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Men with Low Testosterone Now Have Cream; Available Later This Year

 

(01/03/2003) A little dab will now do those men who have low testosterone levels. The Food and Drug Administration has approved Unimed Pharmaceuticals' AndroGel, a clear, testosterone-containing gel rubbed into the skin, as an alternative to current testosterone therapy.

The prescription product comes in ketchup-like packets of natural testosterone, which men rip open, rub in the palm of their hands and then onto the skin of their shoulders or abdomens, according to Dr. Ronald S. Swerdloff, lead investigator of the study that led to the approval.

"The skin acts as reservoir for the testosterone, which then gets released into the blood in a controlled fashion," says Dr. Swerdloff, chief of the division of endocrinology at Harbor-UCLA Medical Center, in Torrance, Calif. Men apply the gel daily. Patches, Injections BeforeBefore the gel became available, men with low testosterone levels would either take injections of the hormone or wear patches with the hormone.

But Dr. Swerdloff said injections would create immediately high blood levels of the hormone and that patients did not enjoy injecting themselves. Patches, he says, also could be irritating and some men complained that certain brands fell off. Other men did not feel comfortable wearing them in parts of their body that either spouses or girlfriends could see or that could be detected in a gym or at the beach.

Which Men Need Testosterone? Men who need testosterone replacement therapy include younger men whose low levels apparently do not allow them to have male sexual characteristics, such as muscle mass, poor beard growth and a healthy sexual drive. Some 4 percent of men who are in the 20s have low testosterone levels. Whether testosterone replacement therapy for older men is appropriate remains an open question, says Dr. Swerdloff. Approximately 25 percent of men who are 65 years old have low testosterone levels.

Decreased levels in older men could lead to reduced muscle mass, osteoporosis and depression. "Early studies on short-term use of testosterone replacement have shown some benefits for older men," says Dr. Swerdloff. "More studies need to be done to follow men for a longer period of time to make sure any benefits are not outweighed by long-term consequences." But Dr. Stanley Korenman, professor of medicine and reproductive endocrinology at the UCLA Medical Center, feels the benefits for older men are already known.

Older patients just need to have their blood count, their prostate specific antigen and their lipids watched when they are taking androgens, he says. Testosterone may thicken the blood, increase PSA and decrease HDL, the good cholesterol, he says. FDA Approval with CautionWhen issuing the approval, the FDA cautioned the drug be used carefully. Men must be careful not to spread the gel from their hands or bodies to women, especially pregnant women because testosterone can harm a developing fetus, the FDA said.

Let the gel dry a few minutes before dressing and wait five to six hours before showering or swimming so it absorbs properly, the FDA said. Illinois-based Unimed said AndroGel, like other testosterone therapy, can restore men's hormone levels to a normal range. It will be available by midsummer.

A price has not been set. Unimed's president and CEO Robert Dudley says that approximately 500,000 to 1 million men in the United States have low testosterone levels and would be candidates for the gel. With this easier means of delivery of testosterone, also may come the potential for abuse. But Dr. Swerdloff reminds that male sex drive does not increase as levels of testosterone rise. Misuse by body-builders and athletes, however, could be possible.

(c) 2002 Sociedad Española de Medicina Antienvejecimiento y Longevidad

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