Male hypogonadism has been associated with signs and symptoms of sexual dysfunction, decreased body hair, and osteoporosis. At present, there are several androgen preparations available in the United States. These include injectable testosterone esters, two oral preparations, fluoxymesterone and methyl-testosterone, and two types of transdermal androgen patches presently available. However, each has its own disadvantages for testosterone supplementation. The most significant disadvantage involves the prostate. Testosterone can increase the prostate size leading to benign prostate hypertrophy (BPH), especially in older men. In looking for an improved androgen delivery system as well as an androgen that would be safer for elderly men, a testosterone derivative, dihydrotestosterone (DHT) 1% hydroalcholic gel (DHT-gel) has been developed to allow transdermal application over broad areas of skin in measured fashion without visible identifying patches. This method uses natural testosterone products and allows a measured dose to be dispensed, which then can be rubbed, on to a given area of skin by the user. The gel liquefies and the alcohol rapidly evaporate leaving an unrecognizable film of testosterone on the skin which is then rapidly incorporated into the epidermal tissue. There is no sticky residue. Results from the phase I testing of DHT-gel indicate that the daily application of 64 grams of gel (100 mg T) to the upper arm/shoulder and trunk region yields stable DHT levels. No evidence of skin irritation was found in patients with T-gel in the phase I study. This study showed some very promising data that the size of prostate did not increase and some decrease in size.
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