Erectile Dysfunction
Conditions
Brief summary
The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).
Interventions
DRUGtadalafil once a day [T(OaD)]
5 mg tablet taken once a day (OaD) by mouth for 8 weeks
DRUGsildenafil citrate as needed [S(PRN)]
100 mg tablet taken as needed (PRN) by mouth for 8 weeks
DRUGtadalafil as needed [T(PRN)]
20 mg tablet taken as needed (PRN) by mouth for 8 weeks
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* History of erectile dysfunction (ED). * Have had satisfactory response to tadalafil, sildenafil citrate, or vardenafil HCl for a period of at least 6 months and expect frequent use (at least one dose per week, on average) when administered as needed. * Have never used tadalafil 5 mg or 2.5 mg once a day therapy. * Anticipate having the same adult female sexual partner willing to participate during the study. * Agree to make at least four sexual intercourse attempts during the first four weeks of the study. * Agree not to use any other treatment for ED (even herbal treatments) during the study. * Agree to follow the directions given by the study doctor and staff about using the study drug.
Exclusion criteria
* Have any other primary sexual disorders present or penile deformity. * Have history of radical prostatectomy or penile implant. * Have problems with your kidneys, liver, or nervous system. * Have uncontrolled diabetes, as measured by a blood test for haemoglobin A1C greater than a value of 11%. * Are being treated for heart disease with any drug that is called a nitrate (for example, nitroglycerin). * Have chest pain (called unstable angina or angina) that requires treatment. * Have heart disease that causes symptoms after you exert yourself. * Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention). * Have a history of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION). * Have retinitis pigmentosa. * Have history of human immunodeficiency virus (HIV). * Have very high or very low blood pressure (your study doctor will discuss the limits with you). * Have had a stroke or a significant injury to your brain or spinal cord within the last 6 months. * Have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption Lactose intolerance. * Have a scheduled or planned surgery requiring anaesthesia during the course of the study. * Have a scheduled cataract surgery during the curse of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | baseline, 8 weeks of each treatment | The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS | baseline, 8 weeks of each treatment | The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity. |
| Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS | baseline, 8 weeks of each treatment | The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence. |
| Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF) | baseline, 8 weeks of each treatment | 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 to Endpoint in the Proportion of Days With at Least One Morning Erection | baseline, 8 weeks of each treatment | — |
| Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF | baseline, 8 weeks of each treatment | 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 Endpoint in the Overall Satisfaction (OS) Domain of the IIEF | baseline, 8 weeks of each treatment | 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 Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | baseline, 8 weeks of each treatment | The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence. |
| Number of Participants With at Least One Serious Adverse Event | baseline through 26 weeks (including two washout periods of 1 week each) | Serious adverse events are listed in the Reported Adverse Event module. |
| Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score | baseline, 8 weeks of each treatment | 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. |
| Question 1 I Felt as if I Did Not Have ED Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 8 weeks of each treatment | Scores for Question 1 range from 0 (not at all) to 4 (extremely). |
| Question 2 I Felt in Control of my Sex Life Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 8 weeks of each treatment | Scores for Question 2 range from 0 (not at all) to 4 (extremely). |
| Question 3 I Felt the Drug Was in Control of my Erections Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 8 weeks of each treatment | Scores for Question 3 range from 0 (not at all) to 4 (extremely). |
| Question 4 I Felt Like a Whole Man Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 8 weeks of each treatment | Scores for Question 4 range from 0 (not at all) to 4 (extremely). |
| Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint | 8 weeks of each treatment | EDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction). |
Countries
Australia, Brazil, Germany, Italy, Mexico, Puerto Rico, Spain, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T(OaD)/S(PRN)/T(PRN) Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks | 62 |
| T(OaD)/T(PRN)/S(PRN) Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks | 63 |
| S(PRN)/T(OaD)/T(PRN) Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks | 63 |
| S(PRN)/T(PRN)/T(OaD) Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks | 63 |
| T(PRN)/T(OaD)/S(PRN) Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks | 63 |
| T(PRN)/S(PRN)/T(OaD) Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks | 64 |
| Total | 378 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 0 | 2 | 1 | 1 |
| Overall Study | Lack of Efficacy | 0 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 2 | 2 | 4 | 2 | 3 |
| Overall Study | Physician Decision | 0 | 1 | 1 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 2 | 0 | 0 | 1 | 0 |
| Overall Study | Serious Adverse Event | 1 | 0 | 1 | 2 | 0 | 1 |
| Overall Study | Sponsor Decision | 1 | 2 | 1 | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 | 1 | 2 | 1 |
Baseline characteristics
| Characteristic | Total | T(OaD)/S(PRN)/T(PRN) | T(PRN)/S(PRN)/T(OaD) | S(PRN)/T(OaD)/T(PRN) | T(OaD)/T(PRN)/S(PRN) | S(PRN)/T(PRN)/T(OaD) | T(PRN)/T(OaD)/S(PRN) |
|---|---|---|---|---|---|---|---|
| Age Continuous | 56.21 years STANDARD_DEVIATION 10.98 | 58.53 years STANDARD_DEVIATION 11.62 | 54.36 years STANDARD_DEVIATION 10.28 | 55.40 years STANDARD_DEVIATION 11.7 | 55.12 years STANDARD_DEVIATION 8.89 | 54.87 years STANDARD_DEVIATION 12.04 | 59.04 years STANDARD_DEVIATION 10.56 |
| Body Mass Index (BMI) | 28.22 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.91 | 28.35 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.18 | 29.08 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.26 | 27.77 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.71 | 27.62 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 2.65 | 28.68 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.74 | 27.80 kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.51 |
| ED Etiology Mixed | 146 participants | 25 participants | 28 participants | 21 participants | 26 participants | 23 participants | 23 participants |
| ED Etiology Organic | 163 participants | 22 participants | 25 participants | 29 participants | 28 participants | 29 participants | 30 participants |
| ED Etiology Psychogenic | 34 participants | 5 participants | 7 participants | 9 participants | 3 participants | 9 participants | 1 participants |
| ED Etiology Unknown | 35 participants | 10 participants | 4 participants | 4 participants | 6 participants | 2 participants | 9 participants |
| Erectile Dysfunction (ED) Duration => 1 year | 356 participants | 59 participants | 59 participants | 58 participants | 61 participants | 58 participants | 61 participants |
| Erectile Dysfunction (ED) Duration => than 6 months through <1 year | 22 participants | 3 participants | 5 participants | 5 participants | 2 participants | 5 participants | 2 participants |
| Prior sildenafil citrate use as needed (PRN) No | 149 participants | 26 participants | 29 participants | 23 participants | 23 participants | 24 participants | 24 participants |
| Prior sildenafil citrate use as needed (PRN) Yes | 229 participants | 36 participants | 35 participants | 40 participants | 40 participants | 39 participants | 39 participants |
| Prior Vardenafil HCl use No | 274 participants | 41 participants | 45 participants | 46 participants | 45 participants | 53 participants | 44 participants |
| Prior Vardenafil HCl use Yes | 104 participants | 21 participants | 19 participants | 17 participants | 18 participants | 10 participants | 19 participants |
| Race/Ethnicity, Customized African | 12 participants | 1 participants | 2 participants | 1 participants | 1 participants | 4 participants | 3 participants |
| Race/Ethnicity, Customized Caucasian | 255 participants | 41 participants | 40 participants | 46 participants | 44 participants | 41 participants | 43 participants |
| Race/Ethnicity, Customized East Asian | 3 participants | 1 participants | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Hispanic | 105 participants | 19 participants | 19 participants | 15 participants | 17 participants | 18 participants | 17 participants |
| Race/Ethnicity, Customized Native American | 2 participants | 0 participants | 2 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized West Asian | 1 participants | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants | 0 participants |
| Region of Enrollment Australia | 24 participants | 3 participants | 4 participants | 5 participants | 4 participants | 4 participants | 4 participants |
| Region of Enrollment Germany | 40 participants | 7 participants | 7 participants | 6 participants | 6 participants | 7 participants | 7 participants |
| Region of Enrollment Italy | 29 participants | 5 participants | 5 participants | 4 participants | 5 participants | 6 participants | 4 participants |
| Region of Enrollment Mexico | 84 participants | 14 participants | 14 participants | 14 participants | 14 participants | 14 participants | 14 participants |
| Region of Enrollment Spain | 57 participants | 10 participants | 9 participants | 10 participants | 10 participants | 9 participants | 9 participants |
| Region of Enrollment United Kingdom | 44 participants | 6 participants | 8 participants | 7 participants | 8 participants | 7 participants | 8 participants |
| Region of Enrollment United States | 100 participants | 17 participants | 17 participants | 17 participants | 16 participants | 16 participants | 17 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 378 Participants | 62 Participants | 64 Participants | 63 Participants | 63 Participants | 63 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 66 / 378 | 73 / 378 | 70 / 378 |
| serious Total, serious adverse events | 4 / 378 | 5 / 378 | 2 / 378 |
Outcome results
Primary
Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)
The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
Time frame: baseline, 8 weeks of each treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Baseline | 2.24 units on a scale | Standard Deviation 0.62 |
| Tadalafil Once a Day [T(OaD)] | Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Change from Baseline | 0.50 units on a scale | Standard Deviation 0.78 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Baseline | 2.23 units on a scale | Standard Deviation 0.63 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline Between Tadalafil Once a Day (OaD) and Sildenafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Change from Baseline | 0.39 units on a scale | Standard Deviation 0.67 |
p-value: 0.00195% CI: [0.04, 0.19]t-test
Secondary
Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS)
The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Sexual Self-Confidence score is the average of responses on 6 PAIRS item scores. Sexual Self-Confidence scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
Time frame: baseline, 8 weeks of each treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Baseline | 2.24 units on a scale | Standard Deviation 0.62 |
| Tadalafil Once a Day [T(OaD)] | Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Change from Baseline | 0.50 units on a scale | Standard Deviation 0.78 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Baseline | 2.24 units on a scale | Standard Deviation 0.63 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline Between Tadalafil Once a Day (OaD) and Tadalafil as Needed (PRN) in Sexual Self-Confidence Domain of Psychological and Interpersonal Relationship Scales (PAIRS) | Change from Baseline | 0.50 units on a scale | Standard Deviation 0.72 |
p-value: 0.87295% CI: [-0.06, 0.08]t-test
Secondary
Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF)
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, 8 weeks of each treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF) | Baseline | 15.60 units on a scale | Standard Deviation 6.26 |
| Tadalafil Once a Day [T(OaD)] | Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF) | Change from Baseline | 8.68 units on a scale | Standard Deviation 6.94 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF) | Baseline | 15.40 units on a scale | Standard Deviation 6.27 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF) | Change from Baseline | 9.70 units on a scale | Standard Deviation 7.01 |
| Tadalafil as Needed [T(PRN)] | Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF) | Baseline | 15.55 units on a scale | Standard Deviation 6.23 |
| Tadalafil as Needed [T(PRN)] | Change From Baseline to Endpoint in the Erectile Function Domain of the International Index of Erectile Function (IIEF) | Change from Baseline | 9.54 units on a scale | Standard Deviation 7 |
p-value: 0.00495% CI: [-1.43, -0.27]t-test
p-value: 0.00795% CI: [-1.37, -0.22]t-test
Secondary
Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF
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, 8 weeks of each treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF | Baseline | 8.35 units on a scale | Standard Deviation 2.76 |
| Tadalafil Once a Day [T(OaD)] | Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF | Change from Baseline | 3.33 units on a scale | Standard Deviation 3.16 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF | Baseline | 8.34 units on a scale | Standard Deviation 2.77 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF | Change from Baseline | 3.99 units on a scale | Standard Deviation 3.17 |
| Tadalafil as Needed [T(PRN)] | Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF | Change from Baseline | 3.83 units on a scale | Standard Deviation 3.13 |
| Tadalafil as Needed [T(PRN)] | Change From Baseline to Endpoint in the Intercourse Satisfaction (IS) Domain of the IIEF | Baseline | 8.37 units on a scale | Standard Deviation 2.73 |
p-value: <0.00195% CI: [-0.91, -0.36]t-test
p-value: <0.00195% CI: [-0.78, -0.23]t-test
Secondary
Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF
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, 8 weeks of each treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF | Baseline | 5.26 units on a scale | Standard Deviation 2.34 |
| Tadalafil Once a Day [T(OaD)] | Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF | Change from Baseline | 2.60 units on a scale | Standard Deviation 2.61 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF | Change from Baseline | 2.87 units on a scale | Standard Deviation 2.55 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF | Baseline | 5.22 units on a scale | Standard Deviation 2.36 |
| Tadalafil as Needed [T(PRN)] | Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF | Baseline | 5.27 units on a scale | Standard Deviation 2.34 |
| Tadalafil as Needed [T(PRN)] | Change From Baseline to Endpoint in the Overall Satisfaction (OS) Domain of the IIEF | Change from Baseline | 2.84 units on a scale | Standard Deviation 2.58 |
p-value: 0.05595% CI: [-0.44, 0]t-test
p-value: 0.04695% CI: [-0.44, 0]t-test
Secondary
Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection
Time frame: baseline, 8 weeks of each treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection | Baseline | 0.28 proportion of days | Standard Deviation 0.26 |
| Tadalafil Once a Day [T(OaD)] | Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection | Change from Baseline | 0.26 proportion of days | Standard Deviation 0.29 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection | Baseline | 0.28 proportion of days | Standard Deviation 0.26 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection | Change from Baseline | 0.20 proportion of days | Standard Deviation 0.25 |
| Tadalafil as Needed [T(PRN)] | Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection | Baseline | 0.27 proportion of days | Standard Deviation 0.26 |
| Tadalafil as Needed [T(PRN)] | Change From Baseline to Endpoint in the Proportion of Days With at Least One Morning Erection | Change from Baseline | 0.11 proportion of days | Standard Deviation 0.24 |
p-value: <0.00195% CI: [0.03, 0.09]t-test
p-value: <0.00195% CI: [0.06, 0.12]t-test
Secondary
Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score
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, 8 weeks of each treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score | Baseline | 50.28 units on a scale | Standard Deviation 21.36 |
| Tadalafil Once a Day [T(OaD)] | Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score | Change from Baseline | 22.94 units on a scale | Standard Deviation 24.86 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score | Baseline | 50.50 units on a scale | Standard Deviation 21.58 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score | Change from Baseline | 22.87 units on a scale | Standard Deviation 24.43 |
| Tadalafil as Needed [T(PRN)] | Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score | Baseline | 50.69 units on a scale | Standard Deviation 21.32 |
| Tadalafil as Needed [T(PRN)] | Change From Baseline to Endpoint in the Self-Esteem And Relationship (SEAR) Questionnaire Transformed Total Score | Change from Baseline | 24.13 units on a scale | Standard Deviation 24.53 |
p-value: 0.91595% CI: [-1.95, 2.17]t-test
p-value: 0.21295% CI: [-3.35, 0.74]t-test
Secondary
Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS
The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Spontaneity score is the average of responses on 9 PAIRS item scores. Spontaneity scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater spontaneity.
Time frame: baseline, 8 weeks of each treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS | Baseline | 3.06 units on a scale | Standard Deviation 0.48 |
| Tadalafil Once a Day [T(OaD)] | Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS | Change from Baseline | 0.10 units on a scale | Standard Deviation 0.5 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS | Baseline | 3.07 units on a scale | Standard Deviation 0.48 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS | Change from Baseline | -0.05 units on a scale | Standard Deviation 0.49 |
| Tadalafil as Needed [T(PRN)] | Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS | Change from Baseline | 0.07 units on a scale | Standard Deviation 0.49 |
| Tadalafil as Needed [T(PRN)] | Change From Baseline to Endpoint in the Spontaneity Domain of PAIRS | Baseline | 3.07 units on a scale | Standard Deviation 0.48 |
p-value: <0.00195% CI: [0.1, 0.2]t-test
p-value: 0.39595% CI: [-0.03, 0.07]t-test
Secondary
Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS
The PAIRS is a self-administed scale that assesses the broader psychological and interpersonal outcomes associated with erectile dysfunction and its treatment. Time Concerns score is the average of responses on 8 PAIRS item scores. Time Concerns scores range from 1 (strongly disagree) to 4 (strongly agree). Higher scores are indicative of greater sexual self-confidence.
Time frame: baseline, 8 weeks of each treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS | Baseline | 2.43 units on a scale | Standard Deviation 0.53 |
| Tadalafil Once a Day [T(OaD)] | Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS | Change from Baseline | -0.30 units on a scale | Standard Deviation 0.03 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS | Baseline | 2.42 units on a scale | Standard Deviation 0.54 |
| Sildenafil as Needed [S(PRN)] | Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS | Change from Baseline | 0.00 units on a scale | Standard Deviation 0.53 |
| Tadalafil as Needed [T(PRN)] | Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS | Baseline | 2.42 units on a scale | Standard Deviation 0.53 |
| Tadalafil as Needed [T(PRN)] | Change From Baseline to Endpoint in the Time Concerns Domain of PAIRS | Change from Baseline | -0.17 units on a scale | Standard Deviation 0.55 |
p-value: <0.00195% CI: [-0.36, -0.25]t-test
p-value: <0.00195% CI: [-0.2, -0.08]t-test
Secondary
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint
EDITS is a questionnaire-based inventory capturing a participant's subjective evaluation of treatment for the participant's erection problems. All items on the 11-item Patient EDITS were scored from zero (no satisfaction or dissatisfaction) to four (high satisfaction). The EDITS Summary Score (transformed) is obtained by adding each individual score for all questions, dividing by the number of questions, and multiplying by 25, so that EDITS scores could range from a low of 0 (extremely low treatment satisfaction) to a high of 100 (extremely high treatment satisfaction).
Time frame: 8 weeks of each treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint | 75.81 units on a scale | Standard Deviation 22.36 |
| Sildenafil as Needed [S(PRN)] | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint | 75.68 units on a scale | Standard Deviation 19.58 |
| Tadalafil as Needed [T(PRN)] | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Score at Endpoint | 79.50 units on a scale | Standard Deviation 19.56 |
p-value: 0.00495% CI: [1.16, 6.17]t-test
p-value: 0.00695% CI: [-6.05, -1.04]t-test
Secondary
Number of Participants With at Least One Serious Adverse Event
Serious adverse events are listed in the Reported Adverse Event module.
Time frame: baseline through 26 weeks (including two washout periods of 1 week each)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Number of Participants With at Least One Serious Adverse Event | 4 participants |
| Sildenafil as Needed [S(PRN)] | Number of Participants With at Least One Serious Adverse Event | 5 participants |
| Tadalafil as Needed [T(PRN)] | Number of Participants With at Least One Serious Adverse Event | 2 participants |
Secondary
Question 1 I Felt as if I Did Not Have ED Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
Scores for Question 1 range from 0 (not at all) to 4 (extremely).
Time frame: 8 weeks of each treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Question 1 I Felt as if I Did Not Have ED Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 1.83 units on a scale | Standard Deviation 1.25 |
| Sildenafil as Needed [S(PRN)] | Question 1 I Felt as if I Did Not Have ED Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 1.78 units on a scale | Standard Deviation 1.13 |
| Tadalafil as Needed [T(PRN)] | Question 1 I Felt as if I Did Not Have ED Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 1.77 units on a scale | Standard Deviation 1.22 |
p-value: 0.40395% CI: [-0.09, 0.22]Generalized Linear Mixed Model
p-value: 0.36795% CI: [-0.08, 0.23]Generalized Linear Mixed Model
Secondary
Question 2 I Felt in Control of my Sex Life Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
Scores for Question 2 range from 0 (not at all) to 4 (extremely).
Time frame: 8 weeks of each treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Question 2 I Felt in Control of my Sex Life Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 2.33 units on a scale | Standard Deviation 1.09 |
| Sildenafil as Needed [S(PRN)] | Question 2 I Felt in Control of my Sex Life Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 2.14 units on a scale | Standard Deviation 1.01 |
| Tadalafil as Needed [T(PRN)] | Question 2 I Felt in Control of my Sex Life Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 2.36 units on a scale | Standard Deviation 1.1 |
p-value: 0.00295% CI: [0.07, 0.32]Generalized Linear Mixed Model
p-value: 0.72295% CI: [-0.15, 0.1]Generalized Linear Mixed Model
Secondary
Question 3 I Felt the Drug Was in Control of my Erections Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
Scores for Question 3 range from 0 (not at all) to 4 (extremely).
Time frame: 8 weeks of each treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Question 3 I Felt the Drug Was in Control of my Erections Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 1.99 units on a scale | Standard Deviation 1.19 |
| Sildenafil as Needed [S(PRN)] | Question 3 I Felt the Drug Was in Control of my Erections Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 2.28 units on a scale | Standard Deviation 1.12 |
| Tadalafil as Needed [T(PRN)] | Question 3 I Felt the Drug Was in Control of my Erections Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 2.50 units on a scale | Standard Deviation 1.14 |
p-value: <0.00195% CI: [-0.65, -0.37]Generalized Linear Mixed Model
p-value: <0.00195% CI: [-0.43, -0.16]Generalized Linear Mixed Model
Secondary
Question 4 I Felt Like a Whole Man Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint
Scores for Question 4 range from 0 (not at all) to 4 (extremely).
Time frame: 8 weeks of each treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tadalafil Once a Day [T(OaD)] | Question 4 I Felt Like a Whole Man Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 2.53 units on a scale | Standard Deviation 1.1 |
| Sildenafil as Needed [S(PRN)] | Question 4 I Felt Like a Whole Man Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 2.57 units on a scale | Standard Deviation 1.06 |
| Tadalafil as Needed [T(PRN)] | Question 4 I Felt Like a Whole Man Score of the Patient Perception and Feelings Questions (PPF-Q) at Endpoint | 2.44 units on a scale | Standard Deviation 0.99 |
p-value: 0.0795% CI: [-0.01, 0.22]Generalized Linear Mixed Model
p-value: 0.63795% CI: [-0.14, 0.09]Generalized Linear Mixed Model