Cases of secondary exposure to testosterone resulting in virilization of children have been reported in postmarket surveillance. Signs and symptoms of these reported cases have included enlargement of the clitoris (with surgical intervention) or the penis, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases with a reported outcome, these signs and symptoms were reported to have regressed with removal of the testosterone gel exposure. In a few cases, however, enlarged genitalia did not fully return to age appropriate normal size, and bone age remained modestly greater than chronological age. In some of the cases, direct contact with the sites of application on the skin of men using testosterone gel was reported. In at least one reported case, the reporter considered the possibility of secondary exposure from items such as the testosterone gel user's shirts and/or other fabric, such as towels and sheets [see WARNINGS AND PRECAUTIONS ].
It is suggested that bioavailable testosterone represents the fraction of circulating testosterone that readily enters cells and better reflects the bioactivity of testosterone than does the simple measurement of serum total testosterone. Also, varying levels of SHBG can result in inaccurate measurements of bioavailable testosterone. Decreased SHBG levels can be seen in obesity, hypothyroidism , androgen use, and nephritic syndrome (a form of kidney disease ). Increased levels are seen in cirrhosis , hyperthyroidism , and estrogen use. In these situations, measurement of free testosterone may be more useful.