A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations

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