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Many men use pharmaceutical testosterone to help with
lowered sex drive, loss of energy and other symptoms associated
with entering mid-life. An expert says a large-scale clinical
trial is needed to learn whether these supplements are indeed
safe and effective.

As men enter mid-life, they often start to experience
decreased sex drive, diminished energy, memory problems and
other symptoms of physical and mental change. This transitional
phase, somewhat analogous to menopause in women, is popularly
known as "manopause" or "viripause."

A growing number of men are turning to hormone replacement
therapy, in the form of testosterone supplements, to help their
bodies adjust to these changes.

Testosterone replacement therapy, which must be prescribed
by a physician, is currently approved by the Food and Drug
Administration for treatment of only one condition in men:
hypogonadism. In this condition, a man's testicles and scrotum
are reduced in size, resulting in abnormally low sperm
production.

However, more and more men, middle-aged and older, are
taking the medication to boost their sex drive, build muscle
mass, strengthen bones and help restore youthful vigor.

While many advocates regard testosterone supplements as a
pharmaceutical fountain of youth, Dr. Dan Blazer, a professor
in the Department of
Psychiatry and Behavioral Sciences at Duke University
Medical Center, says men should be aware of potential health
dangers.

"There are still no large studies that have looked at the
health risks," says Blazer. "There is some suggestion that
testosterone therapy may lead to an increase in prostatic
hypertrophy and in the level of the hormone that is tested for
in looking at the possibility of prostate cancer,
prostatic-specific antigen or PSA."

Blazer was a member of a scientific task force group that
recommended in 2003 that a large-scale clinical trial be
undertaken to study the safety and effectiveness of
testosterone therapy. Since that report, no such trial has
taken place, though a number of smaller trials have been
conducted.

"In an ideal world, what we would like to do is show the
drug is effective in a particular area and then to study it in
more detail, given the fact that it's been shown to be
effective. Or else, get the evidence out there that this drug
has not been shown in clinical trials to be effective and
hopefully that would stop the enthusiasm for using the
drug.

"That's of concern because it's very hard to pin down
exactly what the drug may be doing. Most medications are
effective in one or two areas and not in others and may often
carry harmful effects."

Blazer says one reason for the drug's recent surge in
popularity may be the availability of a new, improved treatment
option.

"It's not a big deal yet, but it's getting to be a much
bigger deal. The recent introduction of some newer ways to
deliver the drug, specifically by means of a topical gel, has
increased the use significantly. The gel works much better than
some of the other methods that have been used in the past, such
as a patch."

Despite the many claims for testosterone replacement
therapy, Blazer believes caution is called for until there is
conclusive evidence as to its efficacy and safety.

"We feel like we're at a very early stage of understanding
what the therapeutic benefit of the testosterone might be, and
we're also at a very early stage in understanding what the
potentially harmful side effects may be."