A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations

Exclusion Criteria

• •Any clinically significant chronic illness or finding and/or laboratory testing that would interfere with the trial objectives or safety of the subject
• •Any man in whom testosterone therapy was contraindicated, which included those with:
• •* Known or suspected carcinoma (or history of carcinoma) of the prostate or clinically significant symptoms of benign prostatic hyperplasia and/or clinically significant symptoms of lower urinary obstructions and with a International Prostate Symptoms Score (IPSS) score of greater than or equal to 19
• •* Known or suspected carcinoma (or history of carcinoma) of the breast
• •* Severe liver disease (i.e. cirrhosis, hepatitis or liver tumours or liver function tests \>2 times the upper limit of the normal range values
• •* Active deep vein thrombosis, thromboembolic disorders or a documented history of these conditions
• •* Current significant cerebrovascular or coronary artery disease
• •* Untreated sleep apnoea
• •* Haematocrit of \>54%
• •* Untreated moderate to severe depression
• •Men with clinically significant prostate exam or clinically significant elevated serum Prostate Specific Antigen (PSA) level (\> 4 ng/mL) or age adjusted reference range of PSA values
• •Men taking concomitant medications (prescribed, over-the-counter or complementary) that would affect Sex Hormone Binding Globulin (SHBG) or testosterone concentrations (excluding Testosterone MD-Lotion (cutaneous solution)) or metabolism such as warfarin, insulin, opiates, gonadotropin-releasing hormone analogues (GnRH), 5 alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for physiological replacement doses), estradiol
• •Men with uncontrolled diabetes (Hemoglobin A1c \[HbA1c\] greater than or equal to 10%)
• •Subjects intending to have any surgical procedure during the course of the trial
• •Subjects with a partner of child bearing potential who are not willing to use adequate contraception for the duration of the trial
• •Subjects whose partners are pregnant