Pharmacokinetic Study of Testosterone Enanthate

3 Arm Open-label Randomized Multidose Study of Pharmacokinetics, Safety & Tolerability of Testosterone Enanthate Administered Subcutaneously Via an Auto-injector Device or Intramuscular Testosterone Enanthate in Hypogonadal Adult Males

Relative Bioavailability and Safety comparison of 3 formulations of Testosterone Enanthate.

Standard Pharmacokinetic (PK) analyses of data for serum testosterone were done. Cmax, Area Under Curve (AUC), and Cavg were used for the comparison of relative bioavailability of the treatments and reference arm.

Safety comparisons were based upon the occurrence, severity and rate of treatment emergent adverse events.

Inclusion Criteria:

• Adult males aged 18 to 75 with a documented diagnosis of hypogonadism

Exclusion Criteria:

• Normal testosterone levels
• Subjects with any clinically significant medical condition which, in the opinion of the Investigator, would make the subject an unsuitable candidate for enrollment in the study