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ABOUT THIS STUDY
The purpose of this study is to demonstrate the usability of the system.
Study Location
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
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
Adult Trials: 18+ Years
40-70 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
Age 40 to 70
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
Prior syringe skills
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Advanced Information
| 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 | ||||