1. Active thromboembolic disease, history of thromboembolic disease (including retinal vein or artery occlusion), known inherited thrombophilia, or family history of thrombosis in a first degree relative 
2. Subject has a severe medical or psychiatric illness that, in the opinion of the Investigator, would affect subject safety or compliance 
3. Clinical evidence of severe bleeding disorder. Patients with mild bleeding disorders such as type 1 von Willebrand disease, mild platelet function defects such as platelet storage pool or release defects, and patients with bleeding due to Ehlers Danlos syndrome WILL be eligible to participate in the study. 
4. Pregnancy within the past 6 months and/or breast-feeding 
5. Use of hormonal contraception (estrogen and progestin) within 3 months of study entry, or anticipated need to initiate estrogen-containing hormonal contraception during the study period 
6. Use of systemic steroids within 1 month of study entry 
7. History of subarachnoid hemorrhage 
8. History of Hepatitis B, C, or HIV 
9. Baseline creatinine >20% above the upper limit of normal for age 
10. Severe anemia (hemoglobin <8 g/dL) 
11. Systolic blood pressure <85 or diastolic blood pressure <55 
12. Heart rate <50 at time of screening 
13. Use of intranasal DDAVP during menses will be permitted, but only if the patient has a history of using DDAVP consistently for ≥3 menstrual cycles prior to study enrollment, so that change in menstrual blood loss due to addition of Lysteda can be assessed. Use of one-time DDAVP during a DDAVP/Stimate challenge is also permitted during the study period, as is use of DDAVP in the event of severe epistaxis, trauma, or surgical procedures during the study period.       
    

NCT01846507_exc_T1
Condition
thromboembolic disease
NCT01846507_exc_T2
Condition
thromboembolic disease
NCT01846507_exc_T3
Observation
history
NCT01846507_exc_T4
Temporal
Active
NCT01846507_exc_T5
Condition
retinal vein
NCT01846507_exc_T6
Condition
artery occlusion
NCT01846507_exc_T7
Scope
retinal vein or artery occlusion
NCT01846507_exc_T8
Condition
inherited thrombophilia
NCT01846507_exc_T9
Observation
family history
NCT01846507_exc_T10
Condition
thrombosis
NCT01846507_exc_T11
Observation
in a first degree relative
NCT01846507_exc_T12
Condition
psychiatric illness
NCT01846507_exc_T13
Condition
medical illness
NCT01846507_exc_T14
Qualifier
severe
NCT01846507_exc_T15
Scope
medical or psychiatric illness
NCT01846507_exc_T17
Qualifier
in the opinion of the Investigator, would affect subject safety or compliance
NCT01846507_exc_T19
Condition
bleeding disorder
NCT01846507_exc_T20
Condition
bleeding disorders
NCT01846507_exc_T21
Condition
type 1 von Willebrand disease
NCT01846507_exc_T22
Condition
mild platelet function defects
NCT01846507_exc_T23
Condition
platelet storage pool defects
NCT01846507_exc_T24
Condition
platelet release defects
NCT01846507_exc_T25
Scope
platelet storage pool or release defects
NCT01846507_exc_T26
Condition
Ehlers Danlos syndrome
NCT01846507_exc_T28
Condition
bleeding
NCT01846507_exc_T29
Qualifier
severe
NCT01846507_exc_T31
Qualifier
mild
NCT01846507_exc_T33
Scope
type 1 von Willebrand disease, mild platelet function defects such as platelet storage pool or release defects
NCT01846507_exc_T34
Scope
mild bleeding disorders
NCT01846507_exc_T35
Condition
Pregnancy
NCT01846507_exc_T36
Temporal
within the past 6 months
NCT01846507_exc_T37
Condition
breast-feeding
NCT01846507_exc_T38
Procedure
hormonal contraception
NCT01846507_exc_T39
Drug
estrogen
NCT01846507_exc_T40
Drug
progestin
NCT01846507_exc_T41
Scope
estrogen and progestin
NCT01846507_exc_T42
Temporal
within 3 months of study entry
NCT01846507_exc_T43
Reference_point
study entry
NCT01846507_exc_T44
Observation
anticipated need
NCT01846507_exc_T45
Procedure
estrogen-containing hormonal contraception
NCT01846507_exc_T46
Drug
estrogen
NCT01846507_exc_T47
Qualifier
estrogen-containing
NCT01846507_exc_T48
Temporal
during the study period
NCT01846507_exc_T49
Reference_point
the study period
NCT01846507_exc_T50
Drug
systemic steroids
NCT01846507_exc_T51
Temporal
within 1 month of study entry
NCT01846507_exc_T52
Reference_point
study entry
NCT01846507_exc_T53
Condition
subarachnoid hemorrhage
NCT01846507_exc_T54
Observation
History
NCT01846507_exc_T55
Condition
Hepatitis B
NCT01846507_exc_T56
Condition
Hepatitis C
NCT01846507_exc_T57
Condition
HIV
NCT01846507_exc_T58
Observation
History
NCT01846507_exc_T59
Scope
Hepatitis B, C, or HIV
NCT01846507_exc_T60
Measurement
creatinine
NCT01846507_exc_T61
Temporal
Baseline
NCT01846507_exc_T62
Value
>20% above the upper limit of normal for age
NCT01846507_exc_T63
Person
age
NCT01846507_exc_T64
Condition
anemia
NCT01846507_exc_T65
Qualifier
Severe
NCT01846507_exc_T66
Measurement
hemoglobin
NCT01846507_exc_T67
Value
<8 g/dL
NCT01846507_exc_T68
Measurement
Systolic blood pressure
NCT01846507_exc_T69
Value
<85
NCT01846507_exc_T70
Measurement
diastolic blood pressure
NCT01846507_exc_T71
Value
<55
NCT01846507_exc_T72
Measurement
Heart rate
NCT01846507_exc_T73
Value
<50
NCT01846507_exc_T74
Temporal
at time of screening
NCT01846507_exc_T75
Reference_point
time of screening
NCT01846507_exc_T76
Device
intranasal DDAVP
NCT01846507_exc_T77
Temporal
during menses
NCT01846507_exc_T78
Reference_point
menses