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临床试验/ACTRN12618000755235
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

发起方
Perron Institute for Neurological and Translational Science

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