Testosterone patch approved by FDA Hormone treatment aimed at rare illness

SAN FRANCISCO — SAN FRANCISCO -- In the beginning there was the skin patch to prevent motion sickness. Then came the nitroglycerin patch to treat people with angina, the estrogen patch to help women deal with the symptoms of menopause, and the nicotine patch to help people quit smoking.

Now, make way for the testosterone patch, to treat men who suffer from a serious deficiency of the male hormone.


Alza Corp., the Palo Alto, Calif., company that pioneered the development of the $1.4 billion a year transdermal patch business, said yesterday that it has received the approval of the U.S. Food and Drug Administration to begin selling its Testoderm patch.

The Alza patch is designed to minimize mood swings among men who suffer from a relatively rare medical condition known as hypogonadism. Doctors also say that someday the patch could be a relatively common treatment for bone and muscle loss among elderly men.


Hypogonadism has a variety of causes, including cancer of the testes or pituitary gland that requires the surgical removal of those organs. It is also caused by a genetic condition called Klinefelter's Syndrome, in which males are born with an extra X chromosome.

The symptoms of the disease, which affects about 150,000 men in the United States, include not only reduced sexual activity, but also persistent fatigue, depression and an inability to grow body hair and develop muscles.

The current treatment -- testosterone injections every two to three weeks -- can cause wide mood swings, from aggressiveness and euphoria in the days after an injection to depression and lethargy as testosterone levels in the blood decline.

Alza's patch is designed to minimize those mood swings by keeping testosterone at more normal levels. The 2 1/2 -inch-by-4-inch cloth patch, which is applied daily to the patient's scrotum, delivers the hormone into the bloodstream and mimics the body's own fluctuations of testosterone over a 24-hour period.

Testosterone levels decline naturally in men over 40. And assuming the current research is borne out, the use of testosterone injections or patches could become a common treatment for osteoporosis among elderly men. "Ten years from now, testosterone could be looked at in men the way estrogen is used in women," said analyst David Steinberg.