Phase 3
N=48
Caverject User Study
Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01008605 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System — 95.83 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- delivery system (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- Pfizer
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System |
95.83 | — |
| SECONDARY Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1 |
44; 4; 0; 0 | — |
| SECONDARY Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2 |
43; 4; 1; 0 | — |
| SECONDARY Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3 |
38; 2; 1; 0; 2; 4 | — |
| SECONDARY Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4 |
43; 4; 1; 0 | — |
| SECONDARY Time Required to Perform Each Step While Using the Caverject Impulse Delivery System |
103.2; 141.7; 119.2; 115.4; 127.5; 110.2 | — |
| SECONDARY Number of Participants Providing Comments to Any Question on the Participant Assessment Tool |
1; 0; 0; 0; 1; 1 | — |
Summary
The purpose of this study is to demonstrate the usability of the system.
Eligibility Criteria
Inclusion Criteria
Age 40 to 70
Exclusion Criteria
Prior syringe skills
Data sourced from ClinicalTrials.gov (NCT01008605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.