Caverject User Study
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01008605
First received: November 5, 2009
Last updated: April 4, 2012
Last verified: April 2012
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Purpose
The purpose of this study is to demonstrate the usability of the system.
| Condition | Intervention | Phase |
|---|---|---|
|
Erectile Dysfunction |
Other: delivery system |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Representative Users Study Of Operating Characteristics Of The Caverject Delivery System. |
Resource links provided by NLM:
MedlinePlus related topics:
Erectile Dysfunction
Drug Information available for:
Alprostadil
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System [ Time Frame: Day 1 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 48 |
| Study Start Date: | February 2011 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Caverject Impulse
representative users
|
Other: delivery system
syringe
|
Detailed Description:
demonstrate usability
Eligibility| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Age 40 to 70
Exclusion Criteria:
Prior syringe skills
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01008605
Locations
| United States, Kansas | |
| Pfizer Investigational Site | |
| Overland Park, Kansas, United States, 66212 | |
| Pfizer Investigational Site | |
| Overland Park, Kansas, United States, 66211 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01008605 History of Changes |
| Other Study ID Numbers: | A6711035 |
| Study First Received: | November 5, 2009 |
| Results First Received: | February 28, 2012 |
| Last Updated: | April 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Erectile Dysfunction |
Additional relevant MeSH terms:
|
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders Alprostadil Platelet Aggregation Inhibitors |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013