a study of the pharmacokinetics of testosterone metered dose (md)-lotion 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 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