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delivery system

Phase 3

Erectile Dysfunction | Unknown | Other |Pfizer, Inc.|Last Updated: Apr 6, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01008605Caverject User StudyPHASE3 COMPLETED 48 — — Feb 1, 2011Feb 1, 2011Apr 6, 20122 United States
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Study Endpoints
Primary Endpoints
Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System
Day 1

Percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Delivery System when relying on the modified Instructions for Use. The process was considered successful if the lower bound of the 95% confidence interval (CI) was more than (\>) 80% overall.

Secondary Endpoints
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1
Day 1
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2
Day 1
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3
Day 1
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
Caverject ImpulseEXPERIMENTALrepresentative users
Interventions
NameTypeDescription
delivery systemOTHERsyringe
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Eligibility Criteria
Age Range40 Years — 70 Years
SexMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: Age 40 to 70 Exclusion Criteria: Prior syringe skills

Countries:United States
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