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Trial record 1 of 1 for:    NCT01008605
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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

Tracking Information
First Submitted Date  ICMJE November 5, 2009
First Posted Date  ICMJE November 6, 2009
Results First Submitted Date  ICMJE February 28, 2012
Results First Posted Date  ICMJE March 28, 2012
Last Update Posted Date April 6, 2012
Study Start Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2012)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
usability rating [ Time Frame: 15 min ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2012)
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2009)
user rating [ Time Frame: 15 min ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Caverject User Study
Official Title  ICMJE Representative Users Study Of Operating Characteristics Of The Caverject Delivery System.
Brief Summary The purpose of this study is to demonstrate the usability of the system.
Detailed Description demonstrate usability
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Erectile Dysfunction
Intervention  ICMJE Other: delivery system
syringe
Study Arms  ICMJE Experimental: Caverject Impulse
representative users
Intervention: Other: delivery system
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2011)
48
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2009)
50
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Age 40 to 70

Exclusion Criteria:

Prior syringe skills

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01008605
Other Study ID Numbers  ICMJE A6711035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP