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Caverject User Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01008605
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : March 28, 2012
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Other: delivery system Phase 3

Detailed Description:
demonstrate usability

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Representative Users Study Of Operating Characteristics Of The Caverject Delivery System.
Study Start Date : February 2011
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Alprostadil

Arm Intervention/treatment
Experimental: Caverject Impulse
representative users
Other: delivery system
syringe




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1 [ Time Frame: 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.

  2. Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2 [ Time Frame: 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.

  3. Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3 [ Time Frame: 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.

  4. Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4 [ Time Frame: 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

  5. Time Required to Perform Each Step While Using the Caverject Impulse Delivery System [ Time Frame: 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.

  6. Number of Participants Providing Comments to Any Question on the Participant Assessment Tool [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Age 40 to 70

Exclusion Criteria:

Prior syringe skills


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01008605


Locations
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United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01008605    
Other Study ID Numbers: A6711035
First Posted: November 6, 2009    Key Record Dates
Results First Posted: March 28, 2012
Last Update Posted: April 6, 2012
Last Verified: April 2012
Keywords provided by Pfizer:
Erectile Dysfunction
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Mental Disorders