NCT01130532已完成4 期
Tadalafil Once Daily Following As-Needed Phosphodiesterase Type 5 Inhibitor Treatment, an Assessment of Return to Normal Erectile Function
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 623
- 试验地点
- 1
- 主要终点
- Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period)
研究概览
简要总结
The purpose of this trial is to evaluate if treatment with tadalafil once daily will allow men to return to normal erectile function in those who did not have normal erectile function following as-needed (PRN) Phosphodiesterase Type 5 (PDE5) Inhibitor treatment.
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
- Triple (Participant, Care Provider, 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
- •At least a 3-month history of erectile dysfunction (ED).
- •Are able to read, understand and provide signed informed consent.
- •Have an International Index of Erectile Function-Erectile Function (IIEF-EF) domain score that is greater than or equal to 17 and less than 26 at screening.
- •Have been taking a maximum dose of sildenafil citrate (100 milligram [mg]), vardenafil (20 mg), or tadalafil (20 mg) on as needed basis for at least one month prior to screening.
- •Anticipate having the same female sexual partner during the study who is willing to participate in the required number of sexual intercourse attempts and complete study measures during the study.
- •Agree to make at least four sexual intercourse attempts during both the 4-week as needed run-in period and the 4-week non-drug run-in period.
- •Agree not to use any other erectile dysfunction (ED) treatment, including herbal therapy during the 4-week non-drug, run-in, the double-blind treatment period, the open label period and for 96 hours after the end of the study.
- •Partner Inclusion Criteria:
- •Are female and at least 18 years of age at screening.
- •Anticipate having the same male study subject as her sexual partner during the study.
- •Able to read, understand and provide signed informed consent.
- •Agree to make the required number of sexual intercourse attempts with the male sexual study partner during the study.
- •Willing to participate in recording responses to the treatment satisfaction scale.
排除标准
- •Have an IIEF-EF domain score of greater than or equal to 26 at screening.
- •Prior ineffective treatment with (or nonresponder to) any PDE5 Inhibitor
- •Have previously used or are currently using any PDE5 inhibitor once daily.
- •Present with ED caused by other primary disorders or ED caused by untreated/inadequately treated endocrine disease.
- •Partner unwilling to complete all study requirements.
- •History of radical prostatectomy or other pelvic surgery or penile implant, or a clinically significant penile deformity, in the opinion of the investigator
- •Exhibit evidence of clinically significant renal insufficiency or hepatobiliary disease, or significant cardiac history as determined by the investigator
- •Currently receive treatment with nitrates, cancer chemotherapy, or antiandrogens
- •Have previously completed or withdrawn from this study or any other study investigating tadalafil for once-daily use.
研究组 & 干预措施
2.5 milligram (mg) titrated to 5 mg Tadalafil
Active Comparator
2.5 mg for 4 weeks, followed by 5 mg for 8 weeks with option to continue treatment at 5 mg for an additional 4 weeks
干预措施: Tadalafil (Drug)
5 mg Tadalafil
Active Comparator
5.0 mg for 12 weeks with option to continue treatment for additional 4 weeks
干预措施: Tadalafil (Drug)
Placebo
Placebo Comparator
for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Having an International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 Through 12-Week Endpoint (Double-Blind Treatment Period)
时间窗: Baseline through 12 weeks
Self-reported erectile function over the past 4 weeks. IIEF- EF is the sum of Questions 1-5 and 15 of the IIEF. Questions 1-5 are scored 0 (low/no erectile function) to 5 (high erectile function) and Question 15 is scored 1 (very low confidence) to 5 (very high confidence), for a total score ranging from 1 to 30. Higher scores represent better erectile function. Data presented are the percentage of participants who return to normal erectile function (IIEF-EF domain score ≥26) at end of double-blind treatment period (Period III).
次要结局
- Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score(Baseline, 12 weeks)
- Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score(Baseline, 12 weeks)
- Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score(Baseline, 12 weeks)
- Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5(Baseline, 12 weeks)
- Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient(Baseline, 12 weeks)
- Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint(Week 12)
- Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence)(Baseline, 12 weeks)
- Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner(Baseline, 12 weeks)
- Treatment Satisfaction Scale (TSS) - Partner Satisfaction With Medication Score at Week 12 Endpoint(Week 12)
- Percentage of Participants Having International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score Greater Than or Equal to 26 From 12 to 16 Weeks(12 weeks through 16 weeks)
- Change From 12 Weeks to 16 Weeks in Participant's International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score(12 weeks and 16 weeks)
- Change From Week 12 to Week 16 Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 3(12 weeks and 16 weeks)
研究者
研究点 (1)
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