An Open Label, Dose-Proportionality, Bioavailability and Dose- Titration Investigation of the Pharmacokinetics, Metabolism, Efficacy and Safety of Two Testosterone Matrix Transdermal Systems (28 cm2 and 48 cm2) in Hypogonadal Men
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percent of Subjects With Testosterone Levels in the Normal Range.
研究概览
简要总结
Watson's testosterone transdermal system delivers male sex hormone through skin for the treatment of men with sex hormone insufficiency.
详细描述
The present study is designed to characterize efficacy and safety of testosterone from the Watson's testosterone matrix transdermal system (TMTS).
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, 18 - 65 years of age;
- •Documented testosterone deficiency;
- •BMI 18 to 33.
排除标准
- •Evidence of prostate cancer and benign prostate hyperplasia;
- •Taking medications that interfere testosterone metabolism;
- •History of alcohol or drug substance abuse;
- •Abnormal ECG;
- •Allergic to transdermal products;
- •Skin condition that interfere transdermal system application and assessment
研究组 & 干预措施
TMTS treatment
Following a lead-in dose-proportionality phase (Days 1-2) and a site-to-site bioavailability phase (Days 2-9), subjects were dosed for efficacy analysis beginning on Day 9 at dose level B (a single 48 cm2 testosterone matrix transdermal system). Based on pharmacokinetic (PK) analysis of blood samples drawn on Day 16, on Day 22 subjects could be dose-titrated up to dose level C (one 28 cm2 plus one 48 cm2 TMTS), down to dose level A (one 28 cm2 TMTS), or remain at dose level B. Subjects at all dose levels were pooled for primary efficacy analysis on Days 29/30.
干预措施: testosterone matrix transdermal system (Drug)
结局指标
主要结局
Percent of Subjects With Testosterone Levels in the Normal Range.
时间窗: Day 29/30
Testosterone serum concentration was determined on Day 29/30 and pharmacokinetic (PK) parameters including Cavg and Cmax were calculated for efficacy assessment. Acceptance was defined as at least 75% of subjects with Cavg in the normal range (\>= 300 ng/dL to \<= 1030 ng/dL), at least 85% of subjects with Cmax \<= 1500 ng/dL, no more than 5% of subjects with Cmax between 1800 and 2500 ng/dL, and no subject with Cmax \>= 2500 ng/dL.
次要结局
未报告次要终点