NCT00816712已完成1 期
A Randomized, Single-Blind, Placebo-Controlled, Single-dose, Parallel Design Study to Evaluate the Effect of Testosterone on Muscle Fractional Synthetic Rate (FSR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone.
研究概览
简要总结
This is a study to evaluate the use of fractional synthetic rate as an early biomarker of muscle anabolism (muscle build-up).
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
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject is weight stable over the past 3 months
- •Patient agrees to refrain from consumption of alcohol from 48 hours prior to entering the study
- •Subject agrees to follow the study restriction of no caffeine while on study
- •Patient agrees to following the meat-free controlled protein weight-maintaining diet
- •Patient is willing to avoid strenuous physical activity
- •Patient has been a nonsmoker for at least 6 months prior to study start
排除标准
- •Subject is currently a regular user of any illicit drugs
- •Subject has taken androgenic steroids in the previous 12 months
- •Subject has participated in sports events, resistance exercise training or heavy exercise in the previous month
- •Subject has prostate cancer
- •Subject has a history of cancer except basal-cell tumors
- •Subject has been diagnosed with HIV
- •Subject has been diagnosed with Hepatitis B or C
- •Subject uses certain anti-inflammatory drugs such as ibuprofen, arcoxia or celecoxib
- •Subject uses a blood anticoagulant, such as Coumadin (Warfarin) or high doses of aspirin
- •Subject is currently taking over the counter supplements such as "muscle builders" or "fat burners"
- •Subject has an allergy or hypersensitivity to intramuscular testosterone
- •Subject has sciatica
- •Subject has donated blood products or has had phlebotomy within 2 months of signing informed consent
- •Subject has undergone a surgical procedure within 1 month of signing informed consent
- •Subject is currently participating or has participated in a study with an investigational drug or device
研究组 & 干预措施
A
Active Comparator
Testosterone - 300 mg IM
干预措施: Comparator: Testosterone 300 mg, intramuscular injection (Drug)
B
Active Comparator
Testosterone - 100 mg IM
干预措施: Comparator: Testosterone 100 mg, Intramuscular injection (Drug)
C
Placebo Comparator
Placebo - IM
干预措施: Comparator: Placebo given by Intramuscular Injection (Drug)
结局指标
主要结局
Thigh (vastus lateralis) muscle protein fractional synthetic rate one week after dosing with testosterone.
时间窗: One week
次要结局
- Variability in the muscle fractional synthetic rate measurements.(One week)
研究者
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