Coronary Atherosclerosis Progression with Testosterone InterVEntion (CAPTIVE)

INTERVENTION: Testosterone undecanoate (Reandron®, Bayer Australia Ltd) 1000 mg/4 ml solution deep intramuscular injection administered at baseline, six weeks after, then every 12 weeks. Total duration of trial is 2 years. Dose administered is 4 mls of 250 mg/ml, 1000 mg testosterone undecanoate in total, site of administration buttock. CONDITION: Cardiovascular ‐ Coronary heart disease Coronary atheroma;Coronary atherosclerosis; ; Coronary atheroma ; Coronary atherosclerosis PRIMARY OUTCOME: Changes in volume of non‐calcified coronary atheromatous plaque from baseline to end of intervention period as measured by Cardiac Computed Tomography Angiography (CCTA); ; [Two years from first study injection] SECONDARY OUTCOME: Low attenuation plaque (<30 Hounsfield Units) assessed using CCTA[Two years from first study injection] Napkin ring sign assessed using CCTA[Two years from first study injection] Plaque Remodelling Index (PRI) >1.10 assessed using CCTA[Two years from first study injection] Spotty calcification (<3mm in size) assessed using CCTA[Two years from first study injection] INCLUSION CRITERIA: Men aged 50‐74 years Waist circumference greater than or equal to 95 cm No known reproductive pathology or CVD Baseline testosterone less than or equal to 14 nmol/L Able and willing to meet protocol requirements, read and understand the Participant Information and Consent Form and provide informed consent