Impotence
Conditions
Brief summary
To determine if tadalafil 5 mg daily compared to placebo when given for 12 weeks improves getting and maintaining an erection in men with erectile dysfunction and if there are improvements in the sexual quality of life of the man and his female study partner
Interventions
DRUGtadalafil
5 mg tadalafil tablet taken by mouth once a day for 12 weeks
DRUGPlacebo
placebo tablet taken by mouth once a day for 12 weeks
Sponsors
ICOS Corporation
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
Male * History of erectile dysfunction (ED) for at least 3 months duration * Anticipate having the same female partner willing to participate throughout the study * At least 18 years of age at Visit 1 and agree to make at least 4 sexual attempts during the early phase of the study * Adequate partner sexual function as determined by a Female Sexual Function Index * Willing to record responses to efficacy questionnaires, sexual quality of life questionnaires and other instruments used in the study
Exclusion criteria
* May not participate in the study if you have taken tadalafil previously. * History of cardiac conditions including angina requiring treatment with nitrates, heart disease of coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for specified time before starting the study. * Have sexual partner not willing to complete the scales. * Use of nitrates.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15) | Baseline and 12 weeks | Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30. |
| Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ) | Baseline and 12 weeks | The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life. |
| Change From Baseline to Endpoint in the Percent of Yes Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3). | Baseline and 12 weeks | The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject's percentage of yes responses to those questions during the run-in period and postbaseline period, respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response | Baseline and 12 weeks | The baseline and endpoint score for each SEP question 4 (Satisfied with hardness) and 5 (Satisfied overall) are the subject's percentage of yes responses to those questions during the run-in period and postbaseline period, respectively. |
| Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response | Baseline and 12 weeks | The baseline and endpoint score for partner SEP question 3 (Satisfied overall) are the partner's percentage of yes responses to the question during the run-in period and postbaseline period, respectively. |
| Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response | Baseline and 12 weeks | The FSFI Satisfaction Domain (items 14-16) measures satisfaction with emotional closeness, sexual relationship, and overall sexual life. Each question is scored on a 0/1 to 5 scale and domain score is calculated by multiplying the total points by 0.4, for a total score range of 0.8 to 6, with higher scores indicating greater satisfaction. |
| Percent of Subjects With Yes Responses to Global Assessment Questionnaire (GAQ) - Subject Response | 12 weeks | Percent of subjects with Yes responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity) |
| Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response | Baseline and 12 weeks | 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 Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response | Baseline and 12 weeks | The baseline and endpoint score for each SEP question 1 (Achieve some erection) and 2 (Insert penis into vagina) are the partner's percentage of yes responses to those questions during the run-in period and postbaseline period, respectively. |
| Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire | Baseline and 12 weeks | Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores. |
| Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales | Baseline and 12 weeks | Measures improvement in confidence (items 9-14). Confidence domain consists of two subscales (Self-Esteem, items 9-12; Overall Relationship, items 13 and 14). Each domain score, subscale score, and overall score are transformed onto a 0 (least favorable) to 100 (most favorable) scale. |
| Percent of Partners With Yes Responses to Global Assessment Questionnaire (GAQ) - Partner Response | 12 weeks | Percent of Partners with Yes responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity) |
| Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response | Baseline and 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. |
| Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain | 12 weeks | The 6 SLQQ-treatment satisfaction questions were answered by subject and partner at Visit 4/Final Visit. Original item scores (1 to 6 range) were converted to 0 to 5 scale by subtracting 1 to each recorded responses. Each transformed score was multiplied by 20. Total range of scores: 0 (low satisfaction) to 100 (high satisfaction). |
Countries
Austria, France, Germany, Mexico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo tablet taken by mouth once a day for 12 weeks | 78 |
| Tadalafil 5 mg tadalafil tablet taken by mouth once a day for 12 weeks | 264 |
| Total | 342 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 |
| Overall Study | Partner Decision | 0 | 3 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 6 |
| Overall Study | Withdrawal by Subject | 12 | 8 |
Baseline characteristics
| Characteristic | Placebo | Tadalafil | Total |
|---|---|---|---|
| Age Continuous | 53.82 years STANDARD_DEVIATION 10.72 | 54.42 years STANDARD_DEVIATION 10.04 | 54.29 years STANDARD_DEVIATION 10.18 |
| Erectile Dysfunction History - Duration >= 1 year | 73 participants | 240 participants | 313 participants |
| Erectile Dysfunction History - Duration >= 3 months and < 6 months | 1 participants | 8 participants | 9 participants |
| Erectile Dysfunction History - Duration >= 6 months and < 1 year | 4 participants | 16 participants | 20 participants |
| Erectile Dysfunction History - Etiology Mixed | 34 participants | 114 participants | 148 participants |
| Erectile Dysfunction History - Etiology Organic | 29 participants | 91 participants | 120 participants |
| Erectile Dysfunction History - Etiology Psychogenic | 12 participants | 30 participants | 42 participants |
| Erectile Dysfunction History - Etiology Unknown | 3 participants | 29 participants | 32 participants |
| International Index of Erectile Function (IIEF) - Erectile Dysfunction Severity Mild (17-30) | 35 participants | 123 participants | 158.0 participants |
| International Index of Erectile Function (IIEF) - Erectile Dysfunction Severity Missing | 1 participants | 7 participants | 8.0 participants |
| International Index of Erectile Function (IIEF) - Erectile Dysfunction Severity Moderate (11-16) | 22 participants | 71 participants | 93.0 participants |
| International Index of Erectile Function (IIEF) - Erectile Dysfunction Severity Severe (1-10) | 20 participants | 63 participants | 83.0 participants |
| International Index of Erectile Function (IIEF) - Erectile Function Domain | 15.27 units on a scale STANDARD_DEVIATION 6.49 | 15.73 units on a scale STANDARD_DEVIATION 6.13 | 15.62 units on a scale STANDARD_DEVIATION 6.21 |
| Race/Ethnicity African | 0 participants | 6 participants | 6 participants |
| Race/Ethnicity Caucasian | 57 participants | 188 participants | 245 participants |
| Race/Ethnicity Hispanic | 21 participants | 69 participants | 90 participants |
| Race/Ethnicity Native American | 0 participants | 1 participants | 1 participants |
| Region of Enrollment Austria | 8 participants | 17 participants | 25 participants |
| Region of Enrollment France | 11 participants | 41 participants | 52 participants |
| Region of Enrollment Germany | 11 participants | 36 participants | 47 participants |
| Region of Enrollment Mexico | 19 participants | 63 participants | 82 participants |
| Region of Enrollment United States | 29 participants | 107 participants | 136 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 78 Participants | 264 Participants | 342 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 21 / — | 77 / — |
| serious Total, serious adverse events | 1 / — | 3 / — |
Outcome results
Primary
Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15)
Measures erectile function over the past 4 weeks on Questions 1-5 and 15 (6 questions) of the International Index of Erecile Function (IIEF) questionnaire. Scores range from 0 (low/no erectile function) to 5 (high erectile function), thus the 6 questions of the IIEF-EF domain range from 0 to 30.
Time frame: Baseline and 12 weeks
Population: last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15) | 0.49 units on a scale | Standard Error 0.781 |
| Tadalafil | Change From Baseline to Endpoint in the International Index of Erectile Function (IIEF)- Erectile Function Domain Score (Sum of IIEF Questions 1-5 and 15) | 8.03 units on a scale | Standard Error 0.449 |
Comparison: The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.p-value: <0.001ANCOVA
Primary
Change From Baseline to Endpoint in the Percent of Yes Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3).
The baseline and endpoint score for each SEP question 2 (Insert penis into vagina) and 3 (Successful intercourse) are the subject's percentage of yes responses to those questions during the run-in period and postbaseline period, respectively.
Time frame: Baseline and 12 weeks
Population: all randomized participants having both baseline and at least one post-baseline data measurement
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Endpoint in the Percent of Yes Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3). | Question 2 change from baseline in percent yes | 2.19 percent | Standard Error 2.833 |
| Placebo | Change From Baseline to Endpoint in the Percent of Yes Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3). | Question 3 change from baseline in percent yes | 10.80 percent | Standard Error 3.767 |
| Tadalafil | Change From Baseline to Endpoint in the Percent of Yes Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3). | Question 2 change from baseline in percent yes | 28.80 percent | Standard Error 1.644 |
| Tadalafil | Change From Baseline to Endpoint in the Percent of Yes Responses to Sexual Encounter Profile (SEP) Diary Questions 2 (SEP2) and 3 (SEP3). | Question 3 change from baseline in percent yes | 46.46 percent | Standard Error 2.185 |
Comparison: The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.p-value: <0.001ANCOVA
Comparison: The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.p-value: <0.001ANCOVA
Primary
Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ)
The original item scores (-4 to 4 range) were converted to 0 to 8 scale score by adding 4 to each recorded responses. Each transformed score was multiplied by 12.5 for a total range of 0 to 100. Higher scores are indicative of a higher sexual quality of life.
Time frame: Baseline and 12 weeks
Population: last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ) | SQoL - Subject (change from baseline) | 12.59 units on a scale | Standard Error 2.866 |
| Placebo | Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ) | SQoL-Partner (change from baseline) (n=70, n=238) | 7.93 units on a scale | Standard Error 2.861 |
| Tadalafil | Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ) | SQoL - Subject (change from baseline) | 39.37 units on a scale | Standard Error 1.651 |
| Tadalafil | Improvement in the Sexual Quality of Life in the Subject and His Study Partner as Measured by the Sexual Quality of Life (SQoL) Domain of the Sexual Life Quality Questionnaire (SLQQ) | SQoL-Partner (change from baseline) (n=70, n=238) | 32.87 units on a scale | Standard Error 1.638 |
Comparison: The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.p-value: <0.001ANCOVA
Comparison: The null hypotheses (no treatment effect with respect to IIEF EF domain or SEP2 or SEP3) were each tested at a specified level of 0.05. In order to pass a serial gatekeeper, it was necessary to reject all three hypotheses. The two null hypotheses (no treatment effect with respect to subject SLQQ-SQoL domain and no treatment effect with respect to partner SLQQ-SQoL domain) were then each tested at a significance level of 0.025.p-value: <0.001ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response
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 and 12 weeks
Population: last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response | 0.44 units on a scale | Standard Error 0.257 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Overall Satisfaction Domain of the International Index of Erectile Function (IIEF-OS) - Subject Response | 2.57 units on a scale | Standard Error 0.148 |
p-value: <0.001ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response
The baseline and endpoint score for partner SEP question 3 (Satisfied overall) are the partner's percentage of yes responses to the question during the run-in period and postbaseline period, respectively.
Time frame: Baseline and 12 weeks
Population: all randomized participants having both baseline and at least one post-baseline data measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response | 10.21 percent | Standard Error 3.595 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Question 3 - Partner Response | 43.16 percent | Standard Error 2.072 |
p-value: <0.001ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response
The baseline and endpoint score for each SEP question 1 (Achieve some erection) and 2 (Insert penis into vagina) are the partner's percentage of yes responses to those questions during the run-in period and postbaseline period, respectively.
Time frame: Baseline and 12 weeks
Population: all randomized participants having both baseline and at least one post-baseline data measurement
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response | Question 1 change from baseline in percent Yes | 1.25 percent | Standard Error 2.224 |
| Placebo | Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response | Question 2 change from baseline in percent Yes | 6.97 percent | Standard Error 2.896 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response | Question 1 change from baseline in percent Yes | 18.34 percent | Standard Error 1.27 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Partner-Sexual Encounter Profile (SEP) Questions 1 and 2 - Partner Response | Question 2 change from baseline in percent Yes | 30.69 percent | Standard Error 1.662 |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response
The baseline and endpoint score for each SEP question 4 (Satisfied with hardness) and 5 (Satisfied overall) are the subject's percentage of yes responses to those questions during the run-in period and postbaseline period, respectively.
Time frame: Baseline and 12 weeks
Population: all randomized participants having both baseline and at least one post-baseline data measurement
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response | Question 4 change from baseline in percent Yes | 12.08 percent | Standard Error 3.936 |
| Placebo | Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response | Question 5 change from baseline in percent Yes | 11.47 percent | Standard Error 3.951 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response | Question 4 change from baseline in percent Yes | 50.05 percent | Standard Error 2.283 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in Percent of Yes Responses to Sexual Encounter Profile (SEP) Questions 4 and 5 - Subject Response | Question 5 change from baseline in percent Yes | 48.78 percent | Standard Error 2.292 |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response
The FSFI Satisfaction Domain (items 14-16) measures satisfaction with emotional closeness, sexual relationship, and overall sexual life. Each question is scored on a 0/1 to 5 scale and domain score is calculated by multiplying the total points by 0.4, for a total score range of 0.8 to 6, with higher scores indicating greater satisfaction.
Time frame: Baseline and 12 weeks
Population: last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response | -0.40 units on a scale | Standard Error 0.13 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in the Satisfaction Domain of the Female Sexual Function Index (FSFI) - Partner Response | 0.32 units on a scale | Standard Error 0.075 |
p-value: <0.001ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire
Measures improvement in self-esteem and relationship satisfaction. Questionnaire consists of two domains, Sexual Relationship (items 1-8) and Confidence (items 9-14). Overall score is transformed onto a 0 (least favorable) to 100 (most favorable) scale. Overall score was calculated from two domains and subscales scores.
Time frame: Baseline and 12 weeks
Population: last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire | Total Score change from baseline | 3.07 units on a scale | Standard Error 2.616 |
| Placebo | Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire | Sexual Relationship change from baseline | 4.61 units on a scale | Standard Error 2.903 |
| Placebo | Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire | Confidence change from baseline | 0.91 units on a scale | Standard Error 2.567 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire | Total Score change from baseline | 30.44 units on a scale | Standard Error 1.506 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire | Sexual Relationship change from baseline | 34.28 units on a scale | Standard Error 1.673 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire | Confidence change from baseline | 25.35 units on a scale | Standard Error 1.475 |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
Secondary
Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales
Measures improvement in confidence (items 9-14). Confidence domain consists of two subscales (Self-Esteem, items 9-12; Overall Relationship, items 13 and 14). Each domain score, subscale score, and overall score are transformed onto a 0 (least favorable) to 100 (most favorable) scale.
Time frame: Baseline and 12 weeks
Population: last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales | Self-Esteem change from baseline | 3.26 units on a scale | Standard Error 2.743 |
| Placebo | Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales | Overall Relationship change from baseline | -4.04 units on a scale | Standard Error 2.792 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales | Self-Esteem change from baseline | 29.56 units on a scale | Standard Error 1.579 |
| Tadalafil | Change From Baseline to 12 Week Endpoint in the Self-Esteem and Relationship (SEAR) Questionnaire - Confidence Domain Subscales | Overall Relationship change from baseline | 16.97 units on a scale | Standard Error 1.603 |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA
Secondary
Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response
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 and 12 weeks
Population: last observation carried forward for all randomized participants having both baseline and at least one post-baseline data measurement
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response | 0.09 units on a scale | Standard Error 0.356 |
| Tadalafil | Change From Baseline to Week 12 Endpoint in the International Index of Erectile Function - Intercourse Satisfaction Domain - Subject Response | 2.74 units on a scale | Standard Error 0.205 |
p-value: <0.001ANCOVA
Secondary
Percent of Partners With Yes Responses to Global Assessment Questionnaire (GAQ) - Partner Response
Percent of Partners with Yes responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)
Time frame: 12 weeks
Population: all randomized participants having post-baseline data measurement on this variable
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percent of Partners With Yes Responses to Global Assessment Questionnaire (GAQ) - Partner Response | GAQ Question 1 | 30 percentage of partners answering Yes |
| Placebo | Percent of Partners With Yes Responses to Global Assessment Questionnaire (GAQ) - Partner Response | GAQ Question 2 | 24 percentage of partners answering Yes |
| Tadalafil | Percent of Partners With Yes Responses to Global Assessment Questionnaire (GAQ) - Partner Response | GAQ Question 1 | 79 percentage of partners answering Yes |
| Tadalafil | Percent of Partners With Yes Responses to Global Assessment Questionnaire (GAQ) - Partner Response | GAQ Question 2 | 76 percentage of partners answering Yes |
p-value: <0.001Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
Percent of Subjects With Yes Responses to Global Assessment Questionnaire (GAQ) - Subject Response
Percent of subjects with Yes responses to Question 1 (Improvement in Erections) and Question 2 (Improvement in the Ability to Engage in Sexual Activity)
Time frame: 12 weeks
Population: all randomized participants having post-baseline data measurement on this variable
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percent of Subjects With Yes Responses to Global Assessment Questionnaire (GAQ) - Subject Response | GAQ Question 1 | 26 percentage of subjects answering Yes |
| Placebo | Percent of Subjects With Yes Responses to Global Assessment Questionnaire (GAQ) - Subject Response | GAQ Question 2 | 22 percentage of subjects answering Yes |
| Tadalafil | Percent of Subjects With Yes Responses to Global Assessment Questionnaire (GAQ) - Subject Response | GAQ Question 1 | 81 percentage of subjects answering Yes |
| Tadalafil | Percent of Subjects With Yes Responses to Global Assessment Questionnaire (GAQ) - Subject Response | GAQ Question 2 | 79 percentage of subjects answering Yes |
p-value: <0.001Regression, Logistic
p-value: <0.001Regression, Logistic
Secondary
Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain
The 6 SLQQ-treatment satisfaction questions were answered by subject and partner at Visit 4/Final Visit. Original item scores (1 to 6 range) were converted to 0 to 5 scale by subtracting 1 to each recorded responses. Each transformed score was multiplied by 20. Total range of scores: 0 (low satisfaction) to 100 (high satisfaction).
Time frame: 12 weeks
Population: all randomized participants having post-baseline data measurement on this variable
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain | SLQQ - Subject (n=72, n=244) | 51.58 units on a scale | Standard Error 2.246 |
| Placebo | Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain | SLQQ - Partner (n=70, n=238) | 55.25 units on a scale | Standard Error 2.115 |
| Tadalafil | Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain | SLQQ - Subject (n=72, n=244) | 75.04 units on a scale | Standard Error 1.293 |
| Tadalafil | Sexual Life Quality Questionnaire (SLQQ) Treatment Satisfaction Domain | SLQQ - Partner (n=70, n=238) | 73.42 units on a scale | Standard Error 1.214 |
p-value: <0.001ANCOVA
p-value: <0.001ANCOVA