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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
| Schering-Plough | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Experimental | 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. |
|
| Placebo | Placebo Comparator | Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vardenafil ODT (STAXYN, BAY38-9456) | Drug | Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) | The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED'.) | from baseline up to 12 weeks |
| Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks | SEP (Sexual Encounter Profile) 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. | from baseline up to 12 weeks of treatment |
| 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. | from baseline up to 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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'). |
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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 |
|---|---|---|---|---|---|---|
| East Valley Family Physicians, PLC | Chandler | Arizona | 85224 | United States | ||
| Mesa Family Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21883954 | Result | 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. | |
| 20456213 | Result |
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473 subjects screened (<65 years: n=230; >=65 years: n=243), 339 randomized (Vardenafil 10 mg ODT=172, placebo=167). The main efficacy analysis set was the ITT (Intent to Treat) population (randomized treated sub. with baseline and post-baseline in any of the efficacy variables and safety assessment); Vardenafil 10 mg ODT=169, placebo=162
Subjects recruited to 35 investigational centers in the USA (20), Canada (4), Mexico (5), and Australia (6). First patient first visit on 28 Apr 2008, last patient last visit on 13 Feb 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet |
|
| up to 12 weeks of treatment |
| 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. | from baseline up to 12 weeks of treatment |
| 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. | from baseline up to 12 weeks of treatment |
| 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. | from baseline up to 12 weeks of treatment |
| 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. | from baseline up to 12 weeks of treatment |
| 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 | Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Ease with Erection" from baseline to Week 12 or LOCF expressed as the least square mean difference. | from baseline up to 12 weeks |
| 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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Erectile function satisfaction" from baseline to Week 12 or LOCF expressed as the least square mean difference | from baseline up to 12 weeks |
| 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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Pleasure of sexual activity" from baseline to Week 12 or LOCF expressed as the least square mean difference | from baseline up to 12 weeks |
| 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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Satisfaction with orgasm" from baseline to Week 12 or LOCF expressed as the least square mean difference | from baseline up to 12 weeks |
| 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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Confidence for completion" from baseline to Week 12 or LOCF expressed as the least square mean difference | from baseline up to 12 weeks |
| Satisfaction With Medication at Week 12 or LOCF | Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Satisfaction with medication" at LOCF expressed as the least square mean difference | up to 12 weeks |
| 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) | up to 12 weeks of treatment |
| Mesa |
| Arizona |
| 85203 |
| United States |
| Desert Clinical Research | Mesa | Arizona | 85213 | United States |
| Arizona Research Center, Inc. | Phoenix | Arizona | 85023 | United States |
| Tatum Highlands Medical Associates, PLLC | Phoenix | Arizona | 85050 | United States |
| Fiel Family & Sports Medicine, PC | Tempe | Arizona | 85283 | United States |
| Irvine Center for Clinical Research | Irvine | California | 92618-3603 | United States |
| Synergy Clinical Research Center | National City | California | 91950 | United States |
| San Diego Uro-Research | San Diego | California | 92103 | United States |
| San Diego Clinical Trials | San Diego | California | 92120 | United States |
| South Florida Medical Research | Aventura | Florida | 33180 | United States |
| Jacksonville Impotence Treatment Center | Jacksonville | Florida | 32223 | United States |
| University Clinical Research, Inc. | Pembroke Pines | Florida | 33024 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70112 | United States |
| Office of Dr. Bruce Gilbert, MD | Great Neck | New York | 11021 | United States |
| Mount Sinai Medical Center | New York | New York | 10029 | United States |
| The Urology Group | Cincinnati | Ohio | 45212-2787 | United States |
| Columbus Urology Research, LLC | Columbus | Ohio | 43220 | United States |
| Family Medical Associates | Levittown | Pennsylvania | 19056 | United States |
| Pearl Clinical Research | Norristown | Pennsylvania | 19401 | United States |
| Office of Dr. Roger Fincher, MD | Spokane | Washington | 99206 | United States |
| Sydney Men's Health | Bondi Junction | New South Wales | 2022 | Australia |
| Berry Road Medical Centre | St Leonards | New South Wales | 2065 | Australia |
| South Terrace Urology | Adelaide | South Australia | 5000 | Australia |
| Cabrini Medical Centre | Melbourne | Victoria | 3144 | Australia |
| Queen Elizabeth II Medical Centre | Nedlands | Western Australia | 6009 | Australia |
| Perth Human Sexuality Centre | Perth | Western Australia | 6009 | Australia |
| St.Joseph's Health Care-London | London | Ontario | N6A 4V2 | Canada |
| The Male Health Centres | Oakville | Ontario | L6H 3P1 | Canada |
| Office of Dr. Rajiv Singal, MD | Toronto | Ontario | M4C 5T2 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Clinique d'Urologie du Saguenay | Chicoutimi | Quebec | G7H 4A3 | Canada |
| Urology South Shore Research | Greenfield Park | Quebec | J4V 2H3 | Canada |
| Centre de Recherche en Sante Sexuelle du Quebec | Montreal | Quebec | H2X 1N8 | Canada |
| Sir Mortimer B. Davis Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Consultorio Dr. Rodríguez Rivera | Guadalajara | Jalisco | 45040 | Mexico |
| Hospital Dalinde | México, D. F. | Mexico City | 06700 | Mexico |
| Centro Médico de las Américas | Mérida | Yucatán | 97001 | Mexico |
| Asociación Mexicana para la Salud Sexual A. C. | México D. F. | 14000 | Mexico |
| Hospital Santa Fé | México, D. F. | 06700 | Mexico |
| Gittelman M, McMahon CG, Rodriguez-Rivera JA, Beneke M, Ulbrich E, Ewald S. The POTENT II randomised trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. Int J Clin Pract. 2010 Apr;64(5):594-603. doi: 10.1111/j.1742-1241.2010.02358.x. |
Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
| Participants Received Treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo | Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | Kilograms per square meter (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 (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF) | The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED'.) | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Mean | Standard Deviation | scores on a scale | from baseline up to 12 weeks |
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| Primary | Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks | SEP (Sexual Encounter Profile) 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. | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Mean | Standard Deviation | percentage of successful penetrations | from baseline up to 12 weeks of treatment |
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| 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. | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Mean | Standard Deviation | percentage of successful maintenance | from baseline up to 12 weeks of treatment |
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| 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'). | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Number | percentage of subjects | up to 12 weeks of treatment |
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| 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. | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Mean | Standard Deviation | percentage of successful erections | from baseline up to 12 weeks of treatment |
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| 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. | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Mean | Standard Deviation | percentage of satisfactory erections | from baseline up to 12 weeks of treatment |
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| 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. | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Mean | Standard Deviation | percentage of satisfactory attempts | from baseline up to 12 weeks of treatment |
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| 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. | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Mean | Standard Deviation | percentage of ejaculation successes | from baseline up to 12 weeks of treatment |
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| Secondary | Number of Sexual Attempts Till First Successful Attempt | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Mean | Standard Deviation | Sexual Attempts | up to 12 weeks of treatment |
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| 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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Ease with Erection" from baseline to Week 12 or LOCF expressed as the least square mean difference. | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Mean | Standard Deviation | scores on a scale | from baseline up to 12 weeks |
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| 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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Erectile function satisfaction" from baseline to Week 12 or LOCF expressed as the least square mean difference | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Mean | Standard Deviation | scores on a scale | from baseline up to 12 weeks |
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| 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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Pleasure of sexual activity" from baseline to Week 12 or LOCF expressed as the least square mean difference | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Mean | Standard Deviation | scores on a scale | from baseline up to 12 weeks |
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| 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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Satisfaction with orgasm" from baseline to Week 12 or LOCF expressed as the least square mean difference | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Mean | Standard Deviation | scores on a scale | from baseline up to 12 weeks |
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| 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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Confidence for completion" from baseline to Week 12 or LOCF expressed as the least square mean difference | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Mean | Standard Deviation | scores on a scale | from baseline up to 12 weeks |
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| Secondary | Satisfaction With Medication at Week 12 or LOCF | Treatment group difference in points on the Treatment Satisfaction Scale (TSS: 0-100 normalized, ordinal; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Satisfaction with medication" at LOCF expressed as the least square mean difference | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with LOCF values. | Posted | Mean | Standard Deviation | scores on a scale | up to 12 weeks |
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| 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) | The primary data set was the ITT (Intent-to treat) population defined as all randomized treated subjects with baseline and post-baseline efficacy data | Posted | Number | percentage of participants | up to 12 weeks of treatment |
|
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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 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. | 2 | 171 | 65 | 171 | ||
| EG001 | Placebo | Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day. | 1 | 166 | 37 | 166 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bundle branch block | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Bundle branch block right | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Ventricular extrasystoles | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Left ventricular hypertrophy | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Bacterial rhinitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Muscle injury | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Penis deviation | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Arthroscopy | Investigations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Testicular pain | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pharmaceutical product complaint | Social circumstances | MedDRA (11.1) | Non-systematic Assessment |
| |
| Skin lesion excision | Surgical and medical procedures | MedDRA (11.1) | Non-systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA (11.1) | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.1) | Non-systematic Assessment |
|
In the protocol it is specified that all results are the property of the sponsor. The investigator must discuss any publication with the sponsor prior to release and obtain written consent of the sponsor. The investigator must send a draft publication to the sponsor thirty days in advance of submission in order to obtain approval prior to submission of the final version for publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | BAYER | clinical-trials-contact@bayerhealthcare.com |
| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069058 | Vardenafil Dihydrochloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| Male |
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