NCT02803073撤回2 期
Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After A Recent Myocardial Infarction.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Metabolic Equivalent
研究概览
简要总结
The purpose of this study is to determine the effects of testosterone replacement in hypogonadal men on exercise tolerance and cardiac rehabilitation after an acute myocardial infarction.
详细描述
Testosterone deficiency can decrease muscle strength. The researchers will replace testosterone in hypogonadal men undergoing rehabilitation exercises after heart attack.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All men status-post Myocardial Infarction or Non-ST Elevation-Acute Coronary Syndrome within the last 3-8 weeks enrolling in the cardiac rehabilitation program at Mission Fitness-Medical Center Hospital.
- •Baseline free testosterone levels less than age-specific normal values.
- •Males 18 years and older
排除标准
- •Prostate Specific Antigen greater than age based, ethnic-specific cut points (see Appendix), history of metastatic prostate cancer or symptoms suggestive of severe Benign Prostatic Enlargement.
- •Current use of testosterone, clomiphene or over the counter testosterone boosters
- •Patients initiating cardiac rehabilitation 8+ weeks after MI or Non-ST Elevation-Acute Coronary Syndrome
- •Congestive heart failure, New York Heart Association class IV
- •Life expectancy less than 1 year,
- •Baseline hematocrit of >50%
- •Allergic reactions to testosterone or testosterone vehicle (i.e. cotton seed oil, etc.)
- •Physical inability to participate in rehabilitation program (examples: severe claudication, massive obesity, etc.)
- •Participation in any other concurrent clinical trial, use of an investigational agent or therapeutic regimen within 30 days of study
- •Patients formerly diagnosed with obstructive sleep apnea.
- •Patients using opiate analgesics
- •Patients with aspartate aminotransferase/alanine aminotransferase values more than 3 times normal
- •History of Deep venous thrombosis
研究组 & 干预措施
Testosterone Replacement
Experimental
The experimental group will receive 0.5 ml (100 mg) testosterone cypionate Intramuscular injections each week for 11 weeks.
干预措施: Testosterone (Drug)
Control
Placebo Comparator
Patients in the control group will receive intramuscular normal saline injections.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Metabolic Equivalent
时间窗: 12 weeks
次要结局
- 6 minute walk test(12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Study of the Effect of Testosterone Treatment on Metabolic Parameters and Urinary Symptoms in Bariatric PatientsHypogonadismProstatic HyperplasiaObesityInsulin ResistanceNCT02248467University of Florence100
已完成
4 期
Study on Effects of Testosterone Replacement Therapy in Hypogonadal Type 2 Diabetic Patients" (SETH2)Hypogonadism, MaleObesityDiabetes Mellitus, Type 2NCT03792321University Medical Centre Ljubljana55
已完成
4 期
Exercise Training and Testosterone Replacement in Heart Failure PatientsHeart FailureNCT01852994University of Sao Paulo General Hospital39
已完成
4 期
Testosterone Therapy in Hypogonadal Men Treated With OpioidsHypogonadismNCT02433730Marianne Andersen40
已完成
2 期
Short-term Testosterone Replacement in Testicular Cancer SurvivorsTesticular CancerNCT03339635University Medical Center Groningen32