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The purpose of this study is to demonstrate the usability of the system.
demonstrate usability
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caverject Impulse | Experimental | representative users |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| delivery system | Other | syringe |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System | 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1 | 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. | Day 1 |
| Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2 |
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Inclusion Criteria:
Age 40 to 70
Exclusion Criteria:
Prior syringe skills
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Overland Park | Kansas | 66211 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System | 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. | Full Analysis Set (FAS): All eligible participants who read the instructions and attempted to deliver Alprostadil using the Caverject Impulse Delivery System. Each participant tested one device/dose combination. | Posted | Number | percentage of participants | Day 1 |
|
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The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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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. |
| Day 1 |
| Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3 | 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. | Day 1 |
| Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4 | Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult | Day 1 |
| Time Required to Perform Each Step While Using the Caverject Impulse Delivery System | Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose. | Day 1 |
| Number of Participants Providing Comments to Any Question on the Participant Assessment Tool | 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. | Day 1 |
| Overland Park |
| Kansas |
| 66212 |
| United States |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1 | 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. | FAS. Each participant tested one device/dose combination. | Posted | Number | participants | Day 1 |
|
|
|
| Secondary | Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2 | 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. | FAS. Each participant tested one device/dose combination. | Posted | Number | participants | Day 1 |
|
|
|
| Secondary | Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3 | 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. | FAS. Each participant tested one device/dose combination. | Posted | Number | participants | Day 1 |
|
|
|
| Secondary | Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4 | Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult | FAS. Each participant tested one device/dose combination. | Posted | Number | participants | Day 1 |
|
|
|
| Secondary | Time Required to Perform Each Step While Using the Caverject Impulse Delivery System | Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose. | FAS. Each participant tested one device/dose combination. n = number of participants with available data. | Posted | Mean | Standard Deviation | seconds | Day 1 |
|
|
|
| Secondary | Number of Participants Providing Comments to Any Question on the Participant Assessment Tool | 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. | FAS. Each participant tested one device/dose combination. | Posted | Number | participants | Day 1 |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| Title | Measurements |
|---|---|
|
| Not useful at all |
|
| Title | Measurements |
|---|---|
|
| Not clear at all |
|
| Title | Measurements |
|---|---|
|
| Getting the air out of syringe |
|
| Dialing dose |
|
| Pushing plunger |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Very difficult |
|
| Step 2: Mixing solution (n=6, 5, 6, 7, 5, 5, 6, 6) |
|
| Step 3: De-aerating (n=6, 5, 6, 7, 5, 5, 6, 6) |
|
| Step 4: Setting the dose (n=6, 4, 6, 7, 5, 5, 6, 6 |
|
| Step 5: Injecting dose (n=6, 5, 6, 7, 5, 5, 6, 6) |
|
| Instructions provided were clear? |
|
| Most difficult step? |
|
| Syringe easy to use? |
|