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The purpose of this study is to see if Stendra causes any changes in vision, eye pressure, pupil dilation, and color vision in healthy males.
The objectives of this study are to assess the effect of Stendra on visual acuity, intraocular pressure, pupillometry, and color vision discrimination in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Stendra 200 mg |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stendra 200 mg | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing | Color vision discrimination was performed using the Lanthony 40-Hue Test according to Farnsworth-Munsell 100-Hue Test. The total error score was derived by counting the number of caps misplaced. | 1 hour |
| Change From Baseline in Visual Acuity 1 Hour Post Dosing | Visual acuity was measured using the Logarithm of the Minimum Angle Resolution (LogMAR) chart. The LogMAR value of the best line read was noted and the number of letters read in the next row was multiplied by 0.02, then subtracted from the LogMAR value of the best line completely read. | 1 hour |
| Change From Baseline in Pupil Dilation 1 Hour Post Dosing | Pupil dilation was measured using the Neuroptics Model VIP 200 pupillometer under standard lighting conditions. | 1 hour |
| Change From Baseline in Intraocular Pressure 1 Hour Post Dosing | Intraocular Pressure was measured using the Goldman applanation tonometry | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Visual Acuity 24 Hours Post Dosing | 24 hours | |
| Change From Baseline in Pupil Dilation 24 Hour Post Dosing | 24 hour | |
| Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion Inc | Tempe | Arizona | 85283 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Stendra 200 mg |
| FG001 | Placebo | placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
healthy male adults between the ages of 18 and 45
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Stendra 200 mg |
| BG001 | Placebo | placebo |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Color Vision Discrimination 1 Hour Post Dosing | Color vision discrimination was performed using the Lanthony 40-Hue Test according to Farnsworth-Munsell 100-Hue Test. The total error score was derived by counting the number of caps misplaced. | Posted | Mean | Standard Deviation | total error score | 1 hour |
|
|
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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 | Active | Stendra 200 mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdomonial pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP of Development | Vivus Inc | 650-934-5200 |
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| ID | Term |
|---|---|
| C553414 | avanafil |
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| Drug |
|
| 24 hours |
| Change From Baseline in Intraocular Pressure 24 Hour Post Dosing | Intraocular pressure was measuring using the Goldman applanation tonometry | 24 hours |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Primary | Change From Baseline in Visual Acuity 1 Hour Post Dosing | Visual acuity was measured using the Logarithm of the Minimum Angle Resolution (LogMAR) chart. The LogMAR value of the best line read was noted and the number of letters read in the next row was multiplied by 0.02, then subtracted from the LogMAR value of the best line completely read. | Posted | Mean | Standard Deviation | LogMar | 1 hour |
|
|
|
|
| Primary | Change From Baseline in Pupil Dilation 1 Hour Post Dosing | Pupil dilation was measured using the Neuroptics Model VIP 200 pupillometer under standard lighting conditions. | Posted | Mean | Standard Deviation | millimeter | 1 hour |
|
|
|
|
| Primary | Change From Baseline in Intraocular Pressure 1 Hour Post Dosing | Intraocular Pressure was measured using the Goldman applanation tonometry | Posted | Mean | Standard Deviation | mm Hg | 1 hour |
|
|
|
|
| Secondary | Change From Baseline in Visual Acuity 24 Hours Post Dosing | Posted | Mean | Standard Deviation | LogMar | 24 hours |
|
|
|
|
| Secondary | Change From Baseline in Pupil Dilation 24 Hour Post Dosing | Posted | Mean | Standard Deviation | mm | 24 hour |
|
|
|
|
| Secondary | Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing | Posted | Mean | Standard Deviation | total error score | 24 hours |
|
|
|
|
| Secondary | Change From Baseline in Intraocular Pressure 24 Hour Post Dosing | Intraocular pressure was measuring using the Goldman applanation tonometry | Posted | Mean | Standard Deviation | mm Hg | 24 hours |
|
|
|
|
| 0 |
| 40 |
| 16 |
| 40 |
| EG001 | Placebo | placebo | 0 | 40 | 2 | 40 |
| diarrhea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| feeling hot | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| blood creatine phosphokinase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| blood lactate dehydrogenase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| blood urine present | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| protein urine present | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| red blood cells urine | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| neck pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| dysgeusia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| libido increased | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| flushing | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
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The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.
| ANCOVA |
| 0.1953 |
| LS Means difference |
| -0.022 |
| Standard Error of the Mean |
| 0.017 |
| 2-Sided |
| 95 |
| -0.056 |
| 0.012 |
| No |
| Superiority or Other |
The sample size provided enough power to detect any meaningful difference between the two treatment groups in the left eye.
| ANCOVA |
| 0.1583 |
| LS means difference |
| -0.087 |
| Standard Error of the Mean |
| 0.061 |
| 2-Sided |
| 95 |
| -0.209 |
| 0.035 |
| No |
| Superiority or Other |
The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in intraocular pressure between the two treatment groups in the left eye. |
| ANCOVA |
| 0.0343 |
| LS means difference |
| 0.751 |
| Standard Error of the Mean |
| 0.348 |
| 2-Sided |
| 95 |
| 0.057 |
| 1.44 |
| No |
| Superiority or Other |
The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.
| ANCOVA |
| 0.9334 |
| LS means difference |
| -0.002 |
| Standard Error of the Mean |
| 0.022 |
| 2-Sided |
| 95 |
| -0.045 |
| 0.042 |
| No |
| Superiority or Other |
The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.
| ANCOVA |
| 0.9107 |
| LS means difference |
| 0.007 |
| Standard Error of the Mean |
| 0.058 |
| 2-Sided |
| 95 |
| -0.109 |
| 0.122 |
| No |
| Superiority or Other |
The sample size had enough power to detect any meaningful difference between treatment groups in the left eye.
| ANCOVA |
| 0.6013 |
| LS means difference |
| -0.180 |
| Standard Error of the Mean |
| 0.344 |
| 2-Sided |
| 95 |
| -0.865 |
| 0.504 |
| No |
| Superiority or Other |
The sample size should provide approximately 90% power to detect a 1.6 mmHg difference in the mean change in IOP between the two treatment groups in the left eye. |
| ANCOVA |
| 0.4931 |
| LS means difference |
| 0.227 |
| Standard Error of the Mean |
| 0.330 |
| 2-Sided |
| 95 |
| -0.430 |
| 0.884 |
| No |
| Superiority or Other |