An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 主要终点
- Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90
研究概览
简要总结
Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.
The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.
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
- •Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by:
- •Single serum total testosterone concentration < 250 ng/dL, or
- •Two consecutive serum total testosterone concentrations < 300 ng/dL (determined at least one week apart during the screening period).
- •Has a BMI ≥ 22 kg/m2 and < 35 kg/m2.
排除标准
- 未提供
研究组 & 干预措施
1
2% testosterone gel
干预措施: Testosterone (Drug)
结局指标
主要结局
Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90
时间窗: 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90
Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL
次要结局
- Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90(0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90)