Trial Outcomes & Findings for A Study in Erectile Dysfunction (NCT NCT01130532)
NCT ID: NCT01130532
Last Updated: 2013-01-04
Results Overview
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).
COMPLETED
PHASE4
623 participants
Baseline through 12 weeks
2013-01-04
Participant Flow
This study consisted of 4 periods. Period I was a 4-week, as needed, run-in period. Period II was a 4-week, non-drug, wash-out period. Period III was a 12-week (Weeks 0-12), double-blind treatment. Period IV was a 4-week (Weeks 13-16), open-label treatment extension. Only participants completing Period III were eligible to continue into Period IV.
Participant milestones
| Measure |
2.5 mg Titrated to 5 mg Tadalafil
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
|
5 mg Tadalafil
5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
|
Placebo
Placebo for 12 weeks during double-blind treatment period.
|
5 mg Tadalafil Open-Label Extension
5 mg Tadalafil for 4 weeks during open-label treatment extension period.
|
|---|---|---|---|---|
|
Period III (Weeks 0-12)
STARTED
|
207
|
207
|
209
|
0
|
|
Period III (Weeks 0-12)
Received at Least 1 Dose of Study Drug
|
205
|
205
|
207
|
0
|
|
Period III (Weeks 0-12)
COMPLETED
|
186
|
189
|
190
|
0
|
|
Period III (Weeks 0-12)
NOT COMPLETED
|
21
|
18
|
19
|
0
|
|
Period IV (Weeks 13-16)
STARTED
|
0
|
0
|
0
|
562
|
|
Period IV (Weeks 13-16)
Received at Least 1 Dose of Study Drug
|
0
|
0
|
0
|
546
|
|
Period IV (Weeks 13-16)
COMPLETED
|
0
|
0
|
0
|
552
|
|
Period IV (Weeks 13-16)
NOT COMPLETED
|
0
|
0
|
0
|
10
|
Reasons for withdrawal
| Measure |
2.5 mg Titrated to 5 mg Tadalafil
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
|
5 mg Tadalafil
5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
|
Placebo
Placebo for 12 weeks during double-blind treatment period.
|
5 mg Tadalafil Open-Label Extension
5 mg Tadalafil for 4 weeks during open-label treatment extension period.
|
|---|---|---|---|---|
|
Period III (Weeks 0-12)
Adverse Event
|
3
|
3
|
2
|
0
|
|
Period III (Weeks 0-12)
Entry Criteria Not Met
|
4
|
2
|
4
|
0
|
|
Period III (Weeks 0-12)
Lack of Efficacy
|
2
|
0
|
1
|
0
|
|
Period III (Weeks 0-12)
Lost to Follow-up
|
2
|
2
|
3
|
0
|
|
Period III (Weeks 0-12)
Protocol Violation
|
0
|
0
|
1
|
0
|
|
Period III (Weeks 0-12)
Sponsor Decision
|
3
|
4
|
2
|
0
|
|
Period III (Weeks 0-12)
Withdrawal by Subject
|
7
|
7
|
6
|
0
|
|
Period IV (Weeks 13-16)
Adverse Event
|
0
|
0
|
0
|
1
|
|
Period IV (Weeks 13-16)
Entry Criteria Not Met
|
0
|
0
|
0
|
1
|
|
Period IV (Weeks 13-16)
Lost to Follow-up
|
0
|
0
|
0
|
5
|
|
Period IV (Weeks 13-16)
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
Baseline Characteristics
A Study in Erectile Dysfunction
Baseline characteristics by cohort
| Measure |
2.5 mg Titrated to 5 mg Tadalafil
n=207 Participants
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
|
5 mg Tadalafil
n=207 Participants
5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
|
Placebo
n=209 Participants
Placebo for 12 weeks during double-blind treatment period.
|
Total
n=623 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
57.3 years
STANDARD_DEVIATION 10.68 • n=5 Participants
|
58.1 years
STANDARD_DEVIATION 10.36 • n=7 Participants
|
57.6 years
STANDARD_DEVIATION 10.17 • n=5 Participants
|
57.6 years
STANDARD_DEVIATION 10.39 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
207 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
623 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
199 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
596 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
173 Participants
n=5 Participants
|
177 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
517 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
199 participants
n=5 Participants
|
195 participants
n=7 Participants
|
191 participants
n=5 Participants
|
585 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
Region of Enrollment
Puerto Rico
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline through 12 weeksPopulation: All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
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).
Outcome measures
| Measure |
2.5 mg Titrated to 5 mg Tadalafil (Period III)
n=194 Participants
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
|
5 mg Tadalafil (Period III)
n=197 Participants
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
|
Placebo (Period III)
n=199 Participants
Placebo for 12 weeks during double-blind treatment period (Period III).
|
|---|---|---|---|
|
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)
|
38.7 percentage of participants
|
39.6 percentage of participants
|
12.1 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-EF measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
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. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
Outcome measures
| Measure |
2.5 mg Titrated to 5 mg Tadalafil (Period III)
n=194 Participants
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
|
5 mg Tadalafil (Period III)
n=197 Participants
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
|
Placebo (Period III)
n=199 Participants
Placebo for 12 weeks during double-blind treatment period (Period III).
|
|---|---|---|---|
|
Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score
|
7.9 units on a scale
Standard Error 0.49
|
8.1 units on a scale
Standard Error 0.49
|
1.8 units on a scale
Standard Error 0.49
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-IS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Self-reported intercourse satisfaction over the past 4 weeks. IIEF-IS is the sum of Questions 6, 7 and 8 of the IIEF. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction) for each question, with the total possible score for the 3 questions of 0 to 15. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
Outcome measures
| Measure |
2.5 mg Titrated to 5 mg Tadalafil (Period III)
n=194 Participants
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
|
5 mg Tadalafil (Period III)
n=197 Participants
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
|
Placebo (Period III)
n=198 Participants
Placebo for 12 weeks during double-blind treatment period (Period III).
|
|---|---|---|---|
|
Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Intercourse Satisfaction (IIEF-IS) Domain Score
|
2.8 units on a scale
Standard Error 0.21
|
2.6 units on a scale
Standard Error 0.21
|
0.6 units on a scale
Standard Error 0.21
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF-OS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Self-reported overall satisfaction over the past 4 weeks. IIEF-OS is the sum of Questions 13 and 14; each question scored as 1 (low/no satisfaction) through 5 (high satisfaction) with total subscore for the 2 questions of 2 to 10. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
Outcome measures
| Measure |
2.5 mg Titrated to 5 mg Tadalafil (Period III)
n=194 Participants
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
|
5 mg Tadalafil (Period III)
n=197 Participants
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
|
Placebo (Period III)
n=199 Participants
Placebo for 12 weeks during double-blind treatment period (Period III).
|
|---|---|---|---|
|
Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function - Overall Satisfaction (IIEF-OS) Domain Score
|
2.4 units on a scale
Standard Error 0.16
|
2.4 units on a scale
Standard Error 0.16
|
0.6 units on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline SEP Questions assessment, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Questions 1-5. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
Outcome measures
| Measure |
2.5 mg Titrated to 5 mg Tadalafil (Period III)
n=193 Participants
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
|
5 mg Tadalafil (Period III)
n=195 Participants
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
|
Placebo (Period III)
n=196 Participants
Placebo for 12 weeks during double-blind treatment period (Period III).
|
|---|---|---|---|
|
Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5
Question 1: Able to Achieve Erection
|
12.2 percentage of "yes" responses
Standard Error 1.63
|
11.4 percentage of "yes" responses
Standard Error 1.62
|
1.8 percentage of "yes" responses
Standard Error 1.62
|
|
Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5
Question 2: Able to Insert
|
26.2 percentage of "yes" responses
Standard Error 2.25
|
26.1 percentage of "yes" responses
Standard Error 2.23
|
6.9 percentage of "yes" responses
Standard Error 2.23
|
|
Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5
Question 3: Successful Intercourse
|
37.3 percentage of "yes" responses
Standard Error 2.52
|
39.4 percentage of "yes" responses
Standard Error 2.50
|
12.6 percentage of "yes" responses
Standard Error 2.51
|
|
Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5
Question 4: Satisfied with Hardness
|
44.2 percentage of "yes" responses
Standard Error 2.73
|
42.8 percentage of "yes" responses
Standard Error 2.70
|
11.5 percentage of "yes" responses
Standard Error 2.71
|
|
Change From Baseline to 12-Week in Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 1-5
Question 5: Overall Satisfaction with Experience
|
43.6 percentage of "yes" responses
Standard Error 2.70
|
41.2 percentage of "yes" responses
Standard Error 2.68
|
10.6 percentage of "yes" responses
Standard Error 2.68
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline TSS measurement, excluding those with International Index of Erectile Function - Erectile Function (IIEF-EF) domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
The TSS measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
Outcome measures
| Measure |
2.5 mg Titrated to 5 mg Tadalafil (Period III)
n=189 Participants
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
|
5 mg Tadalafil (Period III)
n=189 Participants
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
|
Placebo (Period III)
n=192 Participants
Placebo for 12 weeks during double-blind treatment period (Period III).
|
|---|---|---|---|
|
Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient
Confidence to complete sexual activity
|
27.0 units on a scale
Standard Error 1.78
|
29.2 units on a scale
Standard Error 1.78
|
3.8 units on a scale
Standard Error 1.77
|
|
Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient
Ease of erection
|
24.0 units on a scale
Standard Error 1.69
|
24.7 units on a scale
Standard Error 1.69
|
4.1 units on a scale
Standard Error 1.68
|
|
Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient
Pleasure from sexual activity
|
22.6 units on a scale
Standard Error 1.58
|
22.7 units on a scale
Standard Error 1.58
|
3.3 units on a scale
Standard Error 1.57
|
|
Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient
Erectile function satisfaction
|
31.0 units on a scale
Standard Error 1.82
|
33.6 units on a scale
Standard Error 1.81
|
4.9 units on a scale
Standard Error 1.81
|
|
Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Patient
Satisfaction with orgasm
|
25.6 units on a scale
Standard Error 1.90
|
26.3 units on a scale
Standard Error 1.89
|
6.2 units on a scale
Standard Error 1.88
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline participant's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
The TSS - patient satisfaction with medication measured participant satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.
Outcome measures
| Measure |
2.5 mg Titrated to 5 mg Tadalafil (Period III)
n=189 Participants
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
|
5 mg Tadalafil (Period III)
n=189 Participants
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
|
Placebo (Period III)
n=192 Participants
Placebo for 12 weeks during double-blind treatment period (Period III).
|
|---|---|---|---|
|
Treatment Satisfaction Scale (TSS) - Patient Satisfaction With Medication Score at Week 12 Endpoint
|
53.7 units on a scale
Standard Error 1.98
|
55.9 units on a scale
Standard Error 1.98
|
24.8 units on a scale
Standard Error 1.97
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline IIEF question 15 (Sexual Confidence) assessment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Self-reported erectile function over the past 4 weeks. Question 15, confidence in the ability to get an erection, is scored from 1 (very low confidence) to 5 (very high confidence). Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
Outcome measures
| Measure |
2.5 mg Titrated to 5 mg Tadalafil (Period III)
n=194 Participants
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
|
5 mg Tadalafil (Period III)
n=197 Participants
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
|
Placebo (Period III)
n=199 Participants
Placebo for 12 weeks during double-blind treatment period (Period III).
|
|---|---|---|---|
|
Change From Baseline to 12-Week Endpoint in the International Index of Erectile Function (IIEF) Question 15 (Sexual Confidence)
|
1.2 units on a scale
Standard Error 0.08
|
1.3 units on a scale
Standard Error 0.08
|
0.3 units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Baseline, 12 weeksPopulation: All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's TSS measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
The TSS measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score for each of five TSS domains (confidence to complete sexual activity, ease of erection, pleasure from sexual activity, erectile function satisfaction, and satisfaction with orgasm) was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Least Squares (LS) mean of the change from baseline to endpoint is from an analysis of covariance (ANCOVA). The model included centered-baseline as a covariate and factors of study, treatment group, and pooled site within study, and centered-baseline-by-treatment-group interaction.
Outcome measures
| Measure |
2.5 mg Titrated to 5 mg Tadalafil (Period III)
n=184 Participants
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
|
5 mg Tadalafil (Period III)
n=186 Participants
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
|
Placebo (Period III)
n=187 Participants
Placebo for 12 weeks during double-blind treatment period (Period III).
|
|---|---|---|---|
|
Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner
Confidence to complete sexual activity
|
23.7 units on a scale
Standard Error 2.01
|
27.2 units on a scale
Standard Error 1.99
|
2.0 units on a scale
Standard Error 1.99
|
|
Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner
Ease of erection
|
23.1 units on a scale
Standard Error 1.76
|
25.3 units on a scale
Standard Error 1.75
|
0.7 units on a scale
Standard Error 1.75
|
|
Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner
Pleasure from sexual activity
|
18.2 units on a scale
Standard Error 1.69
|
18.5 units on a scale
Standard Error 1.68
|
1.3 units on a scale
Standard Error 1.68
|
|
Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner
Erectile function satisfaction
|
28.6 units on a scale
Standard Error 1.84
|
28.5 units on a scale
Standard Error 1.83
|
3.4 units on a scale
Standard Error 1.83
|
|
Change From Baseline to 12-Week Endpoint in Treatment Satisfaction Scale (TSS) - Partner
Satisfaction with orgasm
|
18.7 units on a scale
Standard Error 2.06
|
21.0 units on a scale
Standard Error 2.05
|
3.6 units on a scale
Standard Error 2.04
|
SECONDARY outcome
Timeframe: Week 12Population: All randomized participants who received at least 1 dose of study drug, had a baseline and at least 1 post-baseline partner's satisfaction with medication measurement, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
The TSS - partner satisfaction with medication measured participant's partner satisfaction with treatment based on a 13-item questionnaire. The overall score was converted to a 0-100 scale with higher numbers on the scale indicating greater satisfaction. Satisfaction with medication was analyzed using analysis of covariance (ANOVA). The model included factors of study, treatment group, and pooled site within study.
Outcome measures
| Measure |
2.5 mg Titrated to 5 mg Tadalafil (Period III)
n=184 Participants
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
|
5 mg Tadalafil (Period III)
n=186 Participants
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
|
Placebo (Period III)
n=187 Participants
Placebo for 12 weeks during double-blind treatment period (Period III).
|
|---|---|---|---|
|
Treatment Satisfaction Scale (TSS) - Partner Satisfaction With Medication Score at Week 12 Endpoint
|
52.5 units on a scale
Standard Error 1.97
|
55.7 units on a scale
Standard Error 1.96
|
27.5 units on a scale
Standard Error 1.96
|
SECONDARY outcome
Timeframe: 12 weeks through 16 weeksPopulation: All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
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 open-label extension treatment period (Period IV).
Outcome measures
| Measure |
2.5 mg Titrated to 5 mg Tadalafil (Period III)
n=178 Participants
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
|
5 mg Tadalafil (Period III)
n=179 Participants
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
|
Placebo (Period III)
n=183 Participants
Placebo for 12 weeks during double-blind treatment period (Period III).
|
|---|---|---|---|
|
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
|
54.5 percentage of participants
|
59.8 percentage of participants
|
62.8 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks and 16 weeksPopulation: All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 IIEF-EF measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
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.
Outcome measures
| Measure |
2.5 mg Titrated to 5 mg Tadalafil (Period III)
n=178 Participants
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
|
5 mg Tadalafil (Period III)
n=179 Participants
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
|
Placebo (Period III)
n=183 Participants
Placebo for 12 weeks during double-blind treatment period (Period III).
|
|---|---|---|---|
|
Change From 12 Weeks to 16 Weeks in Participant's International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score
End of Week 12
|
22.4 units on a scale
Standard Deviation 6.71
|
22.5 units on a scale
Standard Deviation 7.07
|
16.0 units on a scale
Standard Deviation 7.39
|
|
Change From 12 Weeks to 16 Weeks in Participant's International Index of Erectile Function - Erectile Function (IIEF-EF) Domain Score
End of Week 16
|
24.1 units on a scale
Standard Deviation 6.44
|
24.2 units on a scale
Standard Deviation 6.46
|
24.4 units on a scale
Standard Deviation 6.73
|
SECONDARY outcome
Timeframe: 12 weeks and 16 weeksPopulation: All participants who were entered the open-label treatment, received at least 1 dose of study drug during open-label treatment, had Week 12 and at least 1 SEP diary Question 3 measurement during open-label treatment, excluding those with IIEF-EF domain score ≥26 ("normal") at baseline. Last observation carried forward (LOCF) principle was used.
Assessed the percentage of Yes responses to the SEP diary Question 3 "Did your erection last long enough for you to have successful intercourse?" from Week 12 (end of double-Blind treatment) to Week 16 (end of open-label treatment).
Outcome measures
| Measure |
2.5 mg Titrated to 5 mg Tadalafil (Period III)
n=176 Participants
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
|
5 mg Tadalafil (Period III)
n=177 Participants
5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
|
Placebo (Period III)
n=181 Participants
Placebo for 12 weeks during double-blind treatment period (Period III).
|
|---|---|---|---|
|
Change From Week 12 to Week 16 Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 3
End of Week 12
|
68.3 percentage of "yes" responses
Standard Deviation 38.25
|
69.0 percentage of "yes" responses
Standard Deviation 37.88
|
43.1 percentage of "yes" responses
Standard Deviation 39.03
|
|
Change From Week 12 to Week 16 Percentage of "Yes" Responses to Sexual Encounter Profile (SEP) Questions 3
End of Week 16
|
75.0 percentage of "yes" responses
Standard Deviation 34.49
|
75.5 percentage of "yes" responses
Standard Deviation 34.89
|
80.0 percentage of "yes" responses
Standard Deviation 34.37
|
Adverse Events
2.5 mg Titrated to 5 mg Tadalafil
5 mg Tadalafil
Placebo
5 mg Tadalafil Open-Label Extension
Serious adverse events
| Measure |
2.5 mg Titrated to 5 mg Tadalafil
n=205 participants at risk
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
|
5 mg Tadalafil
n=205 participants at risk
5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
|
Placebo
n=207 participants at risk
Placebo for 12 weeks during double-blind treatment period.
|
5 mg Tadalafil Open-Label Extension
n=546 participants at risk
5 mg Tadalafil for 4 weeks during open-label treatment extension period.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
General disorders
Chest discomfort
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Nervous system disorders
Syncope
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
Other adverse events
| Measure |
2.5 mg Titrated to 5 mg Tadalafil
n=205 participants at risk
2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
|
5 mg Tadalafil
n=205 participants at risk
5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
|
Placebo
n=207 participants at risk
Placebo for 12 weeks during double-blind treatment period.
|
5 mg Tadalafil Open-Label Extension
n=546 participants at risk
5 mg Tadalafil for 4 weeks during open-label treatment extension period.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Ear and labyrinth disorders
Motion sickness
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Ear and labyrinth disorders
Vertigo
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Eye disorders
Cataract
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Eye disorders
Vision blurred
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Gastrointestinal disorders
Diarrhoea
|
0.98%
2/205 • Number of events 2
|
1.5%
3/205 • Number of events 3
|
1.4%
3/207 • Number of events 3
|
0.00%
0/546
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Gastrointestinal disorders
Dyspepsia
|
0.98%
2/205 • Number of events 2
|
2.9%
6/205 • Number of events 6
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/205
|
0.98%
2/205 • Number of events 2
|
0.00%
0/207
|
0.00%
0/546
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.97%
2/207 • Number of events 2
|
0.00%
0/546
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
General disorders
Chest pain
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
General disorders
Fatigue
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
General disorders
Hernia
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
General disorders
Impaired healing
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
General disorders
Influenza like illness
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
General disorders
Irritability
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
General disorders
Oedema peripheral
|
0.98%
2/205 • Number of events 2
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
General disorders
Pyrexia
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
General disorders
Suprapubic pain
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Infections and infestations
Bronchitis
|
1.5%
3/205 • Number of events 3
|
0.98%
2/205 • Number of events 2
|
0.00%
0/207
|
0.00%
0/546
|
|
Infections and infestations
Cellulitis
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Infections and infestations
Device related infection
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Infections and infestations
Furuncle
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Infections and infestations
Gastroenteritis viral
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Infections and infestations
Infected bites
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Infections and infestations
Influenza
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Infections and infestations
Nasopharyngitis
|
0.98%
2/205 • Number of events 2
|
1.5%
3/205 • Number of events 3
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Infections and infestations
Otitis externa
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Infections and infestations
Otitis media
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Infections and infestations
Pneumonia
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Infections and infestations
Prostate infection
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Infections and infestations
Sinusitis
|
0.49%
1/205 • Number of events 1
|
1.5%
3/205 • Number of events 3
|
0.48%
1/207 • Number of events 1
|
0.37%
2/546 • Number of events 2
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Infections and infestations
Upper respiratory tract infection
|
1.5%
3/205 • Number of events 3
|
0.98%
2/205 • Number of events 2
|
1.4%
3/207 • Number of events 3
|
0.00%
0/546
|
|
Infections and infestations
Viral infection
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Infections and infestations
Wound infection
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.49%
1/205 • Number of events 1
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/205
|
0.98%
2/205 • Number of events 2
|
0.00%
0/207
|
0.00%
0/546
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Injury, poisoning and procedural complications
Exposure via father
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/205
|
0.98%
2/205 • Number of events 2
|
0.00%
0/207
|
0.00%
0/546
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/205
|
0.00%
0/205
|
0.97%
2/207 • Number of events 2
|
0.00%
0/546
|
|
Injury, poisoning and procedural complications
Overdose
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Investigations
Cytology abnormal
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Investigations
Heart rate increased
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Investigations
Weight increased
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/205
|
0.00%
0/205
|
1.4%
3/207 • Number of events 3
|
0.00%
0/546
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
3/205 • Number of events 3
|
2.9%
6/205 • Number of events 6
|
0.48%
1/207 • Number of events 1
|
0.37%
2/546 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Musculoskeletal and connective tissue disorders
Joint hyperextension
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/205
|
0.98%
2/205 • Number of events 2
|
0.00%
0/207
|
0.00%
0/546
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.49%
1/205 • Number of events 1
|
0.49%
1/205 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.18%
1/546 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.49%
1/205 • Number of events 1
|
1.5%
3/205 • Number of events 3
|
0.00%
0/207
|
0.00%
0/546
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/205
|
0.98%
2/205 • Number of events 2
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/205
|
0.49%
1/205 • Number of events 3
|
0.00%
0/207
|
0.00%
0/546
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Nervous system disorders
Dizziness
|
0.49%
1/205 • Number of events 1
|
1.5%
3/205 • Number of events 3
|
0.48%
1/207 • Number of events 1
|
0.18%
1/546 • Number of events 2
|
|
Nervous system disorders
Headache
|
2.0%
4/205 • Number of events 4
|
4.4%
9/205 • Number of events 9
|
3.4%
7/207 • Number of events 8
|
0.73%
4/546 • Number of events 4
|
|
Nervous system disorders
Nerve compression
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Nervous system disorders
Sciatica
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Nervous system disorders
Syncope
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/205
|
0.00%
0/205
|
0.97%
2/207 • Number of events 2
|
0.00%
0/546
|
|
Psychiatric disorders
Depression
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/205
|
0.00%
0/205
|
0.97%
2/207 • Number of events 2
|
0.00%
0/546
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Renal and urinary disorders
Dysuria
|
0.49%
1/205 • Number of events 1
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Renal and urinary disorders
Haematuria
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Reproductive system and breast disorders
Nipple pain
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Reproductive system and breast disorders
Organic erectile dysfunction
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Reproductive system and breast disorders
Paraesthesia of genital male
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Reproductive system and breast disorders
Penile discharge
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Reproductive system and breast disorders
Spermatocele
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Reproductive system and breast disorders
Testicular pain
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.98%
2/205 • Number of events 2
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.98%
2/205 • Number of events 2
|
0.00%
0/205
|
1.4%
3/207 • Number of events 3
|
0.00%
0/546
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.49%
1/205 • Number of events 1
|
0.49%
1/205 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.18%
1/546 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Surgical and medical procedures
Anal polypectomy
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Surgical and medical procedures
Blepharoplasty
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 2
|
0.00%
0/546
|
|
Surgical and medical procedures
Dental care
|
0.00%
0/205
|
0.00%
0/205
|
0.00%
0/207
|
0.18%
1/546 • Number of events 1
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Surgical and medical procedures
Knee operation
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Surgical and medical procedures
Medical device removal
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.00%
0/207
|
0.00%
0/546
|
|
Surgical and medical procedures
Tooth extraction
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Surgical and medical procedures
Tooth repair
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Surgical and medical procedures
Vasectomy
|
0.49%
1/205 • Number of events 1
|
0.00%
0/205
|
0.00%
0/207
|
0.00%
0/546
|
|
Vascular disorders
Flushing
|
0.49%
1/205 • Number of events 1
|
1.5%
3/205 • Number of events 3
|
0.00%
0/207
|
0.00%
0/546
|
|
Vascular disorders
Hypertension
|
0.98%
2/205 • Number of events 2
|
0.98%
2/205 • Number of events 2
|
1.4%
3/207 • Number of events 3
|
0.18%
1/546 • Number of events 1
|
|
Vascular disorders
Hypotension
|
0.00%
0/205
|
0.49%
1/205 • Number of events 1
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
|
Vascular disorders
Orthostatic hypertension
|
0.00%
0/205
|
0.00%
0/205
|
0.48%
1/207 • Number of events 1
|
0.00%
0/546
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60