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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.
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