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In addition, secondary outcomes included measurements evaluating the general health and well-being of the patients by questionnaires and assessment tools.

Phase III Study Findings

The trial randomized a total of 237 male hypogonadal patients (117 patients treated in the 1000 mg dose arm and 120 patients treated in the 750 mg dose arm). The patient completion rate of all 5 injections with NEBIDO was over 80%, demonstrating very high treatment compliance for a one-year study. Reasons for discontinuation were similar between the treatment groups.

Of the 97 patients in the 1000 mg arm receiving their steady-state injection, 94% had a Cavg over the course of the 12-week period that was within the normal range, demonstrating that treatment with NEBIDO successfully maintained therapeutic testosterone levels in hypogonadal men with injections given only once every 12 weeks (just 4 to 5 times per year). Further, no patients in the 1000 mg arm exceeded a testosterone concentration of 2500 ng/dL; four of 97 (4.1%) patients had a peak level over 1800 ng/dL; and 11 of 97 (11.3%) patients had a peak level exceeding 1500 ng/dL. The duration of time any patient had a concentration over these Cmax thresholds was brief.

Of the 102 patients in the 750 mg arm receiving their fourth injection, 86% had a Cavg within the normal range. No patients in the 750 mg arm exceeded a testosterone level of either 2500 ng/dL or 1800 ng/dL, and only four of 102 (3.9%) patients had a peak level exceeding 1500 ng/dL. For those few patients exceeding the 1500 ng/dL threshold, the duration of time above the threshold was brief.

Both treatment arms demonstrated improvements from baseline in key secondary clinical outcome variables.

Both doses of the drug were well-tolerated as indicated b
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