
of hormones in the blood and in the prostate gland itself. In addition, the investigators
will be studying the effects of DHT on the cells and genes expressed within the prostate.
The effect of DHT on the prostate is not known. Some studies suggest blocking production of
DHT in the prostate helps growth of the gland with aging (a condition known as benign
prostatic hyperplasia, or BPH for short) and may prevent prostate cancer. On the other hand,
DHT administration may shrink the prostate, suggesting it may be beneficial for some men.
Therefore, further studies looking at the effect of DHT on the prostate are needed.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Washington
Collaborators:
ASCEND Therapeutics National Institute on Aging (NIA)