Trial Outcomes & Findings for A Study in Erectile Dysfunction (NCT NCT00833638)
NCT ID: NCT00833638
Last Updated: 2010-08-24
Results Overview
Cumulative percentage of participants achieving successful intercourse, as measured by "yes" responses to Sexual Encounter Profile diary question 3 (SEP3). SEP3 asks if the participant's erection lasted long enough to have successful intercourse.
COMPLETED
PHASE4
372 participants
4 days during double-blind period
2010-08-24
Participant Flow
The first phase of the study was a run-in phase that lasted for approximately 4 weeks. During this time, subjects did not use any form of treatment for erectile dysfunction and were instructed to make at least 4 sexual intercourse attempts with their sexual partner. The purpose of this phase was to obtain baseline data for analysis purposes.
Participant milestones
| Measure |
Tadalafil 2.5 mg
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
|---|---|---|---|
|
Phase 2: Double-blind Treatment Phase
STARTED
|
121
|
118
|
133
|
|
Phase 2: Double-blind Treatment Phase
COMPLETED
|
111
|
108
|
124
|
|
Phase 2: Double-blind Treatment Phase
NOT COMPLETED
|
10
|
10
|
9
|
|
Phase 3: Open-label Extension Phase
STARTED
|
111
|
108
|
124
|
|
Phase 3: Open-label Extension Phase
COMPLETED
|
110
|
105
|
122
|
|
Phase 3: Open-label Extension Phase
NOT COMPLETED
|
1
|
3
|
2
|
Reasons for withdrawal
| Measure |
Tadalafil 2.5 mg
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
|---|---|---|---|
|
Phase 2: Double-blind Treatment Phase
Adverse Event
|
1
|
2
|
0
|
|
Phase 2: Double-blind Treatment Phase
Entry Criteria Not Met
|
3
|
2
|
1
|
|
Phase 2: Double-blind Treatment Phase
Lost to Follow-up
|
1
|
2
|
1
|
|
Phase 2: Double-blind Treatment Phase
Physician Decision
|
1
|
0
|
0
|
|
Phase 2: Double-blind Treatment Phase
Protocol Violation
|
3
|
3
|
3
|
|
Phase 2: Double-blind Treatment Phase
Sponsor Decision
|
0
|
0
|
2
|
|
Phase 2: Double-blind Treatment Phase
Withdrawal by Subject
|
1
|
1
|
2
|
|
Phase 3: Open-label Extension Phase
Lost to Follow-up
|
1
|
2
|
0
|
|
Phase 3: Open-label Extension Phase
Protocol Violation
|
0
|
1
|
2
|
Baseline Characteristics
A Study in Erectile Dysfunction
Baseline characteristics by cohort
| Measure |
Tadalafil 2.5 mg
n=121 Participants
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
n=118 Participants
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
n=133 Participants
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
Total
n=372 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
59.63 years
STANDARD_DEVIATION 10.02 • n=5 Participants
|
57.68 years
STANDARD_DEVIATION 11.07 • n=7 Participants
|
59.23 years
STANDARD_DEVIATION 10.63 • n=5 Participants
|
58.87 years
STANDARD_DEVIATION 10.58 • 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
|
121 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
372 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
4 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
1 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
25 participants
n=5 Participants
|
21 participants
n=7 Participants
|
22 participants
n=5 Participants
|
68 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
2 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
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/Ethnicity, Customized
White
|
89 participants
n=5 Participants
|
87 participants
n=7 Participants
|
107 participants
n=5 Participants
|
283 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
121 participants
n=5 Participants
|
118 participants
n=7 Participants
|
133 participants
n=5 Participants
|
372 participants
n=4 Participants
|
|
Sexual Encounter Profile Diary question number 1
|
74.04 percentage of participants
STANDARD_DEVIATION 35.64 • n=5 Participants
|
75.22 percentage of participants
STANDARD_DEVIATION 35.69 • n=7 Participants
|
82.26 percentage of participants
STANDARD_DEVIATION 28.98 • n=5 Participants
|
77.34 percentage of participants
STANDARD_DEVIATION 33.55 • n=4 Participants
|
|
Sexual Encounter Profile Diary question number 2
|
52.70 percentage of participants
STANDARD_DEVIATION 40.58 • n=5 Participants
|
54.20 percentage of participants
STANDARD_DEVIATION 39.47 • n=7 Participants
|
56.16 percentage of participants
STANDARD_DEVIATION 37.14 • n=5 Participants
|
54.41 percentage of participants
STANDARD_DEVIATION 38.94 • n=4 Participants
|
|
Sexual Encounter Profile Diary question number 3
|
30.90 percentage of participants
STANDARD_DEVIATION 36.99 • n=5 Participants
|
25.42 percentage of participants
STANDARD_DEVIATION 32.62 • n=7 Participants
|
29.95 percentage of participants
STANDARD_DEVIATION 34.85 • n=5 Participants
|
28.80 percentage of participants
STANDARD_DEVIATION 34.85 • n=4 Participants
|
|
Sexual Encounter Profile Diary question number 4
|
8.33 percentage of participants
STANDARD_DEVIATION 19.18 • n=5 Participants
|
4.96 percentage of participants
STANDARD_DEVIATION 13.19 • n=7 Participants
|
8.36 percentage of participants
STANDARD_DEVIATION 16.88 • n=5 Participants
|
7.26 percentage of participants
STANDARD_DEVIATION 16.64 • n=4 Participants
|
|
Sexual Encounter Profile Diary question number 5
|
7.67 percentage of participants
STANDARD_DEVIATION 18.73 • n=5 Participants
|
4.39 percentage of participants
STANDARD_DEVIATION 12.31 • n=7 Participants
|
8.08 percentage of participants
STANDARD_DEVIATION 16.88 • n=5 Participants
|
6.77 percentage of participants
STANDARD_DEVIATION 16.27 • n=4 Participants
|
PRIMARY outcome
Timeframe: 4 days during double-blind periodPopulation: Modified intent-to-treat population consisting of all participants who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.
Cumulative percentage of participants achieving successful intercourse, as measured by "yes" responses to Sexual Encounter Profile diary question 3 (SEP3). SEP3 asks if the participant's erection lasted long enough to have successful intercourse.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=112 Participants
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
n=111 Participants
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
n=123 Participants
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
|---|---|---|---|
|
Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3
<= day 4
|
54.5 cumulative percentage of participants
|
62.2 cumulative percentage of participants
|
47.2 cumulative percentage of participants
|
|
Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3
<= day 3
|
49.1 cumulative percentage of participants
|
55.0 cumulative percentage of participants
|
42.3 cumulative percentage of participants
|
|
Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3
<= day 2
|
42.0 cumulative percentage of participants
|
48.6 cumulative percentage of participants
|
36.6 cumulative percentage of participants
|
|
Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3
<= day 1
|
28.6 cumulative percentage of participants
|
25.2 cumulative percentage of participants
|
28.5 cumulative percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 14 days double-blind periodPopulation: Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.
Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 1: "Were you able to achieve at least some erection (some enlargement of the penis)"? Data are presented as the mean percentage of participants who answered "yes".
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=112 Participants
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
n=111 Participants
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
n=123 Participants
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
|---|---|---|---|
|
Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
|
1.97 percentage of participants
Standard Error 2.33
|
2.74 percentage of participants
Standard Error 2.34
|
-10.06 percentage of participants
Standard Error 2.24
|
SECONDARY outcome
Timeframe: Baseline and 14 days double-blind periodPopulation: Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.
Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 2: "Were you able insert your penis into your partner's vagina?" Data are presented as the mean percentage of participants who answered yes.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=112 Participants
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
n=111 Participants
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
n=123 Participants
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
|---|---|---|---|
|
Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
|
8.11 percentage of participants
Standard Error 2.55
|
13.12 percentage of participants
Standard Error 2.56
|
-7.29 percentage of participants
Standard Error 2.44
|
SECONDARY outcome
Timeframe: Baseline and 14 days double-blind periodPopulation: Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.
Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 3: "Did your erection last long enough for you to have successful intercourse?" Data are presented as the mean percentage of participants who answered "yes".
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=112 Participants
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
n=111 Participants
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
n=123 Participants
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
|---|---|---|---|
|
Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
|
15.67 percentage of participants
Standard Error 2.76
|
21.94 percentage of participants
Standard Error 2.77
|
1.40 percentage of participants
Standard Error 2.64
|
SECONDARY outcome
Timeframe: Baseline and 14 days double-blind periodPopulation: Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.
Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 4: "Were you satisfied with the hardness of your erection?" Data are presented as the mean percentage of participants who answered "yes".
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=112 Participants
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
n=111 Participants
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
n=123 Participants
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
|---|---|---|---|
|
Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
|
20.94 percentage of participants
Standard Error 2.90
|
28.50 percentage of participants
Standard Error 2.92
|
6.70 percentage of participants
Standard Error 2.77
|
SECONDARY outcome
Timeframe: Baseline and 14 days double-blind periodPopulation: Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.
Assessed was the mean change from baseline in the percentage of "yes" responses to the Sexual Encounter Profile Diary question number 5: "Were you satisfied overall with this sexual experience?" Data are presented as the mean percentage of participants who answered "yes".
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=112 Participants
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
n=111 Participants
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
n=123 Participants
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
|---|---|---|---|
|
Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
|
20.45 percentage of participants
Standard Error 2.82
|
25.60 percentage of participants
Standard Error 2.84
|
6.52 percentage of participants
Standard Error 2.71
|
SECONDARY outcome
Timeframe: 4 days double-blind periodPopulation: Included in the analysis were all subjects with successful intercourse within the first 4 days of treatment, who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.
Assessed was the median time to onset of efficacy (day when 50% of participants have had at least 1 successful intercourse attempt) within the first 4 days of therapy based on a "yes" response to the sexual encounter profile diary question 3: "Did your erection last long enough for you to have successful intercourse?" Data are based on participants who responded "yes". For the placebo group, onset of efficacy was not reached within the first 4 days of therapy, therefore, the analysis timeframe was expanded for this group to determine the median time to onset of efficacy.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=61 Participants
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
n=69 Participants
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
n=58 Participants
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
|---|---|---|---|
|
Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses
|
4.0 days
Standard Error 0.878
|
3.0 days
Standard Error 0.384
|
6.0 days
Standard Error 2.283
|
SECONDARY outcome
Timeframe: 14 days during double-blind periodPopulation: Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.
Assessed was the cumulative precentage of successful intercourse attempts (successful attempts relative to the total number of intercourse attempts) over the 14-day double-blind treatment period. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?" Data are presented as the proportion of intercourse attempts for which participants answered "yes" relative to the total number of intercourse attempts. Total number of attempts = TNA.
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=112 Participants
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
n=111 Participants
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
n=123 Participants
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
|---|---|---|---|
|
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
<=day14 (TNA: n=905; n=813; n=781)
|
45.1 percentage of total number of attempts
|
46.6 percentage of total number of attempts
|
30.9 percentage of total number of attempts
|
|
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
<=day13 (TNA: n=877; n=777; n=755)
|
44.5 percentage of total number of attempts
|
46.2 percentage of total number of attempts
|
31.2 percentage of total number of attempts
|
|
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
<=day12 (TNA: n=827; n=730; n=711)
|
44.0 percentage of total number of attempts
|
45.9 percentage of total number of attempts
|
30.8 percentage of total number of attempts
|
|
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
<=day11 (TNA: n=774; n=678; n=668)
|
43.2 percentage of total number of attempts
|
44.9 percentage of total number of attempts
|
30.7 percentage of total number of attempts
|
|
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
<=day10 (TNA: n=726; n=626; n=625)
|
41.9 percentage of total number of attempts
|
44.2 percentage of total number of attempts
|
30.6 percentage of total number of attempts
|
|
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
<=day9 (TNA: n=668; n=574; n=572)
|
40.2 percentage of total number of attempts
|
43.7 percentage of total number of attempts
|
29.8 percentage of total number of attempts
|
|
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
<=day8 (TNA: n=608; n=534; n=523)
|
39.5 percentage of total number of attempts
|
42.8 percentage of total number of attempts
|
29.6 percentage of total number of attempts
|
|
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
<=day7 (TNA: n=563; n=483; n=481)
|
38.7 percentage of total number of attempts
|
42.4 percentage of total number of attempts
|
28.8 percentage of total number of attempts
|
|
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
<=day6 (TNA: n=505; n=439; n=435)
|
37.4 percentage of total number of attempts
|
41.6 percentage of total number of attempts
|
27.9 percentage of total number of attempts
|
|
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
<=day5 (TNA: n=464; n=402; n=396)
|
36.6 percentage of total number of attempts
|
41.4 percentage of total number of attempts
|
27.4 percentage of total number of attempts
|
|
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
<=day4 (TNA: n=412; n=350; n=352)
|
37.1 percentage of total number of attempts
|
40.9 percentage of total number of attempts
|
26.2 percentage of total number of attempts
|
|
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
<=day3 (TNA: n=324; n=265; n=262)
|
35.5 percentage of total number of attempts
|
38.5 percentage of total number of attempts
|
27.2 percentage of total number of attempts
|
|
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
<=day2 (TNA: n=214; n=179; n=175)
|
35.8 percentage of total number of attempts
|
38.9 percentage of total number of attempts
|
28.0 percentage of total number of attempts
|
|
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
<=day1 (TNA: n=109; n=83; n=83)
|
38.6 percentage of total number of attempts
|
33.7 percentage of total number of attempts
|
32.1 percentage of total number of attempts
|
SECONDARY outcome
Timeframe: 14 days double-blind and 14 days open-labelPopulation: Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.
Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?"
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=112 Participants
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
n=112 Participants
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
|---|---|---|---|
|
Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind and Open-label Periods for Participants Who Were Assigned to Placebo in the Double-blind Treatment Period
|
32.21 percentage successful attempts
Standard Deviation 35.35
|
68.27 percentage successful attempts
Standard Deviation 38.76
|
—
|
SECONDARY outcome
Timeframe: 14-day double-blind and 14-day open-labelPopulation: Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation and who took at least 1 dose of study drug followed by at least 1 intercourse attempt, and who recorded SEP diary data for it within the first 4 days of therapy following randomization.
Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?"
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=101 Participants
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
n=101 Participants
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
|---|---|---|---|
|
Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 2.5 mg in the Double-blind Treatment Period
|
46.11 percentage successful attempts
Standard Deviation 37.17
|
68.33 percentage successful attempts
Standard Deviation 40.10
|
—
|
SECONDARY outcome
Timeframe: 14-day double-blind and 14-day open-labelPopulation: Modified intent-to-treat population consisting of all subjects who have at least 1 baseline observation, who took tadalafil 5 mg during the double-blind treatment period, and who took at least 1 dose of tadalafil 5 mg followed by at least 1 intercourse attempt during the open-label period.
Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts over the 14-day open-label treatment period compared with the 14-day double-blind treatment period by dose group during the double-blind treatment period. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?"
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=99 Participants
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
n=99 Participants
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
|---|---|---|---|
|
Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses in the Double-blind Period and the Open-label Period for Participants Who Were Assigned to Tadalafil 5 mg in the Double-blind Treatment Period
|
49.54 percentage successful attempts
Standard Deviation 38.60
|
67.70 percentage successful attempts
Standard Deviation 38.98
|
—
|
SECONDARY outcome
Timeframe: 14 days double-blind and 14 days open-labelPopulation: Modified intent-to-treat population consisting of all subjects who received tadalafil 2.5 mg in the double-blind study period and did not respond to treatment in that treatment period, who have at least 1 baseline observation and who took at least 1 dose of tadalafil 5 mg in the open-label period followed by at least 1 intercourse attempt.
Assessed were percentages of successful intercourse attempts relative to the total number of intercourse attempts in both treatment periods. A successful attempt was defined by a "yes" response to the sexual encounter profile diary question #3: "Did your erection last long enough for you to have successful intercourse?"
Outcome measures
| Measure |
Tadalafil 2.5 mg
n=49 Participants
No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Tadalafil 5 mg
n=49 Participants
No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
|
Placebo
No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
|
|---|---|---|---|
|
Sexual Encounter Profile Diary Question 3, Percentages of Yes Responses During the Double-blind Period and the Open-label Period for Participants Who Didn't Respond to Tadalafil 2.5 mg During Double-blind Period
|
32.51 percentage successful attempts
Standard Deviation 40.77
|
57.62 percentage successful attempts
Standard Deviation 45.27
|
—
|
Adverse Events
Tadalafil 2.5 mg
Tadalafil 5 mg
Placebo
Tadalafil 2.5 mg to Tadalafil 5 mg
Tadalafil 5 mg to Tadalafil 5 mg
Placebo to Tadalafil 5 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tadalafil 2.5 mg
n=121 participants at risk
No drug during baseline period followed by tadalafil 2.5 mg for 14 days.
|
Tadalafil 5 mg
n=118 participants at risk
No drug during baseline period followed by tadalafil 5 mg for 14 days.
|
Placebo
n=133 participants at risk
No drug during baseline period followed by placebo for 14 days.
|
Tadalafil 2.5 mg to Tadalafil 5 mg
n=111 participants at risk
Participants receiving tadalafil 5 mg in the open-label period after receiving tadalafil 2.5 mg in the double-blind period.
|
Tadalafil 5 mg to Tadalafil 5 mg
n=108 participants at risk
Participants receiving open-label tadalafil 5 mg after receiving tadalafil 5 mg in the double-blind period.
|
Placebo to Tadalafil 5 mg
n=124 participants at risk
Participants receiving open-label tadalafil 5 mg after receiving placebo in the double-blind period.
|
|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.83%
1/121 • Number of events 1
|
2.5%
3/118 • Number of events 3
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.81%
1/124 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/121
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.93%
1/108 • Number of events 1
|
0.00%
0/124
|
|
Cardiac disorders
Palpitations
|
0.00%
0/121
|
0.85%
1/118 • Number of events 1
|
0.00%
0/133
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
0.00%
0/124
|
|
Gastrointestinal disorders
Dyspepsia
|
0.83%
1/121 • Number of events 1
|
0.85%
1/118 • Number of events 1
|
0.75%
1/133 • Number of events 1
|
0.00%
0/111
|
0.93%
1/108 • Number of events 1
|
0.00%
0/124
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/121
|
0.00%
0/118
|
0.75%
1/133 • Number of events 1
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/121
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.93%
1/108 • Number of events 1
|
0.00%
0/124
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/121
|
0.85%
1/118 • Number of events 1
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
General disorders
Asthenia
|
0.83%
1/121 • Number of events 1
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
General disorders
Pain
|
0.83%
1/121 • Number of events 1
|
0.85%
1/118 • Number of events 1
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Infections and infestations
Bronchitis
|
0.00%
0/121
|
0.00%
0/118
|
0.00%
0/133
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
0.00%
0/124
|
|
Infections and infestations
Cellulitis
|
0.00%
0/121
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.93%
1/108 • Number of events 1
|
0.00%
0/124
|
|
Infections and infestations
Fungal infection
|
0.83%
1/121 • Number of events 1
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/121
|
0.00%
0/118
|
0.75%
1/133 • Number of events 1
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Infections and infestations
Influenza
|
0.00%
0/121
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.81%
1/124 • Number of events 1
|
|
Infections and infestations
Laryngitis
|
0.00%
0/121
|
0.00%
0/118
|
0.75%
1/133 • Number of events 1
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Infections and infestations
Localised infection
|
0.00%
0/121
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.93%
1/108 • Number of events 1
|
0.00%
0/124
|
|
Infections and infestations
Nasopharyngitis
|
0.83%
1/121 • Number of events 1
|
0.85%
1/118 • Number of events 1
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Infections and infestations
Sinusitis
|
0.00%
0/121
|
0.00%
0/118
|
0.75%
1/133 • Number of events 1
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
2/121 • Number of events 2
|
0.00%
0/118
|
0.00%
0/133
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
0.00%
0/124
|
|
Investigations
Heart rate increased
|
0.00%
0/121
|
0.85%
1/118 • Number of events 1
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/121
|
0.00%
0/118
|
0.00%
0/133
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
0.00%
0/124
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.83%
1/121 • Number of events 1
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/121
|
0.00%
0/118
|
1.5%
2/133 • Number of events 3
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/121
|
1.7%
2/118 • Number of events 2
|
0.75%
1/133 • Number of events 1
|
0.00%
0/111
|
0.00%
0/108
|
0.81%
1/124 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/121
|
0.85%
1/118 • Number of events 1
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.83%
1/121 • Number of events 1
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Nervous system disorders
Dizziness
|
0.83%
1/121 • Number of events 1
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Nervous system disorders
Headache
|
0.83%
1/121 • Number of events 1
|
0.85%
1/118 • Number of events 1
|
0.00%
0/133
|
2.7%
3/111 • Number of events 3
|
0.93%
1/108 • Number of events 1
|
0.81%
1/124 • Number of events 1
|
|
Nervous system disorders
Tension headache
|
0.00%
0/121
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.93%
1/108 • Number of events 1
|
0.00%
0/124
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/121
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.93%
1/108 • Number of events 1
|
0.00%
0/124
|
|
Renal and urinary disorders
Urinary retention
|
0.83%
1/121 • Number of events 1
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/121
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.93%
1/108 • Number of events 1
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/121
|
0.00%
0/118
|
0.00%
0/133
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.83%
1/121 • Number of events 1
|
0.85%
1/118 • Number of events 1
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/121
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
1.9%
2/108 • Number of events 2
|
0.00%
0/124
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/121
|
0.00%
0/118
|
0.75%
1/133 • Number of events 1
|
0.00%
0/111
|
0.00%
0/108
|
0.00%
0/124
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/121
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.00%
0/108
|
0.81%
1/124 • Number of events 1
|
|
Vascular disorders
Flushing
|
0.83%
1/121 • Number of events 1
|
0.00%
0/118
|
0.00%
0/133
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
0.00%
0/124
|
|
Vascular disorders
Wound haemorrhage
|
0.00%
0/121
|
0.00%
0/118
|
0.00%
0/133
|
0.00%
0/111
|
0.93%
1/108 • Number of events 1
|
0.00%
0/124
|
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