None listed
Conditions
Brief summary
Increasing evidence suggests that sex steroids, including male sex hormones (androgens), may an important role in regulating processes critical to cardiovascular health and disease. The capacity for the body to grow new blood vessels (“angiogenesis”) in response to occluded arteries is a critical reparative process in the cardiovascular response to injury. Recently, endothelial progenitor cells (EPC) derived from bone marrow have been implicated in new blood vessel formation and in cardiac repair in cardiovascular disease. While androgens have long been known to stimulate stem cell proliferation, their effects in EPCs are unknown. The current study will investigate the effects of androgen therapy in young and older men on EPC mobilisation and function. By better understanding the role of androgens in cardiovascular health and disease, our study will substantially strengthen the evidence base on which to guide the increasing efforts to exploit the wider therapeutic benefits of androgens, particularly in the context of the rapidly growing population of aging men.
Interventions
Intervention: Testosterone Undecanoate (1000mg) one intramuscular injection on randomisation and one injection at 6 weeks only.
The participants will return for follow-up assessment at week 12 (1 month post final injection) and at week 16.
Sponsors
Dr. Martin Ng, Royal Prince Alfred Hospital.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
Male
Age
35 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Two age-stratified groups of healthy, ambulatory men, comprising: 1) twenty men = 35 years of age and; 2) twenty men = 60 years of age will be asked to participate in this study.
Exclusion criteria
Men will be excluded from the study if they have diseases of the prostate requiring medical or surgical treatment or have chronic medical diseases or medications likely to interfere with safe participation in androgen therapy.Specific exclusion criteria:Patients will be excluded from the study if any of the following criteria is fulfilled:a) Prostate disease still requiring further medical or surgical treatment. Men with an isolated elevation of PSA or with a history of prostatectomy for benign prostatic hyperplasia may be entered with the agreement of their own or the study urologist. If any doubt, volunteer may only enter study after urological review.b) Currently significant, inadequately controlled chronic medical diseases likely to interfere with safe participation. This includes severe chronic renal & liver disease; unstable chronic pulmonary or cardiovascular disease (including within 6 months of myocardial infarction); uncontrolled or severe hypertension, hyperlipidemia, obstructive sleep apnoea or polycythemia; or cancer with poor prognosis. c) Medical conditions which interfere with evaluation of main study end-points. This includes neuromuscular or skeletal diseases which interfere with reliable mobility or dynamometry testing. Patients with type I diabetes mellitus may be included but will not undergo insulin clamp testing. d) Medications interfering with evaluation of study end-points or changes in dosage during the study. e) Disallowed drugs include, androgens or other sex steroids, anti-androgens, cimetidine, spironolactone, GnRH analogs.f) Allowed medication include fixed doses throughout the study period of bisphosphonates, calcitriol, vitamins, statins, antihypertensives, glucocorticoids, benzodiazepines, over-the-counter & non-prescription medications, herbal medications, aspirin, paracetamol, non-steroidal anti-inflammatory drugs, opiates, anticoagulants.g) History of drug or alcohol abuse or psychological disorders requiring regular psychotrophic medication (other than benzodiazepines).h) Any other condition likely in the judgement of the investigator that makes the patient unable to complete, or unsuitable or unsafe for, the study.i) Any medical condition which in the judgement of the Investigator and sponsor may interfere with the absorption, distribution, metabolism or excretion of the drug. j) Refusal or inability to comply with the protocol.
Outcome results
None listed