A skin patch that can be placed on a variety of body sites to boost testosterone levels has received FDA clearance as a treatment for hypogonadism, a condition in which the body produces inadequate levels of the hormone.
Called Androderm (Testosterone Transdermal System), the new patch can be worn on the abdomen, back, thighs, or upper arm to help relieve symptoms of both primary hypogonadism (disorders of the testes) and secondary hypogonadism (disorders of the pituitary gland or hypothalamus area of the brain). A previously approved patch can be applied only to a shaved scrotum. Transdermal patches offer alternatives to testosterone injections, a therapy administered every two to four weeks that can create abnormal highs and lows in hormone levels. Androderm was cleared for marketing last Sept. 29.
Only about S percent of the estimated 4 million to 5 million American men with hypogonadism currently receive testosterone replacement therapy. Symptoms of the disorder include sexual dysfunction (loss of libido or impotence), fatigue, depressed mood, muscle wasting, osteoporosis, or absence or regression of secondary male sexual characteristics (muscle development, deep voice, or hair distribution).
In clinical trials, Androderm restored normal testosterone levels in 86 of 94 patients who completed the trials. The most common side effects reported were temporary mild-to-moderate redness or itching at patch sites.
Androderm is made by TheraTech Inc., of Salt Lake City, and is marketed by SmithKline Beecham Pharmaceuticals of Philadelphia. (See also "Testosterone: Key to Masculinity and More" in the May 1995 FDA Consumer).
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