Drug Name: Testim
Company: Auxilium Pharmaceuticals
Approval Status: Approved October 2002
Treatment for: Low Testosterone

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.

Clinical 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% 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.

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

Mechanism of Action
Testim is a novel, topical gel formulation that supplements low levels of testosterone in men. Testim (testosterone gel) is a clear to translucent hydroalcoholic topical gel containing 1% 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 contains 50 mg or 100 mg of testosterone, respectively, to be applied daily to the skin's surface. Approximately 10% of the applied testosterone dose is absorbed across skin of average permeability during a 24-hour period.