Erectile Dysfunction
Conditions
Keywords
Erectile Dysfunction
Brief summary
The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability.
Interventions
DRUGtadalafil
5 milligrams (mg) administered orally once a day for 12 weeks
DRUGplacebo
tablet administered orally once a day for 12 weeks.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* You are male and aged at least 18 years. * Have a history of erectile dysfunction (ED)(defined as the consistent inability to achieve and/or maintain an erection sufficient to permit satisfactory sexual intercourse) of at least 3 months duration. * Agree not to use any other treatment for ED, including herbal and over-the-counter (OTC) medications, during the study * You agree to make at least four sexual intercourse attempts with the female sexual study partner during the 4-week run-in period without medication * Your entry laboratory test results and medical tests meet study requirements * You agree to use the study drug only as instructed by your study doctor and staff and to return any unused study drug and containers at the end of the study or as otherwise instructed by the study doctor. * If currently using cholesterol lowering medications (for example: statins) or medications to lower blood pressure (example: angiotensin-converting enzyme (ACE) inhibitors or calcium channel blocker medications), you need to be on a stable dose and you and your study doctor do not expect any dose change during the study.
Exclusion criteria
* You have received previous or current treatment with tadalafil or any other PDE5 inhibitor. * Currently receives treatment with doxazosin, nitrates, cancer chemotherapy, or anti-androgens (except finasteride e.g. Propecia™ or Proscar®, or dutasteride e.g. Avodart®). * You have had significant heart disease as determined by your doctor in charge of this study or a member of the doctor's staff. * Have a history of significant central nervous system injuries (including stroke or spinal cord injury) within the last 6 months. * Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 | Baseline, Week 12 | Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30. |
| Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses | Baseline, Week 12 | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. Were you able to insert your penis into your partner's vagina? Data are presented as the mean percentage of yes responses per participant. |
| Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses | Baseline, 12 weeks | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary | Baseline, 12 weeks | The morning erection diary allows the participant to record whether he experienced an erection on waking. The participant is to complete the morning erection diary every morning during the run-in, treatment and follow-up periods. The percentage of mornings the participant reported an erection is analysed. |
| The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint | Week 12 | The subject questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score will be obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), and multiplying by 25, thus obtaining a score that ranges from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction). |
| Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Baseline, Week 12 | SEAR measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). All questions except negatively worded questions 8 and 11 are scored from 1=almost never/never to 5=almost always/always. Questions 8 and 11 were reverse scored, thus a higher score signifies a more favorable response for all 14 items. Overall score is transformed into a 0 (least favorable) to 100 (most favorable) scale. |
| Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF) | Baseline, Week 12 | Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10. |
| Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD) | Baseline, 12 weeks | Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10. |
| Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS) | Baseline, Week 12 | Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15. |
| Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night | Baseline, Week 12 | NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The man wears the device for three nights prior to visit 2 (baseline), visit 5 (end of randomised treatment) and visit 6 (end of follow-up). Data are entered for the 2 nights prior to the visit. During the night the man may have multiple erections. The number of erections is recorded. |
| Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of Yes Responses | Baseline, 12 weeks | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 1. Were you able to achieve at least some erection (some enlargement of the penis)? Data are presented as the mean percentage of yes responses per participant. |
| Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of Yes Responses | Baseline, 12 weeks | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4. Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of yes responses per participant. |
| Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of Yes Responses | Baseline, 12 weeks | Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5. Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of yes responses per participant. |
| Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | Week 12 | GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse. |
| Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | Week 12 | GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse. |
| Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS) | Baseline, 12 weeks | Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10. |
| Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night | Baseline, Week 12 | NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The duration of erections are measured and recorded. Data presented are the duration of erectile events at baseline and the change from baseline to Week 12. |
| Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change | Baseline, Week 12 | NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The percent of volume change of the penis during erections is measured and recorded for each erection. Data presented are mean percentage of volumetric change from baseline to Week 12. |
Countries
Germany, Greece, Italy, Poland, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tadalafil Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.) | 147 |
| Placebo Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks. | 70 |
| Total | 217 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Sponsor Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 9 | 4 |
Baseline characteristics
| Characteristic | Tadalafil | Placebo | Total |
|---|---|---|---|
| Age Continuous | 52.2 years STANDARD_DEVIATION 10.9 | 51.9 years STANDARD_DEVIATION 10.35 | 52.1 years STANDARD_DEVIATION 10.71 |
| Body Mass Index (BMI) | 27.92 kilograms per square meter (kg/m²) STANDARD_DEVIATION 4.685 | 27.74 kilograms per square meter (kg/m²) STANDARD_DEVIATION 3.423 | 27.86 kilograms per square meter (kg/m²) STANDARD_DEVIATION 4.313 |
| Race/Ethnicity, Customized Asian | 2 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Unknown | 1 participants | 1 participants | 2 participants |
| Race/Ethnicity, Customized White | 144 participants | 69 participants | 213 participants |
| Region of Enrollment Germany | 39 participants | 19 participants | 58 participants |
| Region of Enrollment Greece | 19 participants | 9 participants | 28 participants |
| Region of Enrollment Italy | 27 participants | 13 participants | 40 participants |
| Region of Enrollment Poland | 31 participants | 14 participants | 45 participants |
| Region of Enrollment Spain | 31 participants | 15 participants | 46 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 147 Participants | 70 Participants | 217 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 27 / 147 | 7 / 70 |
| serious Total, serious adverse events | 2 / 147 | 1 / 70 |
Outcome results
Primary
Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses
Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 2. Were you able to insert your penis into your partner's vagina? Data are presented as the mean percentage of yes responses per participant.
Time frame: Baseline, Week 12
Population: The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses | Baseline | 60.1 percentage of yes responses | Standard Deviation 38.77 |
| Tadalafil | Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses | Week 12 Change | 23.2 percentage of yes responses | Standard Deviation 31.92 |
| Placebo | Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses | Baseline | 59.9 percentage of yes responses | Standard Deviation 38.83 |
| Placebo | Change From Baseline in Question 2 of the Patient Sexual Encounter Profile (SEP) Diary at Week 12 in Percentage of Yes Responses | Week 12 Change | 11.6 percentage of yes responses | Standard Deviation 25.48 |
Comparison: Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.p-value: <0.00195% CI: [5.1, 18.3]ANCOVA
Primary
Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12
Self-reported erectile function over the past 4 weeks. Scores range from 0 (low or no erectile function) to 5 (high erectile function) on 6 questions (1-5, 15 of the IIEF). Total Erectile Function Domain scores range from 0 to 30.
Time frame: Baseline, Week 12
Population: The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 | Baseline | 15.5 units on a scale | Standard Deviation 6 |
| Tadalafil | Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 | Week 12 Change | 7.3 units on a scale | Standard Deviation 6.01 |
| Placebo | Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 | Baseline | 16.0 units on a scale | Standard Deviation 6.27 |
| Placebo | Change From Baseline in the International Index of Erectile Function - Erectile Function Domain (IIEF-EF) at Week 12 | Week 12 Change | 3.3 units on a scale | Standard Deviation 5.98 |
Comparison: Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.p-value: <0.00195% CI: [2.2, 5.5]ANCOVA
Primary
Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses
Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 3. Did your erection last long enough for you to have successful intercourse? Data are presented as the mean percentage of yes responses per participant.
Time frame: Baseline, 12 weeks
Population: The efficacy analysis of the three primary efficacy variables (IIEF-EF, SEP Question 2, and SEP Question 3) was performed on all randomized subjects who had at least one baseline and one post-baseline observation on all three variables.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses | Baseline | 28.2 percentage of yes responses | Standard Deviation 31.86 |
| Tadalafil | Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses | Week 12 Change | 39.4 percentage of yes responses | Standard Deviation 34.71 |
| Placebo | Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses | Baseline | 32.2 percentage of yes responses | Standard Deviation 35.93 |
| Placebo | Sexual Encounter Profile (SEP) Diary, Question 3 Change From Baseline to Week 12 in Percentage of Yes Responses | Week 12 Change | 19.3 percentage of yes responses | Standard Deviation 36.18 |
Comparison: Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.p-value: <0.00195% CI: [8.9, 27]ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS)
Self-reported intercourse satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 3 questions of the IIEF-IS domain range from 0 to 15.
Time frame: Baseline, Week 12
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS) | Baseline | 8.2 units on a scale | Standard Deviation 2.65 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS) | Week 12 Change | 2.1 units on a scale | Standard Deviation 2.67 |
| Placebo | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS) | Baseline | 7.6 units on a scale | Standard Deviation 2.43 |
| Placebo | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Intercourse Satisfaction (IS) | Week 12 Change | 1.5 units on a scale | Standard Deviation 2.56 |
Comparison: Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.p-value: 0.046195% CI: [0, 1.5]ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF)
Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction) to 5 (high satisfaction), thus the 2 questions of the IIEF-OF domain range from 0 to 10.
Time frame: Baseline, Week 12
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF) | Baseline | 6.5 units on a scale | Standard Deviation 2.99 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF) | Week 12 Change | 2.0 units on a scale | Standard Deviation 2.78 |
| Placebo | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF) | Baseline | 7.2 units on a scale | Standard Deviation 2.81 |
| Placebo | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Orgasmic Functions (OF) | Week 12 Change | 0.5 units on a scale | Standard Deviation 2.02 |
Comparison: Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.p-value: <0.00195% CI: [0.7, 1.9]ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS)
Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-OS domain range from 0 to 10.
Time frame: Baseline, 12 weeks
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS) | Baseline | 5.2 units on a scale | Standard Deviation 2.15 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS) | Week 12 Change | 2.0 units on a scale | Standard Deviation 2.37 |
| Placebo | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS) | Baseline | 5.1 units on a scale | Standard Deviation 2.11 |
| Placebo | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Overall Satisfaction (OS) | Week 12 Change | 0.8 units on a scale | Standard Deviation 2.19 |
Comparison: Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.p-value: <0.00195% CI: [0.7, 1.9]ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD)
Self-reported overall satisfaction over the past 4 weeks. Scores range from 0 (low/no satisfaction to 5 (high satisfaction), thus the 2 questions of the IIEF-SD domain range from 0 to 10.
Time frame: Baseline, 12 weeks
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD) | Baseline | 6.7 units on a scale | Standard Deviation 1.81 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD) | Week 12 Change | 0.5 units on a scale | Standard Deviation 1.93 |
| Placebo | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD) | Baseline | 6.6 units on a scale | Standard Deviation 1.87 |
| Placebo | Change From Baseline to 12 Week Endpoint in International Index of Erectile Function (IIEF), Sexual Desire (SD) | Week 12 Change | -0.1 units on a scale | Standard Deviation 1.78 |
Comparison: Model included terms for baseline value of efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model,if the interaction was not significant (if p≥0.10), then the interaction term was removed and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.p-value: 0.008995% CI: [0.2, 1.1]ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night
NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The duration of erections are measured and recorded. Data presented are the duration of erectile events at baseline and the change from baseline to Week 12.
Time frame: Baseline, Week 12
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night | Baseline (n=104, n=56) | 28.487 minutes | Standard Deviation 14.4791 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night | Week 12 Change (n=65, n=33) | -1.553 minutes | Standard Deviation 16.0073 |
| Placebo | Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night | Baseline (n=104, n=56) | 26.372 minutes | Standard Deviation 11.8969 |
| Placebo | Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Duration of Erectile Events Per Night | Week 12 Change (n=65, n=33) | -0.398 minutes | Standard Deviation 12.4585 |
Secondary
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night
NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The man wears the device for three nights prior to visit 2 (baseline), visit 5 (end of randomised treatment) and visit 6 (end of follow-up). Data are entered for the 2 nights prior to the visit. During the night the man may have multiple erections. The number of erections is recorded.
Time frame: Baseline, Week 12
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night | Baseline (n=122, n=63) | 2.75 Number of events per night | Standard Deviation 2.27 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night | Week 12 Change (n=96, n=49) | -0.11 Number of events per night | Standard Deviation 2.592 |
| Placebo | Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night | Baseline (n=122, n=63) | 2.44 Number of events per night | Standard Deviation 2.002 |
| Placebo | Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Number of Erectile Events Per Night | Week 12 Change (n=96, n=49) | -0.09 Number of events per night | Standard Deviation 2.214 |
Secondary
Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change
NPT was measured using electrobioimpedance volumetric assessment (NEVA). The NEVA device measures a man's erections during the night. The percent of volume change of the penis during erections is measured and recorded for each erection. Data presented are mean percentage of volumetric change from baseline to Week 12.
Time frame: Baseline, Week 12
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil | Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change | -5.96 percent of volumetric change | Standard Deviation 74.647 |
| Placebo | Change From Baseline to 12 Week Endpoint in Nocturnal Penile Tumescence (NPT) Pattern: Percentage Volumetric Change | -50.30 percent of volumetric change | Standard Deviation 150.321 |
Secondary
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of Yes Responses
Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 1. Were you able to achieve at least some erection (some enlargement of the penis)? Data are presented as the mean percentage of yes responses per participant.
Time frame: Baseline, 12 weeks
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of Yes Responses | Baseline | 80.8 percentage of yes responses | Standard Deviation 28.52 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of Yes Responses | Week 12 Change | 12.5 percentage of yes responses | Standard Deviation 24.03 |
| Placebo | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of Yes Responses | Baseline | 74.2 percentage of yes responses | Standard Deviation 34.26 |
| Placebo | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 1 Percentage of Yes Responses | Week 12 Change | 9.5 percentage of yes responses | Standard Deviation 24.67 |
Comparison: The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.p-value: 0.004795% CI: [2, 10.7]ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of Yes Responses
Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 4. Were you satisfied with the hardness of your erection? Data are presented as the mean percentage of yes responses per participant.
Time frame: Baseline, 12 weeks
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of Yes Responses | Baseline | 11.7 percentage of yes responses | Standard Deviation 21.16 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of Yes Responses | Week 12 Change | 44.1 percentage of yes responses | Standard Deviation 35.75 |
| Placebo | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of Yes Responses | Baseline | 14.6 percentage of yes responses | Standard Deviation 23.3 |
| Placebo | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 4 Percentage of Yes Responses | Week 12 Change | 18.3 percentage of yes responses | Standard Deviation 32.14 |
Comparison: The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.p-value: <0.00195% CI: [14.6, 34.3]ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of Yes Responses
Assessed was the mean change from baseline in the percentage of Yes responses to the SEP diary Question 5. Were you satisfied overall with this sexual experience? Data are presented as the mean percentage of yes responses per participant.
Time frame: Baseline, 12 weeks
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of Yes Responses | Baseline | 10.3 percentage of yes responses | Standard Deviation 20.36 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of Yes Responses | Week 12 Change | 43.2 percentage of yes responses | Standard Deviation 35.52 |
| Placebo | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of Yes Responses | Baseline | 12.9 percentage of yes responses | Standard Deviation 22.11 |
| Placebo | Change From Baseline to 12 Week Endpoint in Sexual Encounter Profile (SEP) Question 5 Percentage of Yes Responses | Week 12 Change | 18.5 percentage of yes responses | Standard Deviation 30.98 |
Comparison: The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (that is, if p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on the type 3 sums of squares.p-value: <0.00195% CI: [13.7, 33.2]ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary
The morning erection diary allows the participant to record whether he experienced an erection on waking. The participant is to complete the morning erection diary every morning during the run-in, treatment and follow-up periods. The percentage of mornings the participant reported an erection is analysed.
Time frame: Baseline, 12 weeks
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary | Baseline (n=145, n=67) | 31.0 percent | Standard Deviation 27.21 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary | Week 12 Change (n=145, n=66) | 27.5 percent | Standard Deviation 25.29 |
| Placebo | Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary | Baseline (n=145, n=67) | 28.9 percent | Standard Deviation 25.74 |
| Placebo | Change From Baseline to 12 Week Endpoint in the Frequency of Spontaneous Morning Erections Captured by Patient Diary | Week 12 Change (n=145, n=66) | 11.9 percent | Standard Deviation 22 |
Comparison: The change from baseline to endpoint in morning erection percentages was analyzed with an ANCOVA model including terms for baseline value, treatment group, country, age and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.p-value: <0.00195% CI: [9.5, 22.8]ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire
SEAR measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). All questions except negatively worded questions 8 and 11 are scored from 1=almost never/never to 5=almost always/always. Questions 8 and 11 were reverse scored, thus a higher score signifies a more favorable response for all 14 items. Overall score is transformed into a 0 (least favorable) to 100 (most favorable) scale.
Time frame: Baseline, Week 12
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Total (Baseline) | 47.3 units on a scale | Standard Deviation 21.95 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Total (Change) | 20.4 units on a scale | Standard Deviation 23.85 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Sexual Relationship Domain (Baseline) | 43.0 units on a scale | Standard Deviation 22.54 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Sexual Relationship Domain (Change) | 23.4 units on a scale | Standard Deviation 25.88 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Confidence Domain (Baseline) | 53.1 units on a scale | Standard Deviation 25.58 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Confidence Domain (Change) | 16.5 units on a scale | Standard Deviation 25.58 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Self-Esteem Domain (Baseline) | 50.5 units on a scale | Standard Deviation 28.15 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Self-Esteem Domain (Change) | 19.2 units on a scale | Standard Deviation 27.85 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Overall Relationship Domain (Baseline) | 58.2 units on a scale | Standard Deviation 31.47 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Overall Relationship Domain (Change) | 11.0 units on a scale | Standard Deviation 32.51 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Self-Esteem Domain (Change) | 9.3 units on a scale | Standard Deviation 30.05 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Total (Baseline) | 47.9 units on a scale | Standard Deviation 21.58 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Confidence Domain (Change) | 6.5 units on a scale | Standard Deviation 24.57 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Total (Change) | 8.3 units on a scale | Standard Deviation 21.14 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Overall Relationship Domain (Change) | 0.9 units on a scale | Standard Deviation 30.17 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Sexual Relationship Domain (Baseline) | 43.9 units on a scale | Standard Deviation 21.68 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Self-Esteem Domain (Baseline) | 48.5 units on a scale | Standard Deviation 30.06 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Sexual Relationship Domain (Change) | 9.7 units on a scale | Standard Deviation 22.35 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Overall Relationship Domain (Baseline) | 62.3 units on a scale | Standard Deviation 29.01 |
| Placebo | Change From Baseline to 12 Week Endpoint in Total and Subdomain Scores of the Self-Esteem and Relationship (SEAR) Questionnaire | Confidence Domain (Baseline) | 53.1 units on a scale | Standard Deviation 24.85 |
Comparison: The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.p-value: <0.00195% CI: [5.5, 18]ANCOVA
Comparison: The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.p-value: <0.00195% CI: [6.6, 19.8]ANCOVA
Comparison: The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.p-value: 0.003495% CI: [3.3, 16.5]ANCOVA
Comparison: The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.p-value: 0.00295% CI: [4.1, 17.9]ANCOVA
Comparison: The model included terms for baseline value of the efficacy variable, treatment group, country, and the baseline-by-treatment-group interaction. In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.p-value: 0.065395% CI: [-0.5, 15.6]ANCOVA
Secondary
Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint
GAQ Question 1: Choose the one number which best describes how you perceive your ability to achieve and maintain your erections now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse.
Time frame: Week 12
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | Very Much Better | 49 participants | 33.6 |
| Tadalafil | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | Much Better | 41 participants | 28.1 |
| Tadalafil | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | Little Better | 29 participants | 19.9 |
| Tadalafil | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | No Change | 14 participants | 9.6 |
| Tadalafil | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | A Little Worse | 5 participants | 3.4 |
| Tadalafil | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | Much Worse | 4 participants | 1.4 |
| Tadalafil | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | Very Much Worse | 2 participants | 1.4 |
| Tadalafil | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | Missing | 4 participants | 2.7 |
| Placebo | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | Missing | 2 participants | 2.9 |
| Placebo | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | Very Much Better | 7 participants | 10.1 |
| Placebo | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | A Little Worse | 5 participants | 7.2 |
| Placebo | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | Much Better | 8 participants | 11.6 |
| Placebo | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | Very Much Worse | 1 participants | 1.4 |
| Placebo | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | Little Better | 19 participants | 27.5 |
| Placebo | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | Much Worse | 3 participants | 4.3 |
| Placebo | Global Assessment Question (GAQ) Question 1 at 12 Week Endpoint | No Change | 24 participants | 34.8 |
Comparison: Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint
GAQ Question 2: Choose the one number which best describes how you perceive your sexual life is now, compared to how it was before you began taking medication in this study. Responses range from 1=very much better to 7=very much worse.
Time frame: Week 12
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Tadalafil | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | Very Much Better | 40 participants | 27.4 |
| Tadalafil | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | A Little Worse | 3 participants | 2.1 |
| Tadalafil | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | Little Better | 28 participants | 19.2 |
| Tadalafil | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | Much Better | 49 participants | 33.6 |
| Tadalafil | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | Very Much Worse | 1 participants | 0.7 |
| Tadalafil | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | No Change | 17 participants | 11.6 |
| Tadalafil | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | Missing | 4 participants | 2.7 |
| Tadalafil | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | Much Worse | 4 participants | — |
| Placebo | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | Missing | 2 participants | 2.9 |
| Placebo | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | Very Much Better | 5 participants | 7.2 |
| Placebo | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | Much Better | 11 participants | 15.9 |
| Placebo | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | Little Better | 17 participants | 24.6 |
| Placebo | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | No Change | 27 participants | 39.1 |
| Placebo | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | A Little Worse | 4 participants | 5.8 |
| Placebo | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | Much Worse | 3 participants | — |
| Placebo | Global Assessment Question (GAQ) Question 2 at 12 Week Endpoint | Very Much Worse | 0 participants | 0 |
Comparison: Wilcoxon's rank sum test was used to compare responses to GAQs between treatment groups.p-value: <0.0001Wilcoxon (Mann-Whitney)
Secondary
The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint
The subject questionnaire consists of 11 questions. Each question is rated on a scale of 0 (extremely low treatment satisfaction) to 4 (extremely high treatment satisfaction). The EDITS summary score will be obtained by adding each individual result for all questions, dividing by the number of questions answered (mean satisfaction score), and multiplying by 25, thus obtaining a score that ranges from 0 (extremely low treatment satisfaction) to 100 (extremely high satisfaction).
Time frame: Week 12
Population: The ITT analysis set included all randomized subjects who had a baseline and post-baseline observation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil | The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint | 72.8 units on a scale | Standard Deviation 20.66 |
| Placebo | The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire at 12 Week Endpoint | 52.7 units on a scale | Standard Deviation 22.62 |
Comparison: The models included terms for baseline value of the efficacy variable,treatment group,country, and the baseline-by-treatment-group interaction.In any model, if the interaction was not significant (at p≥0.10), then the interaction term was removed from the model and the main effects model was used to calculate the between-treatment-group p-value. All tests were based on type 3 sums of squares.p-value: >0.00195% CI: [13.9, 26.1]ANOVA