ACTRN12607000363482尚未招募1 期
The Effect of Androgen Therapy on Endothelial Progenitor Cell Mobilisation and Function in Healthy Men
Dr. Martin Ng, Royal Prince Alfred Hospital.0 个研究点目标入组 40 人开始时间: 2007年7月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 35 Years 至 60 Years（—）
- 性别
- Male
入选标准
- •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.
排除标准
- •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.
研究者
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