NCT01765179已完成3 期
Phase III, Open-label Study of the Safety and Efficacy of Oral Testosterone Undecanoate (TU)in Hypogonadal Men
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 25
- 主要终点
- Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL
研究概览
简要总结
The purpose of the study is to determine if oral testosterone undecanoate is effective and safe in the treatment of low testosterone in men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Serum testosterone of less than or equal to 300 ng/dL (the mean of two samples collected 1 hour apart in the morning between 6:00 and 10:00 AM)
排除标准
- •Significant intercurrent disease of any type, in particular liver, kidney, uncontrolled or poorly controlled heart disease including hypertension, CHF or CAD, or psychiatric illness including depression.
- •Recent history of stroke, including transient ischemic attack (TIA) or acute coronary event
- •Untreated, severe obstructive sleep apnea
- •Hematocrit <35% or >48%
- •Serum transaminases >2 times upper limit of normal, serum bilirubin >2.0 mg/dL, and serum creatinine >2.0 mg/dL
- •BMI > or equal to 38
- •Stable doses of lipid-lowering medication for less than three months
- •Stable doses of oral medication for diabetes for less than two months
- •Abnormal prostate digital rectal examination [palpable nodule(s)], elevated PSA (serum PSA >3.9 ng/mL), IPSS score > or equal to 19 points, and /or history of prostate cancer.
- •History of breast cancer
- •Use of dietary supplement saw palmetto or phytoestrogens and use of any dietary supplements that may increase serum T, such as androstenedione or DHEA with the previous 4 weeks
- •Know malabsorption syndrome and/or current treatment iwht oral lipase inhibitors
- •Known history of abuse of alcohol or any drug substance with the previous 2 years
- •Current use of antiandrogens, estrogens, oral CYP3A4 inducers or inhibitors, or long-acting opioid analgesics
- •Receipt of any drug as part of a research study within 30 days of initial dose administration in this study
- •Blood donation within the 12 week period before initial dose administration in this study
研究组 & 干预措施
Oral testosterone undecanoate
Experimental
干预措施: Oral testosterone undecanoate (Drug)
结局指标
主要结局
Percentage of Treated Patients With an Average Serum Testosterone (T) Concentration (Cavg) Between 300 and 1000 ng/dL
时间窗: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114
The number of subjects (116) analyzed includes only those subjects with serum testosterone Cavg data available on study day 114.
次要结局
- Percentage of Treated Patients With Maximum Serum T Concentrations (Cmax) Values in Selected Ranges on Day 114 Efficacy Population(0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on day 114)
研究者
研究点 (25)
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