The FDA has approved AndroGel (testosterone gel; Abbott) 1.62% for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism and hypogonadotropic hypogonadism. This approval was based on a two-phase, 364-day controlled clinical study. The first phase was a multicenter, randomized, double-blind, parallel-group, placebo-controlled study of 274 hypogonadal men. All eligible patients received AndroGel 1.62% or placebo once daily and returned to the clinic for periodic testosterone assessments.
The study found 82% of hypogonadal men who took AndroGel 1.62% achieved a normal average testosterone level (300–1,000ng/dL) at Day 112. For those taking AndroGel 1.62%, the average testosterone level achieved at Day 112 was 561ng/dL. During the second phase in the open-label active treatment maintenance period, 78% of men who received AndroGel 1.62% for one year had an average testosterone level in the normal range at Day 364.
Dosage and administration for AndroGel 1.62% differs from AndroGel 1% and the two are not interchangeable. At the starting dose, AndroGel 1.62% contains 40.5mg of testosterone in two pump presses, whereas AndroGel 1% contains 50mg of testosterone in four pump presses. AndroGel 1.62% is expected to be available in the second quarter of 2011.
For more information call (800) 633-9110 or visit www.abbott.com.