Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems

An Open Label, Dose-Proportionality, Bioavailability and Dose- Titration Investigation of the Pharmacokinetics, Metabolism, Efficacy and Safety of Two Testosterone Matrix Transdermal Systems (28 cm2 and 48 cm2) in Hypogonadal Men

Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.

The present study is designed to characterize efficacy and safety of testosterone from the Watson's testosterone matrix transdermal system (TMTS).

Inclusion Criteria:

• Male, 18 - 65 years of age;
• Documented testosterone deficiency;
• BMI 18 to 33.

Exclusion Criteria:

• Evidence of prostate cancer and benign prostate hyperplasia;
• Taking medications that interfere testosterone metabolism;
• History of alcohol or drug substance abuse;
• Abnormal ECG;
• Allergic to transdermal products;
• Skin condition that interfere transdermal system application and assessment