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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-002140-41 | EudraCT Number | ||
| ED-METABOLIC | Other Identifier | Company Internal |
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This is a controlled, randomized, multi-center prospective study of vardenafil to determine efficacy on Erectile Dysfunction (ED), tolerability and safety in men with ED and Metabolic Syndrome. This study will explore the rate of patients who do need to switch to the highest dosage based upon the expectation that most men can stay on vardenafil 10 mg PRN (pro re nata)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vardenafil (Levitra, BAY38-9456) | Experimental | Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks |
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| Placebo | Placebo Comparator | Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vardenafil (Levitra, BAY38-9456) | Drug | Vardenafil 10 mg tablets daily for 4 weeks, vardenafil 5 mg / 10 mg / 20 mg tablets for consecutive 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Subscore at Week 8 or Last Observation Carried Forward (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. | baseline and up to 8 weeks or LOCF |
| Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8 | 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. | Baseline and 8 weeks |
| Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8 | 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. | Baseline and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (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') | up to 8 weeks or LOCF |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cham | Bavaria | 93413 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21771281 | Result | Schneider T, Gleissner J, Merfort F, Hermanns M, Beneke M, Ulbrich E. Efficacy and safety of vardenafil for the treatment of erectile dysfunction in men with metabolic syndrome: results of a randomized, placebo-controlled trial. J Sex Med. 2011 Oct;8(10):2904-11. doi: 10.1111/j.1743-6109.2011.02383.x. Epub 2011 Jul 19. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vardenafil (Levitra, BAY38-9456) | Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks |
| FG001 | Placebo | Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Matching placebo tablets daily for 4 weeks, placebo tablets daily for consecutive 4 weeks |
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| Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8 | 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. | Baseline and 8 weeks |
| Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8 | 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. | Baseline and 8 weeks |
| Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata)) | Number of participants with no recorded titration of Vardenafil after visit 3. | week 4 and week 8 |
| Regensburg |
| Bavaria |
| 93055 |
| Germany |
| Hamburg | Free and Hanseatic City of Hamburg | 20354 | Germany |
| Frankfurt am Main | Hesse | 60385 | Germany |
| Marburg | Hesse | 35039 | Germany |
| Stuhr | Lower Saxony | 28816 | Germany |
| Bonn | North Rhine-Westphalia | 53119 | Germany |
| Grevenbroich | North Rhine-Westphalia | 41515 | Germany |
| Leverkusen | North Rhine-Westphalia | 51373 | Germany |
| Mülheim | North Rhine-Westphalia | 45468 | Germany |
| Wuppertal | North Rhine-Westphalia | 42103 | Germany |
| Dierdorf | Rhineland-Palatinate | 56269 | Germany |
| Koblenz | Rhineland-Palatinate | 56068 | Germany |
| Trier | Rhineland-Palatinate | 54290 | Germany |
| Homburg | Saarland | 66424 | Germany |
| Dresden | Saxony | 01307 | Germany |
| Leipzig | Saxony | 04109 | Germany |
| Berlin | State of Berlin | 12107 | Germany |
| Berlin | State of Berlin | 14197 | Germany |
| Received Treatment, Safety Population |
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| ITT (Intent To Treatment) Population |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Vardenafil (Levitra, BAY38-9456) | Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks |
| BG001 | Placebo | Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Number of participants analyzed for baseline (visit 2) was safety population. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Number of participants analyzed for baseline (visit 2) was safety population. | Count of Participants | Participants |
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| BMI (body mass index) | Number of participants analyzed for baseline (visit 2) was safety population. | Mean | Standard Deviation | kg/m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | 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. | Number of participants analyzed differs due to missing data. | Posted | Least Squares Mean | 95% Confidence Interval | Scores on a scale | baseline and up to 8 weeks or LOCF |
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| Primary | Change in Percentage From Baseline in Success of Penetration (SEP2: Sexual Encounter Profile Question 2) at Week 8 | 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. | Number of participants analyzed differs due to missing data. | Posted | Least Squares Mean | 95% Confidence Interval | Percent successful penetrations | Baseline and 8 weeks |
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| Primary | Change in Percentage From Baseline in Success of Erection Maintenance (SEP3: Sexual Encounter Profile Question 3) at Week 8 | 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. | Number of participants analyzed differs due to missing data. | Posted | Least Squares Mean | 95% Confidence Interval | Percent erection maintenance | Baseline and 8 weeks |
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| Secondary | Percentage of Participants Achieving "Back to Normal" Erectile Function at Week 8 or Last Observation Carried Forward (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') | Number of participants analyzed differs due to missing data. | Posted | Number | Percentage of participants | up to 8 weeks or LOCF |
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| Secondary | Change in Percentage From Baseline in Ability to Obtain an Erection (SEP1) at Week 8 | 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. | Number of participants analyzed differs due to missing data. | Posted | Least Squares Mean | 95% Confidence Interval | Percent successful erections | Baseline and 8 weeks |
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| Secondary | Change in Percentage From Baseline in Ability to Ejaculate (SEP6) at Week 8 | 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. | Number of participants analyzed differs due to missing data. | Posted | Least Squares Mean | 95% Confidence Interval | Percent successful ejaculations | Baseline and 8 weeks |
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| Secondary | Number of Participants Who Can Stay on the Initially Provided Dosage of Vardenafil (10 mg PRN (Pro re Nata)) | Number of participants with no recorded titration of Vardenafil after visit 3. | Posted | Number | Participants | week 4 and week 8 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vardenafil (Levitra, BAY38-9456) | Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks | 0 | 75 | 16 | 75 | ||
| EG001 | Placebo | Matching placebo tablets PRN (pro re nata) for 4 weeks, placebo tablets PRN for consecutive 4 weeks | 0 | 72 | 8 | 72 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Balanitis candida | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Premature ejaculation | Psychiatric disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Balanitis | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Arrhythmia | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069058 | Vardenafil Dihydrochloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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