None listed
Conditions
Brief summary
The first aim of CAPTIVE is to determine in a randomised double-blind, placebo-controlled trial whether two years treatment with intramuscular testosterone undecanoate is non-inferior to placebo in its effect on non-calcified coronary plaque burden. The second aim is to determine whether testosterone treatment is superior to placebo in slowing progression of coronary atherosclerosis. This study will be conducted in 558 men aged 50-74 years with central adiposity (waist 95 cm or more) and low-normal baseline testosterone (14 nmol/L or less). The primary outcome will be normalised non-calcified coronary plaque volume as measured on computed tomography coronary angiography (CTCA) at baseline and 2 years, with secondary outcomes of high risk plaque characteristics and pericoronary adipose tissue attenuation.
Interventions
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.
Sponsors
The University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
50 Years to 74 Years
Healthy volunteers
Yes
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
Exclusion criteria
Age greater than or equal to 75 years (to exclude older men more likely to be frail or have limited mobility) Presence of hypothalamic, pituitary or testicular disease Use of androgens or anti-androgen therapy within past 12 months Known CVD (established angina, MI, heart failure, stroke, transient ischaemic attack or coronary or carotid artery revascularisation) Previous unprovoked deep vein thrombosis or pulmonary embolism Current anticoagulation (relative contraindication for deep intramuscular injections: use of aspirin in low-moderate dose, or fish oil, are not exclusions) Any malignancy apart from non-melanoma skin cancer Untreated hyper- or hypothyroidism Diabetes mellitus requiring the use of insulin Ongoing episode of major depression or other significant psychiatric disorder Excessive alcohol intake (greater than or equal to 14 standard drinks/week) Use of medications known to affect the production or action of testosterone (e.g. GnRH agonists, spironolactone, or regular opioids) or sex hormone binding globulin (e.g. insulin, growth hormone, antiepileptics, thyroid hormone) Major systemic illnesses (e.g. HIV infection, chronic viral hepatitis) Previous (within past 5 years) or planned bariatric surgery
Outcome results
None listed