Erectile Dysfunction
Conditions
Keywords
Erectile Dysfunction
Brief summary
This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
Interventions
Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT)
DRUGPlacebo
Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet
Sponsors
GlaxoSmithKline
Schering-Plough
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males 18 years-of-age or older. * Stable, heterosexual relationship for at least 6 months. * A history of erectile dysfunction (ED) for at least 6 months
Exclusion criteria
* Any underlying cardiovascular condition, including unstable angina pectoris * History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1 * Uncontrolled atrial fibrillation / flutter at screening * History of congenital QT prolongation * History of surgical prostatectomy due to prostate cancer * Hereditary degenerative retinal disorders * History of loss of vision because of NAION (Non-arteritic anterior ischemic optic neuropathy), temporary or permanent loss of vision * Presence of penile anatomical abnormalities * Spinal cord injury * Resting or postural hypotension or hypertension * Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha-blockers, HIV (Human immunodeficiency virus) protease inhibitors, itraconazole or ketoconazole, and clarithromycin and erythromycin. * Subjects taking medication known to prolong QT interval, such as Type Ia and Type 3 anti-arrhythmics. * Subjects who have been confirmed with phenylketonuria (PKU). * Use of any treatment for ED within 7 days of Visit 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) | from baseline up to 12 weeks | The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: \<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \>25 'no ED'.) |
| Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks | from baseline up to 12 weeks of treatment | SEP (Sexual Encounter Profile) 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. |
| Change From Baseline in Success of Erection Maintenance at 12 Weeks | from baseline up to 12 weeks of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks | from baseline up to 12 weeks of treatment | 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. |
| Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks | from baseline up to 12 weeks of treatment | 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. |
| Number of Sexual Attempts Till First Successful Attempt | up to 12 weeks of treatment | — |
| Change From Baseline in Ease With Erection at 12 Weeks or LOCF | from baseline up to 12 weeks | Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Ease with Erection from baseline to Week 12 or LOCF expressed as the least square mean difference. |
| Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF | from baseline up to 12 weeks | Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Erectile function satisfaction from baseline to Week 12 or LOCF expressed as the least square mean difference |
| Percentage of Subjects Achieving Back to Normal Erectile Function | up to 12 weeks of treatment | 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'). |
| Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF | from baseline up to 12 weeks | Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Satisfaction with orgasm from baseline to Week 12 or LOCF expressed as the least square mean difference |
| Change From Baseline in Confidence for Completion at 12 Weeks or LOCF | from baseline up to 12 weeks | Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Confidence for completion from baseline to Week 12 or LOCF expressed as the least square mean difference |
| Satisfaction With Medication at Week 12 or LOCF | up to 12 weeks | Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Satisfaction with medication at LOCF expressed as the least square mean difference |
| Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale | up to 12 weeks of treatment | 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) |
| Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF | from baseline up to 12 weeks | Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Pleasure of sexual activity from baseline to Week 12 or LOCF expressed as the least square mean difference |
| Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks | from baseline up to 12 weeks of treatment | 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. |
| Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks | from baseline up to 12 weeks of treatment | 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. |
Countries
Australia, Canada, Mexico, United States
Participant flow
Recruitment details
Subjects recruited to 35 investigational centers in the USA (20), Canada (4), Mexico (5), and Australia (6). First patient first visit on 28 Apr 2008, last patient last visit on 13 Feb 2009.
Pre-assignment details
473 subjects screened (\<65 years: n=230; \>=65 years: n=243), 339 randomized (Vardenafil 10 mg ODT=172, placebo=167). The main efficacy analysis set was the ITT (Intent to Treat) population (randomized treated sub. with baseline and post-baseline in any of the efficacy variables and safety assessment); Vardenafil 10 mg ODT=169, placebo=162
Participants by arm
| Arm | Count |
|---|---|
| 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. | 171 |
| Placebo Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. | 166 |
| Total | 337 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 |
| Overall Study | consent withdrawn | 6 | 4 |
| Overall Study | Lack of Efficacy | 2 | 12 |
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Protocol Violation | 5 | 3 |
Baseline characteristics
| Characteristic | Vardenafil ODT (STAXYN, BAY38-9456) | Placebo | Total |
|---|---|---|---|
| Age, Customized <65 years | 86 participants | 84 participants | 170 participants |
| Age, Customized >=65 years | 85 participants | 82 participants | 167 participants |
| Body Mass Index (BMI) | 28.9 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.4 | 28.7 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.2 | 28.8 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.3 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 171 Participants | 166 Participants | 337 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 65 / 171 | 37 / 166 |
| serious Total, serious adverse events | 2 / 171 | 1 / 166 |
Outcome results
Primary
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF)
The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: \<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \>25 'no ED'.)
Time frame: from baseline up to 12 weeks
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) | <65 years | 10.3 scores on a scale | Standard Deviation 7.78 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) | >=65 years | 6.7 scores on a scale | Standard Deviation 8.06 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) | Total | 8.5 scores on a scale | Standard Deviation 8.11 |
| Placebo | Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) | <65 years | 1.7 scores on a scale | Standard Deviation 6.28 |
| Placebo | Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) | >=65 years | 1.1 scores on a scale | Standard Deviation 6.01 |
| Placebo | Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) | Total | 1.4 scores on a scale | Standard Deviation 6.14 |
Comparison: Power adjustment for 3 primary efficacy variables (3 variables have to be significant in favor of Vardenafil to conclude efficacy). Statistical analysis applies to the total population.p-value: <0.000195% CI: [-8.45, -5.38]ANCOVA
Primary
Change From Baseline in Success of Erection Maintenance at 12 Weeks
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.
Time frame: from baseline up to 12 weeks of treatment
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Success of Erection Maintenance at 12 Weeks | <65 years | 53.2 percentage of successful maintenance | Standard Deviation 33.22 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Success of Erection Maintenance at 12 Weeks | >=65 years | 38.8 percentage of successful maintenance | Standard Deviation 38.32 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Success of Erection Maintenance at 12 Weeks | Total | 46.0 percentage of successful maintenance | Standard Deviation 36.47 |
| Placebo | Change From Baseline in Success of Erection Maintenance at 12 Weeks | <65 years | 15.2 percentage of successful maintenance | Standard Deviation 29.55 |
| Placebo | Change From Baseline in Success of Erection Maintenance at 12 Weeks | >=65 years | 8.7 percentage of successful maintenance | Standard Deviation 29.15 |
| Placebo | Change From Baseline in Success of Erection Maintenance at 12 Weeks | Total | 12.0 percentage of successful maintenance | Standard Deviation 29.44 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-40.439, -26.425]ANCOVA
Primary
Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks
SEP (Sexual Encounter Profile) 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.
Time frame: from baseline up to 12 weeks of treatment
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks | <65 years | 33.2 percentage of successful penetrations | Standard Deviation 33.27 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks | >=65 years | 27.3 percentage of successful penetrations | Standard Deviation 37.39 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks | Total | 30.2 percentage of successful penetrations | Standard Deviation 35.4 |
| Placebo | Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks | <65 years | 4.6 percentage of successful penetrations | Standard Deviation 34.12 |
| Placebo | Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks | >=65 years | 3.0 percentage of successful penetrations | Standard Deviation 33.33 |
| Placebo | Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks | Total | 3.8 percentage of successful penetrations | Standard Deviation 33.63 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-32.688, -19.256]ANCOVA
Secondary
Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Confidence for completion from baseline to Week 12 or LOCF expressed as the least square mean difference
Time frame: from baseline up to 12 weeks
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Confidence for Completion at 12 Weeks or LOCF | <65 years | 38.0 scores on a scale | Standard Deviation 28.59 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Confidence for Completion at 12 Weeks or LOCF | >=65 years | 20.2 scores on a scale | Standard Deviation 27.74 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Confidence for Completion at 12 Weeks or LOCF | Total | 29.0 scores on a scale | Standard Deviation 29.46 |
| Placebo | Change From Baseline in Confidence for Completion at 12 Weeks or LOCF | Total | 3.8 scores on a scale | Standard Deviation 27.56 |
| Placebo | Change From Baseline in Confidence for Completion at 12 Weeks or LOCF | <65 years | 4.8 scores on a scale | Standard Deviation 28.22 |
| Placebo | Change From Baseline in Confidence for Completion at 12 Weeks or LOCF | >=65 years | 2.8 scores on a scale | Standard Deviation 27.05 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-28.006, -16.753]ANCOVA
Secondary
Change From Baseline in Ease With Erection at 12 Weeks or LOCF
Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Ease with Erection from baseline to Week 12 or LOCF expressed as the least square mean difference.
Time frame: from baseline up to 12 weeks
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Ease With Erection at 12 Weeks or LOCF | <65 years | 24.0 scores on a scale | Standard Deviation 34.29 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Ease With Erection at 12 Weeks or LOCF | >=65 years | 14.4 scores on a scale | Standard Deviation 29.17 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Ease With Erection at 12 Weeks or LOCF | Total | 19.1 scores on a scale | Standard Deviation 32.07 |
| Placebo | Change From Baseline in Ease With Erection at 12 Weeks or LOCF | <65 years | 6.1 scores on a scale | Standard Deviation 31.77 |
| Placebo | Change From Baseline in Ease With Erection at 12 Weeks or LOCF | >=65 years | 0.0 scores on a scale | Standard Deviation 27.84 |
| Placebo | Change From Baseline in Ease With Erection at 12 Weeks or LOCF | Total | 3.0 scores on a scale | Standard Deviation 29.91 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-22.599, -11.133]ANCOVA
Secondary
Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Erectile function satisfaction from baseline to Week 12 or LOCF expressed as the least square mean difference
Time frame: from baseline up to 12 weeks
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF | <65 years | 41.2 scores on a scale | Standard Deviation 27.78 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF | >=65 years | 25.4 scores on a scale | Standard Deviation 26.11 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF | Total | 33.2 scores on a scale | Standard Deviation 28.01 |
| Placebo | Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF | <65 years | 7.6 scores on a scale | Standard Deviation 24.95 |
| Placebo | Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF | >=65 years | 4.2 scores on a scale | Standard Deviation 24.84 |
| Placebo | Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF | Total | 5.9 scores on a scale | Standard Deviation 24.88 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-31.547, -20.533]ANCOVA
Secondary
Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Pleasure of sexual activity from baseline to Week 12 or LOCF expressed as the least square mean difference
Time frame: from baseline up to 12 weeks
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF | <65 years | 30.1 scores on a scale | Standard Deviation 24.63 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF | >=65 years | 15.3 scores on a scale | Standard Deviation 29.63 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF | Total | 22.6 scores on a scale | Standard Deviation 28.19 |
| Placebo | Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF | <65 years | 4.8 scores on a scale | Standard Deviation 25.82 |
| Placebo | Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF | >=65 years | -1.9 scores on a scale | Standard Deviation 22.42 |
| Placebo | Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF | Total | 1.4 scores on a scale | Standard Deviation 24.31 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-24.676, -14.315]ANCOVA
Secondary
Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Satisfaction with orgasm from baseline to Week 12 or LOCF expressed as the least square mean difference
Time frame: from baseline up to 12 weeks
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF | 23.6 scores on a scale | Standard Deviation 30.81 |
| Placebo | Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF | 3.2 scores on a scale | Standard Deviation 31.36 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-24.439, -12.396]ANCOVA
Secondary
Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
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.
Time frame: from baseline up to 12 weeks of treatment
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks | <65 years | 37.3 percentage of ejaculation successes | Standard Deviation 32.52 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks | >=65 years | 17.7 percentage of ejaculation successes | Standard Deviation 36.27 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks | Total | 27.5 percentage of ejaculation successes | Standard Deviation 35.72 |
| Placebo | Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks | <65 years | 7.1 percentage of ejaculation successes | Standard Deviation 35 |
| Placebo | Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks | >=65 years | 2.7 percentage of ejaculation successes | Standard Deviation 36.51 |
| Placebo | Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks | Total | 4.9 percentage of ejaculation successes | Standard Deviation 35.71 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-27.724, -14.081]ANCOVA
Secondary
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
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.
Time frame: from baseline up to 12 weeks of treatment
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks | <65 years | 13.4 percentage of successful erections | Standard Deviation 28.63 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks | >=65 years | 9.6 percentage of successful erections | Standard Deviation 35.96 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks | Total | 11.5 percentage of successful erections | Standard Deviation 32.46 |
| Placebo | Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks | <65 years | -5.8 percentage of successful erections | Standard Deviation 38.18 |
| Placebo | Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks | >=65 years | -3.8 percentage of successful erections | Standard Deviation 37.04 |
| Placebo | Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks | Total | -4.8 percentage of successful erections | Standard Deviation 37.51 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-22.41, -9.746]ANCOVA
Secondary
Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
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.
Time frame: from baseline up to 12 weeks of treatment
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks | <65 years | 52.0 percentage of satisfactory attempts | Standard Deviation 40.04 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks | >=65 years | 38.4 percentage of satisfactory attempts | Standard Deviation 38.43 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks | Total | 45.1 percentage of satisfactory attempts | Standard Deviation 40.15 |
| Placebo | Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks | <65 years | 12.2 percentage of satisfactory attempts | Standard Deviation 30.89 |
| Placebo | Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks | >=65 years | 10.3 percentage of satisfactory attempts | Standard Deviation 26.7 |
| Placebo | Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks | Total | 11.2 percentage of satisfactory attempts | Standard Deviation 26.39 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-41.119, -26.749]ANCOVA
Secondary
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
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.
Time frame: from baseline up to 12 weeks of treatment
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks | <65 years | 52.0 percentage of satisfactory erections | Standard Deviation 40.04 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks | >=65 years | 36.1 percentage of satisfactory erections | Standard Deviation 41.54 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks | Total | 44.1 percentage of satisfactory erections | Standard Deviation 41.45 |
| Placebo | Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks | <65 years | 12.2 percentage of satisfactory erections | Standard Deviation 30.89 |
| Placebo | Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks | >=65 years | 5.4 percentage of satisfactory erections | Standard Deviation 31.21 |
| Placebo | Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks | Total | 8.8 percentage of satisfactory erections | Standard Deviation 31.14 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-40.281, -25.987]ANCOVA
Secondary
Number of Sexual Attempts Till First Successful Attempt
Time frame: up to 12 weeks of treatment
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Number of Sexual Attempts Till First Successful Attempt | <65 years | 1.2 Sexual Attempts | Standard Deviation 3.7 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Number of Sexual Attempts Till First Successful Attempt | >=65 years | 1.6 Sexual Attempts | Standard Deviation 4.5 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Number of Sexual Attempts Till First Successful Attempt | Total | 1.4 Sexual Attempts | Standard Deviation 4.1 |
| Placebo | Number of Sexual Attempts Till First Successful Attempt | <65 years | 2.6 Sexual Attempts | Standard Deviation 3.5 |
| Placebo | Number of Sexual Attempts Till First Successful Attempt | >=65 years | 3.8 Sexual Attempts | Standard Deviation 3.9 |
| Placebo | Number of Sexual Attempts Till First Successful Attempt | Total | 3.1 Sexual Attempts | Standard Deviation 3.7 |
Secondary
Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
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)
Time frame: up to 12 weeks of treatment
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale | <65 years | 75 percentage of participants |
| Vardenafil ODT (STAXYN, BAY38-9456) | Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale | >=65 years | 59 percentage of participants |
| Vardenafil ODT (STAXYN, BAY38-9456) | Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale | Total | 67 percentage of participants |
| Placebo | Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale | <65 years | 19 percentage of participants |
| Placebo | Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale | >=65 years | 28 percentage of participants |
| Placebo | Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale | Total | 24 percentage of participants |
Comparison: Statistical analysis applies to the total population.p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Percentage of Subjects Achieving Back to Normal Erectile Function
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').
Time frame: up to 12 weeks of treatment
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Percentage of Subjects Achieving Back to Normal Erectile Function | <65 years | 59 percentage of subjects |
| Vardenafil ODT (STAXYN, BAY38-9456) | Percentage of Subjects Achieving Back to Normal Erectile Function | >=65 years | 32 percentage of subjects |
| Vardenafil ODT (STAXYN, BAY38-9456) | Percentage of Subjects Achieving Back to Normal Erectile Function | Total | 46 percentage of subjects |
| Placebo | Percentage of Subjects Achieving Back to Normal Erectile Function | <65 years | 11 percentage of subjects |
| Placebo | Percentage of Subjects Achieving Back to Normal Erectile Function | >=65 years | 8 percentage of subjects |
| Placebo | Percentage of Subjects Achieving Back to Normal Erectile Function | Total | 9 percentage of subjects |
Comparison: Statistical analysis applies to the total population.p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Satisfaction With Medication at Week 12 or LOCF
Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain Satisfaction with medication at LOCF expressed as the least square mean difference
Time frame: up to 12 weeks
Population: The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with LOCF values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Satisfaction With Medication at Week 12 or LOCF | <65 years | 58.6 scores on a scale | Standard Deviation 26.55 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Satisfaction With Medication at Week 12 or LOCF | >=65 years | 42.5 scores on a scale | Standard Deviation 30.26 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Satisfaction With Medication at Week 12 or LOCF | Total | 50.5 scores on a scale | Standard Deviation 29.52 |
| Placebo | Satisfaction With Medication at Week 12 or LOCF | <65 years | 19.3 scores on a scale | Standard Deviation 26.55 |
| Placebo | Satisfaction With Medication at Week 12 or LOCF | >=65 years | 20.2 scores on a scale | Standard Deviation 24.59 |
| Placebo | Satisfaction With Medication at Week 12 or LOCF | Total | 19.7 scores on a scale | Standard Deviation 25.5 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-36.736, -24.779]ANOVA