Research Evaluating an Investigational Medication for Erectile Dysfunction - Post-Prostatectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00895011
First received: May 5, 2009
Last updated: September 14, 2012
Last verified: September 2012
Results First Received: May 25, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Erectile Dysfunction
Interventions: Drug: Placebo
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 April 2009 and December 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects meeting the initial eligibility criteria completed a 4-week non-treatment run-in period during which information on each attempt at intercourse was recorded. At the end of the run-in, subjects meeting the randomization criteria were eligible for assignment to one of the treatment groups.

Reporting Groups
  Description
Placebo placebo 30 minutes orally prior to initiation of sexual activity
Avanafil 100 mg avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
Avanafil 200 mg avanafil 200 mg 30 minutes orally prior to initiation of sexual activity

Participant Flow:   Overall Study
    Placebo     Avanafil 100 mg     Avanafil 200 mg  
STARTED     100     99     99  
COMPLETED     76     85     91  
NOT COMPLETED     24     14     8  
Withdrawal by Subject                 14                 7                 2  
Lost to Follow-up                 5                 4                 1  
Protocol Violation                 3                 1                 3  
Adverse Event                 1                 2                 2  
schedule conflict                 1                 0                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo No text entered.
Avanafil 100 mg No text entered.
Avanafil 200 mg No text entered.
Total Total of all reporting groups

Baseline Measures
    Placebo     Avanafil 100 mg     Avanafil 200 mg     Total  
Number of Participants  
[units: participants]
  100     99     99     298  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     85     81     84     250  
>=65 years     15     18     15     48  
Age  
[units: years]
Mean ± Standard Deviation
  58.6  ± 5.87     58.9  ± 5.88     57.7  ± 6.60     58.4  ± 6.13  
Gender  
[units: participants]
       
Female     0     0     0     0  
Male     100     99     99     298  
Region of Enrollment  
[units: participants]
       
United States     100     99     99     298  



  Outcome Measures
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1.  Primary:   Change in Percentage of Sexual Attempts in Which Subjects Are Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse   [ Time Frame: Baseline, Week 12 ]

2.  Primary:   The Change in Percentage of Sexual Attempts in Which Subjects Are Able to Insert the Penis Into the Partner's Vagina   [ Time Frame: Baseline, Week 12 ]

3.  Primary:   Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score   [ Time Frame: Baseline, End of Treatment (up to 12 weeks) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Wesley W Day, PhD
Organization: Vivus, Inc.
phone: 650-934-5200
e-mail: medaffairs@vivus.com


No publications provided by VIVUS, Inc.

Publications automatically indexed to this study:

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00895011     History of Changes
Obsolete Identifiers: NCT01171001
Other Study ID Numbers: TA-303
Study First Received: May 5, 2009
Results First Received: May 25, 2012
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration