EUCTR2010-021268-13-IE进行中（未招募）1 期
The Effects of Normalising Sex Hormone Levels in Obese Hypogonadal Men: A Prospective Randomized Comparator Controlled Parallel Arm Clinical Trial - Normalising Sex Hormone Levels in Obese Hypogonadal Men
niversity College Dublin0 个研究点目标入组 90 人开始时间: 2010年10月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
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 30kg/m2
- •3.Serum total testosterone concentrations less than 8.0nmol/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.
- •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
- •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 >19)
- •11.Erythrocytosis (Haematocrit > 0.5, or Haemoglobin > 17g/dl)
- •12.Prostate specific antigen (PSA) level >3ng/ml
- •13.Moderate to severe chronic kidney disease (eGFR <30ml/min/1.73m2)
- •14.Severe liver disease (serum Alanine Transferase level >150IU/L)
- •15.Significant cardiomyopathy (Left ventricular ejection fraction <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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