An Open-Label, Long-Term Evaluation of the Safety and Efficacy of Avanafil in Men With Erectile Dysfunction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- VIVUS LLC
- 入组人数
- 712
- 试验地点
- 1
- 主要终点
- Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.
研究概览
简要总结
This open-label study is being conducted to evaluate the long-term safety, tolerability, and efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400 subjects will be enrolled and treated with avanafil for up to 52 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Successfully completed the entire treatment period in a qualifying study (TA-301 [NCT00790751] or TA-302 [NCT00809471]);
- •Demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;
- •Made at least 4 attempts at intercourse during the last treatment period of the qualifying trial;
- •Agree to make at least 4 attempts at intercourse each month through the course of this study;
- •Agree not to use any other treatments for erectile dysfunction during participation in this study.
- •Provide written informed consent;
- •Willing and able to comply with scheduled study visits, treatment plan, laboratory tests, and other study procedures.
排除标准
- •Subjects who, in the opinion of the investigator, have developed one or more comorbidities during the qualifying study that would pose a safety concern to their continuation on treatment in study TA-314;
- •Subjects requiring treatment with an excluded medication.
研究组 & 干预措施
avanafil
干预措施: avanafil (Drug)
结局指标
主要结局
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.
时间窗: Baseline, 52 weeks
Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 "Did your erection last long enough for you to have successful intercourse?" Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina
时间窗: Baseline, 52 weeks
Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 "Were you able to insert your penis into your partner's vagina?" Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.
Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score
时间窗: Baseline, End of Treatment
Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 \& 15 ranges from 1 to 30. A higher score indicates better erectile function. Baseline is the observation at Visit 2 of the qualifying study (TA-301/TA-302). End of treatment is the observation at Visit 8 of the last observation carried forward.
次要结局
未报告次要终点