Tadalafil 5 mg Once a Day Compared to Placebo in Improving Erectile Dysfunction and Sexual Quality of Life
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)
研究概览
简要总结
To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner
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
- •History of erectile dysfunction (ED) for at least 3 months duration
- •Anticipate having the same female partner willing to participate throughout the study
- •At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts during the early phase of the study
- •Adequate partner sexual function as determined by a Female Sexual Function Index
- •Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study
排除标准
- •May not participate in the study if you have taken tadalafil previously.
- •History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study.
- •Have sexual partner not willing to complete the scales.
- •Use of nitrates.
研究组 & 干预措施
1
Placebo
干预措施: Placebo (Drug)
2
5 mg tadalafil
干预措施: tadalafil (Drug)
结局指标
主要结局
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)
时间窗: Baseline and 12 weeks
Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.
Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)
时间窗: Baseline and 12 weeks
The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life.
Change From Baseline to Endpoint in the Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3).
时间窗: Baseline and 12 weeks
The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject's percentage of "yes" responses to those questions during the run-in period and postbaseline period, respectively.
次要结局
- Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response(Baseline and 12 weeks)
- Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response(Baseline and 12 weeks)
- Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain(12 weeks)
- Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response(Baseline and 12 weeks)
- Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response(Baseline and 12 weeks)
- Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response(Baseline and 12 weeks)
- Percent of Subjects With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Subject Response(12 weeks)
- Percent of Partners With "Yes" Responses to Global Assessment Questionnaire (GAQ) - Partner Response(12 weeks)
- Change From Baseline to 12 Week Endpoint in Percent of "Yes" Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response(Baseline and 12 weeks)
- Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire(Baseline and 12 weeks)
- Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales(Baseline and 12 weeks)