A Trial to Evaluate the Ongoing Skin Safety of Testosterone MD-Lotion Formulations
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone MD-Lotion
Intervention description: 30 mg to 120 mg administered topically once daily for 60 days
Intervention MeSH terms: Testosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Testosterone replacement treatment is the most effective way of treating hypogonadism in men.
      Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study
      will assess the occurrence of skin safety events for a further two months of continuous use
      of the Testosterone MD-Lotion® (cutaneous solution) after completion of the MTE08
      (NCT00702650) trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hypogonadal males with a qualifying general medical health who have Completed the
             MTE08 trial up to and including Day 120/121 in a compliant manner

          -  Were able to communicate with the trial staff, understand the Trial Information Sheet
             and sign the Written Informed Consent Forms; were willing to follow the Protocol
             requirements and comply with Protocol restrictions and procedures

        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