FDA Approves Testosterone for Underarms

The FDA last week approved a testosterone replacement solution for men that is applied to armpits using a deodorant-like applicator, a major milestone for the Australian company that developed the solution (partly owned by Eli Lilly) and a questionable breakthrough for men using the drug to correct a deficiency of the male sex-hormone, which causes low-libido among other problems.

Current testosterone therapies are delivered in a variety of ways including topical gels applied by the hands. The big advantage of armpit application is that it's less likely to rub off on others in the household--partners, children, pets--which can cause serious side effects, for example, aggressive behavior and premature development in children.Middle-aged men aspiring to The Situation's abs are trying testosterone replacement therapy. One downside to the new applicators is that the underarm area has many glands, which would absorb the testosterone with uncertain consequences.

Testosterone therapy is currently approved for use only in men with hypogonadism, whose sex glands produce extremely low amounts of testosterone or none at all because of an underlying disorder. But there's been an explosion of off-label use for age-related symptoms of testosterone decline including erectile dysfunction and decreased sexual desire, fatigue and loss of energy, depression and loss of muscle. We are talking about male menopause--dudes with boobs and no libido--who can blame them for seeking a fix?

There are unanswered questions about the use of testosterone as an anti-aging drug for men. Use of the hormone has been shown to speed the growth of existing hormone-related cancers such as prostate tumors. Earlier this year, a federally funded study of testosterone gel--aiming to increase muscle in elderly, frail men--was halted due to a disproportionate number of heart attacks and other serious cardiac problems in the men on testosterone.

Still, some researchers are forging ahead with more research aimed to explore testosterone's anti-aging powers. Dr. Peter J. Snyder of the University of Pennsylvania School of Medicine is leading a much larger $45 million study financed by the National Institute on Aging. In the 12-center trial, 800 men 65 and older who have low testosterone will be randomly assigned to testosterone treatment or placebo for a year. The trial, which is actually a set of studies, will assess testosterone's effect on physical functioning, fatigue and sexual and cognitive function. ''There is even a cardiovascular trial, the hypothesis of which is that testosterone actually makes cardiac risk factors better,'' Dr. Snyder told the New York Times.

One of the major concerns over testosterone replacement as an anti-aging therapy is that it will be used by men who do not have low testosterone. In addition to serious concerns over the effect on cancer growth and heart disease, use of the hormone by men who do not have low testosterone can cause a host of problems, including shriveled testicles and lowered sperm count....not exactly the turn-on guys are looking for.