Trial Outcomes & Findings for Safety Study Looking at the Effects of Stendra on Vision (NCT NCT02033200)
NCT ID: NCT02033200
Last Updated: 2015-03-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
1 hour
Results posted on
2015-03-13
Participant Flow
Participant milestones
| Measure |
Active
Stendra 200 mg
|
Placebo
placebo
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study Looking at the Effects of Stendra on Vision
Baseline characteristics by cohort
| Measure |
Active
n=40 Participants
Stendra 200 mg
|
Placebo
n=40 Participants
placebo
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 7.67 • n=99 Participants
|
35.1 years
STANDARD_DEVIATION 7.67 • n=107 Participants
|
35.0 years
STANDARD_DEVIATION 7.62 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=99 Participants
|
40 participants
n=107 Participants
|
80 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 hourColor 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.
Outcome measures
| Measure |
Active
n=40 Participants
Stendra 200 mg
|
Placebo
n=40 Participants
placebo
|
|---|---|---|
|
Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing
Right eye
|
0.1 total error score
Standard Deviation 1.98
|
-0.4 total error score
Standard Deviation 2.37
|
|
Change From Baseline in Color Vision Discrimination 1 Hour Post Dosing
Left eye
|
-0.2 total error score
Standard Deviation 1.70
|
-0.5 total error score
Standard Deviation 1.99
|
PRIMARY outcome
Timeframe: 1 hourVisual 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.
Outcome measures
| Measure |
Active
n=40 Participants
Stendra 200 mg
|
Placebo
n=40 Participants
placebo
|
|---|---|---|
|
Change From Baseline in Visual Acuity 1 Hour Post Dosing
Right Eye
|
-0.014 LogMar
Standard Deviation 0.0641
|
-0.023 LogMar
Standard Deviation 0.0694
|
|
Change From Baseline in Visual Acuity 1 Hour Post Dosing
Left Eye
|
-0.042 LogMar
Standard Deviation 0.0809
|
-0.011 LogMar
Standard Deviation 0.0836
|
PRIMARY outcome
Timeframe: 1 hourPupil dilation was measured using the Neuroptics Model VIP 200 pupillometer under standard lighting conditions.
Outcome measures
| Measure |
Active
n=40 Participants
Stendra 200 mg
|
Placebo
n=40 Participants
placebo
|
|---|---|---|
|
Change From Baseline in Pupil Dilation 1 Hour Post Dosing
Right eye
|
-0.14 millimeter
Standard Deviation 0.280
|
0.02 millimeter
Standard Deviation 0.270
|
|
Change From Baseline in Pupil Dilation 1 Hour Post Dosing
Left eye
|
-0.19 millimeter
Standard Deviation 0.264
|
-0.10 millimeter
Standard Deviation 0.285
|
PRIMARY outcome
Timeframe: 1 hourIntraocular Pressure was measured using the Goldman applanation tonometry
Outcome measures
| Measure |
Active
n=40 Participants
Stendra 200 mg
|
Placebo
n=40 Participants
placebo
|
|---|---|---|
|
Change From Baseline in Intraocular Pressure 1 Hour Post Dosing
Right eye
|
0.03 mm Hg
Standard Deviation 1.761
|
0.29 mm Hg
Standard Deviation 1.609
|
|
Change From Baseline in Intraocular Pressure 1 Hour Post Dosing
Left eye
|
0.36 mm Hg
Standard Deviation 1.860
|
-0.26 mm Hg
Standard Deviation 1.335
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Active
n=40 Participants
Stendra 200 mg
|
Placebo
n=40 Participants
placebo
|
|---|---|---|
|
Change From Baseline in Visual Acuity 24 Hours Post Dosing
Right eye
|
-0.012 LogMar
Standard Deviation 0.0682
|
-0.035 LogMar
Standard Deviation 0.0920
|
|
Change From Baseline in Visual Acuity 24 Hours Post Dosing
Left eye
|
-0.027 LogMar
Standard Deviation 0.1042
|
-0.020 LogMar
Standard Deviation 0.0908
|
SECONDARY outcome
Timeframe: 24 hourOutcome measures
| Measure |
Active
n=40 Participants
Stendra 200 mg
|
Placebo
n=40 Participants
placebo
|
|---|---|---|
|
Change From Baseline in Pupil Dilation 24 Hour Post Dosing
Right eye
|
0.0 mm
Standard Deviation 0.238
|
-0.02 mm
Standard Deviation 0.249
|
|
Change From Baseline in Pupil Dilation 24 Hour Post Dosing
Left eye
|
-0.06 mm
Standard Deviation 0.223
|
-0.07 mm
Standard Deviation 0.289
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Active
n=40 Participants
Stendra 200 mg
|
Placebo
n=40 Participants
placebo
|
|---|---|---|
|
Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing
Right eye
|
-0.1 total error score
Standard Deviation 1.66
|
-0.4 total error score
Standard Deviation 2.49
|
|
Change From Baseline in Color Vision Discrimination 24 Hour Post Dosing
Left eye
|
-0.2 total error score
Standard Deviation 1.69
|
-0.1 total error score
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: 24 hoursIntraocular pressure was measuring using the Goldman applanation tonometry
Outcome measures
| Measure |
Active
n=40 Participants
Stendra 200 mg
|
Placebo
n=40 Participants
placebo
|
|---|---|---|
|
Change From Baseline in Intraocular Pressure 24 Hour Post Dosing
Right eye
|
-0.10 mm Hg
Standard Deviation 2.176
|
0.03 mm Hg
Standard Deviation 1.423
|
|
Change From Baseline in Intraocular Pressure 24 Hour Post Dosing
Left eye
|
0.03 mm Hg
Standard Deviation 1.694
|
-0.09 mm Hg
Standard Deviation 1.339
|
Adverse Events
Active
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active
n=40 participants at risk
Stendra 200 mg
|
Placebo
n=40 participants at risk
placebo
|
|---|---|---|
|
Gastrointestinal disorders
abdomonial pain
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
|
Gastrointestinal disorders
diarrhea
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
|
Gastrointestinal disorders
nausea
|
7.5%
3/40 • Number of events 3
|
0.00%
0/40
|
|
Gastrointestinal disorders
vomiting
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
|
General disorders
feeling hot
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
|
Investigations
alanine aminotransferase increased
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Investigations
aspartate aminotransferase increased
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Investigations
blood creatine phosphokinase increased
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
|
Investigations
blood lactate dehydrogenase increased
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Investigations
blood urine present
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Investigations
protein urine present
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Investigations
red blood cells urine
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Nervous system disorders
dysgeusia
|
0.00%
0/40
|
2.5%
1/40 • Number of events 1
|
|
Nervous system disorders
headache
|
25.0%
10/40 • Number of events 10
|
2.5%
1/40 • Number of events 1
|
|
Psychiatric disorders
libido increased
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
5.0%
2/40 • Number of events 2
|
0.00%
0/40
|
|
Vascular disorders
flushing
|
2.5%
1/40 • Number of events 1
|
0.00%
0/40
|
Additional Information
VP of Development
Vivus Inc
Phone: 650-934-5200
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60