ACTRN12619001691134尚未招募未知
A randomised, double-blind, placebo-controlled, parallel group study to determine whether Testosterone treatment on a background of exercise improves physical function, pain and body composition in men with OsteoArthritis of the Knee (TEX-OAK)
awley Pharmaceuticals Pty Ltd0 个研究点目标入组 30 人开始时间: 2019年12月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
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
- 40 Years 至 74 Years（—）
- 性别
- Male
入选标准
- •Key inclusion criteria adult men with significant knee OA in accordance with ACR guidelines who are able to provide informed consent
- •Inclusion criteria
- •-Aged 40-74 years
- •-Men with significant knee pain on most days (defined as VAS>40mm)
- •-Meet American College of Rheumatology (ACR) clinical criteria for knee OA confirmed by a rheumatologist
- •-Baseline testosterone less than or equal to 14nmol/L
排除标准
- •Exclusion criteria
- •-Major knee surgery within the last 3 months
- •-Major knee trauma/ significant knee injury within the last 6 months
- •-Arthroscopy or open surgery in the index knee in the last 12 months
- •-Injections of corticosteroids (last 3 months) or hyaluronic acid (last 6 months)
- •-Organic hypogonadism
- •-History of prostate cancer
- •-Suspected malignancy on DRE
- •-Elevated PSA
- •-Elevated haematocrit
- •-Other forms of inflammatory arthritis
- •-Active cardiovascular disease (unstable angina, myocardial infarction, stroke, transient ischaemic attack, or revascularisation procedure within the past 12 months)
- •-Other major co-morbidity (eg advanced lung disease or cancer)
- •-Use of androgens or anti-androgen drugs in past 12 months
- •-Untreated hypertension
研究者
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