A Prospective Study to Evaluate the Efficacy of Silodosin 8 mg as an on-Demand, Reversible, Nonhormonal Oral Contraceptive for Males:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Pregnancy rate in people treated with sildosin as a male contraceptive
研究概览
简要总结
In all, 200 healthy, sexually active, fertile male candidates will be assigned 100 in silodosin group and 100 in placebo group. Males using other contraceptive methods will be excluded. Follow up data of total spermatozoa per ejaculate, semen volume and Post-ejaculation urinalysis after 2, 6 and 12 weeks of the studied groups will be recorded. The various side effects reported in the study groups after 12 weeks from the start of the study will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male sexually active
排除标准
- •male on oral contraceptives Male with female partner on contraceptives
研究组 & 干预措施
Placebo arm
Oral intake of placebo
干预措施: Oral intake of placebo (Other)
Sildosin arm
Oral intake of sildosin
干预措施: Oral intake of sildosin (Drug)
结局指标
主要结局
Pregnancy rate in people treated with sildosin as a male contraceptive
时间窗: 3 months
Pregnancy rate in people treated with sildosin as a male contraceptive treatment
次要结局
未报告次要终点
研究者
Mahmoud Mohamed Farag Ali
Lecturer and consultant of urology
Benha University