NCT00740194已完成1 期
Reciprocal Influence of Sex Steroid Environment and Adipocyte Function in Men.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effects of sex steroids on adipocytes
研究概览
简要总结
Aromatase inhibition versus estradiol during 1 week
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Informed consent obtained.
- •Male subjects
- •Age 18 - 40
- •weight < 120 kg
排除标准
- •Primary hypogonadism or secondary hypogonadism due to genetic causes (Kallman syndrome etc.), tumors, infiltrative diseases, infections, pituitary apoplexy, trauma, critical illness, chronic systemic illness or intentional.
- •Treatment with insulin, corticoids, opiates (on a daily basis), androgen- or estrogen analogs or CYP2A6 substrates (Dexmedetomidine, Ifosfamide, Methoxsalen, Miconazole, Tranylcypromine).
- •Impaired renal function defined as serum-creatine > 1.5 mg/dL
- •Impaired liver function, defined as ALAT > 2.5 times upper limit of normal
- •Clinically significant active cardiovascular disease including history of myocardial infarction within the past 6 months and/or heart failure (NYHA class III or IV) at the discretion of the investigator
- •Cancer or any clinically significant disease or disorder, which in the investigator's opinion could interfere with the results of the trial
- •Palpable prostate nodule or induration, PSA > 3 ng/mL, prostatism, untreated sleep apnee syndrome, erythrocytosis (hematocrit > 50%) or hyperviscosity.
- •Known or suspected abuse of alcohol or narcotics
- •Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation.
研究组 & 干预措施
1
Experimental
Aromatase inhibition
干预措施: Aromatase inhibition (Drug)
2
Active Comparator
Estradiol
干预措施: Estradiol (Drug)
结局指标
主要结局
Effects of sex steroids on adipocytes
时间窗: 1 week
次要结局
- Effects of sex steroids on lipid metabolism(1 week)
研究者
研究点 (1)
Loading locations...
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