Clinical Trial on Efficacy and Tolerability of Two Different Single Doses of Avanafil in Russia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 189
- 主要终点
- Change in the percentage of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse
研究概览
简要总结
Primary Objective:
o To assess the change in percent of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse between the run-in period and treatment period:
- The change in percent of sexual attempts in which subjects are able to insert the penis into the partner's vagina.
- The change in score on the erectile function (EF) domain of the International Index of Erectile Function (IIEF) questionnaire.
Secondary Objective:
o To evaluate the safety and tolerability of avanafil in patients with erectile dysfunction (ED).
详细描述
The total study duration per patient will be up to 12 weeks, consisting of an 8-week treatment period and a 4-week run-in period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Avanafil dose 1
Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period
干预措施: AVANAFIL (Drug)
Avanafil dose 2
Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period
干预措施: AVANAFIL (Drug)
Placebo
Administered 30 minutes prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period
干预措施: placebo (Drug)
结局指标
主要结局
Change in the percentage of sexual attempts in which subjects are able to maintain an erection of sufficient duration to have successful intercourse
时间窗: 12 weeks
Change in the percentage of sexual attempts in which subjects are able to insert the penis into the partner's vagina
时间窗: 8 weeks
Change from baseline in EF score
时间窗: baseline and 8 weeks
次要结局
- Proportion of patients with adverse events(12 weeks)
- Change from baseline in IIEF-EF risk scores(baseline and 8 weeks)