Testosterone, like many anabolic steroids, was classified as a controlled substance in 1991. Testosterone is administered parenterally in normal and delayed-release (depot) forms. In September 1995, the FDA approved testosterone transdermal patches (Androderm), and many transdermal forms and brands are now available including implants, gels, and topical solutions. A testosterone buccal system, Striant, was FDA-approved in July 2003; Striant is a mucoadhesive product that adheres to the buccal mucosa and provides a controlled and sustained release of testosterone. In May 2014, the FDA approved an intranasal gel formulation of testosterone (Natesto). A transdermal patch (Intrinsa) for hormone replacement in women is under investigation; the daily dosages used in women are much lower than for products used in males. The FDA refused approval for Intrinsa in 2004 stating that more data regarding safety, especially in relation to cardiovascular and breast health, were required.
In men, low testosterone levels in the body can be supplemented by hormone replacement with testosterone. Testosterone replacement therapy can be prescribed as an intramuscular injection usually given on a biweekly basis; as a patch or gel placed on the skin, or as putty that is applied to the gums of the mouth. Each of the treatments has its risks and benefits. The decision as to which form of testosterone to use depends upon the clinical situation. Discussions between the patient and health care professional often helps decide which medication to use.
In the United States there are currently no preparations that are FDA approved for testosterone replacement for women.