An Open Label, 6 Month Phase III Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- Testosterone levels
研究概览
简要总结
To determine the safety profile of Androxal in men with secondary hypogonadism.
详细描述
This study is an open-label, multi-center Phase 3 extension study to evaluate the safety on continued treatment with Androxal in subjects who completed either ZA-301 or ZA-302. The study requires 6 study visits (1 for an eye exam) and is approximately 7 months in duration. Subjects will be treated for 26 weeks, starting at a daily dose of 12.5 mg. At Visit 2 (Week 6) subjects who do not achieve morning T values ≥450 ng/dL will be up-titrated to 25 mg. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy, refraction eye exams, clinical laboratory tests and adverse event reporting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Successful completion of either ZA-301 or ZA-302
排除标准
- •Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study
研究组 & 干预措施
Androxal
Androxal (enclomiphene citrate) 12.5 mg, once daily, oral capsule. Subjects will be up-titrated to 25 mg if testosterone levels remain below 450 ng/dL at visit 2.
干预措施: Androxal (Drug)
结局指标
主要结局
Testosterone levels
时间窗: 26 weeks
Values of total morning testosterone levels at each visit
次要结局
- Follicle Stimulating Hormone and Leutinizing Hormone(26 weeks)
- Diabetic Parameters(26 weeks)
- Change in weight and body mass index (BMI)(26 weeks)