Subject unwilling to cease use of any treatment for erectile dysfunction during the study, including oral medication, vacuum devices, constrictive devices, injections, urethral suppositories, gels, any over-the-counter or nonprescription medications, and products purchased via the internet
Subject receiving dopamine agonists, nitrates, alpha-receptor blocking agents, or antihypertensive medication (see other exclusionary medications listed below)
Subject with a history of syncope within the last 6 months prior to screening
Subject with symptomatic postural hypotension (severe dizziness or fainting
Subject with hypotension and a resting systolic blood pressure of < 90 mmHG or hypertension with a resting systolic blood pressure > 170 mmHG or a resting diastolic blood pressure > 110 mmHG
Subject with any underlying cardiovascular condition, including unstable angina pectoris, which preclude sexual activity
Subject with a history of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to screening
Subject with uncontrolled atrial fibrillation/flutter at screening (defined as ventricular response rate = 100 bpm)
Subject with a bleeding disorder
Subject with a history of prostatectomy because of prostate cancer, including nerve sparing techniques. Subjects with a history of surgical procedures for the treatment of benign prostate hypertrophy are permitted, with the exception of cryosurgery, cryotherapy or cryoablation
Subject with hereditary degenerative retinal disorders such as retinitis pigmentosa
Subject with a history of loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), history of temporary or permanent loss of vision, including unilateral loss of vision
Subject with a history of congenital QT prolongation
Subject with a penile anatomical abnormality (e.g., penile fibrosis, fractures, or Peyronie's disease) which, in the investigator's opinion, could significantly impair sexual performance. This will be based on subject's reported medical history (penile exam not required)
Subject with primary hypoactive sexual desire.
Subject with a spinal cord injury
Subject with a severe chronic or acute liver disease, history of moderate (Child-Pugh B), or severe (Child-Pugh C) hepatic impairment
Subject with clinically significant chronic hematological disease which could lead to priapism such as sickle cell anemia, multiple myeloma, and leukemia
Subject with active peptic ulceration
Subject with a history of malignancy within the past 5 years (other than squamous or basal cell skin cancer)
Subject with a history of a positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C
Subject with a known hypersensitivity to any component of the investigational medications, monoamine oxidase inhibitors, phosphodiesterase type 5 inhibitors or phenylethylamines
Subjects with a history of drug or alcohol abuse within the past 6 months
Subjects currently consuming =5 units of alcohol per day
Subject who is illiterate or unable to understand the Informed Consent Form, questionnaires or subject diary
Subject who, in the opinion of the investigator, will be noncompliant with the visit schedule or study procedures
Subject with any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the investigator is likely to affect the subject's ability to complete the study or preclude the subject's participation in the study
Diagnosis of any other neurologic disease
Uncontrolled Diabetes (Hemoglobin A1C > 7.5)

NCT02225548_exc_T1
Procedure
treatment
NCT02225548_exc_T2
Condition
erectile dysfunction
NCT02225548_exc_T3
Temporal
during the study
NCT02225548_exc_T4
Procedure
oral medication
NCT02225548_exc_T5
Device
vacuum devices
NCT02225548_exc_T6
Device
constrictive devices
NCT02225548_exc_T7
Procedure
injections
NCT02225548_exc_T8
Device
urethral suppositories
NCT02225548_exc_T9
Procedure
gels
NCT02225548_exc_T10
Qualifier
over-the-counter
NCT02225548_exc_T11
Qualifier
nonprescription
NCT02225548_exc_T12
Procedure
medications
NCT02225548_exc_T13
Scope
over-the-counter or nonprescription
NCT02225548_exc_T14
Scope
oral medication, vacuum devices, constrictive devices, injections, urethral suppositories, gels, any over-the-counter or nonprescription medications,
NCT02225548_exc_T15
Drug
dopamine agonists
NCT02225548_exc_T16
Drug
nitrates
NCT02225548_exc_T17
Drug
alpha-receptor blocking agents
NCT02225548_exc_T18
Drug
antihypertensive medication
NCT02225548_exc_T19
Condition
syncope
NCT02225548_exc_T20
Temporal
within the last 6 months prior to screening
NCT02225548_exc_T21
Reference_point
screening
NCT02225548_exc_T22
Condition
postural hypotension
NCT02225548_exc_T23
Qualifier
symptomatic
NCT02225548_exc_T24
Condition
dizziness
NCT02225548_exc_T25
Condition
fainting
NCT02225548_exc_T26
Qualifier
severe
NCT02225548_exc_T27
Scope
dizziness or fainting
NCT02225548_exc_T28
Condition
hypotension
NCT02225548_exc_T29
Measurement
systolic blood pressure
NCT02225548_exc_T30
Value
< 90 mmHG
NCT02225548_exc_T31
Condition
hypertension
NCT02225548_exc_T32
Measurement
systolic blood pressure
NCT02225548_exc_T33
Value
> 170 mmHG
NCT02225548_exc_T34
Measurement
diastolic blood pressure
NCT02225548_exc_T35
Value
> 110 mmHG
NCT02225548_exc_T36
Scope
systolic blood pressure > 170 mmHG or a resting diastolic blood pressure > 110 mmHG
NCT02225548_exc_T37
Condition
cardiovascular condition
NCT02225548_exc_T38
Condition
unstable angina pectoris
NCT02225548_exc_T39
Observation
sexual activity
NCT02225548_exc_T40
Negation
preclude
NCT02225548_exc_T41
Condition
myocardial infarction
NCT02225548_exc_T42
Condition
stroke
NCT02225548_exc_T43
Condition
arrhythmia
NCT02225548_exc_T44
Qualifier
life-threatening
NCT02225548_exc_T45
Temporal
within 6 months prior to screening
NCT02225548_exc_T46
Reference_point
screening
NCT02225548_exc_T47
Scope
myocardial infarction, stroke or life-threatening arrhythmia
NCT02225548_exc_T48
Condition
atrial fibrillation
NCT02225548_exc_T49
Condition
fibril  at sc
NCT02225548_exc_T50
Qualifier
uncontrolled
NCT02225548_exc_T51
Temporal
at screening
NCT02225548_exc_T52
Scope
atrial fibrillation/flutter
NCT02225548_exc_T53
Condition
bleeding disorder
NCT02225548_exc_T54
Procedure
prostatectomy
NCT02225548_exc_T55
Condition
prostate cancer
NCT02225548_exc_T56
Procedure
nerve sparing techniques
NCT02225548_exc_T57
Procedure
surgical procedures
NCT02225548_exc_T58
Condition
benign prostate hypertrophy
NCT02225548_exc_T59
Negation
permitted
NCT02225548_exc_T60
Procedure
cryosurgery
NCT02225548_exc_T61
Procedure
cryotherapy
NCT02225548_exc_T62
Procedure
cryoablation
NCT02225548_exc_T63
Scope
cryosurgery, cryotherapy or cryoablation
NCT02225548_exc_T64
Condition
hereditary degenerative retinal disorders
NCT02225548_exc_T65
Condition
retinitis pigmentosa
NCT02225548_exc_T66
Condition
non-arteritic anterior ischemic optic neuropathy
NCT02225548_exc_T67
Condition
NAION
NCT02225548_exc_T68
Condition
loss of vision
NCT02225548_exc_T69
Condition
loss of vision
NCT02225548_exc_T70
Qualifier
temporary
NCT02225548_exc_T71
Qualifier
permanent
NCT02225548_exc_T72
Scope
temporary or permanent
NCT02225548_exc_T73
Qualifier
unilateral
NCT02225548_exc_T74
Condition
loss of vision
NCT02225548_exc_T75
Condition
congenital QT prolongation
NCT02225548_exc_T76
Condition
penile anatomical abnormality
NCT02225548_exc_T77
Condition
penile fibrosis
NCT02225548_exc_T78
Condition
is, fr  Peyroni
NCT02225548_exc_T79
Condition
Peyronie's disease)
NCT02225548_exc_T81
Scope
penile fibrosis, fractures, or Peyronie's disease
NCT02225548_exc_T82
Observation
primary hypoactive sexual desire
NCT02225548_exc_T83
Condition
spinal cord injury
NCT02225548_exc_T84
Condition
ase, istory of mod
NCT02225548_exc_T85
Qualifier
severe
NCT02225548_exc_T86
Condition
 live istory of mod
NCT02225548_exc_T87
Condition
hepatic impairment
NCT02225548_exc_T88
Measurement
Child-Pugh
NCT02225548_exc_T89
Measurement
Child-Pugh
NCT02225548_exc_T90
Value
B
NCT02225548_exc_T91
Value
C
NCT02225548_exc_T92
Qualifier
moderate
NCT02225548_exc_T93
Qualifier
severe
NCT02225548_exc_T94
Scope
chronic or acute liver disease
NCT02225548_exc_T95
Condition
hepatic impairment
NCT02225548_exc_T96
Condition
hematological disease
NCT02225548_exc_T80
Scope
cardiovascular condition, including unstable angina pectoris
NCT02225548_exc_T97
Measurement
ventricular response rate
NCT02225548_exc_T98
Value
= 100 bpm
NCT02225548_exc_T99
Observation
history of
NCT02225548_exc_T100
Negation
with the exception of
NCT02225548_exc_T101
Observation
history of
NCT02225548_exc_T102
Observation
history of
NCT02225548_exc_T104
Qualifier
could significantly impair sexual performance
NCT02225548_exc_T106
Qualifier
chronic
NCT02225548_exc_T107
Qualifier
could lead to priapism
NCT02225548_exc_T108
Condition
sickle cell anemia
NCT02225548_exc_T109
Condition
multiple myeloma
NCT02225548_exc_T110
Condition
leukemia
NCT02225548_exc_T111
Scope
sickle cell anemia, multiple myeloma, and leukemia
NCT02225548_exc_T105
Procedure
penile exam
NCT02225548_exc_T112
Qualifier
clinically significant
NCT02225548_exc_T113
Condition
impair sexual performance
NCT02225548_exc_T114
Condition
priapism
NCT02225548_exc_T115
Qualifier
active
NCT02225548_exc_T116
Condition
peptic ulceration
NCT02225548_exc_T117
Observation
history of
NCT02225548_exc_T118
Condition
malignancy
NCT02225548_exc_T119
Temporal
within the past 5 years
NCT02225548_exc_T120
Negation
other than
NCT02225548_exc_T121
Condition
ell skin t with a hi
NCT02225548_exc_T122
Condition
basal cell skin cancer
NCT02225548_exc_T123
Scope
squamous or basal cell skin cancer
NCT02225548_exc_T124
Observation
history of
NCT02225548_exc_T125
Value
positive
NCT02225548_exc_T126
Measurement
test for Hepatitis B surface antigen (HbsAg)
NCT02225548_exc_T127
Measurement
 surfac with a know
NCT02225548_exc_T128
Scope
test for Hepatitis B surface antigen (HbsAg) or Hepatitis C
NCT02225548_exc_T129
Condition
hypersensitivity
NCT02225548_exc_T130
Qualifier
investigational
NCT02225548_exc_T131
Drug
medications
NCT02225548_exc_T132
Drug
monoamine oxidase inhibitors
NCT02225548_exc_T133
Drug
phosphodiesterase type 5 inhibitors
NCT02225548_exc_T134
Drug
phenylethylamines
NCT02225548_exc_T135
Scope
investigational medications, monoamine oxidase inhibitors, phosphodiesterase type 5 inhibitors or phenylethylamines
NCT02225548_exc_T136
Observation
history of
NCT02225548_exc_T137
Condition
with 6 mon
NCT02225548_exc_T138
Condition
alcohol abuse
NCT02225548_exc_T139
Temporal
within the past 6 months
NCT02225548_exc_T140
Reference_point
the past 6 months
NCT02225548_exc_T141
Scope
drug or alcohol abuse
NCT02225548_exc_T142
Temporal
currently
NCT02225548_exc_T143
Observation
lcohol pe  who is illite
NCT02225548_exc_T144
Value
=5 units
NCT02225548_exc_T145
Observation
illiterate
NCT02225548_exc_T146
Negation
unable to
NCT02225548_exc_T150
Scope
understand the Informed Consent Form, questionnaires or subject diary
NCT02225548_exc_T153
Qualifier
unstable
NCT02225548_exc_T154
Condition
ubstanc on of th
NCT02225548_exc_T155
Condition
abuse disor on of th
NCT02225548_exc_T156
Condition
substance abuse disorder
NCT02225548_exc_T157
Scope
medical, psychiatric, or substance abuse disorder
NCT02225548_exc_T159
Qualifier
likely to affect the subject's ability to complete the study
NCT02225548_exc_T160
Qualifier
preclude the subject's participation in the study
NCT02225548_exc_T161
Scope
likely to affect the subject's ability to complete the study or preclude the subject's participation in the study
NCT02225548_exc_T162
Condition
neurologic disease
NCT02225548_exc_T163
Qualifier
any other
NCT02225548_exc_T164
Qualifier
Uncontrolled
NCT02225548_exc_T165
Condition
Diabetes
NCT02225548_exc_T166
Measurement
Hemoglobin A1C
NCT02225548_exc_T167
Value
> 7.5
NCT02225548_exc_T168
Scope
Hemoglobin A1C > 7.5
NCT02225548_exc_T169
Scope
Uncontrolled Diabetes
NCT02225548_exc_T170
Negation
unwilling
NCT02225548_exc_T171
Mood
cease use of