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临床试验/EUCTR2008-001459-23-GB
EUCTR2008-001459-23-GB进行中(未招募)不适用

Treatment of Testosterone deficiency in men with Sleep Apnoea Syndrome utilising Nebido therapy.

ikolai Sleep Monitoring Clinic0 个研究点开始时间: 2008年6月18日最近更新:
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试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • 20 hypogonadal men requiring Nebido therapy who have proven sleep apnoea syndrome
  • Hypogonadism is defined as:
  • Total testosterone of <8 nmol or free testosterone of < 180 pmol/L
  • Total testosterone between 8-12 nmol/L or free testesterone .180-250 pmol/L who are symptomatic of hypogonadism:
  • - Diminished libido and erectile quality and frequency
  • -Changes in mood and cognitive ability
  • -Sleep disturbance
  • -Decrease in lean body mass
  • -Increase in visceral fat
  • -Decrease in body hair and skin alterations
  • -Dearcreased bone mineral density
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • The patients are ineligible for the study if there is a current or past history of:
  • - Androgen dependent carcinoma of prostate or male mammary galnd
  • -Liver tumours
  • -Hypersensitivity to Nebido or any of its incipients
  • -Symptoms or signs of prostatic enlargement
  • -Polycythaemia (Haematocrit of 55% or more)
  • -Any general systemic illness
  • -Severe cardiac, hepatic or renal insufficiency
  • or those deemed unable to comply with the requirements of the protocol

研究者

发起方
ikolai Sleep Monitoring Clinic

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