A One Year Open Label Study of Androxal in the Treatment of Secondary Hypogonadism in Men Who Have Completed Protocol ZA-203
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Change in testosterone comparing Androxal to Testim
研究概览
简要总结
The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Successful completion of ZA-203
- •Ability to understand and provide written informed consent
- •Agreement to use a condom, and with a fertile female partner, another form of contraception
- •Agreement to provide semen samples in the clinic
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 or 25 mg
干预措施: Androxal (enclomiphene citrate) (Drug)
Testim (topical testosterone)
干预措施: Testim (topical testosterone) (Drug)
结局指标
主要结局
Change in testosterone comparing Androxal to Testim
时间窗: 1 year
Values of total morning testosterone levels at each visit comparing Androxal (enclomiphene citrate) 12.5 and 25 mg and Testim
次要结局
- Change in leuteinizing hormone and follicle stimulating hormone comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)(1 year)
- Changes in sperm parameters from baseline comparing Androxal (enclomiphene citrate) to Testim (topical testosterone)(1 year)