Erectile Dysfunction
Conditions
Keywords
Erectile Dysfunction
Brief summary
The purpose of this study is to determine the day of onset of efficacy of tadalafil dosed once-a-day.
Interventions
DRUGPlacebo
One tablet orally daily
DRUGTadalafil
Orally once daily
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male and at least 18 years old, with at least a 3-month history of erectile dysfunction (ED). * Anticipate having same adult female sexual partner during the study. * Agree to make at least 4 sexual intercourse attempts with the female partner during the 4-week run-in phase without medication. * Agree to make at least 1 sexual intercourse attempt per day with the female partner during days 1-4 following randomization (with a minimum of three attempts required during that period). Also agree to make at least 3 intercourse attempts during days 5-14 following randomization. * Agree not to use any other ED treatment during the study and for 24 hours after the final study visit. Partner Inclusion Criteria: * Female and at least 18 years old. * Agree to make at least 4 sexual intercourse attempts with the male sexual study partner during the 4-week run-in phase without medication. * Agree to make at least 1 sexual intercourse attempt per day with the male partner during days 1-4 following randomization * Agree to make at least 3 intercourse attempts during days 5-14 following randomization.
Exclusion criteria
* Previous or current treatment with tadalafil or any phosphodiesterase type 5 (PDE5) inhibitor on a daily basis for once daily use. * ED caused by other primary sexual disorders, or untreated or inadequately treated endocrine disease. * History of radical prostatectomy, other pelvic surgery or penile implant. * Clinically significant penile deformity in the opinion of the investigator. * Clinically significant renal insufficiency, or hepatobiliary disease as determined by the investigator. * Glycosylated hemoglobin of \>11%. * Present with chronic stable angina treated with long-acting nitrates, or with chronic stable angina requiring short-acting nitrates in the last 90 days, or with angina occurring during sexual intercourse in the last 6 months. * Have any significant cardiac conditions as described in the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3 | 4 days during double-blind period | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Baseline and 14 days double-blind period | 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. |
| Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Baseline and 14 days double-blind period | 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. |
| Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Baseline and 14 days double-blind period | 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. |
| Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Baseline and 14 days double-blind period | 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. |
| Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses | 4 days double-blind period | 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. |
| Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | Baseline and 14 days double-blind period | 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. |
| 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 | 14 days double-blind and 14 days open-label | 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? |
| 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 | 14-day double-blind and 14-day open-label | 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? |
| 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 | 14-day double-blind and 14-day open-label | 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? |
| 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 | 14 days double-blind and 14 days open-label | 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? |
| Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | 14 days during double-blind period | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Tadalafil 2.5 mg No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days. | 121 |
| Tadalafil 5 mg No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days. | 118 |
| Placebo No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days. | 133 |
| Total | 372 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 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
| Characteristic | Tadalafil 2.5 mg | Total | Placebo | Tadalafil 5 mg |
|---|---|---|---|---|
| Age Continuous | 59.63 years STANDARD_DEVIATION 10.02 | 58.87 years STANDARD_DEVIATION 10.58 | 59.23 years STANDARD_DEVIATION 10.63 | 57.68 years STANDARD_DEVIATION 11.07 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 participants | 4 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 2 participants | 7 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Black or African American | 25 participants | 68 participants | 22 participants | 21 participants |
| Race/Ethnicity, Customized Multiple | 1 participants | 9 participants | 2 participants | 6 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized White | 89 participants | 283 participants | 107 participants | 87 participants |
| Region of Enrollment United States | 121 participants | 372 participants | 133 participants | 118 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 121 Participants | 372 Participants | 133 Participants | 118 Participants |
| Sexual Encounter Profile Diary question number 1 | 74.04 percentage of participants STANDARD_DEVIATION 35.64 | 77.34 percentage of participants STANDARD_DEVIATION 33.55 | 82.26 percentage of participants STANDARD_DEVIATION 28.98 | 75.22 percentage of participants STANDARD_DEVIATION 35.69 |
| Sexual Encounter Profile Diary question number 2 | 52.70 percentage of participants STANDARD_DEVIATION 40.58 | 54.41 percentage of participants STANDARD_DEVIATION 38.94 | 56.16 percentage of participants STANDARD_DEVIATION 37.14 | 54.20 percentage of participants STANDARD_DEVIATION 39.47 |
| Sexual Encounter Profile Diary question number 3 | 30.90 percentage of participants STANDARD_DEVIATION 36.99 | 28.80 percentage of participants STANDARD_DEVIATION 34.85 | 29.95 percentage of participants STANDARD_DEVIATION 34.85 | 25.42 percentage of participants STANDARD_DEVIATION 32.62 |
| Sexual Encounter Profile Diary question number 4 | 8.33 percentage of participants STANDARD_DEVIATION 19.18 | 7.26 percentage of participants STANDARD_DEVIATION 16.64 | 8.36 percentage of participants STANDARD_DEVIATION 16.88 | 4.96 percentage of participants STANDARD_DEVIATION 13.19 |
| Sexual Encounter Profile Diary question number 5 | 7.67 percentage of participants STANDARD_DEVIATION 18.73 | 6.77 percentage of participants STANDARD_DEVIATION 16.27 | 8.08 percentage of participants STANDARD_DEVIATION 16.88 | 4.39 percentage of participants STANDARD_DEVIATION 12.31 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 121 | 12 / 118 | 8 / 133 | 6 / 111 | 9 / 108 | 4 / 124 |
| serious Total, serious adverse events | 0 / 121 | 0 / 118 | 0 / 133 | 0 / 111 | 0 / 108 | 0 / 124 |
Outcome results
Primary
Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3
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.
Time frame: 4 days during double-blind period
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 5 mg | Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3 | <= day 1 | 25.2 cumulative percentage of participants |
| Tadalafil 5 mg | Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3 | <= day 4 | 62.2 cumulative percentage of participants |
| Tadalafil 5 mg | Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3 | <= day 2 | 48.6 cumulative percentage of participants |
| Tadalafil 5 mg | Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3 | <= day 3 | 55.0 cumulative percentage of participants |
| Placebo | Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3 | <= day 1 | 28.5 cumulative percentage of participants |
| Placebo | Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3 | <= day 3 | 42.3 cumulative percentage of participants |
| Placebo | Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3 | <= day 2 | 36.6 cumulative percentage of participants |
| Placebo | Earliest Onset Day Measured by Cumulative Percentage of Participants With Yes Response to Sexual Encounter Profile Diary Question 3 | <= day 4 | 47.2 cumulative percentage of participants |
Comparison: The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 2.5 mg and placebo as determined by the earliest day on which the cumulative percentage of subjects achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.p-value: 0.086Regression, Logistic
Comparison: The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.p-value: 0.006Regression, Logistic
Comparison: The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.p-value: 0.019Regression, Logistic
Comparison: The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.p-value: 0.022Regression, Logistic
Comparison: The null-hypothesis was tested that there is no statistically significant difference in the onset of efficacy between tadalafil 5 mg and placebo as determined by the earliest day on which the cumulative percentage of participants achieving at least 1 successful intercourse (within 4 days of starting treatment) is statistically significantly different between active drug and placebo.p-value: 0.573Regression, Logistic
Secondary
Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts
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.
Time frame: 14 days during double-blind period
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 2.5 mg | 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 |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day4 (TNA: n=412; n=350; n=352) | 40.9 percentage of total number of attempts |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day14 (TNA: n=905; n=813; n=781) | 46.6 percentage of total number of attempts |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day13 (TNA: n=877; n=777; n=755) | 46.2 percentage of total number of attempts |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day12 (TNA: n=827; n=730; n=711) | 45.9 percentage of total number of attempts |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day11 (TNA: n=774; n=678; n=668) | 44.9 percentage of total number of attempts |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day10 (TNA: n=726; n=626; n=625) | 44.2 percentage of total number of attempts |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day9 (TNA: n=668; n=574; n=572) | 43.7 percentage of total number of attempts |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day8 (TNA: n=608; n=534; n=523) | 42.8 percentage of total number of attempts |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day7 (TNA: n=563; n=483; n=481) | 42.4 percentage of total number of attempts |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day6 (TNA: n=505; n=439; n=435) | 41.6 percentage of total number of attempts |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day5 (TNA: n=464; n=402; n=396) | 41.4 percentage of total number of attempts |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day3 (TNA: n=324; n=265; n=262) | 38.5 percentage of total number of attempts |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day2 (TNA: n=214; n=179; n=175) | 38.9 percentage of total number of attempts |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day1 (TNA: n=109; n=83; n=83) | 33.7 percentage of total number of attempts |
| Placebo | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day2 (TNA: n=214; n=179; n=175) | 28.0 percentage of total number of attempts |
| Placebo | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day5 (TNA: n=464; n=402; n=396) | 27.4 percentage of total number of attempts |
| Placebo | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day10 (TNA: n=726; n=626; n=625) | 30.6 percentage of total number of attempts |
| Placebo | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day11 (TNA: n=774; n=678; n=668) | 30.7 percentage of total number of attempts |
| Placebo | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day4 (TNA: n=412; n=350; n=352) | 26.2 percentage of total number of attempts |
| Placebo | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day12 (TNA: n=827; n=730; n=711) | 30.8 percentage of total number of attempts |
| Placebo | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day14 (TNA: n=905; n=813; n=781) | 30.9 percentage of total number of attempts |
| Placebo | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day3 (TNA: n=324; n=265; n=262) | 27.2 percentage of total number of attempts |
| Placebo | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day13 (TNA: n=877; n=777; n=755) | 31.2 percentage of total number of attempts |
| Placebo | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day7 (TNA: n=563; n=483; n=481) | 28.8 percentage of total number of attempts |
| Placebo | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day8 (TNA: n=608; n=534; n=523) | 29.6 percentage of total number of attempts |
| Placebo | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day1 (TNA: n=109; n=83; n=83) | 32.1 percentage of total number of attempts |
| Placebo | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day6 (TNA: n=505; n=439; n=435) | 27.9 percentage of total number of attempts |
| Placebo | Sexual Encounter Profile Diary Question 3, Daily Cumulative Percentage of Successful Intercourse Attempts | <=day9 (TNA: n=668; n=574; n=572) | 29.8 percentage of total number of attempts |
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: 0.002Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: 0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: 0.002Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: 0.002Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: 0.002Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: 0.009Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: 0.038Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: 0.003Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: 0.008Regression, Logistic
Comparison: Tested was the null-hypothesis that no differences in the precentage of successful intercourse attempts exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: 0.246Regression, Logistic
Secondary
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
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?
Time frame: 14 days double-blind and 14 days open-label
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil 2.5 mg | 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 |
| Tadalafil 5 mg | 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 | 68.27 percentage successful attempts | Standard Deviation 38.76 |
Comparison: Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received placebo in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving placebo) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001t-test, 2 sided
Secondary
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
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?
Time frame: 14 days double-blind and 14 days open-label
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil 2.5 mg | 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 |
| Tadalafil 5 mg | 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 | 57.62 percentage successful attempts | Standard Deviation 45.27 |
Comparison: Tested was the null-hypothesis that no differences in the percentages of successful intercourse attempts exist in participants who received tadalafil 2.5 mg in the double-blind treatment period and did not respond to treatment when comparing their percentage of succesful intercourse attempts between the double-blind treatment period and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001t-test, 2 sided
Secondary
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
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?
Time frame: 14-day double-blind and 14-day open-label
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil 2.5 mg | 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 |
| Tadalafil 5 mg | 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 | 68.33 percentage successful attempts | Standard Deviation 40.1 |
Comparison: Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received tadalafil 2.5 mg in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving tadalafil 2.5 mg) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001t-test, 2 sided
Secondary
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
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?
Time frame: 14-day double-blind and 14-day open-label
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil 2.5 mg | 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 38.6 |
| Tadalafil 5 mg | 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 | 67.70 percentage successful attempts | Standard Deviation 38.98 |
Comparison: Tested was the null-hypothesis that no differences in the proportion of successful intercourse attempts exist in patients who received tadalfil 5 mg in the double-blind treatment period when comparing their proportion of succesful intercourse attempts between the double-blind treatment period (while receiving tadalafil 5 mg) and the open-label treatment period (while receiving tadalafil 5 mg), measured by a response of yes to the sexual encounter profile diary question number 3.p-value: <0.001t-test, 2 sided
Secondary
Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses
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.
Time frame: 4 days double-blind period
Population: 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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Tadalafil 2.5 mg | Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses | 4.0 days | Standard Error 0.878 |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses | 3.0 days | Standard Error 0.384 |
| Placebo | Sexual Encounter Profile Diary Question 3, the Overall Distribution of Time to Onset by Yes Responses | 6.0 days | Standard Error 2.283 |
Comparison: Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 2.5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: 0.301Log Rank
Comparison: Tested was the null-hypothesis that no differences in the time to onset of efficacy exists between participants who received placebo and participants who received tadalafil 5 mg, measured by a response of yes to the sexual encounter profile diary question number 3.p-value: 0.046Log Rank
Secondary
Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
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.
Time frame: Baseline and 14 days double-blind period
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil 2.5 mg | 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 |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | 2.74 percentage of participants | Standard Error 2.34 |
| Placebo | Sexual Encounter Profile Diary Question Number 1, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | -10.06 percentage of participants | Standard Error 2.24 |
Comparison: Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 2.5 mg.p-value: <0.00195% CI: [5.72, 18.34]ANCOVA
Comparison: Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 1 exist between participants who received placebo and participants who received tadalafil 5 mg.p-value: <0.00195% CI: [6.48, 19.12]ANCOVA
Secondary
Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
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.
Time frame: Baseline and 14 days double-blind period
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil 2.5 mg | 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 |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | 13.12 percentage of participants | Standard Error 2.56 |
| Placebo | Sexual Encounter Profile Diary Question Number 2, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | -7.29 percentage of participants | Standard Error 2.44 |
Comparison: Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 2.5 mg.p-value: <0.00195% CI: [8.51, 22.29]ANCOVA
Comparison: Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 2 exist between participants who received placebo and participants who received tadalafil 5 mg.p-value: <0.00195% CI: [13.5, 27.31]ANCOVA
Secondary
Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
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.
Time frame: Baseline and 14 days double-blind period
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil 2.5 mg | 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 |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | 21.94 percentage of participants | Standard Error 2.77 |
| Placebo | Sexual Encounter Profile Diary Question Number 3, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | 1.40 percentage of participants | Standard Error 2.64 |
Comparison: Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 2.5 mg.p-value: <0.00195% CI: [6.83, 21.71]ANCOVA
Comparison: Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 3 exist between participants who received placebo and participants who received tadalafil 5 mg.p-value: <0.00195% CI: [13.07, 28.01]ANCOVA
Secondary
Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
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.
Time frame: Baseline and 14 days double-blind period
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil 2.5 mg | 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 2.9 |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | 28.50 percentage of participants | Standard Error 2.92 |
| Placebo | Sexual Encounter Profile Diary Question Number 4, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | 6.70 percentage of participants | Standard Error 2.77 |
Comparison: Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 2.5 mg.p-value: <0.00195% CI: [6.42, 22.06]ANCOVA
Comparison: Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 4 exist between participants who received placebo and participants who received tadalafil 5 mg.p-value: <0.00195% CI: [13.94, 29.67]ANCOVA
Secondary
Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses
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.
Time frame: Baseline and 14 days double-blind period
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil 2.5 mg | 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 |
| Tadalafil 5 mg | Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | 25.60 percentage of participants | Standard Error 2.84 |
| Placebo | Sexual Encounter Profile Diary Question Number 5, Change From Baseline to Post Baseline During the Double-blind Period in Percentage of Yes Responses | 6.52 percentage of participants | Standard Error 2.71 |
Comparison: Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 2.5 mg.p-value: <0.00195% CI: [6.3, 21.55]ANCOVA
Comparison: Tested was the null-hypothesis that no differences in the percentages of participants who answered yes to the sexual encounter profile diary question number 5 exist between participants who received placebo and participants who received tadalafil 5 mg.p-value: <0.00195% CI: [11.4, 26.75]ANCOVA