ACTRN12615000071527已完成4 期
Testosterone for Androgen Deficiency-Like Symptoms: A three phase, placebo-controlled, double-blind crossover study for males 40 years or older who believe they have androgen-like deficiency to assess whether testosterone gel treatment is superior to a placebo gel.
Department of Andrology, Concord Repatriation General Hospital0 个研究点目标入组 40 人开始时间: 2015年1月27日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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 o limit(—)
- 性别
- Male
入选标准
- •Men aged 40 years or older
- •Believed to have androgen deficiency (AD)
- •Symptoms consistent with AD (according to US clinical guidelines)
- •Provides written, informed consent and is willing to comply with study requirements
排除标准
- •Pathologically-based AD
- •Major chronic illness causing serious disability or with life expectancy less then 2 years in the opinion of the investigator
- •Major cardiovascular event (new or worsened angina, infarction, angioplasty, uncontrolled arrhythmia or hypertension) within the last 6 months
- •Contraindication to testosterone including prostate or breast cancer.
- •History of androgen or other drug abuse within last year.
- •History of HIV or viral hepatitis.
- •Skin disease that may interfere with transdermal drug administration.
- •History of major psychiatric disease or psychological condition that may limit understanding and compliance with study requirements.
- •Regular use of medications that interfere with absorption, metabolism or action of testosterone and may require dosage change during the study.
- •Haematocrit over 0.50 or history of polycythaemia
研究者
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