Trial Outcomes & Findings for Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied (NCT NCT00301262)
NCT ID: NCT00301262
Last Updated: 2021-02-01
Results Overview
adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
COMPLETED
PHASE4
183 participants
Week 8
2021-02-01
Participant Flow
31 centers in Canada
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.
Participant milestones
| Measure |
DB Viagra / OL 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). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
|
DB Placebo/OL Viagra
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). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
|
|---|---|---|
|
Double Blind Phase (DB)
STARTED
|
94
|
82
|
|
Double Blind Phase (DB)
COMPLETED
|
84
|
69
|
|
Double Blind Phase (DB)
NOT COMPLETED
|
10
|
13
|
|
Open Label Phase (OL)
STARTED
|
83
|
69
|
|
Open Label Phase (OL)
COMPLETED
|
79
|
67
|
|
Open Label Phase (OL)
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
DB Viagra / OL 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). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
|
DB Placebo/OL Viagra
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). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
|
|---|---|---|
|
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)
Withdrawal by Subject
|
5
|
5
|
|
Double Blind Phase (DB)
Other
|
1
|
4
|
|
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
Impact Of Viagra On Sexual Satisfaction Of Men With Mild Erectile Dysfunction Who Are Sexually Dissatisfied
Baseline characteristics by cohort
| Measure |
Start : DB Viagra
n=94 Participants
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).
|
Start : DB Placebo
n=82 Participants
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).
|
Total
n=176 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.6 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
49.9 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: number of subjects in the Full Analysis Set (FAS) population with an observation
adjusted mean : Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Outcome measures
| Measure |
DB Viagra
n=88 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
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
|
62.15 scores on a scale
Standard Error 2.524
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
Possible scores for the EDITS Index range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Outcome measures
| Measure |
DB Viagra
n=88 Participants
|
DB Placebo
n=80 Participants
|
DB Placebo Week 8
n=73 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Index
|
79.21 scores on a scale
Standard Deviation 19.646
|
84.12 scores on a scale
Standard Deviation 17.220
|
61.64 scores on a scale
Standard Deviation 22.752
|
87.42 scores on a scale
Standard Deviation 15.124
|
SECONDARY outcome
Timeframe: Week 8Population: number of subjects in the FAS population with an observation
adjusted mean change; PREFA Total Score: 8 = worst; 32 = best.
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
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
|
2.21 scores on a scale
Standard Error 0.536
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
PREFA Total Score: 8 = worst, 32 = best.
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=80 Participants
|
DB Placebo Week 8
n=73 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
Patient Reported Erectile Function Assessment (PREFA) Total Score
|
28.54 scores on a scale
Standard Deviation 3.468
|
29.58 scores on a scale
Standard Deviation 2.988
|
26.79 scores on a scale
Standard Deviation 3.753
|
29.73 scores on a scale
Standard Deviation 2.895
|
SECONDARY outcome
Timeframe: Week 8Population: number of subjects in the FAS population with an observation
adjusted mean change - Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
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
|
-0.53 scores on a scale
Standard Error 0.698
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: number of subjects in the FAS population with an observation
adjusted mean change - Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
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
|
0.30 scores on a scale
Standard Error 0.271
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: number of subjects in the FAS population with an observation
adjusted mean change - Possible total scores for IIEF-SD range from 2 (worst) to 10 (best).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
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
|
-0.08 scores on a scale
Standard Error 0.223
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: number of subjects in the FAS population with an observation
adjusted mean - Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
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
|
1.00 scores on a scale
Standard Error 0.390
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8Population: number of subjects in the FAS population with an observation
adjusted mean change - Possible total scores for IIEF-OS range from 2 (worst) to 10 (best).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
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
|
1.46 scores on a scale
Standard Error 0.275
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
Possible total scores for IIEF-EF range from 1 (worst) to 30 (best).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=80 Participants
|
DB Placebo Week 8
n=73 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
International Index of Erectile Function (IIEF) Domain Scores- Erectile Function
|
24.92 scores on a scale
Standard Deviation 5.375
|
26.43 scores on a scale
Standard Deviation 5.023
|
22.40 scores on a scale
Standard Deviation 6.403
|
27.67 scores on a scale
Standard Deviation 3.573
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
Possible total scores for IIEF-OF range from 0 (worst) to 10 (best).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=80 Participants
|
DB Placebo Week 8
n=73 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
International Index of Erectile Function (IIEF) Domain Scores- Orgasmic Function
|
8.62 scores on a scale
Standard Deviation 1.812
|
8.95 scores on a scale
Standard Deviation 1.598
|
7.81 scores on a scale
Standard Deviation 2.564
|
9.21 scores on a scale
Standard Deviation 1.213
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=80 Participants
|
DB Placebo Week 8
n=73 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
International Index of Erectile Function (IIEF) Domain Scores- Sexual Desire
|
7.90 scores on a scale
Standard Deviation 1.665
|
8.10 scores on a scale
Standard Deviation 1.539
|
7.37 scores on a scale
Standard Deviation 1.712
|
8.18 scores on a scale
Standard Deviation 1.230
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
Possible total scores for IIEF-IS range from 0 (worst) to 15 (best).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=80 Participants
|
DB Placebo Week 8
n=73 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
International Index of Erectile Function (IIEF) Domain Scores- Intercourse Satisfaction
|
11.82 scores on a scale
Standard Deviation 2.806
|
12.64 scores on a scale
Standard Deviation 2.367
|
10.84 scores on a scale
Standard Deviation 2.635
|
13.12 scores on a scale
Standard Deviation 1.943
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
Possible total scores for IIEF-SD and IIEF-OS range from 2 (worst) to 10 (best).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=80 Participants
|
DB Placebo Week 8
n=73 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
International Index of Erectile Function (IIEF) Domain Scores- Overall Satisfaction
|
8.19 scores on a scale
Standard Deviation 1.827
|
8.94 scores on a scale
Standard Deviation 1.656
|
7.25 scores on a scale
Standard Deviation 2.178
|
9.12 scores on a scale
Standard Deviation 1.332
|
SECONDARY outcome
Timeframe: Week 8Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
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 0.870
|
2.36 scores on a scale
Standard Error 0.926
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=80 Participants
|
DB Placebo Week 8
n=73 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
Erectile Distress Scale (EDS) Total Score
|
24.58 scores on a scale
Standard Deviation 6.039
|
24.55 scores on a scale
Standard Deviation 6.552
|
21.23 scores on a scale
Standard Deviation 6.246
|
26.58 scores on a scale
Standard Deviation 4.717
|
SECONDARY outcome
Timeframe: Week 8Population: number of subjects in the FAS population with an observation
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).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
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 3.260
|
5.62 scores on a scale
Standard Error 3.558
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: Full Analysis Set
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).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=80 Participants
|
DB Placebo Week 8
n=73 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
Quality of Erection Questionnaire (QEQ) Total Score
|
80.20 scores on a scale
Standard Deviation 23.954
|
86.46 scores on a scale
Standard Deviation 20.918
|
63.64 scores on a scale
Standard Deviation 28.559
|
89.74 scores on a scale
Standard Deviation 17.473
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=88 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
n=80 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
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
|
43.8 percentage of subjects
|
90.0 percentage of subjects
|
94.0 percentage of subjects
|
|
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
|
56.2 percentage of subjects
|
10.0 percentage of subjects
|
6.0 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=88 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
n=80 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
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
|
54.8 percentage of subjects
|
13.8 percentage of subjects
|
7.5 percentage of subjects
|
|
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
|
45.2 percentage of subjects
|
86.3 percentage of subjects
|
92.5 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=88 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
n=80 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
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
|
81.7 percentage of subjects
|
95.0 percentage of subjects
|
98.5 percentage of subjects
|
|
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
|
18.3 percentage of subjects
|
5.0 percentage of subjects
|
1.5 percentage of subjects
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=88 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
Percentage of Occasions of Successful Intercourse (Event Log)
|
73.64 percentage of occasions
Standard Deviation 26.689
|
59.73 percentage of occasions
Standard Deviation 33.332
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=88 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
Percentage of Occasions of Ejaculation and/or Orgasm (Event Log)
|
74.31 Percentage of occasions
Standard Deviation 25.300
|
64.60 Percentage of occasions
Standard Deviation 31.903
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8 to Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=80 Participants
|
DB Placebo
n=67 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
Percentage of Occasions of Successful Intercourse (Event Log)
|
79.65 percentage of occasions
Standard Deviation 25.309
|
87.63 percentage of occasions
Standard Deviation 21.936
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8 to Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=80 Participants
|
DB Placebo
n=67 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
Percentage of Occasions of Ejaculation and/or Orgasm Event Log
|
77.69 percentage of occasions
Standard Deviation 25.099
|
85.29 percentage of occasions
Standard Deviation 22.257
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline to Week 8Population: number of subjects in the FAS population with an observation
mean change - scale of 0 (worst) to 10 (best).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
Change From Baseline to Week 8 in Analog Scales- Firmness
|
1.55 units on a scale
Standard Deviation 2.023
|
0.38 units on a scale
Standard Deviation 1.800
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline to Week 8Population: number of subjects in the FAS population with an observation
mean change - scale of 0 (worst) to 10 (best).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
Change From Baseline to Week 8 in Analog Scales- Maintenance
|
1.84 units on a scale
Standard Deviation 2.421
|
0.40 units on a scale
Standard Deviation 2.152
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline to Week 8Population: number of subjects in the FAS population with an observation
mean change - scale of 0 (worst) to 10 (best).
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
Change From Baseline to Week 8 in Analog Scales- Reliability
|
1.61 units on a scale
Standard Deviation 2.795
|
0.42 units on a scale
Standard Deviation 2.081
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline to week 8Population: number of subjects in the FAS population with an observation
mean change - scale of 0 (worst) to 10 (best)
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=73 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
Change From Baseline to Week 8 in Analog Scales- General Sexual Performance
|
1.72 units on a scale
Standard Deviation 2.355
|
0.51 units on a scale
Standard Deviation 2.109
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
mean - scale of 0 (worst) to 10 (best)
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=80 Participants
|
DB Placebo Week 8
n=73 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
Analog Scales- Firmness
|
7.87 units on a scale
Standard Deviation 1.872
|
8.25 units on a scale
Standard Deviation 1.932
|
6.60 units on a scale
Standard Deviation 2.171
|
8.64 units on a scale
Standard Deviation 1.264
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
mean - scale of 0 (worst) to 10 (best)
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=80 Participants
|
DB Placebo Week 8
n=73 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
Analog Scales- Maintenance
|
7.65 units on a scale
Standard Deviation 2.138
|
8.01 units on a scale
Standard Deviation 2.155
|
5.99 units on a scale
Standard Deviation 2.519
|
8.55 units on a scale
Standard Deviation 1.617
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
mean - scale of 0 (worst) to 10 (best)
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=80 Participants
|
DB Placebo Week 8
n=73 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
Analog Scales- Reliability
|
7.35 units on a scale
Standard Deviation 2.360
|
7.96 units on a scale
Standard Deviation 2.292
|
6.04 units on a scale
Standard Deviation 2.306
|
8.55 units on a scale
Standard Deviation 1.550
|
SECONDARY outcome
Timeframe: Week 8, Week 14Population: number of subjects in the FAS population with an observation
mean - scale of 0 (worst) to 10 (best)
Outcome measures
| Measure |
DB Viagra
n=89 Participants
|
DB Placebo
n=80 Participants
|
DB Placebo Week 8
n=73 Participants
|
DB Placebo/OL Viagra Week 14
n=67 Participants
|
|---|---|---|---|---|
|
Analog Scales- General Sexual Performance
|
7.58 units on a scale
Standard Deviation 2.077
|
8.01 units on a scale
Standard Deviation 1.978
|
6.53 units on a scale
Standard Deviation 2.128
|
8.49 units on a scale
Standard Deviation 1.319
|
SECONDARY outcome
Timeframe: Week 8 to Week 14Population: 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.
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.
Outcome measures
| Measure |
DB Viagra
n=80 Participants
|
DB Placebo
n=67 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
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
|
36 subjects
|
—
|
—
|
|
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
|
27 subjects
|
—
|
—
|
|
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
|
0 subjects
|
—
|
—
|
|
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
|
4 subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8 to Week 14Population: 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.
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.
Outcome measures
| Measure |
DB Viagra
n=79 Participants
|
DB Placebo
n=67 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
Shift in Responder Rate From Week 8 to Week 14 for GEQ2
Responder at Week 8 / Responder at Week 14
|
60 subjects
|
29 subjects
|
—
|
—
|
|
Shift in Responder Rate From Week 8 to Week 14 for GEQ2
Responder at Week 8 / Non-Responder at Week 14
|
1 subjects
|
0 subjects
|
—
|
—
|
|
Shift in Responder Rate From Week 8 to Week 14 for GEQ2
Non-Responder at Week 8 / Responder at Week 14
|
8 subjects
|
33 subjects
|
—
|
—
|
|
Shift in Responder Rate From Week 8 to Week 14 for GEQ2
Non-Responder at Week 8 / Non-Responder at Week 14
|
10 subjects
|
5 subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 8 to Week 14Population: 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.
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.
Outcome measures
| Measure |
DB Viagra
n=79 Participants
|
DB Placebo
n=65 Participants
|
DB Placebo Week 8
|
DB Placebo/OL Viagra Week 14
|
|---|---|---|---|---|
|
Shift in Responder Rate From Week 8 to Week 14 for GEQ3
Responder at Week 8 / Responder at Week 14
|
74 subjects
|
54 subjects
|
—
|
—
|
|
Shift in Responder Rate From Week 8 to Week 14 for GEQ3
Responder at Week 8 / Non-Responder at Week 14
|
0 subjects
|
0 subjects
|
—
|
—
|
|
Shift in Responder Rate From Week 8 to Week 14 for GEQ3
Non-Responder at Week 8 / Responder at Week 14
|
1 subjects
|
10 subjects
|
—
|
—
|
|
Shift in Responder Rate From Week 8 to Week 14 for GEQ3
Non-Responder at Week 8 / Non-Responder at Week 14
|
4 subjects
|
1 subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to <Week 8 and Week 8 to <=Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=88 Participants
|
DB Placebo
n=74 Participants
|
DB Placebo Week 8
n=83 Participants
|
DB Placebo/OL Viagra Week 14
n=68 Participants
|
|---|---|---|---|---|
|
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
|
12.64 percentage of occasions
Standard Deviation 23.834
|
4.50 percentage of occasions
Standard Deviation 12.217
|
3.12 percentage of occasions
Standard Deviation 9.855
|
SECONDARY outcome
Timeframe: Baseline to <= Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=88 Participants
|
DB Placebo
n=74 Participants
|
DB Placebo Week 8
n=83 Participants
|
DB Placebo/OL Viagra Week 14
n=68 Participants
|
|---|---|---|---|---|
|
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 9.600
|
6.31 percentage of occasions
Standard Deviation 15.144
|
3.48 percentage of occasions
Standard Deviation 14.300
|
1.88 percentage of occasions
Standard Deviation 8.269
|
SECONDARY outcome
Timeframe: Baseline to <Week 8 and Week 8 to <=Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=88 Participants
|
DB Placebo
n=74 Participants
|
DB Placebo Week 8
n=83 Participants
|
DB Placebo/OL Viagra Week 14
n=68 Participants
|
|---|---|---|---|---|
|
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
|
8.72 percentage of occasions
Standard Deviation 15.190
|
4.62 percentage of occasions
Standard Deviation 10.038
|
2.26 percentage of occasions
Standard Deviation 7.813
|
SECONDARY outcome
Timeframe: Baseline to <Week 8 and Week 8 to <=Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=88 Participants
|
DB Placebo
n=74 Participants
|
DB Placebo Week 8
n=83 Participants
|
DB Placebo/OL Viagra Week 14
n=68 Participants
|
|---|---|---|---|---|
|
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
|
47.17 percentage of occasions
Standard Deviation 32.167
|
29.50 percentage of occasions
Standard Deviation 28.515
|
30.12 percentage of occasions
Standard Deviation 31.412
|
SECONDARY outcome
Timeframe: Baseline to <Week 8 and Week 8 to <=Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=88 Participants
|
DB Placebo
n=74 Participants
|
DB Placebo Week 8
n=83 Participants
|
DB Placebo/OL Viagra Week 14
n=68 Participants
|
|---|---|---|---|---|
|
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
|
25.16 percentage of occasions
Standard Deviation 33.764
|
57.89 percentage of occasions
Standard Deviation 35.934
|
62.63 percentage of occasions
Standard Deviation 35.112
|
SECONDARY outcome
Timeframe: Baseline to <Week 8 and Week 8 to <=Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=88 Participants
|
DB Placebo
n=74 Participants
|
DB Placebo Week 8
n=83 Participants
|
DB Placebo/OL Viagra Week 14
n=68 Participants
|
|---|---|---|---|---|
|
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
|
72.33 percentage of occasions
Standard Deviation 31.798
|
87.39 percentage of occasions
Standard Deviation 22.496
|
92.75 percentage of occasions
Standard Deviation 15.386
|
SECONDARY outcome
Timeframe: Baseline to <Week 8 and Week 8 to <=Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=73 Participants
|
DB Placebo
n=38 Participants
|
DB Placebo Week 8
n=61 Participants
|
DB Placebo/OL Viagra Week 14
n=51 Participants
|
|---|---|---|---|---|
|
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 0.000
|
3.18 percentage of occasions
Standard Deviation 15.052
|
0.13 percentage of occasions
Standard Deviation 0.985
|
2.17 percentage of occasions
Standard Deviation 14.014
|
SECONDARY outcome
Timeframe: Baseline to <Week 8 and Week 8 to <=Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=73 Participants
|
DB Placebo
n=38 Participants
|
DB Placebo Week 8
n=61 Participants
|
DB Placebo/OL Viagra Week 14
n=51 Participants
|
|---|---|---|---|---|
|
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
|
7.47 percentage of occasions
Standard Deviation 22.317
|
1.70 percentage of occasions
Standard Deviation 9.143
|
2.03 percentage of occasions
Standard Deviation 8.638
|
SECONDARY outcome
Timeframe: Baseline to <Week 8 and Week 8 to <=Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=73 Participants
|
DB Placebo
n=38 Participants
|
DB Placebo Week 8
n=61 Participants
|
DB Placebo/OL Viagra Week 14
n=51 Participants
|
|---|---|---|---|---|
|
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
|
15.27 percentage of occasions
Standard Deviation 30.431
|
11.96 percentage of occasions
Standard Deviation 24.555
|
12.66 percentage of occasions
Standard Deviation 28.294
|
SECONDARY outcome
Timeframe: Baseline to <Week 8 and Week 8 to <=Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=73 Participants
|
DB Placebo
n=38 Participants
|
DB Placebo Week 8
n=61 Participants
|
DB Placebo/OL Viagra Week 14
n=51 Participants
|
|---|---|---|---|---|
|
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
|
47.59 percentage of occasions
Standard Deviation 41.025
|
42.97 percentage of occasions
Standard Deviation 38.322
|
33.29 percentage of occasions
Standard Deviation 31.633
|
SECONDARY outcome
Timeframe: Baseline to <Week 8 and Week 8 to <=Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=73 Participants
|
DB Placebo
n=38 Participants
|
DB Placebo Week 8
n=61 Participants
|
DB Placebo/OL Viagra Week 14
n=51 Participants
|
|---|---|---|---|---|
|
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
|
26.49 percentage of occasions
Standard Deviation 34.300
|
43.24 percentage of occasions
Standard Deviation 39.891
|
49.86 percentage of occasions
Standard Deviation 36.921
|
SECONDARY outcome
Timeframe: Baseline to <Week 8 and Week 8 to <=Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=73 Participants
|
DB Placebo
n=38 Participants
|
DB Placebo Week 8
n=61 Participants
|
DB Placebo/OL Viagra Week 14
n=51 Participants
|
|---|---|---|---|---|
|
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
|
74.08 percentage of occasions
Standard Deviation 40.922
|
86.21 percentage of occasions
Standard Deviation 27.647
|
83.14 percentage of occasions
Standard Deviation 31.561
|
SECONDARY outcome
Timeframe: Baseline to <Week 8 and Week 8 to <=Week 14Population: number of subjects in the FAS population with an observation
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.
Outcome measures
| Measure |
DB Viagra
n=88 Participants
|
DB Placebo
n=74 Participants
|
DB Placebo Week 8
n=83 Participants
|
DB Placebo/OL Viagra Week 14
n=68 Participants
|
|---|---|---|---|---|
|
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
|
19.20 percentage of occasions
Standard Deviation 28.977
|
44.07 percentage of occasions
Standard Deviation 38.632
|
39.15 percentage of occasions
Standard Deviation 37.159
|
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of \<60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), \<12 mo from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
- Publication restrictions are in place
Restriction type: OTHER