ACTRN12618000755235已完成未知
Testosterone plus exercise to improve muscle strength and performance in men affected by inclusion body myositis (IBM).
Perron Institute for Neurological and Translational Science0 个研究点目标入组 15 人开始时间: 2018年5月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- 18 Years 至 o limit(—)
- 性别
- Male
入选标准
- •Adult men with a diagnosis of IBM in accordance with the ENMC criteria 2011 who are
- •able to provide informed consent.
- •Inclusion criterion for the extension study:
- •*Completion of the first 26 week phase of the study.
排除标准
- •- Active cardiovascular disease (unstable angina, myocardial infarction, stroke, transient
- •ischaemic attack, or revascularisation procedure within the past 12 months)
- •- History of prostate cancer or other major medical comorbidity (e.g. advanced lung disease or cancer)
- •- Men on anti-androgen drugs for benign prostatic hyperplasia (BPH)
- •- Elevated blood pressure ( >160 mmHg systolic and > 100 mmHg diastolic)
- •- Abnormal prostate examinations suspicious for malignancy
- •- Total cholesterol > 6.5 mmol/L or LDL > 4.0 mmol/L
- •- eGFR <45 ml/min
- •- Testosterone concentration must be in the 5-14 nmol/L range with non-elevated haematocrit and PSA. Men with Testosterone concentration <5 nmol/L would be referred for endocrine assessment, and can participate if no pituitary or testicular disease is found.
研究者
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