ISRCTN21665331已完成不适用
The effects of normalising sex hormone levels in obese hypogonadal men: a prospective randomised comparator controlled parallel arm clinical trial
niversity College Dublin (UCD) (Ireland)0 个研究点目标入组 90 人开始时间: 2010年9月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •Men who satisfy all of the following may be included in the study:
- •1. Age between 18 and 65 years inclusive
- •2. Body mass index (BMI) greater than 30 kg/m2
- •3. Serum total testosterone concentrations less than 8.0 nmol/L on two consecutive occasions. The blood that will be used for measurement of the testosterone concentrations will be taken from research participants after a 12 hour fast and between the hours of 0800 to 1100.
- •4. Willingness to voluntarily sign a statement of informed consent to participate in the study
排除标准
- •Men with any of the following conditions will be excluded from the study:
- •1. Use of systemic glucocorticoid, sex hormone or anticoagulant therapy, or a medication known to effect sex hormone bioactivity during the 6 months prior to study entry (i.e., screening visit)
- •2. Known hypersensitivity to the active substances or any of the excipients of Femara® or Nebido®
- •3. Hypothalamic pituitary disease
- •4. Untreated obstructive sleep apnoea syndrome
- •5. Haemophilia
- •6. Psychotic mental illness
- •7. Inability to understand the participant information or to give informed consent
- •8. History of cancer
- •9. History of prostatic intra-epithelial neoplasia (PIN)
- •10. Severe lower urinary tract symptoms (International Prostate Symptom Score greater than 19)
- •11. Erythrocytosis (haematocrit greater than 0.5, or haemoglobin greater than 17 g/dl)
- •12. Prostate specific antigen (PSA) level greater than 3 ng/ml
- •13. Moderate to severe chronic kidney disease (estimated glomerular filtration rate [eGFR] less than 30 ml/min/1.73 m2)
- •14. Severe liver disease (serum alanine transferase level greater than 150 IU/L)
- •15. Significant cardiomyopathy (left ventricular ejection fraction less than 30%)
- •16. Greater than 2 seizures during the 12 months prior to study entry
- •17. Requiring fertility treatment
- •18. Any clinically significant chronic disease that might, in the opinion of the investigator, interfere with the evaluations or preclude completion of the trial (e.g., severe chronic lung disease, terminal illness)
- •19. Previous randomisation into this study
- •20. Concurrent participation in another clinical trial
- •21. Participation in another clinical trial during the twelve weeks prior to study entry (i.e. screening visit)
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