A Study of LY900010 (LY2452473 + Tadalafil) in the Treatment of Men With Erectile Dysfunction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score
研究概览
简要总结
The primary purpose of the study is to compare the efficacy of LY2452473 + tadalafil to tadalafil alone in improving the erectile function (EF) of men with erectile dysfunction (ED) who incompletely respond to tadalafil alone.
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
- 45 Years 至 70 Years（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
10 mg tadalafil + placebo
干预措施: placebo (LY2452473) (Drug)
1 milligram (mg) LY2452473 + 5 mg tadalafil
干预措施: LY2452473 (Drug)
10 mg tadalafil + placebo
干预措施: placebo (tadalafil) (Drug)
1 milligram (mg) LY2452473 + 5 mg tadalafil
干预措施: placebo (tadalafil) (Drug)
5 mg LY2452473 + placebo
干预措施: placebo (tadalafil) (Drug)
5 mg tadalafil + placebo
干预措施: placebo (tadalafil) (Drug)
5 mg LY2452473 + 5 mg tadalafil
干预措施: placebo (tadalafil) (Drug)
5 mg tadalafil + placebo
干预措施: placebo (LY2452473) (Drug)
5 mg LY2452473 + placebo
干预措施: LY2452473 (Drug)
5 mg LY2452473 + 5 mg tadalafil
干预措施: LY2452473 (Drug)
1 milligram (mg) LY2452473 + 5 mg tadalafil
干预措施: tadalafil (Drug)
5 mg LY2452473 + 5 mg tadalafil
干预措施: tadalafil (Drug)
10 mg tadalafil + placebo
干预措施: tadalafil (Drug)
5 mg tadalafil + placebo
干预措施: tadalafil (Drug)
结局指标
主要结局
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score
时间窗: Baseline, Week 12
The IIEF EF domain score was the sum of Questions (Q) 1 to Q5 and Q15 of the IIEF self-reported questionnaire. Q1 to Q5 were rated 0 (low/no EF) to 5 (high EF) and Q15 was rated 1 (no/low confidence) to 5 (high confidence). IIEF EF domain scores ranged from 1 to 30. Higher scores denoted better EF.
次要结局
- Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups(Baseline, Week 12)
- Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary(Baseline, Week 12)
- Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA)(Baseline, Week 12)
- Change From Baseline to 12 Week Endpoint in Fasting Insulin(Baseline, Week 12)
- Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction)(Baseline, Week 12)
- Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides(Baseline, Week 12)
- Percent Change From Baseline to 12 Week Endpoint in High-Density Lipoprotein Cholesterol (HDL-C) and Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline, Week 12)
- Change From Baseline to 12 Week Endpoint in Fasting Glucose(Baseline, Week 12)
- Change From Baseline to 12 Week Endpoint in the Percentage of Participants Who Return to "Normal" on the International Index of Erectile Function (IIEF) Scale (EF>25)(Baseline, Week 12)