Trial · NCT00738400
Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome
NCT00738400, Phase 4, Completed, Bayer; results first posted 2011-06-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome. Trials, record NCT00738400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00738400
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Vardenafil in Patients Suffering From Erectile Dysfunction and Metabolic Syndrome
- NCT number
- NCT00738400
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 150 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Erectile Dysfunction, Metabolic Syndrome
- Interventions
- Vardenafil (Levitra, BAY38-9456), Placebo
- First posted
- 2008-08-20
- Last updated
- 2015-11-16
- Other registries' IDs
- eudract:2008-002140-41
- Results first posted
- 2011-06-01
Source ClinicalTrials.gov
Registered outcomes7
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 - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF) | baseline and up to 8 weeks or LOCF | The primary variable was the least square (LS)-mean difference between treatment groups in the IIEF-EF domain score (6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no erectile dysfunction \[ED\]'). The target variable is the LS-mean difference between treatment groups at endpoint. The LS-means of both treatment groups are derived from a baseline-adjusted endpoint measure (week 8/last observation carried forward \[LOCF\]) as calculated via an ANCOVA. |
| Primary | Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8 | Baseline and 8 weeks | Percent successful penetrations were calculated per participant as the number of successful sexual attempts (penetrations) divided by the total number of attempts. The mean percent successful penetrations was then calculated across all participants. |
| Primary | Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8 | Baseline and 8 weeks | Percent successful maintenance of erection were calculated per participant as the number of successful attempts (maintenance of erection) divided by the total number of attempts. The mean percent successful maintenance of erection was then calculated across all participants. |
| Secondary | Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (LOCF) | up to 8 weeks or LOCF | Responders: percentage of participants achieving an IIEF-EF score \>25.(IIEF-EF domain score: 6-30 ordinal points, specifying the severity of erectile dysfunction: 6-10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; 26-30 'no ED') |
| Secondary | Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8 | Baseline and 8 weeks | Percent successful erections were calculated per participant as the number of successful attempts (achievement of erection) divided by the total number of attempts. The mean percent successful erections was then calculated across all participants. |
| Secondary | Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8 | Baseline and 8 weeks | Percent successful ejaculations were calculated per participant as the number of successful attempts (achievement of ejaculation) divided by the total number of attempts. The mean percent successful ejaculations was then calculated across all participants. |
| Secondary | Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata)) | week 4 and week 8 | Number of participants with no recorded titration of Vardenafil after visit 3. |
Source ClinicalTrials.gov
Outcomes7
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 - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF) | baseline and up to 8 weeks or LOCF | Number of participants analyzed differs due to missing data. | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8 | Baseline and 8 weeks | Number of participants analyzed differs due to missing data. | Percent successful penetrations | LEAST_SQUARES_MEAN |
| PRIMARY | Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8 | Baseline and 8 weeks | Number of participants analyzed differs due to missing data. | Percent erection maintenance | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Achieving Back to Normal Erectile Function at Week 8 or Last Observation Carried Forward (LOCF) | up to 8 weeks or LOCF | Number of participants analyzed differs due to missing data. | Percentage of participants | NUMBER |
| SECONDARY | Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8 | Baseline and 8 weeks | Number of participants analyzed differs due to missing data. | Percent successful erections | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8 | Baseline and 8 weeks | Number of participants analyzed differs due to missing data. | Percent successful ejaculations | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata)) | week 4 and week 8 | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group14
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 - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF) | Vardenafil (Levitra, BAY38-9456) | 20.96 | 95% Confidence Interval 19.38 to 22.54 | Scores on a scale | |
| Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (LOCF) | Placebo | 14.20 | 95% Confidence Interval 12.57 to 15.83 | Scores on a scale | |
| Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8 | Vardenafil (Levitra, BAY38-9456) | 73.50 | 95% Confidence Interval 66.71 to 80.30 | Percent successful penetrations | |
| Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8 | Placebo | 52.79 | 95% Confidence Interval 45.51 to 60.08 | Percent successful penetrations | |
| Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8 | Vardenafil (Levitra, BAY38-9456) | 53.15 | 95% Confidence Interval 45.42 to 60.89 | Percent erection maintenance | |
| Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8 | Placebo | 27.00 | 95% Confidence Interval 18.70 to 35.29 | Percent erection maintenance | |
| Percentage of Participants Achieving Back to Normal Erectile Function at Week 8 or Last Observation Carried Forward (LOCF) | Vardenafil (Levitra, BAY38-9456) | 35 | Percentage of participants | ||
| Percentage of Participants Achieving Back to Normal Erectile Function at Week 8 or Last Observation Carried Forward (LOCF) | Placebo | 10 | Percentage of participants | ||
| Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8 | Vardenafil (Levitra, BAY38-9456) | 91.36 | 95% Confidence Interval 85.74 to 96.97 | Percent successful erections | |
| Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8 | Placebo | 75.79 | 95% Confidence Interval 69.76 to 81.81 | Percent successful erections |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vardenafil (Levitra, BAY38-9456) | 76 | |
| Overall Study | STARTED | Placebo | 74 | |
| Overall Study | Received Treatment, Safety Population | Vardenafil (Levitra, BAY38-9456) | 75 | |
| Overall Study | Received Treatment, Safety Population | Placebo | 72 | |
| Overall Study | ITT (Intent To Treatment) Population | Vardenafil (Levitra, BAY38-9456) | 75 | |
| Overall Study | ITT (Intent To Treatment) Population | Placebo | 70 | |
| Overall Study | COMPLETED | Vardenafil (Levitra, BAY38-9456) | 72 | |
| Overall Study | COMPLETED | Placebo | 67 | |
| Overall Study | NOT COMPLETED | Vardenafil (Levitra, BAY38-9456) | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 7 |
Source ClinicalTrials.gov
Adverse events34
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 | Abscess | Infections and infestations | Vardenafil (Levitra, BAY38-9456) | 1 | 75 | 1 |
| other | Abscess | Infections and infestations | Placebo | 0 | 72 | 0 |
| other | Balanitis candida | Infections and infestations | Vardenafil (Levitra, BAY38-9456) | 0 | 75 | 0 |
| other | Balanitis candida | Infections and infestations | Placebo | 1 | 72 | 1 |
| other | Nasopharyngitis | Infections and infestations | Vardenafil (Levitra, BAY38-9456) | 3 | 75 | 3 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 1 | 72 | 1 |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Vardenafil (Levitra, BAY38-9456) | 0 | 75 | 0 |
| other | Diabetes mellitus | Metabolism and nutrition disorders | Placebo | 1 | 72 | 1 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Vardenafil (Levitra, BAY38-9456) | 2 | 75 | 2 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 0 | 72 | 0 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vardenafil (Levitra, BAY38-9456) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Vardenafil (Levitra, BAY38-9456) | 16 | 75 |
| Total, other adverse events | Placebo | 8 | 72 |
| Total, serious adverse events | Vardenafil (Levitra, BAY38-9456) | 0 | 75 |
| Total, serious adverse events | Placebo | 0 | 72 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21771281 | RESULT |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vardenafil (Levitra, BAY38-9456) vs Placebo: Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata)) | Trial comparisons |
| Vardenafil (Levitra, BAY38-9456) vs Placebo: serious adverse events | 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/NCT00738400
GET https://conductscience.org/api/trials/v1/NCT00738400/events?page=2