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Caverject User Study

Last updated on November 6, 2019

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Study Location
Pfizer Investigational Site
Overland Park, Kansas, 66211 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Erectile Dysfunction
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
40-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Age 40 to 70

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Prior syringe skills

NCT01008605
Pfizer
Completed
Caverject User Study

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Descriptive Information
Brief Title  ICMJE Caverject User Study
Official Title  ICMJE Representative Users Study Of Operating Characteristics Of The Caverject Delivery System.
Brief SummaryThe purpose of this study is to demonstrate the usability of the system.
Detailed Descriptiondemonstrate 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 DateFebruary 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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