Pharmacokinetic Study to Determine Time to Steady-state of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Serum T Concentration at Steady State
研究概览
简要总结
The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.
详细描述
Serum testosterone levels will be obtained in hypogonadal (serum testosterone <300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-state is reached.
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
- •Male, age 18-75
- •Morning serum testosterone (T) <300 ng/dL on two occasions
- •Naive to androgen-replacement therapy or willing to wash-out from current T therapy
排除标准
- •Significant intercurrent disease
- •Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history of prostate cancer.
- •Serum transaminases >2 times upper limit of normal
- •Serum bilirubin >2.0 mg/dL
- •Hematocrit <35% or >50%
- •Untreated, obstructive sleep apnea.
研究组 & 干预措施
Testosterone Undecanoate
Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.
干预措施: Testosterone undecanoate (Drug)
结局指标
主要结局
Serum T Concentration at Steady State
时间窗: pre-dose on Days 1, 3, 5, 6, and 7
Serum T at steady state by evaluating the day-to-day changes in pre-dose concentrations on Days 1, 3, 5, 6, and 7 of treatment.
Serum T Concentration at Steady-State
时间窗: pre-dose on Days 10, 14, 17, 21, 24, 27, and 28
Serum T at steady-state by evaluating the day-to-day changes in pre-dose concentrations on Days 10, 14, 17, 21, 24, 27, and 28 of treatment.
次要结局
未报告次要终点