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临床试验/ACTRN12615000071527
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

发起方
Department of Andrology, Concord Repatriation General Hospital

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