A Study of the Pharmacokinetics of Testosterone Metered Dose (MD)-Lotion Formulations
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone MD-Lotion
Intervention description: Administered Topically
Intervention MeSH terms: Testosterone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Male
Minimum age: 18 Years
Maximum age: 70 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 evaluate pharmacokinetics of testosterone MD-Lotion formulations.The study will also
      assess safety of the product.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male study participants with a prior documented diagnosis of hypoandrogenism as
             evidenced by previously documented: Hypothalamic, pituitary or testicular disorder or
             a Serum testosterone less than or equal to 300 ng/dL

          -  Were receiving, or in the investigator's opinion were eligible to receive treatment
             for hypoandrogenism

          -  Body Mass Index (BMI) less than 35 kg/m^2

          -  Passed the required laboratory and physical screening tests

          -  Haemoglobin levels at screening greater than or equal to 13.0 g/dL

          -  Adequate venous access on left or right arm

          -  Able to communicate with study staff, understand the study information sheet and sign
             the written Informed Consent forms; willing to follow and comply with study procedures

        Exclusion Criteria:

          -  Any significant history of allergy and/or sensitivity to the drug products or their
             excipients, including any history of sensitivity to testosterone and/or sunscreens

          -  Any clinically significant chronic illness or finding on screening physical exam
             and/or laboratory testing

          -  Chronic skin disorder (e.g. eczema, psoriasis) likely to interfere with transdermal
             drug absorption

          -  Men with suspected reversible hypoandrogenism (i.e. due to medications, stress)

          -  Any man in whom testosterone therapy is contraindicated, which included those with:

               -  Known or suspected carcinoma (or history of carcinoma) of the prostate or
                  symptoms of benign prostatic hyperplasia and/or symptoms of lower urinary
                  obstruction,

               -  Known or suspected carcinoma (or history of carcinoma) of the breast,

               -  Severe liver damage i.e. cirrhosis, hepatitis or liver tumours,

               -  Active deep vein thrombosis, thromboembolic disorders or a documented history of
                  these conditions,

               -  Significant cerebrovascular or coronary artery disease,

               -  Known or suspected sleep apnoea,

               -  Hematocrit > 51%

          -  Men with clinically significant prostate exam or clinically significant elevated serum
             prostate specific antigen (PSA) level, or age adjusted reference range of PSA values.

          -  Current history of drug or alcohol abuse (more than 4 standard drinks per day and/or
             abnormal liver function tests 3 times the upper limit of the normal range values)

          -  Men taking concomitant medications that affect sex hormone binding globulin (SHBG) or
             testosterone concentrations or metabolism, or that were cytochrome P450 inducers or
             inhibitors, anti-coagulants (warfarin), or diabetic medications (insulin),
             anti-histamines

          -  Men involved in sport in which there was screening for anabolic steroids

          -  Men with uncontrolled diabetes (hemoglobin A1c [HbA1c] greater than or equal to 10%)

          -  Men taking any Investigational Product, or who had received an Investigational Product
             within 28 days prior to screening or 5 half-lives (whichever was the longer)

          -  Any contraindication to blood sampling

          -  Study participants who planned to have a surgical procedure during the course of the
             study

          -  Study participants with a partner of child bearing potential who was not willing to
             use adequate contraception (i.e. condoms) for the duration of the study

          -  Study participants whose partners were pregnant