A Study of LY900010 (LY2452473 + Tadalafil) in the Treatment of Men With Erectile Dysfunction
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 410
- Locations
- 1
- Primary Endpoint
- Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 45 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
10 mg tadalafil + placebo
Intervention: placebo (LY2452473) (Drug)
1 milligram (mg) LY2452473 + 5 mg tadalafil
Intervention: LY2452473 (Drug)
10 mg tadalafil + placebo
Intervention: placebo (tadalafil) (Drug)
1 milligram (mg) LY2452473 + 5 mg tadalafil
Intervention: placebo (tadalafil) (Drug)
5 mg LY2452473 + placebo
Intervention: placebo (tadalafil) (Drug)
5 mg tadalafil + placebo
Intervention: placebo (tadalafil) (Drug)
5 mg LY2452473 + 5 mg tadalafil
Intervention: placebo (tadalafil) (Drug)
5 mg tadalafil + placebo
Intervention: placebo (LY2452473) (Drug)
5 mg LY2452473 + placebo
Intervention: LY2452473 (Drug)
5 mg LY2452473 + 5 mg tadalafil
Intervention: LY2452473 (Drug)
1 milligram (mg) LY2452473 + 5 mg tadalafil
Intervention: tadalafil (Drug)
5 mg LY2452473 + 5 mg tadalafil
Intervention: tadalafil (Drug)
10 mg tadalafil + placebo
Intervention: tadalafil (Drug)
5 mg tadalafil + placebo
Intervention: tadalafil (Drug)
Outcomes
Primary Outcomes
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score
Time Frame: 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.
Secondary Outcomes
- 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)