Eligibility criteria
Condition
Erectile Dysfunction
Sex
Male
Age
40-70 years
Inclusion criteria
Show details
Age 40 to 70
Exclusion criteria
Show details
Prior syringe skills
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Caverject User Study
NCT01008605
Last updated on November 6, 2019
About this Study
The purpose of this study is to demonstrate the usability of the system.
NCT01008605
Pfizer
Completed
Caverject User Study
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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 | 48 | |||
| Original Estimated Enrollment ICMJE | 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 |
| |||
| 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 |
| |||
| 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 | ||||
FOR MORE INFORMATION
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