A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone MD-Lotion
Intervention description: 30 mg to 120 mg administered topically once daily for 120 days
Intervention MeSH terms: Testosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 155.0
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 (cutaneous
      solution), and this study will evaluate the efficacy via pharmacokinetics of various doses of
      this product. The study will also assess safety of the product.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male subjects with a prior documented definitive diagnosis of hypogonadism as
             evidenced by previously documented:

               -  Hypothalamic, pituitary or testicular disorder or age related idiopathic
                  hypogonadism

               -  Screening serum testosterone of less than or equal to 300 ng/dL (based on the
                  average of two morning samples taken at least 30 minutes apart)

          -  Were currently receiving treatment for hypogonadism in accordance with approved
             labelling, or in the Investigator's opinion are eligible to receive such treatment

          -  Body Mass Index (BMI) < 35.0 kg/m^2

          -  Haemoglobin levels at screening greater than or equal to 11.5 g/dL

          -  Adequate venous access on left or right arm to allow collection of a number of samples
             by venipuncture

          -  Ability to communicate with the trial staff, understand the Trial Information Sheet
             and sign the Written Informed Consent Forms; willing to follow the Protocol
             requirements and comply with Protocol restrictions and procedures

        Exclusion Criteria:

          -  Current use of long acting testosterone injectables such as Nebido®

          -  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 that makes it undesirable for the Investigator to enrol the
             trial subject in the trial and/or that in the Investigator's opinion, would interfere
             with the trial objectives or safety of the subject

          -  Chronic skin disorder (e.g. eczema, psoriasis) likely to interfere with transdermal
             drug absorption

          -  Men with suspected reversible hypogonadism

          -  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 obstruction and International Prostate
                  Symptom Scores (IPSS) scores 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 > 51

               -  Untreated moderate to severe depression

          -  Men with clinically significant prostate exam (such as irregularities or nodules
             palpated) or clinically significant elevated serum Prostate Specific Antigen (PSA)
             levels (>4 ng/mL), or age adjusted reference range of PSA values

          -  Current or history of drug or alcohol abuse (more than 4 standard drinks per day
             and/or abnormal liver function tests >2 times the upper limit of the normal range
             values)

          -  Men taking concomitant medications (prescribed, over-the-counter or complementary)
             that would affect sex hormone binding globulin (SHBG) or testosterone concentrations
             or metabolism, warfarin, insulin, opiates, Gonadotropin-releasing hormone (GnRH), 5
             alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for
             physiological replacement doses), estradiol

          -  Men involved in sport in which there is screening for anabolic steroids

          -  Men with uncontrolled diabetes (haemoglobin A1c [HbA1c] greater than or equal to 10%)

          -  Men currently taking any investigational product, or have received an investigational
             product within 28 days prior to screening or 5 half-lives

          -  Any contraindication to blood sampling

          -  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