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The FDA has approved Fortesta (Endo), a topical gel, for testosterone replacement therapy in adult males with hypogonadism. It is classified as a Schedule III controlled substance. Table 1 lists some available testosterone products, including 2 other gels.
HYPOGONADISM — Failure of the testes to produce adequate amounts of testosterone can lead to loss of energy, decreased libido, erectile dysfunction, decreased axillary and pubic hair, loss of muscle mass, anemia and osteoporosis.1 Testosterone serum concentrations are difficult to measure and may require 2 or more determinations. Levels decrease with age, falling by about 1-2% per year after the age of 40.2 The normal range (usually ≥300 ng/dL) is based on serum concentrations in young men. Older men with signs and symptoms of hypogonadism may have levels... more
2. HA Feldman et al. Age trends in the level of serum testosterone and other hormones in middle-aged men: longitudinal results from the Massachusetts male aging study. J Clin Endocrinol Metab 2002; 87:589.
3. Food and Drug Administration. Testosterone gel safety concerns prompt FDA to require label changes, medication guide. Available from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2009/ucm149580.htm. Accessed April 11, 2011.