Postmarketing Surveillance Study: A Randomized, Open-Label, 3-Month Interventional Study of Tadalafil Effectiveness (2.5 mg and 5 mg) and Long-Term Safety Administered Once Daily in Chinese Men With Erectile Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 635
- 试验地点
- 1
- 主要终点
- Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the study drug, taken once daily, known as tadalafil in Chinese participants with erectile dysfunction (ED). The study will last about up to 25 months for each participant.
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
- None
入排标准
- 年龄范围
- 22 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Have a history of erectile dysfunction for at least 3 months.
- •Are sexually active and willing to remain sexually active with the same female partner during the study.
- •Are willing to have 4 or more attempts of sexual intercourse with female partner between screening and first treatment start day.
- •Are willing to stay away from any other medicines that the participants were already taking for erectile dysfunction during this study period.
排除标准
- •Have erectile dysfunction, which is caused by any other primary sexual disorder.
- •Have certain problems with kidneys, liver, heart, blood sugar levels, eyes, or central nervous system (study doctor will discuss with participants).
- •Have a penis deformity or penile implant that in the opinion of the participants' doctor is significant.
- •Have human immunodeficiency virus (HIV) infection.
- •Are using certain kinds of medicines, which are not allowed in this study.
- •Are allergic to tadalafil.
- •Are planning to father a baby or are in a relationship with a pregnant partner.
- •Are participating or discontinued participation in the past 30 days from any another clinical trial, which is not compatible with this trial.
- •Have participated or discontinued from any other tadalafil clinical trial.
- •Have a history of drug, alcohol, or substance abuse within the past 6 months.
研究组 & 干预措施
2.5 mg/5 mg tadalafil
2.5 mg tadalafil orally once daily for 3 months (Period 1) and then 5 mg tadalafil orally once daily for 21 months (Period 2).
干预措施: Tadalafil (Drug)
5 mg tadalafil
5 mg tadalafil orally once daily for 24 months (Period 1 and Period 2).
干预措施: Tadalafil (Drug)
结局指标
主要结局
Percentage of Participants Experiencing at Least One Treatment Emergent Adverse Event (Serious or Non-Serious)
时间窗: Baseline through Month 12
A Treatment Emergent Adverse Event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline, regardless of causality or severity. The percentage of participants with TEAEs was calculated by dividing the number of participants with at least 1 TEAE over the 12-Month treatment period by the total number of participants analyzed, multiplied by 100%. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
Percentage of Participants Experiencing at Least One Adverse Event Leading to Discontinuation
时间窗: Baseline through Month 12
Data presented are the number of participants who experienced 1 or more AEs (all causalities and drug-related) and serious AEs (SAEs) that lead to discontinuation. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module.
次要结局
- Change From Baseline in the International Index of Erectile Function- Erectile Function (IIEF-EF) Domain Questionnaire Score(Baseline, Month 1; Baseline, Month 3)
- Change From Baseline in the IIEF-EF Domain Questionnaire Score of 5 mg Tadalafil Treatments(Baseline, Month 6; Baseline, Month 12;Baseline, Month 18; Baseline, Month 24)
- Percentage of Participants With "Yes" Responses to Sexual Encounter Profile (SEP) Diary(Month 1, Month 3)
- Percentage of Participants Achieving Normal Erectile Functioning(Month 1, Month 3)
- Percentage of Participants Achieving Normal Erectile Functioning of 5 mg Tadalafil Treatments(Month 6, Month 12, Month 18, Month 24)
- Percentage of Participants With "Yes" Responses to Global Assessment Questions (GAQ)1 and GAQ2(Month 3, Month12, Month 24)