Impotence
Conditions
Brief summary
Men's quality of life (QoL) is potentially affected by mild erectile dysfunction (ED) to the same extent as it is by moderate and severe ED. This study will provide controlled clinical data measuring efficacy, QoL parameters and satisfaction changes in men with mild ED treated with Viagra versus those treated with a placebo. With an open-label extension, this study will also provide all study subjects the opportunity to receive the active drug treatment for 6 weeks.
Interventions
Sponsors
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men above age of majority * Mild erectile dysfunction (IIEF-EF 22-25) and sexual dissatisfaction (IIEF-OS 7 or less)
Exclusion criteria
* Use of more than 4 doses of any PDE5 inhibitor in the past 12 weeks and use of any PDE5 inhibitor in the past 4 weeks * Subjects currently taking any other commercially available drug or non-drug treatment for ED
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8) | Week 8 | adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score | Week 8 | adjusted mean change; PREFA Total Score: 8 = worst; 32 = best. |
| Patient Reported Erectile Function Assessment (PREFA) Total Score | Week 8, Week 14 | PREFA Total Score: 8 = worst, 32 = best. |
| Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function | Week 8 | adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best). |
| Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function | Week 8 | adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best). |
| Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire | Week 8 | adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best). |
| Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction | Week 8 | adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best). |
| Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction | Week 8 | adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best). |
| International Index of Erectile Function (IIEF) Domain Scores- Erectile Function | Week 8, Week 14 | Possible total scores for IIEF-EF range from 1 (worst) to 30 (best). |
| International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function | Week 8, Week 14 | Possible total scores for IIEF-OF range from 0 (worst) to 10 (best). |
| International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire | Week 8, Week 14 | Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best). |
| International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction | Week 8, Week 14 | Possible total scores for IIEF-IS range from 0 (worst) to 15 (best). |
| International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction | Week 8, Week 14 | Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best). |
| Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score | Week 8 | adjusted mean change - Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED. |
| Erectile Distress Scale (EDS) Total Score | Week 8, Week 14 | Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED. |
| Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score | Week 8 | adjusted mean change - QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest). |
| Quality of Erection Questionnaire (QEQ) Total Score | Week 8, Week 14 | QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest). |
| Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | Week 8, Week 14 | GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?Responder was defined as answering Yes. % of responders/non-responders was calculated based on subjects who attempted intercourse. |
| Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | Week 8, Week 14 | GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes. % of responders/non-responders was calculated based on subjects who attempted intercourse. |
| Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | Week 8, Week 14 | GEQ 3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Resp. was defined as answering almost always or always, most times, or sometimes, and non-resp was defined as answering a few times or almost never or never. |
| Percentage of Occasions of Successful Intercourse (Event Log) | Baseline to Week 8 | Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Percentage of Occasions of Ejaculation and/or Orgasm (Event Log) | Baseline to Week 8 | Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Percentage of Occasions of Ejaculation and/or Orgasm Event Log | Week 8 to Week 14 | Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Change From Baseline to Week 8 in Analog Scales- Firmness | baseline to Week 8 | mean change - scale of 0 (worst) to 10 (best). |
| Change From Baseline to Week 8 in Analog Scales- Maintenance | baseline to Week 8 | mean change - scale of 0 (worst) to 10 (best). |
| Change From Baseline to Week 8 in Analog Scales- Reliability | baseline to Week 8 | mean change - scale of 0 (worst) to 10 (best). |
| Change From Baseline to Week 8 in Analog Scales- General Sexual Performance | baseline to week 8 | mean change - scale of 0 (worst) to 10 (best) |
| Analog Scales- Firmness | Week 8, Week 14 | mean - scale of 0 (worst) to 10 (best) |
| Analog Scales- Maintenance | Week 8, Week 14 | mean - scale of 0 (worst) to 10 (best) |
| Analog Scales- Reliability | Week 8, Week 14 | mean - scale of 0 (worst) to 10 (best) |
| Analog Scales- General Sexual Performance | Week 8, Week 14 | mean - scale of 0 (worst) to 10 (best) |
| Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1 | Week 8 to Week 14 | GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections? Responder was defined as answering Yes to GEQ 1. |
| Shift in Responder Rate From Week 8 to Week 14 for GEQ2 | Week 8 to Week 14 | GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes to GEQ 2. |
| Shift in Responder Rate From Week 8 to Week 14 for GEQ3 | Week 8 to Week 14 | GEQ3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Responder = almost always or always, most times, or sometimes. Non-responder = a few times (much less than half the time) or almost never or never. |
| Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0 | Baseline to <Week 8 and Week 8 to <=Week 14 | Per-patient percentage of hardness of erections:Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1 | Baseline to <= Week 14 | Per-patient percentage of hardness of erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2 | Baseline to <Week 8 and Week 8 to <=Week 14 | Per-patient percentage of hardness of erections: Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 | Baseline to <Week 8 and Week 8 to <=Week 14 | Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4 | Baseline to <Week 8 and Week 8 to <=Week 14 | Per-patient percentage of hardness of erections: Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4 | Baseline to <Week 8 and Week 8 to <=Week 14 | Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0 | Baseline to <Week 8 and Week 8 to <=Week 14 | Per-patient percentage of hardness of second erections: Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index | Week 8, Week 14 | Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction). |
| Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2 | Baseline to <Week 8 and Week 8 to <=Week 14 | Per-patient percentage of hardness of second erections:Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 | Baseline to <Week 8 and Week 8 to <=Week 14 | Per-patient percentage of hardness of second erections:Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4 | Baseline to <Week 8 and Week 8 to <=Week 14 | Per-patient percentage of hardness of second erections:Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4 | Baseline to <Week 8 and Week 8 to <=Week 14 | Per-patient percentage of hardness of second erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections | Baseline to <Week 8 and Week 8 to <=Week 14 | Percentage of occasions at which second erection was achieved. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
| Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1 | Baseline to <Week 8 and Week 8 to <=Week 14 | Per-patient percentage of hardness of second erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100. |
Countries
Canada
Participant flow
Recruitment details
31 centers in Canada
Pre-assignment details
183 subjects entered the study, and 176 subjects were treated in the Double Blind (DB) phase. One subject completed DB phase and continued into the open-label (OL) phase but had no events of sexual activity and therefore, did not take study drug and was excluded from the number of treated subjects, the safety analysis set, and PP population.
Participants by arm
| Arm | Count |
|---|---|
| Start : DB Viagra Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). | 94 |
| Start : DB Placebo Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). | 82 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Double Blind Phase (DB) | Adverse Event | 1 | 0 |
| Double Blind Phase (DB) | Lack of Efficacy | 0 | 1 |
| Double Blind Phase (DB) | Lost to Follow-up | 3 | 3 |
| Double Blind Phase (DB) | Other | 1 | 4 |
| Double Blind Phase (DB) | Withdrawal by Subject | 5 | 5 |
| Open Label Phase (OL) | Adverse Event | 1 | 0 |
| Open Label Phase (OL) | Lost to Follow-up | 1 | 2 |
| Open Label Phase (OL) | Other | 2 | 0 |
Baseline characteristics
| Characteristic | Start : DB Viagra | Start : DB Placebo | Total |
|---|---|---|---|
| Age, Continuous | 51.6 years STANDARD_DEVIATION 12.5 | 48.0 years STANDARD_DEVIATION 11.9 | 49.9 years STANDARD_DEVIATION 12.3 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 94 Participants | 82 Participants | 176 Participants |
Outcome results
Primary
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8)
adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Time frame: Week 8
Population: number of subjects in the Full Analysis Set (FAS) population with an observation
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8) | 80.27 scores on a scale | Standard Error 2.329 |
| DB Placebo | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index at the End of the DB Treatment (Week 8) | 62.15 scores on a scale | Standard Error 2.524 |
Comparison: The primary analysis population was the FAS. The sample size was estimated based on an expected difference of 16.5 with a standard deviation of 28.4, based on previously observed data.p-value: <0.000195% CI: [11.4, 24.86]ANCOVA
Secondary
Analog Scales- Firmness
mean - scale of 0 (worst) to 10 (best)
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Analog Scales- Firmness | 7.87 units on a scale | Standard Deviation 1.872 |
| DB Placebo | Analog Scales- Firmness | 8.25 units on a scale | Standard Deviation 1.932 |
| DB Placebo Week 8 | Analog Scales- Firmness | 6.60 units on a scale | Standard Deviation 2.171 |
| DB Placebo/OL Viagra Week 14 | Analog Scales- Firmness | 8.64 units on a scale | Standard Deviation 1.264 |
p-value: 0.019595% CI: [0.064, 0.711]paired t-test
p-value: <0.000195% CI: [1.551, 2.628]paired t-test
Secondary
Analog Scales- General Sexual Performance
mean - scale of 0 (worst) to 10 (best)
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Analog Scales- General Sexual Performance | 7.58 units on a scale | Standard Deviation 2.077 |
| DB Placebo | Analog Scales- General Sexual Performance | 8.01 units on a scale | Standard Deviation 1.978 |
| DB Placebo Week 8 | Analog Scales- General Sexual Performance | 6.53 units on a scale | Standard Deviation 2.128 |
| DB Placebo/OL Viagra Week 14 | Analog Scales- General Sexual Performance | 8.49 units on a scale | Standard Deviation 1.319 |
p-value: 0.014395% CI: [0.093, 0.807]paired t-test
p-value: <0.000195% CI: [1.454, 2.516]paired t-test
Secondary
Analog Scales- Maintenance
mean - scale of 0 (worst) to 10 (best)
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Analog Scales- Maintenance | 7.65 units on a scale | Standard Deviation 2.138 |
| DB Placebo | Analog Scales- Maintenance | 8.01 units on a scale | Standard Deviation 2.155 |
| DB Placebo Week 8 | Analog Scales- Maintenance | 5.99 units on a scale | Standard Deviation 2.519 |
| DB Placebo/OL Viagra Week 14 | Analog Scales- Maintenance | 8.55 units on a scale | Standard Deviation 1.617 |
p-value: 0.018695% CI: [0.069, 0.731]paired t-test
p-value: <0.000195% CI: [2.044, 3.299]paired t-test
Secondary
Analog Scales- Reliability
mean - scale of 0 (worst) to 10 (best)
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Analog Scales- Reliability | 7.35 units on a scale | Standard Deviation 2.36 |
| DB Placebo | Analog Scales- Reliability | 7.96 units on a scale | Standard Deviation 2.292 |
| DB Placebo Week 8 | Analog Scales- Reliability | 6.04 units on a scale | Standard Deviation 2.306 |
| DB Placebo/OL Viagra Week 14 | Analog Scales- Reliability | 8.55 units on a scale | Standard Deviation 1.55 |
p-value: 0.003395% CI: [0.223, 1.077]paired t-test
p-value: <0.000195% CI: [2.042, 3.182]paired t-test
Secondary
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections
Percentage of occasions at which second erection was achieved. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections | 38.06 percentage of occasions | Standard Deviation 33.287 |
| DB Placebo | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections | 19.20 percentage of occasions | Standard Deviation 28.977 |
| DB Placebo Week 8 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections | 44.07 percentage of occasions | Standard Deviation 38.632 |
| DB Placebo/OL Viagra Week 14 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Frequency of Second Erections | 39.15 percentage of occasions | Standard Deviation 37.159 |
p-value: 0.000295% CI: [9.08, 28.64]Independent-samples t-test
p-value: 0.42995% CI: [-7.35, 17.2]Independent-samples t-test
Secondary
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0
Per-patient percentage of hardness of erections:Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0 | 7.09 percentage of occasions | Standard Deviation 13.041 |
| DB Placebo | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0 | 12.64 percentage of occasions | Standard Deviation 23.834 |
| DB Placebo Week 8 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0 | 4.50 percentage of occasions | Standard Deviation 12.217 |
| DB Placebo/OL Viagra Week 14 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 0 | 3.12 percentage of occasions | Standard Deviation 9.855 |
p-value: 0.062495% CI: [-11.39, 0.29]Independent-samples t-test
p-value: 0.452395% CI: [-2.24, 5.01]Independent-samples t-test
Secondary
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1
Per-patient percentage of hardness of erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to <= Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1 | 3.83 percentage of occasions | Standard Deviation 9.6 |
| DB Placebo | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1 | 6.31 percentage of occasions | Standard Deviation 15.144 |
| DB Placebo Week 8 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1 | 3.48 percentage of occasions | Standard Deviation 14.3 |
| DB Placebo/OL Viagra Week 14 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 1 | 1.88 percentage of occasions | Standard Deviation 8.269 |
p-value: 0.208195% CI: [-6.35, 1.4]Independent-samples t-test
p-value: 0.413195% CI: [-2.26, 5.48]Independent-samples t-test
Secondary
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2
Per-patient percentage of hardness of erections: Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2 | 6.96 percentage of occasions | Standard Deviation 11.858 |
| DB Placebo | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2 | 8.72 percentage of occasions | Standard Deviation 15.19 |
| DB Placebo Week 8 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2 | 4.62 percentage of occasions | Standard Deviation 10.038 |
| DB Placebo/OL Viagra Week 14 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 2 | 2.26 percentage of occasions | Standard Deviation 7.813 |
p-value: 0.406995% CI: [-5.97, 2.43]Independent-samples t-test
p-value: 0.113795% CI: [-0.57, 5.31]Independent-samples t-test
Secondary
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3
Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 | 34.94 percentage of occasions | Standard Deviation 29.253 |
| DB Placebo | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 | 47.17 percentage of occasions | Standard Deviation 32.167 |
| DB Placebo Week 8 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 | 29.50 percentage of occasions | Standard Deviation 28.515 |
| DB Placebo/OL Viagra Week 14 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 | 30.12 percentage of occasions | Standard Deviation 31.412 |
p-value: 0.012395% CI: [-21.77, -2.7]Independent-samples t-test
p-value: 0.899395% CI: [-10.27, 9.03]Independent-samples t-test
Secondary
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4
Per-patient percentage of hardness of erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4 | 82.13 percentage of occasions | Standard Deviation 23.476 |
| DB Placebo | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4 | 72.33 percentage of occasions | Standard Deviation 31.798 |
| DB Placebo Week 8 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4 | 87.39 percentage of occasions | Standard Deviation 22.496 |
| DB Placebo/OL Viagra Week 14 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 3 or 4 | 92.75 percentage of occasions | Standard Deviation 15.386 |
p-value: 0.025795% CI: [1.21, 18.39]Independent-samples t-test
p-value: 0.097195% CI: [-11.7, 0.98]Independent-samples t-test
Secondary
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4
Per-patient percentage of hardness of erections: Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4 | 47.19 percentage of occasions | Standard Deviation 35.293 |
| DB Placebo | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4 | 25.16 percentage of occasions | Standard Deviation 33.764 |
| DB Placebo Week 8 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4 | 57.89 percentage of occasions | Standard Deviation 35.934 |
| DB Placebo/OL Viagra Week 14 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of First Erections Grade 4 | 62.63 percentage of occasions | Standard Deviation 35.112 |
p-value: <0.000195% CI: [11.25, 32.81]Independent-samples t-test
p-value: 0.416595% CI: [-16.24, 6.76]Independent-samples t-test
Secondary
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0
Per-patient percentage of hardness of second erections: Grade 0 = no erection at all. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0 | 0.00 percentage of occasions | Standard Deviation 0 |
| DB Placebo | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0 | 3.18 percentage of occasions | Standard Deviation 15.052 |
| DB Placebo Week 8 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0 | 0.13 percentage of occasions | Standard Deviation 0.985 |
| DB Placebo/OL Viagra Week 14 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 0 | 2.17 percentage of occasions | Standard Deviation 14.014 |
p-value: 0.072695% CI: [-6.66, 0.3]Independent-samples t-test
p-value: 0.258195% CI: [-5.61, 1.52]Independent-samples t-test
Secondary
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1
Per-patient percentage of hardness of second erections: Grade 1 = increase in size but not hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1 | 6.43 percentage of occasions | Standard Deviation 22.211 |
| DB Placebo | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1 | 7.47 percentage of occasions | Standard Deviation 22.317 |
| DB Placebo Week 8 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1 | 1.70 percentage of occasions | Standard Deviation 9.143 |
| DB Placebo/OL Viagra Week 14 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 1 | 2.03 percentage of occasions | Standard Deviation 8.638 |
p-value: 0.815895% CI: [-9.86, 7.78]Independent-samples t-test
p-value: 0.846495% CI: [-3.68, 3.02]Independent-samples t-test
Secondary
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2
Per-patient percentage of hardness of second erections:Grade 2 = hard but not hard enough for penetration. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2 | 14.93 percentage of occasions | Standard Deviation 28.145 |
| DB Placebo | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2 | 15.27 percentage of occasions | Standard Deviation 30.431 |
| DB Placebo Week 8 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2 | 11.96 percentage of occasions | Standard Deviation 24.555 |
| DB Placebo/OL Viagra Week 14 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 2 | 12.66 percentage of occasions | Standard Deviation 28.294 |
p-value: 0.952995% CI: [-11.82, 11.13]Independent-samples t-test
p-value: 0.889995% CI: [-10.59, 9.2]Independent-samples t-test
Secondary
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3
Per-patient percentage of hardness of second erections:Grade 3 = hard enough for penetration but not completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 | 37.41 percentage of occasions | Standard Deviation 38.658 |
| DB Placebo | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 | 47.59 percentage of occasions | Standard Deviation 41.025 |
| DB Placebo Week 8 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 | 42.97 percentage of occasions | Standard Deviation 38.322 |
| DB Placebo/OL Viagra Week 14 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 | 33.29 percentage of occasions | Standard Deviation 31.633 |
p-value: 0.200195% CI: [-25.83, 5.47]Independent-samples t-test
p-value: 0.152795% CI: [-3.64, 23.01]Independent-samples t-test
Secondary
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4
Per-patient percentage of hardness of second erections: Grade 3 = hard enough for penetration but not completely hard, Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4 | 78.64 percentage of occasions | Standard Deviation 35.395 |
| DB Placebo | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4 | 74.08 percentage of occasions | Standard Deviation 40.922 |
| DB Placebo Week 8 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4 | 86.21 percentage of occasions | Standard Deviation 27.647 |
| DB Placebo/OL Viagra Week 14 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 3 or 4 | 83.14 percentage of occasions | Standard Deviation 31.561 |
p-value: 0.542995% CI: [-10.25, 19.37]Independent-samples t-test
p-value: 0.584995% CI: [-8.02, 14.15]Independent-samples t-test
Secondary
Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4
Per-patient percentage of hardness of second erections:Grade 4 = completely hard. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to <Week 8 and Week 8 to <=Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4 | 41.23 percentage of occasions | Standard Deviation 41.013 |
| DB Placebo | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4 | 26.49 percentage of occasions | Standard Deviation 34.3 |
| DB Placebo Week 8 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4 | 43.24 percentage of occasions | Standard Deviation 39.891 |
| DB Placebo/OL Viagra Week 14 | Baseline to <Week 8 and Week 8 to <=Week 14 in Event Log: Hardness of Second Erections Grade 4 | 49.86 percentage of occasions | Standard Deviation 36.921 |
p-value: 0.060695% CI: [-0.67, 30.15]Independent-samples t-test
p-value: 0.367895% CI: [-21.12, 7.88]Independent-samples t-test
Secondary
Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score
adjusted mean change - Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.
Time frame: Week 8
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score | 5.14 scores on a scale | Standard Error 0.87 |
| DB Placebo | Change From Baseline to End of DB Phase (Week 8) in Erectile Distress Scale (EDS) Total Score | 2.36 scores on a scale | Standard Error 0.926 |
p-value: 0.008395% CI: [0.73, 4.83]ANCOVA
Secondary
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Time frame: Week 8
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function | 2.08 scores on a scale | Standard Error 0.642 |
| DB Placebo | Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Erectile Function | -0.53 scores on a scale | Standard Error 0.698 |
p-value: 0.005495% CI: [0.78, 4.43]ANCOVA
Secondary
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Time frame: Week 8
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction | 2.20 scores on a scale | Standard Error 0.365 |
| DB Placebo | Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction | 1.00 scores on a scale | Standard Error 0.39 |
p-value: 0.009695% CI: [0.3, 2.11]ANCOVA
Secondary
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Time frame: Week 8
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function | 0.59 scores on a scale | Standard Error 0.248 |
| DB Placebo | Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function | 0.30 scores on a scale | Standard Error 0.271 |
p-value: 0.423295% CI: [-0.43, 1.02]ANCOVA
Secondary
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).
Time frame: Week 8
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction | 2.35 scores on a scale | Standard Error 0.254 |
| DB Placebo | Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction | 1.46 scores on a scale | Standard Error 0.275 |
p-value: 0.013595% CI: [0.19, 1.61]ANCOVA
Secondary
Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).
Time frame: Week 8
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire | 0.60 scores on a scale | Standard Error 0.207 |
| DB Placebo | Change From Baseline to End of DB Phase (Week 8) in International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire | -0.08 scores on a scale | Standard Error 0.223 |
p-value: 0.015695% CI: [0.13, 1.22]ANCOVA
Secondary
Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score
adjusted mean change - QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).
Time frame: Week 8
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score | 24.04 scores on a scale | Standard Error 3.26 |
| DB Placebo | Change From Baseline to End of DB Phase (Week 8) in Quality of Erection Questionnaire (QEQ) Total Score | 5.62 scores on a scale | Standard Error 3.558 |
p-value: 0.000295% CI: [8.88, 27.96]ANCOVA
Secondary
Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score
adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.
Time frame: Week 8
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score | 3.97 scores on a scale | Standard Error 0.498 |
| DB Placebo | Change From Baseline to End of Double-Blind Phase (Week 8) in Patient Reported Erectile Function Assessment (PREFA) Total Score | 2.21 scores on a scale | Standard Error 0.536 |
p-value: 0.00895% CI: [0.47, 3.06]ANCOVA
Secondary
Change From Baseline to Week 8 in Analog Scales- Firmness
mean change - scale of 0 (worst) to 10 (best).
Time frame: baseline to Week 8
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Change From Baseline to Week 8 in Analog Scales- Firmness | 1.55 units on a scale | Standard Deviation 2.023 |
| DB Placebo | Change From Baseline to Week 8 in Analog Scales- Firmness | 0.38 units on a scale | Standard Deviation 1.8 |
p-value: 0.000295% CI: [0.566, 1.768]2-sample independent t-test
Secondary
Change From Baseline to Week 8 in Analog Scales- General Sexual Performance
mean change - scale of 0 (worst) to 10 (best)
Time frame: baseline to week 8
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Change From Baseline to Week 8 in Analog Scales- General Sexual Performance | 1.72 units on a scale | Standard Deviation 2.355 |
| DB Placebo | Change From Baseline to Week 8 in Analog Scales- General Sexual Performance | 0.51 units on a scale | Standard Deviation 2.109 |
p-value: 0.000895% CI: [0.511, 1.913]2-sample independent t-test
Secondary
Change From Baseline to Week 8 in Analog Scales- Maintenance
mean change - scale of 0 (worst) to 10 (best).
Time frame: baseline to Week 8
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Change From Baseline to Week 8 in Analog Scales- Maintenance | 1.84 units on a scale | Standard Deviation 2.421 |
| DB Placebo | Change From Baseline to Week 8 in Analog Scales- Maintenance | 0.40 units on a scale | Standard Deviation 2.152 |
p-value: 0.000195% CI: [0.727, 2.164]2-sample independent t-test
Secondary
Change From Baseline to Week 8 in Analog Scales- Reliability
mean change - scale of 0 (worst) to 10 (best).
Time frame: baseline to Week 8
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Change From Baseline to Week 8 in Analog Scales- Reliability | 1.61 units on a scale | Standard Deviation 2.795 |
| DB Placebo | Change From Baseline to Week 8 in Analog Scales- Reliability | 0.42 units on a scale | Standard Deviation 2.081 |
p-value: 0.003295% CI: [0.403, 1.961]2-sample independent t-test
Secondary
Erectile Distress Scale (EDS) Total Score
Possible total scores for EDS range from 5 (all of the time) to 30 (none of the time). Higher scores indicate less impact of ED.
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Erectile Distress Scale (EDS) Total Score | 24.58 scores on a scale | Standard Deviation 6.039 |
| DB Placebo | Erectile Distress Scale (EDS) Total Score | 24.55 scores on a scale | Standard Deviation 6.552 |
| DB Placebo Week 8 | Erectile Distress Scale (EDS) Total Score | 21.23 scores on a scale | Standard Deviation 6.246 |
| DB Placebo/OL Viagra Week 14 | Erectile Distress Scale (EDS) Total Score | 26.58 scores on a scale | Standard Deviation 4.717 |
p-value: 0.914695% CI: [-1.218, 1.093]paired t-test
p-value: <0.000195% CI: [3.961, 7.114]paired t-test
Secondary
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index
Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index | 79.21 scores on a scale | Standard Deviation 19.646 |
| DB Placebo | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index | 84.12 scores on a scale | Standard Deviation 17.22 |
| DB Placebo Week 8 | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index | 61.64 scores on a scale | Standard Deviation 22.752 |
| DB Placebo/OL Viagra Week 14 | Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index | 87.42 scores on a scale | Standard Deviation 15.124 |
p-value: 0.002895% CI: [1.8, 8.37]paired t-test
p-value: <0.000195% CI: [20.58, 31.455]paired t-test
Secondary
Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections?Responder was defined as answering Yes. % of responders/non-responders was calculated based on subjects who attempted intercourse.
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Viagra | Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ1 Responder | 81.8 percentage of subjects |
| DB Viagra | Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ1 Non-Responder | 18.2 percentage of subjects |
| DB Placebo | Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ1 Non-Responder | 56.2 percentage of subjects |
| DB Placebo | Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ1 Responder | 43.8 percentage of subjects |
| DB Placebo Week 8 | Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ1 Responder | 90.0 percentage of subjects |
| DB Placebo Week 8 | Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ1 Non-Responder | 10.0 percentage of subjects |
| DB Placebo/OL Viagra Week 14 | Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ1 Responder | 94.0 percentage of subjects |
| DB Placebo/OL Viagra Week 14 | Global Efficacy Question 1 (GEQ1) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ1 Non-Responder | 6.0 percentage of subjects |
p-value: 0.000195% CI: [3.042, 13.851]Regression, Logistic
Secondary
Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes. % of responders/non-responders was calculated based on subjects who attempted intercourse.
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Viagra | Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ2 Non-Responder | 20.7 percentage of subjects |
| DB Viagra | Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ2 Responder | 79.3 percentage of subjects |
| DB Placebo | Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ2 Responder | 45.2 percentage of subjects |
| DB Placebo | Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ2 Non-Responder | 54.8 percentage of subjects |
| DB Placebo Week 8 | Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ2 Responder | 86.3 percentage of subjects |
| DB Placebo Week 8 | Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ2 Non-Responder | 13.8 percentage of subjects |
| DB Placebo/OL Viagra Week 14 | Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ2 Non-Responder | 7.5 percentage of subjects |
| DB Placebo/OL Viagra Week 14 | Global Efficacy Question 2 (GEQ2) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ2 Responder | 92.5 percentage of subjects |
p-value: <0.000195% CI: [2.396, 10.08]Regression, Logistic
Secondary
Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14)
GEQ 3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Resp. was defined as answering almost always or always, most times, or sometimes, and non-resp was defined as answering a few times or almost never or never.
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Viagra | Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ3 Non-Responders | 5.7 percentage of subjects |
| DB Viagra | Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ3 Responders | 94.3 percentage of subjects |
| DB Placebo | Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ3 Responders | 81.7 percentage of subjects |
| DB Placebo | Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ3 Non-Responders | 18.3 percentage of subjects |
| DB Placebo Week 8 | Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ3 Non-Responders | 5.0 percentage of subjects |
| DB Placebo Week 8 | Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ3 Responders | 95.0 percentage of subjects |
| DB Placebo/OL Viagra Week 14 | Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ3 Non-Responders | 1.5 percentage of subjects |
| DB Placebo/OL Viagra Week 14 | Global Efficacy Question 3 (GEQ3) Response at End of the Double-Blind Phase (Week 8) and at End of the Open-Label Phase (Week 14) | GEQ3 Responders | 98.5 percentage of subjects |
p-value: 0.018795% CI: [1.242, 10.875]Regression, Logistic
Secondary
International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | International Index of Erectile Function (IIEF) Domain Scores- Erectile Function | 24.92 scores on a scale | Standard Deviation 5.375 |
| DB Placebo | International Index of Erectile Function (IIEF) Domain Scores- Erectile Function | 26.43 scores on a scale | Standard Deviation 5.023 |
| DB Placebo Week 8 | International Index of Erectile Function (IIEF) Domain Scores- Erectile Function | 22.40 scores on a scale | Standard Deviation 6.403 |
| DB Placebo/OL Viagra Week 14 | International Index of Erectile Function (IIEF) Domain Scores- Erectile Function | 27.67 scores on a scale | Standard Deviation 3.573 |
p-value: 0.003395% CI: [0.051, 2.465]paired t-test
p-value: <0.000195% CI: [3.676, 6.772]paired t-test
Secondary
International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction | 11.82 scores on a scale | Standard Deviation 2.806 |
| DB Placebo | International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction | 12.64 scores on a scale | Standard Deviation 2.367 |
| DB Placebo Week 8 | International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction | 10.84 scores on a scale | Standard Deviation 2.635 |
| DB Placebo/OL Viagra Week 14 | International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction | 13.12 scores on a scale | Standard Deviation 1.943 |
p-value: 0.010295% CI: [0.183, 1.317]paired t-test
p-value: <0.000195% CI: [1.557, 3.01]paired t-test
Secondary
International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function | 8.62 scores on a scale | Standard Deviation 1.812 |
| DB Placebo | International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function | 8.95 scores on a scale | Standard Deviation 1.598 |
| DB Placebo Week 8 | International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function | 7.81 scores on a scale | Standard Deviation 2.564 |
| DB Placebo/OL Viagra Week 14 | International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function | 9.21 scores on a scale | Standard Deviation 1.213 |
p-value: 0.258195% CI: [-0.149, 0.549]paired t-test
p-value: <0.000195% CI: [0.758, 2.018]paired t-test
Secondary
International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction | 8.19 scores on a scale | Standard Deviation 1.827 |
| DB Placebo | International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction | 8.94 scores on a scale | Standard Deviation 1.656 |
| DB Placebo Week 8 | International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction | 7.25 scores on a scale | Standard Deviation 2.178 |
| DB Placebo/OL Viagra Week 14 | International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction | 9.12 scores on a scale | Standard Deviation 1.332 |
p-value: 0.001695% CI: [0.264, 1.086]paired t-test
p-value: <0.000195% CI: [1.335, 2.456]paired t-test
Secondary
International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire | 7.90 scores on a scale | Standard Deviation 1.665 |
| DB Placebo | International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire | 8.10 scores on a scale | Standard Deviation 1.539 |
| DB Placebo Week 8 | International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire | 7.37 scores on a scale | Standard Deviation 1.712 |
| DB Placebo/OL Viagra Week 14 | International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire | 8.18 scores on a scale | Standard Deviation 1.23 |
p-value: 0.285795% CI: [-0.149, 0.499]paired t-test
p-value: 0.000595% CI: [0.345, 1.177]paired t-test
Secondary
Patient Reported Erectile Function Assessment (PREFA) Total Score
PREFA Total Score: 8 = worst, 32 = best.
Time frame: Week 8, Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Patient Reported Erectile Function Assessment (PREFA) Total Score | 28.54 scores on a scale | Standard Deviation 3.468 |
| DB Placebo | Patient Reported Erectile Function Assessment (PREFA) Total Score | 29.58 scores on a scale | Standard Deviation 2.988 |
| DB Placebo Week 8 | Patient Reported Erectile Function Assessment (PREFA) Total Score | 26.79 scores on a scale | Standard Deviation 3.753 |
| DB Placebo/OL Viagra Week 14 | Patient Reported Erectile Function Assessment (PREFA) Total Score | 29.73 scores on a scale | Standard Deviation 2.895 |
p-value: 0.005195% CI: [0.29, 1.585]paired t-test
p-value: <0.000195% CI: [1.812, 3.77]paired t-test
Secondary
Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to Week 8
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Percentage of Occasions of Ejaculation and/or Orgasm (Event Log) | 74.31 Percentage of occasions | Standard Deviation 25.3 |
| DB Placebo | Percentage of Occasions of Ejaculation and/or Orgasm (Event Log) | 64.60 Percentage of occasions | Standard Deviation 31.903 |
p-value: 0.032195% CI: [0.84, 18.6]independent-samples t-test
Secondary
Percentage of Occasions of Ejaculation and/or Orgasm Event Log
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Week 8 to Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Percentage of Occasions of Ejaculation and/or Orgasm Event Log | 77.69 percentage of occasions | Standard Deviation 25.099 |
| DB Placebo | Percentage of Occasions of Ejaculation and/or Orgasm Event Log | 85.29 percentage of occasions | Standard Deviation 22.257 |
p-value: 0.053395% CI: [-15.32, 0.11]independent-samples t-test
Secondary
Percentage of Occasions of Successful Intercourse (Event Log)
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Baseline to Week 8
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Percentage of Occasions of Successful Intercourse (Event Log) | 73.64 percentage of occasions | Standard Deviation 26.689 |
| DB Placebo | Percentage of Occasions of Successful Intercourse (Event Log) | 59.73 percentage of occasions | Standard Deviation 33.332 |
p-value: 0.003795% CI: [4.59, 23.22]independent-samples t-test
Secondary
Percentage of Occasions of Successful Intercourse (Event Log)
Percentage of occasions at which subjects answered yes to the question, did your erection last long enough to have successful intercourse. Calculation for each subject for each event log endpoint: percentage = (number of occasions with an answer of 'Yes' within visit interval) / (number of occasions within visit interval) x 100.
Time frame: Week 8 to Week 14
Population: number of subjects in the FAS population with an observation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Percentage of Occasions of Successful Intercourse (Event Log) | 79.65 percentage of occasions | Standard Deviation 25.309 |
| DB Placebo | Percentage of Occasions of Successful Intercourse (Event Log) | 87.63 percentage of occasions | Standard Deviation 21.936 |
p-value: 0.042795% CI: [-15.68, -0.27]independent-samples t-test
Secondary
Quality of Erection Questionnaire (QEQ) Total Score
QEQ raw total score (defined as the sum of scores from QEQ Questions 1 and 3 to 7 and ranged from 6 to 30) was transformed to QEQ total score on a scale of 0 (lowest) to 100 (highest).
Time frame: Week 8, Week 14
Population: Full Analysis Set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DB Viagra | Quality of Erection Questionnaire (QEQ) Total Score | 80.20 scores on a scale | Standard Deviation 23.954 |
| DB Placebo | Quality of Erection Questionnaire (QEQ) Total Score | 86.46 scores on a scale | Standard Deviation 20.918 |
| DB Placebo Week 8 | Quality of Erection Questionnaire (QEQ) Total Score | 63.64 scores on a scale | Standard Deviation 28.559 |
| DB Placebo/OL Viagra Week 14 | Quality of Erection Questionnaire (QEQ) Total Score | 89.74 scores on a scale | Standard Deviation 17.473 |
p-value: 0.006495% CI: [1.857, 10.956]paired t-test
p-value: <0.000195% CI: [19.636, 33.971]paired t-test
Secondary
Shift in Responder Rate From Week 8 to Week 14 for GEQ2
GEQ 2: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your ability to have sexual intercourse? Responder was defined as answering Yes to GEQ 2.
Time frame: Week 8 to Week 14
Population: number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 2 under the treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Viagra | Shift in Responder Rate From Week 8 to Week 14 for GEQ2 | Responder at Week 8 / Responder at Week 14 | 60 subjects |
| DB Viagra | Shift in Responder Rate From Week 8 to Week 14 for GEQ2 | Responder at Week 8 / Non-Responder at Week 14 | 1 subjects |
| DB Viagra | Shift in Responder Rate From Week 8 to Week 14 for GEQ2 | Non-Responder at Week 8 / Responder at Week 14 | 8 subjects |
| DB Viagra | Shift in Responder Rate From Week 8 to Week 14 for GEQ2 | Non-Responder at Week 8 / Non-Responder at Week 14 | 10 subjects |
| DB Placebo | Shift in Responder Rate From Week 8 to Week 14 for GEQ2 | Non-Responder at Week 8 / Non-Responder at Week 14 | 5 subjects |
| DB Placebo | Shift in Responder Rate From Week 8 to Week 14 for GEQ2 | Responder at Week 8 / Responder at Week 14 | 29 subjects |
| DB Placebo | Shift in Responder Rate From Week 8 to Week 14 for GEQ2 | Non-Responder at Week 8 / Responder at Week 14 | 33 subjects |
| DB Placebo | Shift in Responder Rate From Week 8 to Week 14 for GEQ2 | Responder at Week 8 / Non-Responder at Week 14 | 0 subjects |
Comparison: Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.p-value: 0.0196McNemar
Comparison: Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.p-value: <0.0001McNemar
Secondary
Shift in Responder Rate From Week 8 to Week 14 for GEQ3
GEQ3: When you took a dose of study drug and had sexual stimulation, how often did you get an erection that allowed you to engage in satisfactory sexual intercourse? Responder = almost always or always, most times, or sometimes. Non-responder = a few times (much less than half the time) or almost never or never.
Time frame: Week 8 to Week 14
Population: number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 3 under the treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Viagra | Shift in Responder Rate From Week 8 to Week 14 for GEQ3 | Non-Responder at Week 8 / Responder at Week 14 | 1 subjects |
| DB Viagra | Shift in Responder Rate From Week 8 to Week 14 for GEQ3 | Responder at Week 8 / Non-Responder at Week 14 | 0 subjects |
| DB Viagra | Shift in Responder Rate From Week 8 to Week 14 for GEQ3 | Non-Responder at Week 8 / Non-Responder at Week 14 | 4 subjects |
| DB Viagra | Shift in Responder Rate From Week 8 to Week 14 for GEQ3 | Responder at Week 8 / Responder at Week 14 | 74 subjects |
| DB Placebo | Shift in Responder Rate From Week 8 to Week 14 for GEQ3 | Non-Responder at Week 8 / Non-Responder at Week 14 | 1 subjects |
| DB Placebo | Shift in Responder Rate From Week 8 to Week 14 for GEQ3 | Responder at Week 8 / Non-Responder at Week 14 | 0 subjects |
| DB Placebo | Shift in Responder Rate From Week 8 to Week 14 for GEQ3 | Non-Responder at Week 8 / Responder at Week 14 | 10 subjects |
| DB Placebo | Shift in Responder Rate From Week 8 to Week 14 for GEQ3 | Responder at Week 8 / Responder at Week 14 | 54 subjects |
Comparison: Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.p-value: 0.3173McNemar
Comparison: Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.p-value: 0.0016McNemar
Secondary
Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1
GEQ 1: Compared to having no treatment at all for your erection problem, has the medication you have been taking over the past 4 weeks improved your erections? Responder was defined as answering Yes to GEQ 1.
Time frame: Week 8 to Week 14
Population: number of subjects in the FAS population with an observation: Number of subjects with both Week 8 and Week 14 response to GEQ Question 1 under the treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DB Viagra | Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1 | Responder at Week 8 / Responder at Week 14 | 61 subjects |
| DB Viagra | Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1 | Responder at Week 8 / Non-Responder at Week 14 | 3 subjects |
| DB Viagra | Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1 | Non-Responder at Week 8 / Responder at Week 14 | 11 subjects |
| DB Viagra | Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1 | Non-Responder at Week 8 / Non-Responder at Week 14 | 5 subjects |
| DB Placebo | Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1 | Non-Responder at Week 8 / Non-Responder at Week 14 | 4 subjects |
| DB Placebo | Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1 | Responder at Week 8 / Responder at Week 14 | 27 subjects |
| DB Placebo | Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1 | Non-Responder at Week 8 / Responder at Week 14 | 36 subjects |
| DB Placebo | Shift in Responder Rate From Week 8 to Week 14 for Global Efficacy Question (GEQ) 1 | Responder at Week 8 / Non-Responder at Week 14 | 0 subjects |
Comparison: Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.p-value: 0.0325McNemar
Comparison: Exact p-values calculated using McNemar's test for difference between Week 8 and Week 14.p-value: <0.0001McNemar