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Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00853606
First received: February 27, 2009
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
Results First Received: May 25, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Erectile Dysfunction
Intervention: Drug: avanafil

  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
Subject recruitment occurred at US investigative sites between March 2009 and April 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Avanafil All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.

Participant Flow:   Overall Study
    Avanafil  
STARTED     712  
COMPLETED     492  
NOT COMPLETED     220  



  Baseline Characteristics
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Reporting Groups
  Description
Avanafil All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.

Baseline Measures
    Avanafil  
Number of Participants  
[units: participants]
 		  712  
Age  
[units: years]
Mean ± Standard Deviation 		  56.4  ± 10.19  
Gender  
[units: participants]
 		 
Female     0  
Male     712  
Region of Enrollment  
[units: participants]
 		 
United States     712  



  Outcome Measures
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1.  Primary:   Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.   [ Time Frame: Baseline, 52 weeks ]
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2.  Primary:   Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina   [ Time Frame: Baseline, 52 weeks ]
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3.  Primary:   Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score   [ Time Frame: Baseline, End of Treatment ]
  Show Outcome Measure 3


  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:
unchecked 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.
unchecked 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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Wesley W Day PhD
Organization: Vivus, Inc
phone: 650-934-5200


No publications provided by VIVUS, Inc.

Publications automatically indexed to this study:


Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00853606     History of Changes
Other Study ID Numbers: TA-314
Study First Received: February 27, 2009
Results First Received: May 25, 2012
Last Updated: August 10, 2012
Health Authority: United States: Food and Drug Administration