Caverject User Study

Phase 3

Completed

• Conditions: Erectile Dysfunction
• Interventions: Other: delivery system

• Registration Number: NCT01008605
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

demonstrate usability

Study Timeline

• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-05
• Study First Posted: 2009-11-06
• Study Start: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-02-28
• Results First Submitted QC: 2012-02-28
• Results First Posted: 2012-03-28
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-04
• Last Update Posted: 2012-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

Age 40 to 70

Exclusion Criteria

Prior syringe skills

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Caverject Impulse	delivery system	representative users

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3	Day 1	Participant Assessment Tool, Question 3: Most difficult step? Participant responses were reported as follows: No Steps Particularly Difficult, Attaching Needle, Mixing Solution, Getting The Air Out Of Syringe, Dialing Dose, Pushing Plunger, Other.
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2	Day 1	Participant Assessment Tool, Question 2: Instructions provided were clear? Participant responses were reported as follows: Very Clear, Somewhat Clear, Not Very Clear, Not Clear At All.
Number of Participants Providing Comments to Any Question on the Participant Assessment Tool	Day 1	Number of participants providing comments on questions in the Participant Assessment Tool. Questions were as follows: were instructions clear, were instructions useful, which was the most difficult step, and was the syringe easy to use.
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1	Day 1	Participant Assessment Tool, Question 1: Instructions provided were useful? Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4	Day 1	Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult
Time Required to Perform Each Step While Using the Caverject Impulse Delivery System	Day 1	Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Overland Park, Kansas, United States