General Information

Testim is an externally administered testosterone supplement, indicated for men with abnormally low levels of the hormone. Testosterone is responsible for normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. Abnormally low levels of testosterone are linked to a decline in energy, decreased muscle mass, reduced bone density, decreased libido and sexual function, fatigue and depression.

Testim is approved for use in treating men with low testosterone levels but has not been clinically evaluated in males under 18 years of age.

Mechanism of Action

Testim is a novel, topical gel formulation that supplements low levels of testosterone in men. The active pharmacological ingredient in Testim is testosterone.

Side Effects

Adverse events associated with the use of Testim may include, but are not limited to, the following:

• Application site reactions
• Benign prostatic hyperplasia
• Decreased blood pressure
• Increased blood pressure
• Gynecomastia
• Headache
• Increased hematocrit/hemoglobin
• Hot Flashes
• Insomnia
• Lacrimation
• Increased mood swings
• Smell disorder
• Taste disorder
• Spontaneous penile erection

Dosing/Administration

Testim (testosterone gel) is a clear to translucent hydroalcoholic topical gel containing 1 percent testosterone and provides continuous transdermal delivery of testosterone for 24 hours, following a single application to intact, clean, dry skin of the shoulders and upper arms. One 5 g or two 5 g tubes contain 50 mg or 100 mg of testosterone, respectively, to be applied daily to the skin’s surface. Approximately 10 percent of the applied testosterone dose is absorbed across skin of average permeability during a 24-hour period.

Clinical Trial Results

Clinical trials of Testim involved 644 hypogonadal men treated at more than 70 centers in six countries. Auxilium found that Testim normalized testosterone levels and improved sexual function and other symptoms associated with low testosterone. Of 192 hypogonadal men who were appropriately titrated with Testim and who had sufficient data for analysis, 74 percent achieved an average serum testosterone level within the normal range on treatment day 90.

Auxilium's worldwide development program for Testim also included a placebo-controlled testosterone replacement study with over 400 patients at 43 centers in the U.S.

Additional Information

For additional web site information on Testim, please visit the web site.