Prospective Randomized Double-Blind Study Of Sperm Production In Healthy Volunteers Receiving Pregabalin Or Placebo
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 222
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a 50 Percent (%) or More Reduction in Sperm Concentration From Baseline (Bsl) to End of Study (EOS)
研究概览
简要总结
This study is being performed as a Phase IV FDA commitment study and is being powered adequately to assess changes in sperm concentration, FSH and testosterone in healthy male subjects treated with pregabalin as compared to placebo, in addition to confirming lack of effects on sperm motility.
详细描述
This is a Phase 4 FDA commitment study. The purpose of the study is to evaluate the effects of pregabalin as compared to placebo on sperm concentration in healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy 18 to 55 years old males
排除标准
- •Screening sperm count <20 x 106/mL; screening sperm motility <50% motile (a+b) or <25% Class "a" motile or screening sperm morphology <30% normal or semen volume <1.5 mL or white blood cell count >1 x 106 /mL on any screening visit sample
研究组 & 干预措施
2
干预措施: Placebo (Drug)
1
干预措施: Pregabalin (Drug)
结局指标
主要结局
Percentage of Participants With a 50 Percent (%) or More Reduction in Sperm Concentration From Baseline (Bsl) to End of Study (EOS)
时间窗: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
Baseline is the average of sperm concentrations from semen samples collected on or before Study Day 1. End of study is average of sperm concentrations from semen samples collected at end of washout period (Week 26) following 12 weeks of double-blind treatment. Mean sperm concentration (MSC) of a visit is average of the 2 sperm concentration samples collected at that visit. If sperm concentration was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead. Confidence intervals (CI) based on exact distribution.
次要结局
- Change From Baseline in Sperm Motility to Week 26(Baseline, Week 26 (last observation in the Week 26 window))
- Change From Baseline in Follicle Stimulating Hormone (FSH) to End of Study (EOS)(Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26))
- Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 26(Baseline, Week 26 (last observation in the Week 26 window))
- Change From Baseline in Testosterone to End of Study (EOS)(Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26))
- Change From Baseline in Testosterone to Week 26(Baseline, Week 26 (last observation in the Week 26 window))
- Change From Baseline in Sperm Motility to End of Study (EOS)(Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26))
- Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 12(Baseline, Week 12 (last observation in the Week 12 window))
- Change From Baseline in Testosterone to Week 12(Baseline, Week 12 (last observation in the Week 12 window))
- Change From Baseline in Sperm Motility to Week 12(Baseline, Week 12 (last observation in the Week 12 window))