Users Study Of The Caverject Delivery System

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01747928

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: dual-chamber syringe	Early Phase 1

Detailed Description

Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

A Representative Users Study Of The Operating Characteristics Of The Caverject Delivery System

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1	Other: dual-chamber syringe dual-chamber syringe for mock injection

Arm

Intervention/Treatment

Experimental: Group 1

Other: dual-chamber syringe

dual-chamber syringe for mock injection

Outcome Measures

Primary Outcome Measures

Delivery System Success Rate (DSSR) [Day 1]
DSSR was defined as percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Dual Chamber Delivery System when relying on the modified Instructions for Use (IFU). The process was considered successful if the attempt was observed and documented by study personnel AND the participant didn't receive any operational/"hands on" demonstration on how to operate the plunger from study personnel AND after performing all preparatory steps, the participant was able to expel the dose to the selected plunger stop-point without any unexpected interruption.

Secondary Outcome Measures

Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? [Day 1]
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 PAT: Instructions Provided Were Clear? [Day 1]
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 PAT: Most Difficult Step? [Day 1]
Participant responses were reported as follows: No steps really difficult, Attaching needle, Mixing the solution, Getting the air out of syringe, Setting the dose, Pushing plunger, Other.
Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? [Day 1]
Participant responses were reported as follows: Very easy, Somewhat easy, Somewhat difficult, Very difficult.
Number of Participants Providing Responses to Any Question on the PAT [Day 1]
Number of participants providing responses on questions in the PAT. Questions were as follows: What step did you stop? Why?; Instructions provided were useful?; Instructions provided were clear?; Most difficult step?; Syringe easy to use?
Time Required to Perform Segments 1 to 5 [Day 1]
Steps involved while using the Caverject Impulse Delivery System were categorized into segments: Segment 1 (Assembly While Using the Caverject Impulse Delivery System), Segment 2 (Mixing the Solution), Segment 3 (De-aerating the Syring While Using the Caverject Impulse Delivery System), Segment 4 (Setting the Dose) and Segment 5 (Performing the Injection While Using the Caverject Impulse Delivery System).
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 [Day 1]
OAT, Q1: Participant assembled the components correctly. Observer responses were reported as follows: Yes, No. A "No" answer indicated failure according to the OAT. Q1 and Q2 made up Segment 1: Assembly of Components.
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 [Day 1]
OAT, Q2: Evidence of mechanical malfunction or defect for Segment 1. Observer responses were reported as follows: Yes, No. Q1 and Q2 made up Segment 1: Assembly of Components.
Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 [Day 1]
OAT, Q3: Participant performed mixing step correctly. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q3 to Q5 made up Segment 2: Mixing the Solution.
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 [Day 1]
OAT, Q4: Participant positioned piston correctly. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the SAP. Q3 to Q5 made up Segment 2: Mixing the Solution.
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 [Day 1]
OAT, Q5: Evidence of mechanical malfunction/defect for Segment 2. Observer responses were reported as follows: Yes, No. Q3 to Q5 made up Segment 2: Mixing the Solution.
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 [Day 1]
OAT, Q6: De-aeration step performed successfully. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 [Day 1]
OAT, Q7: Participant depressed the plunger correctly to de-aerate the syringe. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the SAP. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 [Day 1]
OAT, Q8: Evidence of mechanical malfunction/defect for Segment 3. Observer responses were reported as follows: Yes, No. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 [Day 1]
OAT, Q9: Participant was able to set a dose (any dose) for delivery. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q9 and Q10 made up Segment 4: Setting the Dose.
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 [Day 1]
OAT, Q10: Evidence of mechanical malfunction/defect for Segment 4. Observer responses were reported as follows: Yes, No. Q9 and Q10 made up Segment 4: Setting the Dose.
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 [Day 1]
OAT, Q11: Participant successfully set the correct dose (as assigned). Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 [Day 1]
OAT, Q12: Participant successfully expelled the dose into the target. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 [Day 1]
OAT, Q13: Was there any difficulty/obstruction encountered in expelling dose? Observer responses were reported as follows: Yes, No. A "Yes" response indicated failure according to the SAP. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b [Day 1]
OAT, Q14b: Participant successfully expelled/injected the assigned dose (per Dose Card). Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 [Day 1]
OAT, Q16: Evidence of mechanical malfunction/defect. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 [Day 1]
OAT, Q17: Participant understood reason excess liquid was present after a partial-dose injection. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy males

Exclusion Criteria:

Inability to read English;
physical limitations preventing participant from operating the syringe

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vince and Associates Clinical Research	Overland Park	Kansas	United States	66212

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT01747928

Other Study ID Numbers:

A6711036

First Posted:

Dec 12, 2012

Last Update Posted:

May 2, 2014

Last Verified:

Apr 1, 2014

Keywords provided by Pfizer

usability study

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail	A total of 50 participants were screened, among whom 2 did not meet entrance criteria. The remaining 48 participants did and were randomized to study treatment.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Period Title: Overall Study
STARTED	6	6	6	6	6	6	6	6
COMPLETED	6	6	6	6	6	6	6	6
NOT COMPLETED	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting	Total
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Total of all reporting groups
Overall Participants	6	6	6	6	6	6	6	6	48
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.0 (9.1)	52.7 (10.0)	51.3 (9.0)	53.5 (9.0)	63.0 (2.5)	55.3 (4.8)	57.8 (6.8)	51.8 (5.6)	54.8 (7.9)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Male	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	48 100%

Outcome Measures

1. Primary Outcome

Title	Delivery System Success Rate (DSSR)
Description	DSSR was defined as percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Dual Chamber Delivery System when relying on the modified Instructions for Use (IFU). The process was considered successful if the attempt was observed and documented by study personnel AND the participant didn't receive any operational/"hands on" demonstration on how to operate the plunger from study personnel AND after performing all preparatory steps, the participant was able to expel the dose to the selected plunger stop-point without any unexpected interruption.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
The full analysis set (FAS) consisted of all protocol defined valid attempts to perform the study procedure as documented in the Observer Assessment Tool (OAT).

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting	All Participants
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
Measure Participants	6	6	6	6	6	6	6	6	48
Number (95% Confidence Interval) [percentage of participants]	66.67 1111.2%	66.67 1111.2%	100.00 1666.7%	100.00 1666.7%	100.00 1666.7%	83.33 1388.8%	100.00 1666.7%	100.00 1666.7%	89.58 186.6%

2. Post-Hoc Outcome

Title	DSSR Based on the Primary Objective
Description	This post-hoc DSSR was calculated in order to provide a DSSR that recognized as a "failure" only those participants who were unable to successfully complete the overall injection task, regardless of whether they met with difficulties at any step.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting	All Participants
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
Measure Participants	6	6	6	6	6	6	6	6	48
Number (95% Confidence Interval) [percentage of participants]	83.33 1388.8%	83.33 1388.8%	100.00 1666.7%	100.00 1666.7%	100.00 1666.7%	83.33 1388.8%	100.00 1666.7%	100.00 1666.7%	93.75 195.3%

3. Secondary Outcome

Title	Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?
Description	Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Very useful	5 83.3%	5 83.3%	6 100%	5 83.3%	6 100%	5 83.3%	5 83.3%	6 100%
Somewhat useful	0 0%	1 16.7%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%
Not very useful	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%	0 0%	0 0%
Not useful at all	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Missing answer	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%

4. Secondary Outcome

Title	Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?
Description	Participant responses were reported as follows: Very clear, Somewhat clear, Not very clear, Not clear at all.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Very clear	5 83.3%	4 66.7%	6 100%	6 100%	6 100%	5 83.3%	5 83.3%	5 83.3%
Somewhat clear	0 0%	2 33.3%	0 0%	0 0%	0 0%	1 16.7%	1 16.7%	1 16.7%
Not very clear	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Not clear at all	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Missing answer	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

5. Secondary Outcome

Title	Number of Participants With Categorical Responses to the PAT: Most Difficult Step?
Description	Participant responses were reported as follows: No steps really difficult, Attaching needle, Mixing the solution, Getting the air out of syringe, Setting the dose, Pushing plunger, Other.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
No steps really difficult	5 83.3%	3 50%	4 66.7%	5 83.3%	6 100%	4 66.7%	5 83.3%	5 83.3%
Attaching needle	0 0%	1 16.7%	2 33.3%	1 16.7%	0 0%	2 33.3%	0 0%	0 0%
Mixing the solution	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Getting the air out of syringe	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Setting the dose	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	1 16.7%
Pushing plunger	0 0%	1 16.7%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%
Other	0 0%	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Missing answer	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

6. Secondary Outcome

Title	Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?
Description	Participant responses were reported as follows: Very easy, Somewhat easy, Somewhat difficult, Very difficult.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Very easy	4 66.7%	3 50%	5 83.3%	6 100%	6 100%	5 83.3%	6 100%	6 100%
Somewhat easy	1 16.7%	3 50%	1 16.7%	0 0%	0 0%	1 16.7%	0 0%	0 0%
Somewhat difficult	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Very difficult	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Missing answer	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

7. Secondary Outcome

Title	Number of Participants Providing Responses to Any Question on the PAT
Description	Number of participants providing responses on questions in the PAT. Questions were as follows: What step did you stop? Why?; Instructions provided were useful?; Instructions provided were clear?; Most difficult step?; Syringe easy to use?
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
What step did you stop? Why?	1 16.7%	1 16.7%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%
Instructions provided were useful?	5 83.3%	6 100%	6 100%	6 100%	6 100%	6 100%	5 83.3%	6 100%
Instructions provided were clear?	5 83.3%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%
Most difficult step?	5 83.3%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%
Syringe easy to use?	5 83.3%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%

8. Secondary Outcome

Title	Time Required to Perform Segments 1 to 5
Description	Steps involved while using the Caverject Impulse Delivery System were categorized into segments: Segment 1 (Assembly While Using the Caverject Impulse Delivery System), Segment 2 (Mixing the Solution), Segment 3 (De-aerating the Syring While Using the Caverject Impulse Delivery System), Segment 4 (Setting the Dose) and Segment 5 (Performing the Injection While Using the Caverject Impulse Delivery System).
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
The FAS consisted of all protocol defined valid attempts to perform the study procedure as documented in the OAT. n=number of participants analyzed for that segment.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Segment 1 (n = 6, 6, 6, 6, 6, 6, 6, 6)	148.8 (37.20)	189.3 (140.13)	176.0 (72.92)	194.3 (107.53)	246.5 (131.85)	168.2 (82.76)	142.3 (105.78)	144.5 (23.35)
Segment 2 (n = 5, 6, 6, 6, 6, 5, 6, 6)	47.2 (21.53)	73.0 (63.11)	42.3 (14.19)	53.8 (30.73)	53.8 (21.68)	50.2 (35.90)	64.2 (50.03)	39.5 (13.92)
Segment 3 (n = 5, 6, 6, 6, 6, 5, 6, 6)	49.2 (15.69)	60.2 (40.41)	71.8 (22.69)	79.5 (89.17)	55.8 (32.03)	42.6 (5.86)	43.2 (22.13)	63.3 (24.82)
Segment 4 (n = 5, 5, 6, 6, 6, 5, 6, 6)	34.4 (29.55)	37.4 (59.77)	29.0 (23.08)	30.0 (26.71)	20.0 (13.07)	8.4 (6.31)	31.7 (24.20)	35.7 (16.50)
Segment 5 (n = 5, 5, 6, 6, 6, 5, 6, 6)	30.4 (17.04)	38.8 (53.64)	30.3 (17.77)	19.2 (11.96)	30.8 (15.25)	17.4 (13.24)	27.3 (20.38)	30.8 (17.51)

9. Secondary Outcome

Title	Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1
Description	OAT, Q1: Participant assembled the components correctly. Observer responses were reported as follows: Yes, No. A "No" answer indicated failure according to the OAT. Q1 and Q2 made up Segment 1: Assembly of Components.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS: all protocol defined valid attempts to perform the study procedures as documented in the OAT. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	5 83.3%	6 100%	6 100%	6 100%	6 100%	5 83.3%	6 100%	6 100%
No (FAIL per OAT)	1 16.7%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%

10. Secondary Outcome

Title	Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2
Description	OAT, Q2: Evidence of mechanical malfunction or defect for Segment 1. Observer responses were reported as follows: Yes, No. Q1 and Q2 made up Segment 1: Assembly of Components.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS: all protocol defined valid attempts to perform the study procedures as documented in the OAT. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant in the 10 mcg device-2.5 mcg dose was excluded as failure at Q1 did not involve mechanical failure or defect.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No	5 83.3%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%
Excluded from Q2	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

11. Secondary Outcome

Title	Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3
Description	OAT, Q3: Participant performed mixing step correctly. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q3 to Q5 made up Segment 2: Mixing the Solution.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the "did not participate" category.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	5 83.3%	6 100%	6 100%	6 100%	6 100%	5 83.3%	6 100%	6 100%
No (FAIL per OAT)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Did not participate	1 16.7%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%

12. Secondary Outcome

Title	Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4
Description	OAT, Q4: Participant positioned piston correctly. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the SAP. Q3 to Q5 made up Segment 2: Mixing the Solution.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the "did not participate" category.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	5 83.3%	6 100%	6 100%	6 100%	6 100%	5 83.3%	6 100%	6 100%
No (FAIL per SAP)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Did not participate	1 16.7%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%

13. Secondary Outcome

Title	Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5
Description	OAT, Q5: Evidence of mechanical malfunction/defect for Segment 2. Observer responses were reported as follows: Yes, No. Q3 to Q5 made up Segment 2: Mixing the Solution.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the "did not participate" category.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No	5 83.3%	6 100%	6 100%	6 100%	6 100%	5 83.3%	6 100%	6 100%
Did not participate	1 16.7%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%

14. Secondary Outcome

Title	Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6
Description	OAT, Q6: De-aeration step performed successfully. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. 1 participant each in the 10 mcg device-2.5 mcg dose and the 20 mcg device-10 mcg dose were excluded as they failed in Segment 1 and did not proceed to Segment 2. These 2 participants are counted in the "did not participate" category.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	5 83.3%	5 83.3%	6 100%	6 100%	6 100%	5 83.3%	6 100%	6 100%
No (FAIL per OAT)	0 0%	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Did not participate	1 16.7%	0 0%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%

15. Secondary Outcome

Title	Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7
Description	OAT, Q7: Participant depressed the plunger correctly to de-aerate the syringe. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the SAP. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	5 83.3%	5 83.3%	6 100%	6 100%	6 100%	5 83.3%	6 100%	6 100%
No (FAIL per SAP)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Did not participate	1 16.7%	1 16.7%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%

16. Secondary Outcome

Title	Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8
Description	OAT, Q8: Evidence of mechanical malfunction/defect for Segment 3. Observer responses were reported as follows: Yes, No. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No	5 83.3%	5 83.3%	6 100%	6 100%	6 100%	5 83.3%	6 100%	6 100%
Did not participate	1 16.7%	1 16.7%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%

17. Secondary Outcome

Title	Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9
Description	OAT, Q9: Participant was able to set a dose (any dose) for delivery. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q9 and Q10 made up Segment 4: Setting the Dose.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	5 83.3%	5 83.3%	6 100%	6 100%	6 100%	5 83.3%	6 100%	6 100%
No (FAIL per OAT)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Did not participate	1 16.7%	1 16.7%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%

18. Secondary Outcome

Title	Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10
Description	OAT, Q10: Evidence of mechanical malfunction/defect for Segment 4. Observer responses were reported as follows: Yes, No. Q9 and Q10 made up Segment 4: Setting the Dose.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No	5 83.3%	5 83.3%	6 100%	6 100%	6 100%	5 83.3%	6 100%	6 100%
Did not participate	1 16.7%	1 16.7%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%

19. Secondary Outcome

Title	Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11
Description	OAT, Q11: Participant successfully set the correct dose (as assigned). Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	5 83.3%	5 83.3%	6 100%	6 100%	6 100%	5 83.3%	6 100%	6 100%
No (FAIL per OAT)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Did not participate	1 16.7%	1 16.7%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%

20. Secondary Outcome

Title	Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12
Description	OAT, Q12: Participant successfully expelled the dose into the target. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	5 83.3%	5 83.3%	6 100%	6 100%	6 100%	5 83.3%	6 100%	6 100%
No (FAIL per OAT)	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Did not participate	1 16.7%	1 16.7%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%

21. Secondary Outcome

Title	Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13
Description	OAT, Q13: Was there any difficulty/obstruction encountered in expelling dose? Observer responses were reported as follows: Yes, No. A "Yes" response indicated failure according to the SAP. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes (FAIL per SAP)	1 16.7%	1 16.7%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No	4 66.7%	4 66.7%	6 100%	6 100%	6 100%	5 83.3%	6 100%	6 100%
Did not participate	1 16.7%	1 16.7%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%

22. Secondary Outcome

Title	Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b
Description	OAT, Q14b: Participant successfully expelled/injected the assigned dose (per Dose Card). Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	5 83.3%	5 83.3%	6 100%	6 100%	6 100%	5 83.3%	6 100%	6 100%
No	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Did not participate	1 16.7%	1 16.7%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%

23. Secondary Outcome

Title	Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16
Description	OAT, Q16: Evidence of mechanical malfunction/defect. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
No	5 83.3%	5 83.3%	6 100%	6 100%	6 100%	5 83.3%	6 100%	6 100%
Did not participate	1 16.7%	1 16.7%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%

24. Secondary Outcome

Title	Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17
Description	OAT, Q17: Participant understood reason excess liquid was present after a partial-dose injection. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description
FAS. All 48 participants were included in the FAS. Each participant tested 1 device/dose combination. All participants in the 10 mcg device-10 mcg dose and 20 mcg device-20 mcg dose (total 12 participants) are stated as "not applicable" as they tested the full dose.

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting	Caverject 10 mcg Device - 5 mcg Dose Setting	Caverject 10 mcg Device - 7.5 mcg Dose Setting	Caverject 10 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 5 mcg Dose Setting	Caverject 20 mcg Device - 10 mcg Dose Setting	Caverject 20 mcg Device - 15 mcg Dose Setting	Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.	Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
Measure Participants	6	6	6	6	6	6	6	6
Yes	5 83.3%	5 83.3%	6 100%	0 0%	6 100%	5 83.3%	6 100%	0 0%
No	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Did not participate	1 16.7%	1 16.7%	0 0%	0 0%	0 0%	1 16.7%	0 0%	0 0%
Not applicable (tested full dose)	0 0%	0 0%	0 0%	6 100%	0 0%	0 0%	0 0%	6 100%

Adverse Events

	Caverject 10 mcg Device - 2.5 mcg Dose Setting		Caverject 10 mcg Device - 5 mcg Dose Setting		Caverject 10 mcg Device - 7.5 mcg Dose Setting		Caverject 10 mcg Device - 10 mcg Dose Setting		Caverject 20 mcg Device - 5 mcg Dose Setting		Caverject 20 mcg Device - 10 mcg Dose Setting		Caverject 20 mcg Device - 15 mcg Dose Setting		Caverject 20 mcg Device - 20 mcg Dose Setting
Time Frame
Adverse Event Reporting Description

Arm/Group Title	Caverject 10 mcg Device - 2.5 mcg Dose Setting		Caverject 10 mcg Device - 5 mcg Dose Setting		Caverject 10 mcg Device - 7.5 mcg Dose Setting		Caverject 10 mcg Device - 10 mcg Dose Setting		Caverject 20 mcg Device - 5 mcg Dose Setting		Caverject 20 mcg Device - 10 mcg Dose Setting		Caverject 20 mcg Device - 15 mcg Dose Setting		Caverject 20 mcg Device - 20 mcg Dose Setting
Arm/Group Description	Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.		Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.		Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.		Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.		Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.		Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.		Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.		Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Caverject 10 mcg Device - 2.5 mcg Dose Setting		Caverject 10 mcg Device - 5 mcg Dose Setting		Caverject 10 mcg Device - 7.5 mcg Dose Setting		Caverject 10 mcg Device - 10 mcg Dose Setting		Caverject 20 mcg Device - 5 mcg Dose Setting		Caverject 20 mcg Device - 10 mcg Dose Setting		Caverject 20 mcg Device - 15 mcg Dose Setting		Caverject 20 mcg Device - 20 mcg Dose Setting
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Caverject 10 mcg Device - 2.5 mcg Dose Setting		Caverject 10 mcg Device - 5 mcg Dose Setting		Caverject 10 mcg Device - 7.5 mcg Dose Setting		Caverject 10 mcg Device - 10 mcg Dose Setting		Caverject 20 mcg Device - 5 mcg Dose Setting		Caverject 20 mcg Device - 10 mcg Dose Setting		Caverject 20 mcg Device - 15 mcg Dose Setting		Caverject 20 mcg Device - 20 mcg Dose Setting
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)

Limitations/Caveats

For outcome measure 7, the endpoint was originally the comments provided as part of the PAT. As clinicaltrials.gov do not support textual results, the number of participants who provided comments to any questions on the PAT are reported instead.

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title	Pfizer ClinicalTrials.gov Call Center
Organization	Pfizer, Inc.
Phone	1-800-718-1021
Email	ClinicalTrials.gov_Inquiries@pfizer.com

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT01747928

Other Study ID Numbers:

A6711036

First Posted:

Dec 12, 2012

Last Update Posted:

May 2, 2014

Last Verified:

Apr 1, 2014

Users Study Of The Caverject Delivery System

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