Representative Users Study Of Operating Characteristics Of The Caverject Delivery System.

Pfizer1 site in 1 country48 target enrollmentFebruary 2011

ConditionsErectile Dysfunction

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Erectile Dysfunction
Sponsor: Pfizer
Enrollment: 48
Locations: 1
Primary Endpoint: Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to demonstrate the usability of the system.

Detailed Description

demonstrate usability

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

February 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 40 to 70

Exclusion Criteria

•Prior syringe skills

Outcomes

Primary Outcomes

Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System

Time Frame: 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 Outcomes

Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3(Day 1)
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2(Day 1)
Number of Participants Providing Comments to Any Question on the Participant Assessment Tool(Day 1)
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 4(Day 1)
Time Required to Perform Each Step While Using the Caverject Impulse Delivery System(Day 1)