Effect of Dihydrotestosterone (DHT) on Prostate Tissue [Short Title: DHT-3]

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: Male

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Washington
• Collaborators: ASCEND Therapeutics; National Institute on Aging (NIA)
• Treatments: Androgens; Dihydrotestosterone

Criteria

Inclusion Criteria:

• Males 35-55 years old

• Normal serum total testosterone (300 ng/dl-1000 ng/dl)

• Normal Luteinizing Hormone [LH] and Follicle Stimulating Hormone [FSH] levels

• Informed consent

• Taking no regular medications

• Normal baseline prostate ultrasound, hematology, and liver function tests

Exclusion Criteria:

• History of prostate cancer

• Prostate Specific Antigen [PSA] > 2.0

• American Urological Association [AUA] prostate symptom score > 10

• History of testosterone or anabolic steroid use in the past

• Chronic medical illness or prostate disease

• History of a bleeding disorder or need for anticoagulation

• A first-degree relative (i.e. father, brother) with a history of prostate cancer

• Abnormal digital rectal examination

• Skin condition that might interfere with or be exacerbated by DHT gel use

• History of untreated sleep apnea and/or psychiatric problems

• Participation in another study in the past 2 months

• Participating in a regular physical relationship with a pregnant woman