Caverject User Study

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01008605
• Other study ID #: A6711035
• Status: Completed
• Phase: Phase 3
• First received: November 5, 2009
• Last updated: April 4, 2012
• Start date: February 2011
• Est. completion date: February 2011

Study information

• Verified date: April 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

demonstrate usability

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

Age 40 to 70

Exclusion Criteria:

Prior syringe skills

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Other:
• delivery system
syringe

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Overland Park	Kansas
United States	Pfizer Investigational Site	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System	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.	Day 1	No
Secondary	Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 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.	Day 1	No
Secondary	Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2	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.	Day 1	No
Secondary	Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3	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.	Day 1	No
Secondary	Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4	Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult	Day 1	No
Secondary	Time Required to Perform Each Step While Using the Caverject Impulse Delivery System	Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose.	Day 1	No
Secondary	Number of Participants Providing Comments to Any Question on the Participant Assessment Tool	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.	Day 1	No

External Links

•   To obtain contact information for a study center near you, click here.