Androgel is a gel containing testosterone. It is administered through the skin for treatment of low testosterone levels. It belongs to a class of drugs called androgens. Other testosterone replacement products include Androderm , Axiron , Testim, and Fortesta. Testosterone is the major male sex hormone responsible for the normal growth and development of the male sex organs and secondary sex characteristics. These effects include development of the prostate, penis, and scrotum; distribution of facial, pubic, chest and axillary hair; development of a deep voice and alterations in muscle mass and fat distribution. Low production of testosterone leads to erectile dysfunction , reduced sexual desire, fatigue and loss of energy, depression , regression of secondary sexual characteristics, and weakening of bones ( osteoporosis ). Androgel and other testosterone replacement products supplement or replace natural production of testosterone and reverse symptoms of low testosterone levels. The FDA approved Androgel in February 2000.
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 ].