NCT01092858终止4 期
Effect of Exercise Alone or in Combination With Testosterone Replacement on Muscle Strength and Quality of Life in Older Men With Low Testosterone Concentrations: a Randomized Double-blind, Placebo Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 4
- 主要终点
- Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks
研究概览
简要总结
The design of the study is a standard double-blind design, which is needed in this study to allow for unbiased evaluation of efficacy and safety. The effect of the additional impact of testosterone replacement therapy in hypogonadal men on muscle strength and quality of life in comparison to physical exercise alone will be assessed. Treatment duration will be 54 weeks, to monitor the increase as well as the "steady state" of the parameters assessed.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men aged 60 years and older (>60yrs), untrained
- •Symptomatic hypogonadism as defined by a) and b)
- •a) Total testosterone below 12 nmol/l (measurement 7.00-11.00 a.m.)
- •b)Total Aging Males' symptom score above 36
- •Willing to avoid significant change in the pattern of physical exercise and lifestyle for the duration of the study
- •Residence in Cologne Area
排除标准
- •Previous assignment to treatment during this study
- •Use of androgen therapy or anabolic steroids respectively 12 months of entry into the study (i.e. screening visit/visit 1)
- •Current participation in an exercise program or within the last 6 months
- •Suspicion or known history of prostate or breast cancer or other hormone dependent neoplasia
- •Abnormal finding on Digital Rectal Examination (DRE)
- •Prostate specific antigen (PSA) level >4 ng/ml
- •History of clinically significant post void residual urine (> 150 ml)
- •Suspicion or known history of liver tumor
- •Hypersensitivity to the active substances or any of the excipients of NEBIDO e.g. benzyl-benzoate and castor oil
- •Blood coagulation irregularities presenting an increased risk of bleeding after intramuscular injections including vitamin-K-antagonists or other strong anticoagulants
- •32 Additional Exclusion Criteria
研究组 & 干预措施
Arm 1
Experimental
干预措施: Testosterone Undeconate (Nebido, BAY86-5037) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Dynamic maximum strength -one repetition maximum (1-RM ) - of upper and lower extremity after 54 weeks
时间窗: At baseline, at week 54
次要结局
- Isometric maximum strength(At baseline, at week 54)
- Grip strength(At baseline, at week 54)
- Chair raising test(At baseline, at week 54)
- Arm curl test(At baseline, at week 54)
- Bicycle stress test with spirometry(At baseline, at week 54)
- SF-36 Questionnaire(At baseline, at week 54)
- AMS-Questionnaire(At baseline, at week 54)
- FINGER Questionnaire(At baseline, at week 54)
研究者
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