Caverject User Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01008605

First received: November 5, 2009

Last updated: April 4, 2012

Last verified: April 2012

History of Changes

Results First Received: February 28, 2012

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Open Label
Condition:	Erectile Dysfunction
Intervention:	Other: delivery system

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow: Overall Study

	All Participants
STARTED	48
COMPLETED	48
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
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.

Baseline Measures

	All Participants
Number of Participants [units: participants]	48
Age [units: years] Mean ± Standard Deviation	51.6 ± 8.5
Age, Customized [units: participants]
Between 18 and 44 years	11
Between 45 and 64 years	31
>= 65 years	6
Gender [units: participants]
Female	0
Male	48

Outcome Measures

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1. Primary:

Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System [ Time Frame: Day 1 ]

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2. Secondary:

Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1 [ Time Frame: Day 1 ]

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3. Secondary:

Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2 [ Time Frame: Day 1 ]

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4. Secondary:

Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3 [ Time Frame: Day 1 ]

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5. Secondary:

Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4 [ Time Frame: Day 1 ]

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6. Secondary:

Time Required to Perform Each Step While Using the Caverject Impulse Delivery System [ Time Frame: Day 1 ]

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7. Secondary:

Number of Participants Providing Comments to Any Question on the Participant Assessment Tool [ Time Frame: Day 1 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01008605 History of Changes
Other Study ID Numbers:	A6711035
Study First Received:	November 5, 2009
Results First Received:	February 28, 2012
Last Updated:	April 4, 2012
Health Authority:	United States: Food and Drug Administration

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