Trial Outcomes & Findings for A Study in Patients With Erectile Dysfunction (NCT NCT01122264)
NCT ID: NCT01122264
Last Updated: 2012-10-19
Results Overview
Time to discontinuation of randomized treatment was defined as the number of days from randomization until the day the participant discontinued the randomized treatment. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered switching of treatment. This outcome measure was estimated using the Kaplan-Meier product-limit method.
COMPLETED
PHASE4
770 participants
Baseline up to 334 days
2012-10-19
Participant Flow
Participant milestones
| Measure |
Tadalafil On Demand
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
252
|
257
|
261
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
250
|
257
|
260
|
|
Overall Study
COMPLETED
|
220
|
228
|
214
|
|
Overall Study
NOT COMPLETED
|
32
|
29
|
47
|
Reasons for withdrawal
| Measure |
Tadalafil On Demand
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
6
|
5
|
7
|
|
Overall Study
Death
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
9
|
13
|
|
Overall Study
Entry Criteria Not Met
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
7
|
7
|
9
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
16
|
|
Overall Study
Physician Decision
|
3
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
3
|
1
|
1
|
Baseline Characteristics
A Study in Patients With Erectile Dysfunction
Baseline characteristics by cohort
| Measure |
Tadalafil On Demand
n=252 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=257 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=261 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Total
n=770 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
53.2 years
STANDARD_DEVIATION 11.57 • n=5 Participants
|
52.9 years
STANDARD_DEVIATION 11.69 • n=7 Participants
|
53.0 years
STANDARD_DEVIATION 11.76 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 11.66 • 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
|
252 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
770 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
248 Participants
n=5 Participants
|
251 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
753 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
Portugal
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
18 participants
n=4 Participants
|
|
Region of Enrollment
France
|
99 participants
n=5 Participants
|
102 participants
n=7 Participants
|
100 participants
n=5 Participants
|
301 participants
n=4 Participants
|
|
Region of Enrollment
Greece
|
9 participants
n=5 Participants
|
8 participants
n=7 Participants
|
9 participants
n=5 Participants
|
26 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
16 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
48 participants
n=5 Participants
|
49 participants
n=7 Participants
|
52 participants
n=5 Participants
|
149 participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
21 participants
n=5 Participants
|
63 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
45 participants
n=5 Participants
|
45 participants
n=7 Participants
|
47 participants
n=5 Participants
|
137 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
29 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 334 daysPopulation: The analysis included all randomly assigned participants.
Time to discontinuation of randomized treatment was defined as the number of days from randomization until the day the participant discontinued the randomized treatment. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered switching of treatment. This outcome measure was estimated using the Kaplan-Meier product-limit method.
Outcome measures
| Measure |
Tadalafil On Demand
n=252 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=257 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=261 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Time to Discontinuation of Randomized Treatment
|
NA days
Interval 187.0 to
The median and the 95% confidence interval were not estimable because an insufficient number of participants reached the event at the time of the data cutoff.
|
130 days
Interval 113.0 to
The 95% confidence interval was not estimable because an insufficient number of participants reached the event at the time of the data cutoff.
|
67 days
Interval 64.0 to 77.0
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 16, and 24 weeksPopulation: The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF-EF observation.
Self-reported EF score over past 4 weeks. Items 1-5 scores range from 0 (no sexual activity) to 5 (high EF). Item 15 score ranges from 1 (very low confidence to get/keep erection) to 5 (very high confidence). Total scores range from 1 to 30; lower scores denote greater erectile dysfunction severity. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis included terms for baseline score, treatment group, country, baseline\*treatment (if p\<0.10), visit, and visit\*treatment. Correlation matrix for repeated observations assumed to be unstructured.
Outcome measures
| Measure |
Tadalafil On Demand
n=241 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=251 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=250 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain
Change from Baseline to Week 24 (n=141, 116, 81)
|
10.70 units on a scale
Standard Error 0.43
|
10.01 units on a scale
Standard Error 0.45
|
11.05 units on a scale
Standard Error 0.49
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain
Change from Baseline to Week 4
|
7.92 units on a scale
Standard Error 0.44
|
8.60 units on a scale
Standard Error 0.43
|
8.86 units on a scale
Standard Error 0.43
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain
Change from Baseline to Week 8 (n=231, 232, 232)
|
8.98 units on a scale
Standard Error 0.45
|
9.08 units on a scale
Standard Error 0.45
|
9.70 units on a scale
Standard Error 0.44
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain
Change from Baseline to Week 16 (n=167, 146, 101)
|
10.60 units on a scale
Standard Error 0.41
|
9.93 units on a scale
Standard Error 0.42
|
10.56 units on a scale
Standard Error 0.45
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 16, and 24 weeksPopulation: The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Orgasmic Function observation.
Self-reported orgasmic function on the IIEF over past 4 weeks and consists of 2 questions (items 9 and 10). Each question is rated on a scale from 0 (no sexual stimulation) to 5 (almost always/always). Total scores range from 0 to 10; lower scores represent lower orgasmic function. Least Squares Mean changes from baseline to endpoint for each visit were from a repeated measures analysis and included terms for baseline score, treatment group, country, baseline\*treatment (if p\<0.10), visit, and visit\*treatment. The correlation matrix for the repeated observations was assumed to be unstructured.
Outcome measures
| Measure |
Tadalafil On Demand
n=241 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=251 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=250 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain
Change from Baseline to Week 4
|
1.64 units on a scale
Standard Error 0.16
|
1.75 units on a scale
Standard Error 0.16
|
1.92 units on a scale
Standard Error 0.16
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain
Change from Baseline to Week 16 (n=167, 146, 101)
|
2.37 units on a scale
Standard Error 0.15
|
2.25 units on a scale
Standard Error 0.16
|
2.66 units on a scale
Standard Error 0.17
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain
Change from Baseline to Week 8 (n=231, 232, 232)
|
1.77 units on a scale
Standard Error 0.16
|
2.08 units on a scale
Standard Error 0.16
|
2.26 units on a scale
Standard Error 0.16
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Orgasmic Function Domain
Change from Baseline to Week 24 (n=141, 116, 81)
|
2.55 units on a scale
Standard Error 0.15
|
2.48 units on a scale
Standard Error 0.16
|
2.62 units on a scale
Standard Error 0.18
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 16, and 24 weeksPopulation: The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Sexual Desire observation.
Self-reported sexual desire on IIEF over past 4 weeks; comprises 2 questions (items 11 and 12). Each question rated on a scale from 1 (almost never or low/no sexual desire) to 5 (almost always or very high sexual desire). Total scores range: 2 to 10; lower numerical scores denote lower sexual desire. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis and included terms for baseline score, treatment group, country, baseline\*treatment (if p\<0.10), visit, and visit\*treatment. Correlation matrix for repeated observations assumed to be unstructured.
Outcome measures
| Measure |
Tadalafil On Demand
n=244 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=250 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=249 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain
Change from Baseline to 16 Weeks (n=167, 146, 101)
|
1.15 units on a scale
Standard Error 0.12
|
0.87 units on a scale
Standard Error 0.12
|
1.07 units on a scale
Standard Error 0.14
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain
Change from Baseline to 24 Weeks (n=140, 117, 81)
|
1.19 units on a scale
Standard Error 0.12
|
0.78 units on a scale
Standard Error 0.13
|
1.29 units on a scale
Standard Error 0.14
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain
Change from Baseline to 4 Weeks
|
0.77 units on a scale
Standard Error 0.10
|
0.75 units on a scale
Standard Error 0.10
|
0.69 units on a scale
Standard Error 0.10
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Sexual Desire Domain
Change from Baseline to 8 Weeks (n=230, 232, 232)
|
0.96 units on a scale
Standard Error 0.11
|
0.90 units on a scale
Standard Error 0.11
|
0.87 units on a scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 16, and 24 weeksPopulation: The analysis included all randomly assigned participants who had a baseline and post-baseline SEP observation.
Participant-assessed diary. Has 5 questions (Question\[Q\]1:erection achievement, Q2:successful penetration, Q3:successful intercourse, Q4:satisfied with erection, and Q5:satisfied with sexual experience) for each sexual encounter made over specified period of time. SEP Q1-Q5 scores determined as percentage of 'Yes' responses to each of 5 questions out of all sexual attempts recorded during the time period. Least Squares Mean changes from baseline to endpoint for each visit from a repeated measures analysis included terms for baseline score, treatment group, country, visit, and visit\*treatment.
Outcome measures
| Measure |
Tadalafil On Demand
n=242 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=246 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=248 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q1:Change from Baseline to 4 Weeks
|
14.50 percentage of "yes" responses
Interval 11.82 to 17.18
|
18.49 percentage of "yes" responses
Interval 15.83 to 21.14
|
18.41 percentage of "yes" responses
Interval 15.77 to 21.05
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q1:Change from Baseline to 8 Weeks (n=224,231,229)
|
16.62 percentage of "yes" responses
Interval 14.05 to 19.19
|
19.88 percentage of "yes" responses
Interval 17.33 to 22.43
|
20.41 percentage of "yes" responses
Interval 17.87 to 22.96
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q1:Change from Baseline to 16 Weeks (n=166,146,99)
|
18.46 percentage of "yes" responses
Interval 16.02 to 20.89
|
19.19 percentage of "yes" responses
Interval 16.72 to 21.67
|
20.58 percentage of "yes" responses
Interval 17.9 to 23.27
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q1:Change from Baseline to 24 Weeks (n=139,115,81)
|
19.97 percentage of "yes" responses
Interval 17.78 to 22.15
|
19.60 percentage of "yes" responses
Interval 17.33 to 21.86
|
20.34 percentage of "yes" responses
Interval 17.94 to 22.74
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q2:Change from Baseline to 4 Weeks
|
27.48 percentage of "yes" responses
Interval 23.77 to 31.19
|
28.56 percentage of "yes" responses
Interval 24.87 to 32.24
|
29.64 percentage of "yes" responses
Interval 25.96 to 33.31
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q2:Change from Baseline to 8 Weeks (n=224,231,229)
|
31.16 percentage of "yes" responses
Interval 27.57 to 34.76
|
31.66 percentage of "yes" responses
Interval 28.09 to 35.22
|
34.08 percentage of "yes" responses
Interval 30.52 to 37.64
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q2:Change from Baseline to 16 Weeks (n=166,146,99)
|
32.76 percentage of "yes" responses
Interval 29.38 to 36.14
|
32.76 percentage of "yes" responses
Interval 29.33 to 36.2
|
36.07 percentage of "yes" responses
Interval 32.38 to 39.76
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q2:Change from Baseline to 24 Weeks (n=139,115,81)
|
35.83 percentage of "yes" responses
Interval 32.71 to 38.94
|
34.70 percentage of "yes" responses
Interval 31.48 to 37.92
|
35.93 percentage of "yes" responses
Interval 32.51 to 39.35
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q3:Change from Baseline to 4 Weeks
|
41.52 percentage of "yes" responses
Interval 36.79 to 46.26
|
41.76 percentage of "yes" responses
Interval 37.05 to 46.47
|
44.45 percentage of "yes" responses
Interval 39.76 to 49.13
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q3:Change from Baseline to 8 Weeks (n=224,231,229)
|
47.45 percentage of "yes" responses
Interval 42.65 to 52.26
|
44.58 percentage of "yes" responses
Interval 39.8 to 49.35
|
52.11 percentage of "yes" responses
Interval 47.36 to 56.86
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q3:Change from Baseline to 16 Weeks (n=166,146,99)
|
54.26 percentage of "yes" responses
Interval 49.86 to 58.67
|
50.62 percentage of "yes" responses
Interval 46.14 to 55.11
|
56.96 percentage of "yes" responses
Interval 52.1 to 61.82
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q3:Change from Baseline to 24 Weeks (n=139,115,81)
|
56.39 percentage of "yes" responses
Interval 51.89 to 60.89
|
53.83 percentage of "yes" responses
Interval 49.13 to 58.53
|
56.28 percentage of "yes" responses
Interval 51.18 to 61.38
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q4:Change from Baseline to 4 Weeks
|
49.59 percentage of "yes" responses
Interval 44.22 to 54.97
|
51.78 percentage of "yes" responses
Interval 46.44 to 57.12
|
51.45 percentage of "yes" responses
Interval 46.13 to 56.76
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q4:Change from Baseline to 8 Weeks (n=224,231,229)
|
60.86 percentage of "yes" responses
Interval 55.37 to 66.36
|
55.59 percentage of "yes" responses
Interval 50.14 to 61.05
|
59.28 percentage of "yes" responses
Interval 53.85 to 64.71
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q4:Change from Baseline to 16 Weeks (n=166,146,99)
|
66.17 percentage of "yes" responses
Interval 60.92 to 71.43
|
63.00 percentage of "yes" responses
Interval 57.64 to 68.36
|
66.48 percentage of "yes" responses
Interval 60.65 to 72.31
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q4:Change from Baseline to 24 Weeks (n=139,115,81)
|
72.67 percentage of "yes" responses
Interval 67.46 to 77.89
|
68.06 percentage of "yes" responses
Interval 62.58 to 73.54
|
69.04 percentage of "yes" responses
Interval 63.06 to 75.02
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q5:Change from Baseline to 4 Weeks
|
46.12 percentage of "yes" responses
Interval 40.79 to 51.46
|
45.71 percentage of "yes" responses
Interval 40.41 to 51.01
|
49.63 percentage of "yes" responses
Interval 44.35 to 54.9
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q5:Change from Baseline to 8 Weeks (n=224,231,229)
|
53.92 percentage of "yes" responses
Interval 48.46 to 59.37
|
50.06 percentage of "yes" responses
Interval 44.65 to 55.47
|
55.73 percentage of "yes" responses
Interval 50.33 to 61.13
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q5:Change from Baseline to 16 Weeks (n=166,146,99)
|
61.57 percentage of "yes" responses
Interval 56.26 to 66.88
|
54.56 percentage of "yes" responses
Interval 49.16 to 59.96
|
62.40 percentage of "yes" responses
Interval 56.55 to 68.25
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the Sexual Encounter Profile (SEP)
Q5:Change from Baseline to 24 Weeks (n=139,115,81)
|
65.45 percentage of "yes" responses
Interval 60.29 to 70.6
|
62.17 percentage of "yes" responses
Interval 56.78 to 67.57
|
66.57 percentage of "yes" responses
Interval 60.72 to 72.42
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: The analysis included all randomly assigned participants. The last available GAQ assessment for each participant was used in the analysis.
The GAQ consists of 2 Yes/No/No Response (No Respo) questions. GAQ Question (Q)1: Has the treatment you have been taking during this study improved your erections? GAQ Q2: Has the treatment improved your ability to engage in sexual activity?
Outcome measures
| Measure |
Tadalafil On Demand
n=252 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=257 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=261 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Global Assessment Questions (GAQ)
Q2: Treatment improved ability to engage? No Respo
|
29 participants
|
36 participants
|
49 participants
|
|
Global Assessment Questions (GAQ)
Q1:Treatment improved erections? Yes
|
218 participants
|
219 participants
|
203 participants
|
|
Global Assessment Questions (GAQ)
Q1:Treatment improved erections? No
|
20 participants
|
23 participants
|
34 participants
|
|
Global Assessment Questions (GAQ)
Q1: Treatment improved erections? No Response
|
14 participants
|
15 participants
|
24 participants
|
|
Global Assessment Questions (GAQ)
Q2:Treatment improved ability to engage? Yes
|
209 participants
|
214 participants
|
204 participants
|
|
Global Assessment Questions (GAQ)
Q2:Treatment improved ability to engage? No
|
14 participants
|
7 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Baseline through 24 weeksPopulation: The analysis included all randomly assigned participants who switched erectile dysfunction medication and had a baseline and post-baseline observation.
The number of times participants switched erectile dysfunction medication within the 3 treatments being studied (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand).
Outcome measures
| Measure |
Tadalafil On Demand
n=87 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=120 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=151 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Number of Treatment Switches
|
1.2 number of treatment switches
Standard Deviation 0.4
|
1.2 number of treatment switches
Standard Deviation 0.5
|
1.3 number of treatment switches
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: Baseline through 24 weeksPopulation: All randomly assigned participants were included in the analysis.
Results are reported as the number of participants per sequence of study medications (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) that were taken as a result of switching treatments. The Other Treatment Sequence reports the number of participants per sequence of study medications that were taken as a result of switching treatments more than once. The number of participants who did not switch is also reported.
Outcome measures
| Measure |
Tadalafil On Demand
n=770 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Patterns of Erectile Dysfunction Treatment Change
No Treatment Intake
|
3 participants
|
—
|
—
|
|
Patterns of Erectile Dysfunction Treatment Change
No Switch
|
409 participants
|
—
|
—
|
|
Patterns of Erectile Dysfunction Treatment Change
From Once a Day to Any On Demand
|
95 participants
|
—
|
—
|
|
Patterns of Erectile Dysfunction Treatment Change
From Any On Demand to Once a Day
|
84 participants
|
—
|
—
|
|
Patterns of Erectile Dysfunction Treatment Change
From Any On Demand to Any On Demand
|
97 participants
|
—
|
—
|
|
Patterns of Erectile Dysfunction Treatment Change
Returning Back to Randomized Treatment
|
35 participants
|
—
|
—
|
|
Patterns of Erectile Dysfunction Treatment Change
Other Treatment Sequence
|
47 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 24 weeksPopulation: The analysis included all randomly assigned participants.
The reported reasons for a decision to discontinue from initial randomized treatment prior to Week 24 are reported. Discontinuation of randomized treatment was defined as switching between the 3 study treatments (tadalafil on demand, tadalafil once a day, or sildenafil citrate on demand) or discontinuing from all treatments. A change of dose within the same treatment was not considered as switching of treatment.
Outcome measures
| Measure |
Tadalafil On Demand
n=252 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=257 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=261 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Slow onset of action
|
5 participants
|
9 participants
|
10 participants
|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Completed treatment
|
1 participants
|
1 participants
|
1 participants
|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Lack of efficacy (hardness of erection)
|
46 participants
|
55 participants
|
55 participants
|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Lack of efficacy (duration of erection)
|
7 participants
|
11 participants
|
24 participants
|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Participant discontinuation from the trial
|
11 participants
|
11 participants
|
14 participants
|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Lack of confidence in medication working each time
|
3 participants
|
5 participants
|
2 participants
|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Adverse event
|
7 participants
|
10 participants
|
16 participants
|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Feel medication controls my sexual life
|
1 participants
|
0 participants
|
7 participants
|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Participant did not take any study drug
|
2 participants
|
0 participants
|
1 participants
|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Non-desired spontaneous erections
|
2 participants
|
4 participants
|
0 participants
|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Participants without discontinuation event
|
146 participants
|
122 participants
|
89 participants
|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Time constraints due to short drug action window
|
1 participants
|
0 participants
|
11 participants
|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Partner's request
|
0 participants
|
2 participants
|
3 participants
|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Don't want to take a pill every day
|
0 participants
|
27 participants
|
0 participants
|
|
Reasons for Discontinuation of Randomized Erectile Dysfunction Treatment
Prefer a pill every day, not on demand
|
20 participants
|
0 participants
|
28 participants
|
SECONDARY outcome
Timeframe: 8 weeks up to 334 daysPopulation: The analysis included all randomly assigned participants who completed the 8-week randomized treatment.
The differences in time between the 8-week time point and the discontinuation of all study treatments (that is, discontinuation from the study and not switching to another treatment) are reported by the median (95% confidence interval). Duration was measured as the number of days from Week 8 to the date of the last dose of the study drug. This outcome measure was estimated using the Kaplan-Meier product-limit method.
Outcome measures
| Measure |
Tadalafil On Demand
n=234 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=238 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=236 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Number of Days From the 8-Week Study Visit to the Time the Participant Discontinues From All Phosphodiesterase Type 5 (PDE5) Inhibitor Treatments
|
NA days
The median and the 95% confidence interval were not estimable because an insufficient number of participants reached the event at the time of the data cutoff.
|
NA days
Interval 200.0 to
The median and the 95% confidence interval were not estimable because an insufficient number of participants reached the event at the time of the data cutoff.
|
187 days
Interval 165.0 to
The 95% confidence interval was not estimable because an insufficient number of participants reached the event at the time of the data cutoff.
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 16, and 24 weeksPopulation: The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Intercourse Satisfaction observation.
Self-reported intercourse satisfaction score over past 4 weeks (1 intercourse attempt item, 2 intercourse satisfaction items). Each item range: 0 (no intercourse attempts/no satisfaction) to 5 (more attempts/high satisfaction). Total scores range: 0-15; lower scores=lower intercourse satisfaction. Least Squares Mean changes from baseline to endpoint for each visit from repeated measures analysis and included terms for baseline score, treatment group, country, baseline\*treatment (if p\<0.10), visit, and visit\*treatment. Correlation matrix for repeated observations assumed to be unstructured.
Outcome measures
| Measure |
Tadalafil On Demand
n=242 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=251 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=251 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain
Change from Baseline to Week 4
|
3.21 units on a scale
Standard Error 0.20
|
3.22 units on a scale
Standard Error 0.20
|
3.53 units on a scale
Standard Error 0.20
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain
Change from Baseline to Week 8 (n=231, 232, 232)
|
3.69 units on a scale
Standard Error 0.20
|
3.15 units on a scale
Standard Error 0.20
|
3.95 units on a scale
Standard Error 0.20
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain
Change from Baseline to Week 16 (n=167, 146, 101)
|
4.38 units on a scale
Standard Error 0.20
|
3.60 units on a scale
Standard Error 0.21
|
4.41 units on a scale
Standard Error 0.23
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Intercourse Satisfaction Domain
Change from Baseline to Week 24 (n=141, 116, 81)
|
4.48 units on a scale
Standard Error 0.21
|
3.71 units on a scale
Standard Error 0.22
|
4.70 units on a scale
Standard Error 0.24
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 16, and 24 weeksPopulation: The analysis included all randomly assigned participants who had a baseline and post-baseline IIEF Overall Satisfaction observation.
Self-reported overall satisfaction on the IIEF over past 4 weeks and consists of 2 questions (items 13 and 14), each rated on a scale from 1 (very dissatisfied) to 5 (very satisfied). Total scores range from 2 to 10; lower numerical scores represent lower overall satisfaction. Least Squares Mean changes from baseline to endpoint for each visit were from a repeated measures analysis and included terms for baseline score, treatment group, country, baseline\*treatment (if p\<0.10), visit, and visit\*treatment. The correlation matrix for the repeated observations was assumed to be unstructured.
Outcome measures
| Measure |
Tadalafil On Demand
n=245 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=250 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=251 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Overall Satisfaction Domain
Change from Baseline to Week 4
|
2.46 units on a scale
Standard Error 0.16
|
2.58 units on a scale
Standard Error 0.15
|
2.72 units on a scale
Standard Error 0.15
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Overall Satisfaction Domain
Change from Baseline to Week 8 (n=230, 231, 233)
|
2.80 units on a scale
Standard Error 0.16
|
2.85 units on a scale
Standard Error 0.16
|
2.98 units on a scale
Standard Error 0.16
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Overall Satisfaction Domain
Change from Baseline to Week 16 (n=167, 145, 101)
|
3.34 units on a scale
Standard Error 0.15
|
3.09 units on a scale
Standard Error 0.15
|
3.48 units on a scale
Standard Error 0.17
|
|
Change From Baseline to 4, 8, 16 and 24 Weeks of the International Index of Erectile Function (IIEF) Overall Satisfaction Domain
Change from Baseline to Week 24 (n=141, 116, 81)
|
3.50 units on a scale
Standard Error 0.15
|
3.24 units on a scale
Standard Error 0.16
|
3.41 units on a scale
Standard Error 0.17
|
SECONDARY outcome
Timeframe: 4, 8, 16, and 24 weeksPopulation: The analysis included all randomly assigned participants who had a baseline and post-baseline EDITS observation.
The participant questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score was obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), then multiplying by 25, thus obtaining a score range from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction). Least Squares Mean changes were adjusted for treatment group, country, visit, and visit\*treatment.
Outcome measures
| Measure |
Tadalafil On Demand
n=246 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=252 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=249 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4, 8, 16, and 24 Weeks
EDITS at Week 4
|
72.36 units on a scale
Interval 69.64 to 75.08
|
75.20 units on a scale
Interval 72.51 to 77.9
|
71.98 units on a scale
Interval 69.28 to 74.67
|
|
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4, 8, 16, and 24 Weeks
EDITS at Week 8 (n=231, 235, 231)
|
75.28 units on a scale
Interval 72.51 to 78.05
|
76.64 units on a scale
Interval 73.88 to 79.39
|
72.74 units on a scale
Interval 69.99 to 75.49
|
|
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4, 8, 16, and 24 Weeks
EDITS at Week 16 (n=168, 147, 100)
|
79.64 units on a scale
Interval 77.0 to 82.29
|
77.66 units on a scale
Interval 74.97 to 80.35
|
76.64 units on a scale
Interval 73.71 to 79.56
|
|
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 4, 8, 16, and 24 Weeks
EDITS at Week 24 (n=141, 118, 80)
|
81.01 units on a scale
Interval 78.44 to 83.58
|
78.75 units on a scale
Interval 76.1 to 81.41
|
77.98 units on a scale
Interval 75.09 to 80.87
|
SECONDARY outcome
Timeframe: Baseline, 24 weeksPopulation: The analysis included all randomly assigned participants who had a baseline and post-baseline PAIRS observation.
The PAIRS is a 23-item scale that assesses broader psychological/interpersonal outcomes associated with erectile dysfunction and its treatment. Each question is rated on a Likert scale from 1 (strongly disagree) to 4 (strongly agree). The scale consists of 3 domains: Sexual Self-Confidence (items 1-6), Spontaneity domain (items 7-15), and Time Concerns (items 16-23). The average domain score for each domain was calculated by adding the nonmissing items for the respective domain, then dividing by the number of nonmissing items for the respective domain. Each average domain score ranged from 1 to 4. Higher scores represent the following: greater sexual self-confidence (better outcome); greater spontaneity (better outcome); higher time concerns (worse outcome). The Least Squares Mean changes were adjusted for treatment group, country, baseline IIEF-EF severity, baseline domain score, and baseline domain score\*treatment (if p\<0.10).
Outcome measures
| Measure |
Tadalafil On Demand
n=252 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=257 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=261 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline to 24 Week Endpoint of the Sexual Self-Confidence, Spontaneity, and Time Concerns Domains (23-items) of the Psychological and Interpersonal Relationships Scale (PAIRS)
Sexual Self-Confidence Domain (n=196, 203, 185)
|
0.93 units on a scale
Interval 0.83 to 1.03
|
0.90 units on a scale
Interval 0.81 to 1.0
|
0.73 units on a scale
Interval 0.64 to 0.83
|
|
Change From Baseline to 24 Week Endpoint of the Sexual Self-Confidence, Spontaneity, and Time Concerns Domains (23-items) of the Psychological and Interpersonal Relationships Scale (PAIRS)
Spontaneity Domain (n=197, 202, 186)
|
0.13 units on a scale
Interval 0.07 to 0.2
|
0.11 units on a scale
Interval 0.04 to 0.18
|
0.02 units on a scale
Interval -0.05 to 0.09
|
|
Change From Baseline to 24 Week Endpoint of the Sexual Self-Confidence, Spontaneity, and Time Concerns Domains (23-items) of the Psychological and Interpersonal Relationships Scale (PAIRS)
Time Concerns Domain (n=196, 200, 184)
|
-0.08 units on a scale
Interval -0.16 to -0.01
|
-0.20 units on a scale
Interval -0.27 to -0.12
|
0.04 units on a scale
Interval -0.03 to 0.12
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 16, and 24 weeksPopulation: The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Sexual Relationship observation.
SEAR assesses psychosocial outcomes in men with erectile dysfunction. Sexual Relationship domain consists of 8 items (items 1-8). Items 2-8 are rated on a scale of 1 (Never) to 5 (Always), whereas item 1 is reverse scored (1=Always and 5=Never). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. Transformed score = 100 x \[(actual raw score - lowest possible raw score)/possible raw score range\]. Least Squares Mean changes adjusted for baseline score, treatment group, country, visit, and visit\*treatment.
Outcome measures
| Measure |
Tadalafil On Demand
n=244 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=250 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=246 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to Week 16 (n=167, 146, 101)
|
37.59 units on a scale
Interval 34.58 to 40.61
|
32.90 units on a scale
Interval 29.84 to 35.96
|
37.32 units on a scale
Interval 34.03 to 40.6
|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to Week 24 (n=140, 117, 81)
|
39.37 units on a scale
Interval 36.31 to 42.43
|
34.96 units on a scale
Interval 31.79 to 38.13
|
37.46 units on a scale
Interval 34.05 to 40.87
|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to Week 8 (n=230, 232, 231)
|
31.42 units on a scale
Interval 28.23 to 34.61
|
31.07 units on a scale
Interval 27.9 to 34.24
|
31.15 units on a scale
Interval 27.99 to 34.31
|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Sexual Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to Week 4
|
27.65 units on a scale
Interval 24.65 to 30.65
|
29.26 units on a scale
Interval 26.29 to 32.23
|
29.50 units on a scale
Interval 26.53 to 32.48
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 16, and 24 weeksPopulation: The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Confidence observation.
SEAR assesses psychosocial outcomes in men with erectile dysfunction. Confidence domain measures improvement in confidence; 2 subscales (6 items: Self-Esteem \[items 9-12\]; Overall Relationship \[items 13-14\]). Each item range: 1 (Never) to 5 (Always); item 11 reverse scored. Domain score=sum of domain's respective items, then transformed into 0 (least favorable) to 100 (most favorable) scale. Transformed score=100x\[(actual raw score-lowest possible raw score)/possible raw score range\]. Least Squares Mean change adjusted for baseline score, treatment group, country, visit, and visit\*treatment.
Outcome measures
| Measure |
Tadalafil On Demand
n=245 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=251 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=247 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to Week 4
|
23.43 units on a scale
Interval 20.32 to 26.54
|
23.04 units on a scale
Interval 19.96 to 26.13
|
25.03 units on a scale
Interval 21.94 to 28.12
|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to Week 8 (n=230, 233, 232)
|
26.97 units on a scale
Interval 23.83 to 30.11
|
26.10 units on a scale
Interval 22.97 to 29.22
|
27.14 units on a scale
Interval 24.03 to 30.25
|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to Week 16 (n=167, 147, 100)
|
33.15 units on a scale
Interval 30.28 to 36.02
|
28.33 units on a scale
Interval 25.41 to 31.25
|
31.86 units on a scale
Interval 28.71 to 35.0
|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Confidence Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to Week 24 (n=140, 116, 81)
|
33.74 units on a scale
Interval 30.64 to 36.84
|
30.42 units on a scale
Interval 27.21 to 33.63
|
31.66 units on a scale
Interval 28.21 to 35.12
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 16, and 24 weeksPopulation: The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Self-Esteem observation.
SEAR assesses psychosocial outcomes in men with erectile dysfunction. The Self-Esteem domain consists of 4 items (items 9-12), each rated on a scale of 1 (Never) to 5 (Always). Item 11 is reverse scored (1=Always and 5=Never). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. The transformed score = 100 x \[(actual raw score - lowest possible raw score)/possible raw score range\]. Least Squares Mean changes were adjusted for baseline score, treatment group, country, visit, and visit\*treatment.
Outcome measures
| Measure |
Tadalafil On Demand
n=245 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=251 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=247 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to 4 Weeks
|
25.18 units on a scale
Interval 21.95 to 28.41
|
24.10 units on a scale
Interval 20.9 to 27.3
|
26.59 units on a scale
Interval 23.39 to 29.79
|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to 8 Weeks (n=230, 233, 233)
|
29.14 units on a scale
Interval 25.93 to 32.35
|
27.80 units on a scale
Interval 24.6 to 30.99
|
28.92 units on a scale
Interval 25.75 to 32.1
|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to 24 Weeks (n=140, 116, 81)
|
35.86 units on a scale
Interval 32.59 to 39.12
|
31.14 units on a scale
Interval 27.75 to 34.52
|
33.52 units on a scale
Interval 29.88 to 37.16
|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Self Esteem Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to 16 Weeks (n=167, 147, 100)
|
35.23 units on a scale
Interval 32.2 to 38.26
|
29.46 units on a scale
Interval 26.37 to 32.55
|
33.85 units on a scale
Interval 30.5 to 37.2
|
SECONDARY outcome
Timeframe: Baseline, 4, 8, 16, and 24 weeksPopulation: The analysis included all randomly assigned participants who had a baseline and post-baseline SEAR Overall Relationship observation.
SEAR assesses psychosocial outcomes in men with erectile dysfunction. The Overall Relationship domain consists of 2 items (items 13-14), each rated on a scale of 1 (Never) to 5 (Always). The domain score was computed by summing its respective items, then transforming it into a 0 (least favorable) to 100 (most favorable) scale. The transformed score = 100 x \[(actual raw score - lowest possible raw score)/possible raw score range\]. Least Squares Mean changes were adjusted for baseline score, treatment group, country, visit, and visit\*treatment.
Outcome measures
| Measure |
Tadalafil On Demand
n=244 Participants
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=251 Participants
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=247 Participants
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to Week 4
|
19.92 units on a scale
Interval 16.41 to 23.44
|
21.10 units on a scale
Interval 17.63 to 24.57
|
22.00 units on a scale
Interval 18.52 to 25.48
|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to Week 8 (n=229, 232, 232)
|
22.75 units on a scale
Interval 19.19 to 26.31
|
22.96 units on a scale
Interval 19.43 to 26.5
|
23.74 units on a scale
Interval 20.22 to 27.27
|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to Week 16 (n=166, 147, 100)
|
29.63 units on a scale
Interval 26.46 to 32.79
|
26.96 units on a scale
Interval 23.74 to 30.17
|
28.57 units on a scale
Interval 25.07 to 32.08
|
|
Change From Baseline to 4, 8, 16, and 24 Weeks of the Overall Relationship Domain of the Self-Esteem and Relationship (SEAR) Questionnaire
Change from Baseline to Week 24 (n=139, 116, 81)
|
30.28 units on a scale
Interval 26.93 to 33.62
|
29.93 units on a scale
Interval 26.43 to 33.43
|
28.74 units on a scale
Interval 24.93 to 32.56
|
Adverse Events
Tadalafil On Demand
Tadalafil Once a Day
Sildenafil Citrate On Demand
Serious adverse events
| Measure |
Tadalafil On Demand
n=250 participants at risk
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=257 participants at risk
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=260 participants at risk
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders
|
0.40%
1/250 • Number of events 1
|
0.00%
0/257
|
0.00%
0/260
|
|
Congenital, familial and genetic disorders
Pulmonary sequestration
|
0.40%
1/250 • Number of events 1
|
0.00%
0/257
|
0.00%
0/260
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.00%
0/250
|
0.39%
1/257 • Number of events 1
|
0.00%
0/260
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/250
|
0.39%
1/257 • Number of events 1
|
0.00%
0/260
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/250
|
0.39%
1/257 • Number of events 1
|
0.00%
0/260
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
0.00%
0/250
|
0.39%
1/257 • Number of events 1
|
0.00%
0/260
|
|
Infections and infestations
Diverticulitis
|
0.40%
1/250 • Number of events 2
|
0.00%
0/257
|
0.00%
0/260
|
|
Infections and infestations
Infections and infestations
|
0.80%
2/250 • Number of events 3
|
0.00%
0/257
|
0.00%
0/260
|
|
Infections and infestations
Parotitis
|
0.40%
1/250 • Number of events 1
|
0.00%
0/257
|
0.00%
0/260
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/250
|
0.00%
0/257
|
0.38%
1/260 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.00%
0/250
|
0.00%
0/257
|
0.38%
1/260 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.40%
1/250 • Number of events 5
|
0.00%
0/257
|
0.00%
0/260
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
0.40%
1/250 • Number of events 5
|
0.00%
0/257
|
0.00%
0/260
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/250
|
0.39%
1/257 • Number of events 1
|
0.00%
0/260
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
0.80%
2/250 • Number of events 2
|
0.39%
1/257 • Number of events 1
|
0.38%
1/260 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasm
|
0.40%
1/250 • Number of events 1
|
0.00%
0/257
|
0.00%
0/260
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.40%
1/250 • Number of events 1
|
0.00%
0/257
|
0.00%
0/260
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/250
|
0.00%
0/257
|
0.38%
1/260 • Number of events 2
|
|
Psychiatric disorders
Completed suicide
|
0.40%
1/250 • Number of events 1
|
0.00%
0/257
|
0.00%
0/260
|
|
Psychiatric disorders
Psychiatric disorders
|
0.40%
1/250 • Number of events 1
|
0.00%
0/257
|
0.00%
0/260
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.00%
0/250
|
0.00%
0/257
|
0.38%
1/260 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/250
|
0.00%
0/257
|
0.38%
1/260 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.40%
1/250 • Number of events 1
|
0.00%
0/257
|
0.00%
0/260
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.40%
1/250 • Number of events 1
|
0.00%
0/257
|
0.00%
0/260
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.00%
0/250
|
0.39%
1/257 • Number of events 1
|
0.00%
0/260
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.00%
0/250
|
0.39%
1/257 • Number of events 1
|
0.00%
0/260
|
|
Vascular disorders
Vascular disorders
|
0.40%
1/250 • Number of events 2
|
0.00%
0/257
|
0.00%
0/260
|
|
Vascular disorders
Venous insufficiency
|
0.40%
1/250 • Number of events 2
|
0.00%
0/257
|
0.00%
0/260
|
Other adverse events
| Measure |
Tadalafil On Demand
n=250 participants at risk
Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
Tadalafil Once a Day
n=257 participants at risk
Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
|
Sildenafil Citrate On Demand
n=260 participants at risk
Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
8.4%
21/250 • Number of events 52
|
11.7%
30/257 • Number of events 79
|
3.8%
10/260 • Number of events 32
|
|
Infections and infestations
Infections and infestations
|
6.8%
17/250 • Number of events 27
|
3.9%
10/257 • Number of events 22
|
3.8%
10/260 • Number of events 17
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
17.6%
44/250 • Number of events 117
|
7.4%
19/257 • Number of events 51
|
15.4%
40/260 • Number of events 110
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
6.4%
16/250 • Number of events 40
|
1.9%
5/257 • Number of events 12
|
3.1%
8/260 • Number of events 26
|
|
Injury, poisoning and procedural complications
Overdose
|
8.4%
21/250 • Number of events 56
|
3.1%
8/257 • Number of events 24
|
8.8%
23/260 • Number of events 63
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
6.4%
16/250 • Number of events 45
|
6.6%
17/257 • Number of events 33
|
3.5%
9/260 • Number of events 20
|
|
Nervous system disorders
Headache
|
4.0%
10/250 • Number of events 30
|
5.4%
14/257 • Number of events 32
|
8.8%
23/260 • Number of events 49
|
|
Nervous system disorders
Nervous system disorders
|
5.6%
14/250 • Number of events 36
|
7.4%
19/257 • Number of events 41
|
10.4%
27/260 • Number of events 60
|
|
Vascular disorders
Vascular disorders
|
4.4%
11/250 • Number of events 37
|
1.2%
3/257 • Number of events 7
|
6.5%
17/260 • Number of events 46
|
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