Trial · NCT00631969
Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction
NCT00631969, Phase 3, Completed, Bayer; results first posted 2011-01-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction. Trials, record NCT00631969. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00631969
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction
- NCT number
- NCT00631969
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 362 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Erectile Dysfunction
- Interventions
- Vardenafil ODT (STAXYN, BAY38-9456), Placebo
- First posted
- 2008-03-10
- Last updated
- 2014-12-30
- Other registries' IDs
- eudract:2008-000536-40
- Results first posted
- 2011-01-21
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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'). |
| Primary | 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. |
| Primary | 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 | 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'). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | Number of Sexual Attempts Till First Successful Attempt | up to 12 weeks of treatment | |
| Secondary | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data. | scores on a scale | MEAN |
| PRIMARY | Change in Percentage From Baseline in Success of Penetration at 12 Weeks | from baseline up to 12 weeks of treatment | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data. | percentage of successful penetrations | MEAN |
| PRIMARY | Change From Baseline in Success of Erection Maintenance at 12 Weeks | from baseline up to 12 weeks of treatment | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data. | percentage of success in maintenance | MEAN |
| SECONDARY | Percentage of Subjects Achieving Back to Normal Erectile Function | up to 12 weeks of treatment | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data. | percentage of participants | NUMBER |
| SECONDARY | Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks | from baseline up to 12 weeks of treatment | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data. | percentage of successful erections | MEAN |
| SECONDARY | Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks | from baseline up to 12 weeks of treatment | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data. | percentage of satisfactory erections | MEAN |
| SECONDARY | Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks | from baseline up to 12 weeks of treatment | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data. | percentage of satisfactory attempts | MEAN |
| SECONDARY | Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks | from baseline up to 12 weeks of treatment | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data. | percentage of ejaculation successes | MEAN |
| SECONDARY | Number of Sexual Attempts Till First Successful Attempt | up to 12 weeks of treatment | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data. | Sexual Attempts | MEAN |
| SECONDARY | Change From Baseline in Ease With Erection at 12 Weeks or LOCF | from baseline up to 12 weeks | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data. | scores on a scale | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group104
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF | Vardenafil ODT (STAXYN, BAY38-9456) | <65 years | 9.6 | Standard Deviation 6.28 | scores on a scale |
| Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF | Placebo | <65 years | 2.1 | Standard Deviation 7.33 | scores on a scale |
| Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF | Vardenafil ODT (STAXYN, BAY38-9456) | ≥65 years | 7.7 | Standard Deviation 8.19 | scores on a scale |
| Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF | Placebo | ≥65 years | 0.9 | Standard Deviation 6.42 | scores on a scale |
| Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF | Vardenafil ODT (STAXYN, BAY38-9456) | Total | 8.6 | Standard Deviation 7.40 | scores on a scale |
| Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF | Placebo | Total | 1.4 | Standard Deviation 6.86 | scores on a scale |
| Change in Percentage From Baseline in Success of Penetration at 12 Weeks | Vardenafil ODT (STAXYN, BAY38-9456) | <65 years | 35.8 | Standard Deviation 33.63 | percentage of successful penetrations |
| Change in Percentage From Baseline in Success of Penetration at 12 Weeks | Placebo | <65 years | 5.5 | Standard Deviation 42.82 | percentage of successful penetrations |
| Change in Percentage From Baseline in Success of Penetration at 12 Weeks | Vardenafil ODT (STAXYN, BAY38-9456) | ≥65 years | 35.2 | Standard Deviation 38.06 | percentage of successful penetrations |
| Change in Percentage From Baseline in Success of Penetration at 12 Weeks | Placebo | ≥65 years | 8.7 | Standard Deviation 28.41 | percentage of successful penetrations |
1 to 10 of 104Source ClinicalTrials.gov
See all 104 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vardenafil ODT (STAXYN, BAY38-9456) | 186 | |
| Overall Study | STARTED | Placebo | 176 | |
| Overall Study | Received Treatment | Vardenafil ODT (STAXYN, BAY38-9456) | 184 | |
| Overall Study | Received Treatment | Placebo | 174 | |
| Overall Study | COMPLETED | Vardenafil ODT (STAXYN, BAY38-9456) | 171 | |
| Overall Study | COMPLETED | Placebo | 155 | |
| Overall Study | NOT COMPLETED | Vardenafil ODT (STAXYN, BAY38-9456) | 15 | |
| Overall Study | NOT COMPLETED | Placebo | 21 |
Source ClinicalTrials.gov
Adverse events168
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Angina pectoris | Cardiac disorders | Vardenafil ODT (STAXYN, BAY 38-9456) | 0 | 184 | |
| other | Angina pectoris | Cardiac disorders | Placebo | 1 | 174 | |
| other | Bundle branch block left | Cardiac disorders | Vardenafil ODT (STAXYN, BAY 38-9456) | 1 | 184 | |
| other | Bundle branch block left | Cardiac disorders | Placebo | 1 | 174 | |
| other | Bundle branch block right | Cardiac disorders | Vardenafil ODT (STAXYN, BAY 38-9456) | 0 | 184 | |
| other | Bundle branch block right | Cardiac disorders | Placebo | 3 | 174 | |
| other | Mitral valve incompetence | Cardiac disorders | Vardenafil ODT (STAXYN, BAY 38-9456) | 0 | 184 | |
| other | Mitral valve incompetence | Cardiac disorders | Placebo | 1 | 174 | |
| other | Palpitations | Cardiac disorders | Vardenafil ODT (STAXYN, BAY 38-9456) | 1 | 184 | |
| other | Palpitations | Cardiac disorders | Placebo | 1 | 174 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vardenafil ODT (STAXYN, BAY 38-9456) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Vardenafil ODT (STAXYN, BAY 38-9456) | 70 | 184 |
| Total, other adverse events | Placebo | 36 | 174 |
| Total, serious adverse events | Vardenafil ODT (STAXYN, BAY 38-9456) | 4 | 184 |
| Total, serious adverse events | Placebo | 1 | 174 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vardenafil ODT (STAXYN, BAY 38-9456) vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00631969
GET https://conductscience.org/api/trials/v1/NCT00631969/results?page=2