A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone

An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males

Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.

The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.

Inclusion Criteria:

• Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by:

  • Single serum total testosterone concentration < 250 ng/dL, or
  • Two consecutive serum total testosterone concentrations < 300 ng/dL (determined at least one week apart during the screening period).

• Has a BMI ≥ 22 kg/m2 and < 35 kg/m2.