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 10mg 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 surgical prostatectomy for prostate cancer * Hereditary degenerative retinal disorders * History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision * Presence of penile anatomical abnormalities * Subjects who have been confirmed with phenylketonuria (PKU) * Spinal cord injury * Resting or postural hypotension or hypertension * Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin * Use of any treatment for ED within 7 days of Visit 1 * History of congenital QT prolongation * History of syncope within the last 6 months prior to entry into the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF | from baseline up to 12 weeks | 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 in Percentage From Baseline in Success of Penetration at 12 Weeks | from baseline up to 12 weeks of treatment | 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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'). |
| 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 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. |
| 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) |
| Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma | Visit 5 after 12 weeks of treatment | Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose. |
| Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma | Visit 5 after 12 weeks of treatment | Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose. |
| Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma | Visit 5 after 12 weeks of treatment | Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose. |
| Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma | Visit 5 after 12 weeks of treatment | Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose. |
| 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 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. |
| 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
Belgium, France, Germany, Netherlands, South Africa, Spain
Participant flow
Recruitment details
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.
Pre-assignment details
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.
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. | 184 |
| Placebo Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. | 174 |
| Total | 358 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 |
| Overall Study | Consent Withdrawn | 5 | 7 |
| Overall Study | Lack of Efficacy | 2 | 8 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | No Drug Exposure | 2 | 2 |
| Overall Study | Noncompliant With Study Medication | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 1 |
Baseline characteristics
| Characteristic | Vardenafil ODT (STAXYN, BAY38-9456) | Placebo | Total |
|---|---|---|---|
| Age, Customized <65 years | 87 Participants | 81 Participants | 168 Participants |
| Age, Customized >=65 years | 97 Participants | 93 Participants | 190 Participants |
| Body Mass Index (BMI) < 65 years | 27.5 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.5 | 27.9 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4.3 | 27.7 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.9 |
| Body Mass Index (BMI) >= 65 years | 26.9 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.2 | 27.1 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.6 | 27.0 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.4 |
| Body Mass Index (BMI) All age groups | 27.2 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.4 | 27.5 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 4 | 27.3 Kilograms per square meter (kg/m^2) STANDARD_DEVIATION 3.7 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 184 Participants | 174 Participants | 358 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 70 / 184 | 36 / 174 |
| serious Total, serious adverse events | 4 / 184 | 1 / 174 |
Outcome results
Primary
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF
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: 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 LOCF | <65 years | 9.6 scores on a scale | Standard Deviation 6.28 |
| Vardenafil ODT (STAXYN, BAY38-9456) | 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 |
| Vardenafil ODT (STAXYN, BAY38-9456) | 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 7.4 |
| Placebo | Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF | <65 years | 2.1 scores on a scale | Standard Deviation 7.33 |
| Placebo | Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF | ≥65 years | 0.9 scores on a scale | Standard Deviation 6.42 |
| Placebo | Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF | Total | 1.4 scores on a scale | Standard Deviation 6.86 |
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: [-8.562, -5.6561]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 | 54.5 percentage of success in maintenance | Standard Deviation 32.72 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Success of Erection Maintenance at 12 Weeks | ≥65 years | 49.2 percentage of success in maintenance | Standard Deviation 37.28 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Success of Erection Maintenance at 12 Weeks | Total | 51.7 percentage of success in maintenance | Standard Deviation 35.18 |
| Placebo | Change From Baseline in Success of Erection Maintenance at 12 Weeks | <65 years | 15.2 percentage of success in maintenance | Standard Deviation 31.3 |
| Placebo | Change From Baseline in Success of Erection Maintenance at 12 Weeks | ≥65 years | 7.7 percentage of success in maintenance | Standard Deviation 25.72 |
| Placebo | Change From Baseline in Success of Erection Maintenance at 12 Weeks | Total | 11.3 percentage of success in maintenance | Standard Deviation 28.67 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-45.021, -31.366]ANCOVA
Primary
Change in Percentage From Baseline in Success of Penetration at 12 Weeks
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.
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 at 12 Weeks | <65 years | 35.8 percentage of successful penetrations | Standard Deviation 33.63 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Success of Penetration at 12 Weeks | ≥65 years | 35.2 percentage of successful penetrations | Standard Deviation 38.06 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Success of Penetration at 12 Weeks | Total | 35.5 percentage of successful penetrations | Standard Deviation 35.93 |
| Placebo | Change in Percentage From Baseline in Success of Penetration at 12 Weeks | <65 years | 5.5 percentage of successful penetrations | Standard Deviation 42.82 |
| Placebo | Change in Percentage From Baseline in Success of Penetration at 12 Weeks | ≥65 years | 8.7 percentage of successful penetrations | Standard Deviation 28.41 |
| Placebo | Change in Percentage From Baseline in Success of Penetration at 12 Weeks | Total | 7.2 percentage of successful penetrations | Standard Deviation 35.79 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-35.519, -22.534]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 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.
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 | 28.7 scores on a scale | Standard Deviation 27.56 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Confidence for Completion at 12 Weeks or LOCF | ≥65 years | 25.8 scores on a scale | Standard Deviation 30.18 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Confidence for Completion at 12 Weeks or LOCF | Total | 27.7 scores on a scale | Standard Deviation 28.94 |
| Placebo | Change From Baseline in Confidence for Completion at 12 Weeks or LOCF | <65 years | 5.0 scores on a scale | Standard Deviation 27.53 |
| Placebo | Change From Baseline in Confidence for Completion at 12 Weeks or LOCF | ≥65 years | 3.6 scores on a scale | Standard Deviation 26.57 |
| Placebo | Change From Baseline in Confidence for Completion at 12 Weeks or LOCF | Total | 4.2 scores on a scale | Standard Deviation 26.94 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-28.594, -18.175]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 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.
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 | 28.6 scores on a scale | Standard Deviation 28.02 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Ease With Erection at 12 Weeks or LOCF | ≥65 years | 25.0 scores on a scale | Standard Deviation 31.2 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Ease With Erection at 12 Weeks or LOCF | Total | 26.7 scores on a scale | Standard Deviation 29.73 |
| Placebo | Change From Baseline in Ease With Erection at 12 Weeks or LOCF | <65 years | 4.2 scores on a scale | Standard Deviation 27.92 |
| Placebo | Change From Baseline in Ease With Erection at 12 Weeks or LOCF | ≥65 years | 0.8 scores on a scale | Standard Deviation 28.98 |
| Placebo | Change From Baseline in Ease With Erection at 12 Weeks or LOCF | Total | 2.4 scores on a scale | Standard Deviation 28.46 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-30.067, -19.34]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 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.
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 | 1.3 scores on a scale | Standard Deviation 1.28 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF | ≥65 years | 1.2 scores on a scale | Standard Deviation 1.18 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF | Total | 1.3 scores on a scale | Standard Deviation 1.23 |
| Placebo | Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF | <65 years | 0.1 scores on a scale | Standard Deviation 1.35 |
| Placebo | Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF | ≥65 years | -0.1 scores on a scale | Standard Deviation 1.28 |
| Placebo | Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF | Total | 0.0 scores on a scale | Standard Deviation 1.31 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-34.865, -24.128]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 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.
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 | 28.6 scores on a scale | Standard Deviation 29.34 |
| Vardenafil ODT (STAXYN, BAY38-9456) | 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 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF | Total | 26.8 scores on a scale | Standard Deviation 29.78 |
| Placebo | Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF | <65 years | 3.2 scores on a scale | Standard Deviation 29.06 |
| Placebo | Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF | ≥65 years | -3.6 scores on a scale | Standard Deviation 29.48 |
| Placebo | Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF | Total | -0.4 scores on a scale | Standard Deviation 29.4 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-33.155, -22.394]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 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.
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 Satisfaction With Orgasm at 12 Weeks or LOCF | <65 years | 31.0 scores on a scale | Standard Deviation 29.46 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF | ≥65 years | 26.8 scores on a scale | Standard Deviation 32.29 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF | Total | 28.8 scores on a scale | Standard Deviation 30.98 |
| Placebo | Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF | <65 years | 7.1 scores on a scale | Standard Deviation 32.66 |
| Placebo | Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF | ≥65 years | 5.5 scores on a scale | Standard Deviation 31.8 |
| Placebo | Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF | Total | 6.3 scores on a scale | Standard Deviation 32.11 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-29.062, -17.598]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 | 34.5 percentage of ejaculation successes | Standard Deviation 36.19 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks | ≥65 years | 32.7 percentage of ejaculation successes | Standard Deviation 35.23 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks | Total | 33.5 percentage of ejaculation successes | Standard Deviation 35.6 |
| Placebo | Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks | <65 years | 5.4 percentage of ejaculation successes | Standard Deviation 36.86 |
| Placebo | Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks | ≥65 years | 10.1 percentage of ejaculation successes | Standard Deviation 29.96 |
| Placebo | Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks | Total | 7.9 percentage of ejaculation successes | Standard Deviation 33.38 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-31.562, -18.824]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 | 18.8 percentage of successful erections | Standard Deviation 29.6 |
| Vardenafil ODT (STAXYN, BAY38-9456) | 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 |
| Vardenafil ODT (STAXYN, BAY38-9456) | 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 |
| Placebo | Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks | <65 years | -1.8 percentage of successful erections | Standard Deviation 37.86 |
| Placebo | Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks | ≥65 years | 1.2 percentage of successful erections | Standard Deviation 37.43 |
| Placebo | Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks | Total | -0.2 percentage of successful erections | Standard Deviation 37.55 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-22.424, -10.764]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 | 55.7 percentage of satisfactory attempts | Standard Deviation 36.83 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks | ≥65 years | 45.8 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 | 50.5 percentage of satisfactory attempts | Standard Deviation 37.9 |
| Placebo | Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks | <65 years | 14.4 percentage of satisfactory attempts | Standard Deviation 30.26 |
| Placebo | Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks | ≥65 years | 5.6 percentage of satisfactory attempts | Standard Deviation 25.74 |
| Placebo | Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks | Total | 9.8 percentage of satisfactory attempts | Standard Deviation 28.24 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-43.645, -29.465]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 | 51.7 percentage of satisfactory erections | Standard Deviation 36.1 |
| Vardenafil ODT (STAXYN, BAY38-9456) | 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 |
| Vardenafil ODT (STAXYN, BAY38-9456) | 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 |
| Placebo | Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks | <65 years | 11.2 percentage of satisfactory erections | Standard Deviation 27.69 |
| Placebo | Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks | ≥65 years | 7.5 percentage of satisfactory erections | Standard Deviation 27.7 |
| Placebo | Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks | Total | 9.2 percentage of satisfactory erections | Standard Deviation 27.67 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-45.261, -31.073]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 | 1.0 Sexual Attempts | Standard Deviation 2.6 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Number of Sexual Attempts Till First Successful Attempt | ≥65 years | 1.4 Sexual Attempts | Standard Deviation 3.1 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Number of Sexual Attempts Till First Successful Attempt | Total | 1.2 Sexual Attempts | Standard Deviation 2.9 |
| Placebo | Number of Sexual Attempts Till First Successful Attempt | <65 years | 2.7 Sexual Attempts | Standard Deviation 4.4 |
| Placebo | Number of Sexual Attempts Till First Successful Attempt | ≥65 years | 4.4 Sexual Attempts | Standard Deviation 7.4 |
| Placebo | Number of Sexual Attempts Till First Successful Attempt | Total | 3.6 Sexual Attempts | Standard Deviation 6.2 |
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 | 76 percentage of participants |
| Vardenafil ODT (STAXYN, BAY38-9456) | Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale | ≥65 years | 69 percentage of participants |
| Vardenafil ODT (STAXYN, BAY38-9456) | Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale | Total | 72 percentage of participants |
| Placebo | Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale | <65 years | 30 percentage of participants |
| Placebo | Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale | ≥65 years | 22 percentage of participants |
| Placebo | Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale | Total | 26 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 | 46 percentage of participants |
| Vardenafil ODT (STAXYN, BAY38-9456) | Percentage of Subjects Achieving Back to Normal Erectile Function | ≥65 years | 34 percentage of participants |
| Vardenafil ODT (STAXYN, BAY38-9456) | Percentage of Subjects Achieving Back to Normal Erectile Function | Total | 40 percentage of participants |
| Placebo | Percentage of Subjects Achieving Back to Normal Erectile Function | <65 years | 13 percentage of participants |
| Placebo | Percentage of Subjects Achieving Back to Normal Erectile Function | ≥65 years | 11 percentage of participants |
| Placebo | Percentage of Subjects Achieving Back to Normal Erectile Function | Total | 12 percentage of participants |
Comparison: Statistical analysis applies to the total population.p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Time frame: Visit 5 after 12 weeks of treatment
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma | 33.36 µg*h/L |
| Placebo | Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma | 41.80 µg*h/L |
Comparison: Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years/ patients aged \< 65 years) were calculated.90% CI: [73.65, 213.11]
Comparison: A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.p-value: 0.7375Regression, Linear
Secondary
Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Time frame: Visit 5 after 12 weeks of treatment
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma | 47.16 μg*h/L |
| Placebo | Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma | 55.37 μg*h/L |
Comparison: Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.90% CI: [79.59, 173.23]
Comparison: A linear regression line is fitted to the logarithm of AUC. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.p-value: 0.7064Regression, Linear
Secondary
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Time frame: Visit 5 after 12 weeks of treatment
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma | 9.260 µg/L |
| Placebo | Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma | 11.47 µg/L |
Comparison: Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.90% CI: [80.12, 191.42]
Comparison: A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α = 0.05.p-value: 0.394Regression, Linear
Secondary
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Time frame: Visit 5 after 12 weeks of treatment
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma | 10.09 μg/L |
| Placebo | Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma | 13.43 μg/L |
Comparison: Point estimate and 90% confidence interval of ratio (patients aged ≥ 65 years / patients aged \< 65 years) were calculated.90% CI: [87.46, 202.46]
Comparison: A linear regression line is fitted to the logarithm of Cmax. Test of the hypothesis of a zero slope using the two-sided t-test at α=0.05.p-value: 0.8749Regression, Linear
Secondary
Satisfaction With Medication at Week 12 or LOCF
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.
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 | 57.2 scores on a scale | Standard Deviation 28.09 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Satisfaction With Medication at Week 12 or LOCF | ≥65 years | 52.3 scores on a scale | Standard Deviation 29.54 |
| Vardenafil ODT (STAXYN, BAY38-9456) | Satisfaction With Medication at Week 12 or LOCF | Total | 54.6 scores on a scale | Standard Deviation 28.9 |
| Placebo | Satisfaction With Medication at Week 12 or LOCF | <65 years | 22.1 scores on a scale | Standard Deviation 25.58 |
| Placebo | Satisfaction With Medication at Week 12 or LOCF | ≥65 years | 20.4 scores on a scale | Standard Deviation 24.55 |
| Placebo | Satisfaction With Medication at Week 12 or LOCF | Total | 21.2 scores on a scale | Standard Deviation 24.96 |
Comparison: Statistical analysis applies to the total population.p-value: <0.000195% CI: [-38.745, -27.407]ANCOVA