a titration trial to determine the effectiveness of testosterone md-lotion (cutaneous solution) formulations

Conditions: Hypogonadism

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