Bioequivalence study comparing AndroForte 5 (Registered Trademark (R)) and Testogel (R) 1%

Exclusion Criteria28

• Untreated obstructive sleep apnoea as determined by the Berlin Sleep Apnoea questionnaire
• Clinically significant non-malignant disease including, active clinically significant infection (requiring systemic antibiotics), cerebrovascular event or transient ischemic attack within 12 months prior to randomisation or major surgery within 3 months of randomisation
• Active cardiac disease defined as one or more of the following
• New York Heart Association functional classification of heart failure of greater than or equal to 2 or symptomatic angina
• Uncontrolled arrhythmias, or arrhythmias deemed clinically significant by the investigator
• Myocardial infarction, cardiac stenting or angioplasty in past 6 months
• Prior history of prostate cancer or other malignancy, which could affect compliance with the protocol or interpretation of study results. Cancer(s) treated with curative intent (including non-melanoma skin cancer) are eligible if disease-free for at least 2 years.
• Any form of respiratory failure requiring oxygen supplementation
• Evidence of a significant medical illness, abnormal laboratory finding or adverse event from prior androgen replacement therapy that would, in the investigators’ judgment, make the participant inappropriate for this study
• Receipt of therapy with another investigational drug within 4 weeks of Day 1 or current enrolment in another clinical trial
• Current smoker or past smoker who has ceased smoking within the past year
• Elevated blood pressure (greater than or equal to 140/90mmHg) at screening or a diagnosis of hypertension unless on stable therapy for at least 3 months and currently normotensive
• History of mental illness (requiring ongoing psychotropic medications)
• Active substance abuse
• Known to be human immunodeficiency virus (HIV) or hepatitis B surface antigen positive
• Planned elective surgery within 1 month of randomisation or during the study period
• Generalised skin disease on the abdomen that may be affected by or affect testosterone absorption at the site of transdermal absorption – e.g. psoriasis
• Body Mass Index (BMI) of less than 18 kg/m2 or more than 35 kg/m2 as either extreme may result in hypogonadism responsive to normalisation of weight
• Currently on medications, herbal remedies or vitamins/juices (e.g. grapefruit juice) known to
• Be strong inducers/ inhibitors of Cytochrome 3A4 (CYP 3A4)
• Affect the production (e.g. opiates, gonadotropin releasing hormone (GnRH) agonists) or action (e.g. spironolactone) of androgens
• Affect the production of SHBG (e.g. thyroxine, insulin, growth hormone, antiepileptics), unless the dose has been stable for at least 3 months and will remain so.
• Dementia or altered cognitive function that would interfere with the participant’s safety or compliance to the study procedures
• Use of topical salves or topical steroids to abdomen within past 7 days
• Participants unwilling to adhere to the guidelines in regard to intimate contact post application
• Known allergy to almonds
• Participants experiencing severe voiding symptoms as identified on the International Prostate Symptom Score (IPSS) questionnaire
• Men who are able to father a child who are unwilling to use an acceptable method of contraception during the trial