A Study of LY900010 in Erectile Dysfunction
- Conditions
- Erectile Dysfunction
- Interventions
- Registration Number
- NCT01160289
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 410
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10 mg tadalafil + placebo placebo (tadalafil) - 10 mg tadalafil + placebo placebo (LY2452473) - 1 milligram (mg) LY2452473 + 5 mg tadalafil LY2452473 - 1 milligram (mg) LY2452473 + 5 mg tadalafil placebo (tadalafil) - 5 mg LY2452473 + placebo placebo (tadalafil) - 5 mg tadalafil + placebo placebo (tadalafil) - 5 mg LY2452473 + 5 mg tadalafil LY2452473 - 5 mg LY2452473 + 5 mg tadalafil placebo (tadalafil) - 5 mg LY2452473 + placebo LY2452473 - 5 mg tadalafil + placebo placebo (LY2452473) - 1 milligram (mg) LY2452473 + 5 mg tadalafil tadalafil - 5 mg LY2452473 + 5 mg tadalafil tadalafil - 10 mg tadalafil + placebo tadalafil - 5 mg tadalafil + placebo tadalafil -
- Primary Outcome Measures
Name Time Method Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF) Erectile Function (EF) Domain Score 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 Outcome Measures
Name Time Method Change From Baseline to 12 Week Endpoint in IIEF EF Domain Score Reported by Testosterone Concentration Subgroups Baseline, Week 12 The International Index of Erectile Function (IIEF) EF 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 erectile function) to 5 (high erectile function) 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. Testosterone concentration subgroups were based on optimal baseline testosterone levels (\<340 nanograms per deciliter \[ng/dL\] or ≥340 ng/dL). The least squares (LS) mean was estimated from an analysis of covariance (ANCOVA) model that included terms for treatment group, baseline, and baseline\*treatment interaction (if p-value\<0.25).
Change From Baseline to 12 Week Endpoint in the Percentage of "Yes" Responses on the Sexual Encounter Profile (SEP) Diary Baseline, Week 12 The SEP diary was a participant-assessed diary with 5 questions (Q): Q1 (erection achievement), Q2 (successful penetration), Q3 (successful intercourse), Q4 (satisfied with erection), and Q5 (satisfied with sexual experience) for each sexual encounter made over a specified period of time. SEP Q1 to Q5 scores were determined as a percentage of "Yes" responses to each of the 5 questions out of all sexual attempts recorded during the time period. A higher percentage of "Yes" responses indicated better EF. Assessed was the mean change from baseline in the percentage of "Yes" responses to the SEP diary Q1 to Q5. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value \<0.25).
Change From Baseline to 12 Week Endpoint in Prostate-Specific Antigen (PSA) Baseline, Week 12 The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Change From Baseline to 12 Week Endpoint in Fasting Insulin Baseline, Week 12 Change from baseline to 12 Week endpoint in fasting blood insulin concentration. The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Change From Baseline to 12 Week Endpoint in IIEF Domain Scores (Intercourse Satisfaction, Orgasmic Function, Sexual Desire, and Overall Satisfaction) Baseline, Week 12 Intercourse Satisfaction (IS) domain score: sum of Questions (Q) 6, Q7, and Q8, each rated 0 (low/no satisfaction) to 5 (high satisfaction). IS domain score range: 0 to 15; lower scores denoted lower satisfaction. Orgasmic Function (OF) domain score: sum of Q9 and Q10, each rated 0 (no sexual stimulation) to 5 (almost always/always). OF domain score range: 0 to 10; lower scores denoted lower OF. Sexual Desire (SD) domain score: sum of Q11 and Q12, each rated 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). SD domain score range: 2 to 10; lower scores denoted lower SD. Overall Satisfaction (OS) domain score: sum of Q13 and Q14, each rated 1 (low/no satisfaction) to 5 (high satisfaction). OS domain score range: 2 to 10; lower scores denoted lower OS. Least squares (LS) mean estimated from repeated measures analysis of variance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Change From Baseline to 12 Week Endpoint in Total Cholesterol and Triglycerides Baseline, Week 12 The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
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 The least squares (LS) was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
Change From Baseline to 12 Week Endpoint in Fasting Glucose Baseline, Week 12 The least squares (LS) mean was estimated from a repeated measures analysis of covariance model that included terms for treatment, visit, treatment\*visit, baseline, baseline\*treatment (if p-value\<0.25).
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 The percentage of participants whose IIEF Erectile Function (EF) domain scores changed from ≤25 at baseline to \>25 (normal) at Week 12. The IIEF EF domain score was the sum of IIEF Question (Q) 1 to Q5 and Q15. 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.
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇺🇸Spokane, Washington, United States