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CompletedNCT00631969Updated Dec 30, 2014Results posted

Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction

A Phase 3 interventional study of Vardenafil ODT (STAXYN, BAY38-9456) and Placebo in Erectile Dysfunction, sponsored by Bayer. Completed at 47 sites in 6 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-30.

Sponsored by Bayer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
362
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

02

Conditions studied

  • Erectile Dysfunction

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Keywords

  • Erectile Dysfunction
03

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.

This study's enrollment of 362 is above the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts 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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
362 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Vardenafil ODT (STAXYN, BAY38-9456)

  • Placebo comparator
    Placebo

    Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.

    Drug: Placebo

Interventions

  • DrugVardenafil ODT (STAXYN, BAY38-9456)

    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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Number of Sexual Attempts Till First Successful Attempt

    Time frame: up to 12 weeks of treatment

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

07

Results

Posted Jan 21, 2011

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.

Participant flow — Overall Study
MilestoneVardenafil ODT (STAXYN, BAY38-9456)Placebo
Started186176
Received treatment184174
Completed171155
Not completed1521
Withdrew: Adverse event31
Withdrew: Lack of efficacy28
Withdrew: Lost to follow-up21
Withdrew: Protocol violation11
Withdrew: Consent withdrawn57
Withdrew: Noncompliant with study medication01
Withdrew: No drug exposure22

Outcome measures

PrimaryChange 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
Reported as:
Mean · scores on a scale
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF
scores on a scaleVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years9.6 ± 6.282.1 ± 7.33
≥65 years7.7 ± 8.190.9 ± 6.42
Total8.6 ± 7.401.4 ± 6.86
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · ANCOVA · p = < 0.0001 · Mean difference (final values): -7.109 · 95% CI -8.562 to -5.6561
PrimaryChange 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
Reported as:
Mean · percentage of successful penetrations
Change in Percentage From Baseline in Success of Penetration at 12 Weeks
percentage of successful penetrationsVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years35.8 ± 33.635.5 ± 42.82
≥65 years35.2 ± 38.068.7 ± 28.41
Total35.5 ± 35.937.2 ± 35.79
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · ANCOVA · p = < 0.0001 · Mean difference (final values): -29.027 · 95% CI -35.519 to -22.534
PrimaryChange 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
Reported as:
Mean · percentage of success in maintenance
Change From Baseline in Success of Erection Maintenance at 12 Weeks
percentage of success in maintenanceVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years54.5 ± 32.7215.2 ± 31.30
≥65 years49.2 ± 37.287.7 ± 25.72
Total51.7 ± 35.1811.3 ± 28.67
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · ANCOVA · p = < 0.0001 · Mean difference (final values): -38.193 · 95% CI -45.021 to -31.366
SecondaryPercentage 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
Reported as:
Number · percentage of participants
Percentage of Subjects Achieving "Back to Normal" Erectile Function
percentage of participantsVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years4613
≥65 years3411
Total4012
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001 · Cochran-mantel-haenszel: 34.778Cochran-Mantel-Haenszel (CMH) adjusted for age group and pooled center.
SecondaryChange 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
Reported as:
Mean · percentage of successful erections
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
percentage of successful erectionsVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years18.8 ± 29.6-1.8 ± 37.86
≥65 years14.6 ± 33.211.2 ± 37.43
Total16.6 ± 31.54-0.2 ± 37.55
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · ANCOVA · p = < 0.0001 · Mean difference (final values): -16.503 · 95% CI -22.424 to -10.764
SecondaryChange 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
Reported as:
Mean · percentage of satisfactory erections
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
percentage of satisfactory erectionsVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years51.7 ± 36.1011.2 ± 27.69
≥65 years45.3 ± 43.097.5 ± 27.70
Total48.4 ± 39.959.2 ± 27.67
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · ANCOVA · p = < 0.0001 · Mean difference (final values): -38.167 · 95% CI -45.261 to -31.073
SecondaryChange 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
Reported as:
Mean · percentage of satisfactory attempts
Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
percentage of satisfactory attemptsVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years55.7 ± 36.8314.4 ± 30.26
≥65 years45.8 ± 38.435.6 ± 25.74
Total50.5 ± 37.909.8 ± 28.24
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · ANCOVA · p = < 0.0001 · Mean difference (final values): -36.555 · 95% CI -43.645 to -29.465
SecondaryChange 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
Reported as:
Mean · percentage of ejaculation successes
Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
percentage of ejaculation successesVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years34.5 ± 36.195.4 ± 36.86
≥65 years32.7 ± 35.2310.1 ± 29.96
Total33.5 ± 35.607.9 ± 33.38
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · ANCOVA · p = < 0.0001 · Mean difference (final values): -25.193 · 95% CI -31.562 to -18.824
SecondaryNumber of Sexual Attempts Till First Successful Attempt
Time frame:
up to 12 weeks of treatment
Reported as:
Mean · Sexual Attempts
Number of Sexual Attempts Till First Successful Attempt
Sexual AttemptsVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years1.0 ± 2.62.7 ± 4.4
≥65 years1.4 ± 3.14.4 ± 7.4
Total1.2 ± 2.93.6 ± 6.2
SecondaryChange 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
Reported as:
Mean · scores on a scale
Change From Baseline in Ease With Erection at 12 Weeks or LOCF
scores on a scaleVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years28.6 ± 28.024.2 ± 27.92
≥65 years25.0 ± 31.200.8 ± 28.98
Total26.7 ± 29.732.4 ± 28.46
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · ANCOVA · p = < 0.0001 · Mean difference (final values): -24.703 · 95% CI -30.067 to -19.340
SecondaryChange 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
Reported as:
Mean · scores on a scale
Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
scores on a scaleVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years1.3 ± 1.280.1 ± 1.35
≥65 years1.2 ± 1.18-0.1 ± 1.28
Total1.3 ± 1.230.0 ± 1.31
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · ANCOVA · p = < 0.0001 · Mean difference (final values): -24.496 · 95% CI -34.865 to -24.128
SecondaryChange 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
Reported as:
Mean · scores on a scale
Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
scores on a scaleVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years28.6 ± 29.343.2 ± 29.06
≥65 years25.3 ± 30.24-3.6 ± 29.48
Total26.8 ± 29.78-0.4 ± 29.40
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · ANCOVA · p = < 0.0001 · Mean difference (final values): -27.775 · 95% CI -33.155 to -22.394
SecondaryChange 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
Reported as:
Mean · scores on a scale
Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
scores on a scaleVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years31.0 ± 29.467.1 ± 32.66
≥65 years26.8 ± 32.295.5 ± 31.80
Total28.8 ± 30.986.3 ± 32.11
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · ANCOVA · p = < 0.0001 · Mean difference (final values): -23.326 · 95% CI -29.062 to -17.598
SecondaryChange 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
Reported as:
Mean · scores on a scale
Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
scores on a scaleVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years28.7 ± 27.565.0 ± 27.53
≥65 years25.8 ± 30.183.6 ± 26.57
Total27.7 ± 28.944.2 ± 26.94
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · ANCOVA · p = < 0.0001 · Mean difference (final values): -23.384 · 95% CI -28.594 to -18.175
SecondarySatisfaction 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
Reported as:
Mean · scores on a scale
Satisfaction With Medication at Week 12 or LOCF
scores on a scaleVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years57.2 ± 28.0922.1 ± 25.58
≥65 years52.3 ± 29.5420.4 ± 24.55
Total54.6 ± 28.9021.2 ± 24.96
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · ANCOVA · p = < 0.0001 · Mean difference (final values): -33.076 · 95% CI -38.745 to -27.407
SecondaryPatient 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
Reported as:
Number · percentage of participants
Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
percentage of participantsVardenafil ODT (STAXYN, BAY38-9456)Placebo
<65 years7630
≥65 years6922
Total7226
Statistical analysis
  • Vardenafil ODT (STAXYN, BAY38-9456) vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001 · Cochran-mantel-haenszel: 74.449Cochran-Mantel-Haenszel (CMH) adjusted for pooled centers and age group.
SecondaryPharmacokinetics 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
Reported as:
Geometric mean · μg*h/L
Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma
μg*h/LED Patients Aged < 65 YearsED Patients Aged ≥ 65 Years
Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma47.16 (18.97 to 112.8)55.37 (21.23 to 104.4)
Statistical analysis
  • ED Patients Aged < 65 Years vs ED Patients Aged ≥ 65 Years · Point estimate of ratio: 117.42 · 90% CI 79.59 to 173.23
  • ED Patients Aged < 65 Years vs ED Patients Aged ≥ 65 Years · Regression, Linear · p = 0.7064
SecondaryPharmacokinetics 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
Reported as:
Geometric mean · μg/L
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma
μg/LED Patients Aged < 65 YearsED Patients Aged ≥ 65 Years
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma10.09 (3.134 to 19.04)13.43 (2.913 to 27.91)
Statistical analysis
  • ED Patients Aged < 65 Years vs ED Patients Aged ≥ 65 Years · Point estimate of ratio: 133.07 · 90% CI 87.46 to 202.46
  • ED Patients Aged < 65 Years vs ED Patients Aged ≥ 65 Years · Regression, Linear · p = 0.8749
SecondaryPharmacokinetics 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
Reported as:
Geometric mean · µg*h/L
Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma
µg*h/LED Patients Aged < 65 YearsED Patients Aged ≥ 65 Years
Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma33.36 (10.94 to 68.46)41.80 (16.56 to 148.5)
Statistical analysis
  • ED Patients Aged < 65 Years vs ED Patients Aged ≥ 65 Years · Point estimate of ratio: 125.28 · 90% CI 73.65 to 213.11
  • ED Patients Aged < 65 Years vs ED Patients Aged ≥ 65 Years · Regression, Linear · p = 0.7375
SecondaryPharmacokinetics 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
Reported as:
Geometric mean · µg/L
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma
µg/LED Patients Aged < 65 YearsED Patients Aged ≥ 65 Years
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma9.260 (3.756 to 23.32)11.47 (5.563 to 41.17)
Statistical analysis
  • ED Patients Aged < 65 Years vs ED Patients Aged ≥ 65 Years · Point estimate of ratio: 123.84 · 90% CI 80.12 to 191.42
  • ED Patients Aged < 65 Years vs ED Patients Aged ≥ 65 Years · Regression, Linear · p = 0.3940

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vardenafil ODT (STAXYN, BAY 38-9456)—4/184 (2.2%)70/184 (38%)
Placebo—1/174 (0.6%)36/174 (20.7%)
Most frequent serious events
Most frequent serious events
EventVardenafil ODT (STAXYN, BAY 38-9456)Placebo
Deafness neurosensoryEar and labyrinth disorders0/1841/174
Acute coronary syndromeCardiac disorders1/1840/174
Gastrointestinal haemorrhageGastrointestinal disorders1/1840/174
SyncopeNervous system disorders1/1840/174
PneumothoraxRespiratory, thoracic and mediastinal disorders1/1840/174
Femoral arterial stenosisVascular disorders1/1840/174
Most frequent other events
Showing 10 of 78
Most frequent other events
EventVardenafil ODT (STAXYN, BAY 38-9456)Placebo
HeadacheNervous system disorders30/1842/174
FlushingVascular disorders14/1840/174
DyspepsiaGastrointestinal disorders7/1840/174
DysgeusiaNervous system disorders4/1844/174
Bundle branch block rightCardiac disorders0/1843/174
Pharmaceutical product complaintSocial circumstances0/1843/174
Supraventricular extrasystolesCardiac disorders3/1842/174
DiarrhoeaGastrointestinal disorders3/1842/174
Back painMusculoskeletal and connective tissue disorders3/1840/174
DizzinessNervous system disorders3/1840/174

Baseline characteristics

Age, Customized
Age, Customized(Participants)Vardenafil ODT (STAXYN, BAY38-9456)PlaceboTotal
<65 years8781168
>=65 years9793190
Sex: Female, Male
Sex: Female, Male(Participants)Vardenafil ODT (STAXYN, BAY38-9456)PlaceboTotal
Female000
Male184174358
Body Mass Index (BMI)
Body Mass Index (BMI)(Kilograms per square meter (kg/m^2))Vardenafil ODT (STAXYN, BAY38-9456)PlaceboTotal
All age groups27.2 ± 3.427.5 ± 4.027.3 ± 3.7
< 65 years27.5 ± 3.527.9 ± 4.327.7 ± 3.9
>= 65 years26.9 ± 3.227.1 ± 3.627.0 ± 3.4
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Study locations

47 sites
  • Antwerpen, 2020, Belgium
  • Bruxelles - Brussel, 1000, Belgium
  • Bruxelles - Brussel, 1070, Belgium
  • Bruxelles - Brussel, 1200, Belgium
  • Genk, 3600, Belgium
  • Gent, 9000, Belgium
  • Liege, 4000, Belgium
  • Lille, 59000, France
  • Lyon Cedex, 69437, France
  • Lyon, 69000, France
  • Marseille, 13006, France
  • Marseille, 13009, France
  • Mont-de-marsan, 40000, France
  • Paris, 75008, France
  • München, Bayern 81925, Germany
  • Weiden, Bayern 92637, Germany
  • Osnabrück, Niedersachsen 49076, Germany
  • Mönchengladbach, Nordrhein-Westfalen 41063, Germany
  • Mülheim, Nordrhein-Westfalen 45468, Germany
  • Bautzen, Sachsen 02625, Germany
  • Leipzig, Sachsen 04109, Germany
  • Meißen, Sachsen 01662, Germany
  • Hamburg, 20246, Germany
  • Hamburg, 20354, Germany
  • Arnhem, 6836 BH, Netherlands
  • Deurne, 5751 XJ, Netherlands
  • Leiden, 2316 ZL, Netherlands
  • Losser, 7581 BV, Netherlands
  • Maastricht, 6212 XN, Netherlands
  • Nijverdal, 7442 LS, Netherlands
  • Centurion, Gauteng 0140, South Africa
  • Johannesburg, Gauteng 1818, South Africa
  • Johannesburg, Gauteng 2198, South Africa
  • Krugersdorp, Gauteng 1739, South Africa
  • Pretoria, Gauteng 0001, South Africa
  • Pretoria, Gauteng 0083, South Africa
  • Durban, KwaZulu Natal 4037, South Africa
  • Durban, KwaZulu Natal 4091, South Africa
  • Durban, Kwazulu-Natal 4001, South Africa
  • Cape Town, Western Cape 7463, South Africa
  • Cape Town, Western Cape 7530, South Africa
  • Alicante, 03010, Spain
  • Barcelona, 08003, Spain
  • Barcelona, 08034, Spain
  • La Laguna, 38320, Spain
  • Valencia, 46010, Spain
  • Vigo, 36211, Spain
09

References and documents

Publications

  • Debruyne FM, Gittelman M, Sperling H, Borner M, Beneke M. Time to onset of action of vardenafil: a retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. J Sex Med. 2011 Oct;8(10):2912-23. doi: 10.1111/j.1743-6109.2011.02462.x. Epub 2011 Aug 30. PubMed 21883954 ↗
  • Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, Ewald S. The POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. J Sex Med. 2010 Apr;7(4 Pt 1):1497-507. doi: 10.1111/j.1743-6109.2010.01806.x. Epub 2010 Mar 3. PubMed 20233275 ↗
  • Heinig R, Weimann B, Dietrich H, Bottcher MF. Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Clin Drug Investig. 2011;31(1):27-41. doi: 10.2165/11584950-000000000-00000. PubMed 20925442 ↗
  • Sperling H, Gittelman M, Norenberg C, Ulbrich E, Ewald S. Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials. J Sex Med. 2011 Jan;8(1):261-71. doi: 10.1111/j.1743-6109.2010.02005.x. Epub 2010 Aug 30. PubMed 20807322 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00631969
Lead sponsor
Bayer
Collaborators
GlaxoSmithKline, Schering-Plough
Responsible party
Sponsor
First posted
Mar 10, 2008
Start date
Apr 2008
Primary completion
Jan 2009
Completion
Jan 2009
Results posted
Jan 21, 2011
Last update
Dec 30, 2014

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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