NCT00696748Unknown3 期
A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study With Open-Label Follow-up to Investigate the Effect of IM Testosterone Undecanoate on Biochemical and Anthropometric Characteristics of Metabolic Syndrome in Hypogonadal Men
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- waist-to-hip ratio
研究概览
简要总结
The objective of the study is to assess the effect of the testosterone therapy on the body composition, lipid and glucose metabolism, inflammatory markers in patients with metabolic syndrome and hypogonadism.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •A signed informed consent to participate in the study
- •Men aged 35 to 70 with testosterone levels below 12 nmol/L or free testosterone below 225 pmol/L
- •Presence of the metabolic syndrome according to the IDF definition
排除标准
- •Patients under 35 or above 70 years.
- •Participation in any clinical study within 30 days before the first injection of the drug
- •Simultaneous participation in another clinical study
- •Incapable subjects as well as prisoners
- •Suspicion of a serious organic or mental disease according to medical history and/or clinical examination
- •Prostate cancer, breast cancer or suspicion thereof
- •Presence or history of hepatic tumors
- •Acute or chronic hepatic disease
- •Presence of renal diseases with renal failure
- •Changes in biochemical or hematological laboratory values in spite of lack of clinical manifestations, in the investigator's opinion
- •Suspected lack of the patient's compliance
- •Hypersensitivity to the active substance
研究组 & 干预措施
1
Active Comparator
Men receiving Nebido
干预措施: Nebido (testosterone undecanoate) (Drug)
2
Placebo Comparator
Men receiving Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
waist-to-hip ratio
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (1)
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