Trial Outcomes & Findings for Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction (NCT NCT00631969)
NCT ID: NCT00631969
Last Updated: 2014-12-30
Results Overview
The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: \<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \>25 'no ED').
COMPLETED
PHASE3
362 participants
from baseline up to 12 weeks
2014-12-30
Participant Flow
Subjects recruited to 40 investigational centers in Belgium (4), France (8), Germany (9), Spain (3), Netherlands (5), and South Africa (11). First patient first visit on 25 April 2008, last patient last visit on 19 January 2009.
409 male subjects screened (\<65 years: n=185; \>=65 years: n=224), 362 randomized to treatment (186 to Vardenafil ODT, and 176 to placebo). The main efficacy analysis set was the Intent-to-treat (ITT) population (randomized treated subjects with baseline and post-baseline efficacy and safety assessments); 183 on Vardenafil ODT and 172 on placebo.
Participant milestones
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Overall Study
STARTED
|
186
|
176
|
|
Overall Study
Received Treatment
|
184
|
174
|
|
Overall Study
COMPLETED
|
171
|
155
|
|
Overall Study
NOT COMPLETED
|
15
|
21
|
Reasons for withdrawal
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
8
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Consent Withdrawn
|
5
|
7
|
|
Overall Study
Noncompliant With Study Medication
|
0
|
1
|
|
Overall Study
No Drug Exposure
|
2
|
2
|
Baseline Characteristics
Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction
Baseline characteristics by cohort
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=184 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=174 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Total
n=358 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
87 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
97 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
190 Participants
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
|
184 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
358 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
All age groups
|
27.2 Kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.4 • n=5 Participants
|
27.5 Kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.0 • n=7 Participants
|
27.3 Kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Body Mass Index (BMI)
< 65 years
|
27.5 Kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.5 • n=5 Participants
|
27.9 Kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 4.3 • n=7 Participants
|
27.7 Kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Body Mass Index (BMI)
>= 65 years
|
26.9 Kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.2 • n=5 Participants
|
27.1 Kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.6 • n=7 Participants
|
27.0 Kilograms per square meter (kg/m^2)
STANDARD_DEVIATION 3.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: from baseline up to 12 weeksPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: \<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \>25 'no ED').
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=183 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=172 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF
<65 years
|
9.6 scores on a scale
Standard Deviation 6.28
|
2.1 scores on a scale
Standard Deviation 7.33
|
|
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF
≥65 years
|
7.7 scores on a scale
Standard Deviation 8.19
|
0.9 scores on a scale
Standard Deviation 6.42
|
|
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF
Total
|
8.6 scores on a scale
Standard Deviation 7.40
|
1.4 scores on a scale
Standard Deviation 6.86
|
PRIMARY outcome
Timeframe: from baseline up to 12 weeks of treatmentPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
Sexual encounter profile (SEP) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=179 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=169 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Change in Percentage From Baseline in Success of Penetration at 12 Weeks
<65 years
|
35.8 percentage of successful penetrations
Standard Deviation 33.63
|
5.5 percentage of successful penetrations
Standard Deviation 42.82
|
|
Change in Percentage From Baseline in Success of Penetration at 12 Weeks
≥65 years
|
35.2 percentage of successful penetrations
Standard Deviation 38.06
|
8.7 percentage of successful penetrations
Standard Deviation 28.41
|
|
Change in Percentage From Baseline in Success of Penetration at 12 Weeks
Total
|
35.5 percentage of successful penetrations
Standard Deviation 35.93
|
7.2 percentage of successful penetrations
Standard Deviation 35.79
|
PRIMARY outcome
Timeframe: from baseline up to 12 weeks of treatmentPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=178 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=164 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Change From Baseline in Success of Erection Maintenance at 12 Weeks
<65 years
|
54.5 percentage of success in maintenance
Standard Deviation 32.72
|
15.2 percentage of success in maintenance
Standard Deviation 31.30
|
|
Change From Baseline in Success of Erection Maintenance at 12 Weeks
≥65 years
|
49.2 percentage of success in maintenance
Standard Deviation 37.28
|
7.7 percentage of success in maintenance
Standard Deviation 25.72
|
|
Change From Baseline in Success of Erection Maintenance at 12 Weeks
Total
|
51.7 percentage of success in maintenance
Standard Deviation 35.18
|
11.3 percentage of success in maintenance
Standard Deviation 28.67
|
SECONDARY outcome
Timeframe: up to 12 weeks of treatmentPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
Responders: percentage of subjects achieving an IIEF-EF score \> 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: \<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \>25 'no ED').
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=181 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=172 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Percentage of Subjects Achieving "Back to Normal" Erectile Function
<65 years
|
46 percentage of participants
|
13 percentage of participants
|
|
Percentage of Subjects Achieving "Back to Normal" Erectile Function
≥65 years
|
34 percentage of participants
|
11 percentage of participants
|
|
Percentage of Subjects Achieving "Back to Normal" Erectile Function
Total
|
40 percentage of participants
|
12 percentage of participants
|
SECONDARY outcome
Timeframe: from baseline up to 12 weeks of treatmentPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=180 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=169 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
<65 years
|
18.8 percentage of successful erections
Standard Deviation 29.6
|
-1.8 percentage of successful erections
Standard Deviation 37.86
|
|
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
≥65 years
|
14.6 percentage of successful erections
Standard Deviation 33.21
|
1.2 percentage of successful erections
Standard Deviation 37.43
|
|
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
Total
|
16.6 percentage of successful erections
Standard Deviation 31.54
|
-0.2 percentage of successful erections
Standard Deviation 37.55
|
SECONDARY outcome
Timeframe: from baseline up to 12 weeks of treatmentPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=179 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=164 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
<65 years
|
51.7 percentage of satisfactory erections
Standard Deviation 36.10
|
11.2 percentage of satisfactory erections
Standard Deviation 27.69
|
|
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
≥65 years
|
45.3 percentage of satisfactory erections
Standard Deviation 43.09
|
7.5 percentage of satisfactory erections
Standard Deviation 27.70
|
|
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
Total
|
48.4 percentage of satisfactory erections
Standard Deviation 39.95
|
9.2 percentage of satisfactory erections
Standard Deviation 27.67
|
SECONDARY outcome
Timeframe: from baseline up to 12 weeks of treatmentPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=178 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=164 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
<65 years
|
55.7 percentage of satisfactory attempts
Standard Deviation 36.83
|
14.4 percentage of satisfactory attempts
Standard Deviation 30.26
|
|
Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
≥65 years
|
45.8 percentage of satisfactory attempts
Standard Deviation 38.43
|
5.6 percentage of satisfactory attempts
Standard Deviation 25.74
|
|
Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
Total
|
50.5 percentage of satisfactory attempts
Standard Deviation 37.90
|
9.8 percentage of satisfactory attempts
Standard Deviation 28.24
|
SECONDARY outcome
Timeframe: from baseline up to 12 weeks of treatmentPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=179 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=163 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
<65 years
|
34.5 percentage of ejaculation successes
Standard Deviation 36.19
|
5.4 percentage of ejaculation successes
Standard Deviation 36.86
|
|
Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
≥65 years
|
32.7 percentage of ejaculation successes
Standard Deviation 35.23
|
10.1 percentage of ejaculation successes
Standard Deviation 29.96
|
|
Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
Total
|
33.5 percentage of ejaculation successes
Standard Deviation 35.60
|
7.9 percentage of ejaculation successes
Standard Deviation 33.38
|
SECONDARY outcome
Timeframe: up to 12 weeks of treatmentPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=180 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=169 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Number of Sexual Attempts Till First Successful Attempt
<65 years
|
1.0 Sexual Attempts
Standard Deviation 2.6
|
2.7 Sexual Attempts
Standard Deviation 4.4
|
|
Number of Sexual Attempts Till First Successful Attempt
≥65 years
|
1.4 Sexual Attempts
Standard Deviation 3.1
|
4.4 Sexual Attempts
Standard Deviation 7.4
|
|
Number of Sexual Attempts Till First Successful Attempt
Total
|
1.2 Sexual Attempts
Standard Deviation 2.9
|
3.6 Sexual Attempts
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: from baseline up to 12 weeksPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Ease with Erection" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=180 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=168 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Change From Baseline in Ease With Erection at 12 Weeks or LOCF
<65 years
|
28.6 scores on a scale
Standard Deviation 28.02
|
4.2 scores on a scale
Standard Deviation 27.92
|
|
Change From Baseline in Ease With Erection at 12 Weeks or LOCF
≥65 years
|
25.0 scores on a scale
Standard Deviation 31.20
|
0.8 scores on a scale
Standard Deviation 28.98
|
|
Change From Baseline in Ease With Erection at 12 Weeks or LOCF
Total
|
26.7 scores on a scale
Standard Deviation 29.73
|
2.4 scores on a scale
Standard Deviation 28.46
|
SECONDARY outcome
Timeframe: from baseline up to 12 weeksPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain " Erectile function satisfaction" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=180 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=168 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
<65 years
|
1.3 scores on a scale
Standard Deviation 1.28
|
0.1 scores on a scale
Standard Deviation 1.35
|
|
Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
≥65 years
|
1.2 scores on a scale
Standard Deviation 1.18
|
-0.1 scores on a scale
Standard Deviation 1.28
|
|
Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
Total
|
1.3 scores on a scale
Standard Deviation 1.23
|
0.0 scores on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: from baseline up to 12 weeksPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain " Pleasure of sexual activity" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=180 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=168 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
<65 years
|
28.6 scores on a scale
Standard Deviation 29.34
|
3.2 scores on a scale
Standard Deviation 29.06
|
|
Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
≥65 years
|
25.3 scores on a scale
Standard Deviation 30.24
|
-3.6 scores on a scale
Standard Deviation 29.48
|
|
Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
Total
|
26.8 scores on a scale
Standard Deviation 29.78
|
-0.4 scores on a scale
Standard Deviation 29.40
|
SECONDARY outcome
Timeframe: from baseline up to 12 weeksPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Satisfaction with orgasm" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=180 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=168 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
<65 years
|
31.0 scores on a scale
Standard Deviation 29.46
|
7.1 scores on a scale
Standard Deviation 32.66
|
|
Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
≥65 years
|
26.8 scores on a scale
Standard Deviation 32.29
|
5.5 scores on a scale
Standard Deviation 31.80
|
|
Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
Total
|
28.8 scores on a scale
Standard Deviation 30.98
|
6.3 scores on a scale
Standard Deviation 32.11
|
SECONDARY outcome
Timeframe: from baseline up to 12 weeksPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Confidence for completion" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=180 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=168 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
<65 years
|
28.7 scores on a scale
Standard Deviation 27.56
|
5.0 scores on a scale
Standard Deviation 27.53
|
|
Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
≥65 years
|
25.8 scores on a scale
Standard Deviation 30.18
|
3.6 scores on a scale
Standard Deviation 26.57
|
|
Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
Total
|
27.7 scores on a scale
Standard Deviation 28.94
|
4.2 scores on a scale
Standard Deviation 26.94
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with LOCF values.
Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Satisfaction with medication" at LOCF expressed as the least square mean difference.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=180 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=167 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Satisfaction With Medication at Week 12 or LOCF
<65 years
|
57.2 scores on a scale
Standard Deviation 28.09
|
22.1 scores on a scale
Standard Deviation 25.58
|
|
Satisfaction With Medication at Week 12 or LOCF
≥65 years
|
52.3 scores on a scale
Standard Deviation 29.54
|
20.4 scores on a scale
Standard Deviation 24.55
|
|
Satisfaction With Medication at Week 12 or LOCF
Total
|
54.6 scores on a scale
Standard Deviation 28.90
|
21.2 scores on a scale
Standard Deviation 24.96
|
SECONDARY outcome
Timeframe: up to 12 weeks of treatmentPopulation: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data.
Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=180 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=168 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
<65 years
|
76 percentage of participants
|
30 percentage of participants
|
|
Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
≥65 years
|
69 percentage of participants
|
22 percentage of participants
|
|
Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
Total
|
72 percentage of participants
|
26 percentage of participants
|
SECONDARY outcome
Timeframe: Visit 5 after 12 weeks of treatmentPopulation: Pharmacokinetics (PK) were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above. The PK data of one elderly patient were only evaluable for Cmax but not for AUC.
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=12 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=12 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma
|
47.16 μg*h/L
Interval 18.97 to 112.8
|
55.37 μg*h/L
Interval 21.23 to 104.4
|
SECONDARY outcome
Timeframe: Visit 5 after 12 weeks of treatmentPopulation: Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above.
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=12 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=13 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma
|
10.09 μg/L
Interval 3.134 to 19.04
|
13.43 μg/L
Interval 2.913 to 27.91
|
SECONDARY outcome
Timeframe: Visit 5 after 12 weeks of treatmentPopulation: Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above. AUC data were not available in 3 elderly patients.
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=12 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=10 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma
|
33.36 µg*h/L
Interval 10.94 to 68.46
|
41.80 µg*h/L
Interval 16.56 to 148.5
|
SECONDARY outcome
Timeframe: Visit 5 after 12 weeks of treatmentPopulation: Pharmacokinetics were studied in a sub-group of 25 ED patients receiving a single dose of 10 mg Vardenafil ODT on a separate visit. This sub-population comprised 12 patients aged 18-64 years and 13 patients aged 65 years and above.
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Outcome measures
| Measure |
Vardenafil ODT (STAXYN, BAY38-9456)
n=12 Participants
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=13 Participants
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma
|
9.260 µg/L
Interval 3.756 to 23.32
|
11.47 µg/L
Interval 5.563 to 41.17
|
Adverse Events
Vardenafil ODT (STAXYN, BAY 38-9456)
Placebo
Serious adverse events
| Measure |
Vardenafil ODT (STAXYN, BAY 38-9456)
n=184 participants at risk
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=174 participants at risk
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.54%
1/184
|
0.00%
0/174
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/184
|
0.57%
1/174
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.54%
1/184
|
0.00%
0/174
|
|
Nervous system disorders
Syncope
|
0.54%
1/184
|
0.00%
0/174
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.54%
1/184
|
0.00%
0/174
|
|
Vascular disorders
Femoral arterial stenosis
|
0.54%
1/184
|
0.00%
0/174
|
Other adverse events
| Measure |
Vardenafil ODT (STAXYN, BAY 38-9456)
n=184 participants at risk
Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
Placebo
n=174 participants at risk
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
|
|---|---|---|
|
General disorders
Chest pain
|
0.00%
0/184
|
0.57%
1/174
|
|
General disorders
Fatigue
|
1.1%
2/184
|
0.00%
0/174
|
|
General disorders
Feeling hot
|
1.1%
2/184
|
0.00%
0/174
|
|
General disorders
Oedema
|
0.54%
1/184
|
0.00%
0/174
|
|
General disorders
Pyrexia
|
0.54%
1/184
|
0.00%
0/174
|
|
General disorders
Asthenia
|
0.54%
1/184
|
0.00%
0/174
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/184
|
0.57%
1/174
|
|
Cardiac disorders
Bundle branch block left
|
0.54%
1/184
|
0.57%
1/174
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/184
|
1.7%
3/174
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/184
|
0.57%
1/174
|
|
Cardiac disorders
Palpitations
|
0.54%
1/184
|
0.57%
1/174
|
|
Cardiac disorders
Supraventricular extrasystoles
|
1.6%
3/184
|
1.1%
2/174
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/184
|
0.57%
1/174
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.54%
1/184
|
0.00%
0/174
|
|
Ear and labyrinth disorders
Vertigo
|
0.54%
1/184
|
0.00%
0/174
|
|
Eye disorders
Conjunctival haemorrhage
|
0.54%
1/184
|
0.00%
0/174
|
|
Eye disorders
Eye disorder
|
0.54%
1/184
|
0.00%
0/174
|
|
Eye disorders
Eye irritation
|
0.54%
1/184
|
0.00%
0/174
|
|
Eye disorders
Ocular hyperaemia
|
0.54%
1/184
|
0.00%
0/174
|
|
Gastrointestinal disorders
Colitis
|
0.54%
1/184
|
0.00%
0/174
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
3/184
|
1.1%
2/174
|
|
Gastrointestinal disorders
Dyspepsia
|
3.8%
7/184
|
0.00%
0/174
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.54%
1/184
|
0.00%
0/174
|
|
Eye disorders
Vision blurred
|
0.00%
0/184
|
0.57%
1/174
|
|
General disorders
Sluggishness
|
0.00%
0/184
|
0.57%
1/174
|
|
General disorders
Induration
|
0.54%
1/184
|
0.00%
0/174
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.54%
1/184
|
0.00%
0/174
|
|
Infections and infestations
Acute sinusitis
|
0.54%
1/184
|
0.00%
0/174
|
|
Infections and infestations
Bronchitis
|
0.00%
0/184
|
0.57%
1/174
|
|
Infections and infestations
Gastroenteritis
|
0.54%
1/184
|
0.00%
0/174
|
|
Infections and infestations
Herpes zoster
|
0.54%
1/184
|
0.00%
0/174
|
|
Infections and infestations
Influenza
|
0.54%
1/184
|
0.57%
1/174
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
2/184
|
0.57%
1/174
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/184
|
0.57%
1/174
|
|
Infections and infestations
Tooth infection
|
0.00%
0/184
|
0.57%
1/174
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/184
|
0.57%
1/174
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.54%
1/184
|
0.00%
0/174
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.54%
1/184
|
0.57%
1/174
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.54%
1/184
|
0.00%
0/174
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.54%
1/184
|
0.00%
0/174
|
|
Investigations
Alanine aminotransferase increased
|
0.54%
1/184
|
0.00%
0/174
|
|
Investigations
Platelet count decreased
|
0.00%
0/184
|
0.57%
1/174
|
|
Investigations
Platelet count increased
|
0.54%
1/184
|
0.00%
0/174
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/184
|
0.57%
1/174
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/184
|
0.57%
1/174
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.6%
3/184
|
0.00%
0/174
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.1%
2/184
|
1.1%
2/174
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.1%
2/184
|
0.00%
0/174
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.54%
1/184
|
0.00%
0/174
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.54%
1/184
|
0.00%
0/174
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.54%
1/184
|
0.00%
0/174
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/184
|
0.57%
1/174
|
|
Nervous system disorders
Dizziness
|
1.6%
3/184
|
0.00%
0/174
|
|
Nervous system disorders
Dysgeusia
|
2.2%
4/184
|
2.3%
4/174
|
|
Nervous system disorders
Headache
|
16.3%
30/184
|
1.1%
2/174
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/184
|
0.57%
1/174
|
|
Nervous system disorders
Paraesthesia
|
0.54%
1/184
|
0.00%
0/174
|
|
Nervous system disorders
Tension headache
|
0.54%
1/184
|
0.00%
0/174
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/184
|
0.57%
1/174
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/184
|
0.57%
1/174
|
|
Renal and urinary disorders
Polyuria
|
0.54%
1/184
|
0.00%
0/174
|
|
Reproductive system and breast disorders
Prostatitis
|
0.54%
1/184
|
0.00%
0/174
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.54%
1/184
|
0.57%
1/174
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/184
|
0.57%
1/174
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/184
|
0.57%
1/174
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.6%
3/184
|
0.00%
0/174
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/184
|
0.57%
1/174
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.54%
1/184
|
0.00%
0/174
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/184
|
0.57%
1/174
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.54%
1/184
|
0.00%
0/174
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.54%
1/184
|
0.00%
0/174
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.54%
1/184
|
0.00%
0/174
|
|
Social circumstances
Pharmaceutical product complaint
|
0.00%
0/184
|
1.7%
3/174
|
|
Surgical and medical procedures
Meniscus removal
|
0.00%
0/184
|
0.57%
1/174
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/184
|
0.57%
1/174
|
|
Vascular disorders
Flushing
|
7.6%
14/184
|
0.00%
0/174
|
|
Vascular disorders
Hypertension
|
0.54%
1/184
|
0.57%
1/174
|
|
Vascular disorders
Orthostatic hypotension
|
1.1%
2/184
|
1.1%
2/174
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee In the protocol it is specified that all results are the property of the sponsor. The investigator must discuss any publication with the sponsor prior to release and obtain written consent of the sponsor. The investigator must send a draft publication to the sponsor thirty days in advance of submission in order to obtain approval prior to submission of the final version for publication.
- Publication restrictions are in place
Restriction type: OTHER