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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00853606
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : June 28, 2012
Last Update Posted : August 17, 2012
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.

Brief Summary:
This open-label study is being conducted to evaluate the long-term safety, tolerability, and efficacy of avanafil in men with mild to severe erectile dysfunction. Approximately 400 subjects will be enrolled and treated with avanafil for up to 52 weeks.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Drug: avanafil Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 712 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Long-Term Evaluation of the Safety and Efficacy of Avanafil in Men With Erectile Dysfunction
Study Start Date : March 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Avanafil

Arm Intervention/treatment
Experimental: avanafil Drug: avanafil
All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with 100 mg may undergo dose reduction to 50 mg. Subjects who tolerate avanafil 100 mg but who desire increased efficacy may request a dose increase to 200 mg.
Other Names:
  • TA-1790
  • Stendra




Primary Outcome Measures :
  1. 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 ]
    Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 3 "Did your erection last long enough for you to have successful intercourse?" Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.

  2. 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 ]
    Data presented as mean change from baseline and the treatment period in the percentage of Yes responses to Sexual Encounter Profile (SEP) diary question 2 "Were you able to insert your penis into your partner's vagina?" Baseline is the run-in period from the qualifying study (TA-301/TA-302) consisting of all data reported during the non-treatment interval from Visit 1 to Visit 2. The treatment period is the on-treatment interval beginning with the first dose of study drug and ending on the last study visit.

  3. Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score [ Time Frame: Baseline, End of Treatment ]
    Questionnaire assesses subject's evaluation of erectile function over the previous 4-week period. Total score from questions 1-5 & 15 ranges from 1 to 30. A higher score indicates better erectile function. Baseline is the observation at Visit 2 of the qualifying study (TA-301/TA-302). End of treatment is the observation at Visit 8 of the last observation carried forward.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Successfully completed the entire treatment period in a qualifying study (TA-301 [NCT00790751] or TA-302 [NCT00809471]);
  • Demonstrated compliance with the study protocol, including drug administration, diary completion, and scheduled study visits, during the qualifying trial;
  • Made at least 4 attempts at intercourse during the last treatment period of the qualifying trial;
  • Agree to make at least 4 attempts at intercourse each month through the course of this study;
  • Agree not to use any other treatments for erectile dysfunction during participation in this study.
  • Provide written informed consent;
  • Willing and able to comply with scheduled study visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Subjects who, in the opinion of the investigator, have developed one or more comorbidities during the qualifying study that would pose a safety concern to their continuation on treatment in study TA-314;
  • Subjects requiring treatment with an excluded medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853606


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States, 35209
Research Site
Homewood, Alabama, United States, 35209
United States, Arizona
Research Site
Tucson, Arizona, United States, 85712
United States, California
Research Site
Sacramento, California, United States, 95821
Research Site
San Diego, California, United States, 92120
Research Site
San Diego, California, United States, 92123
United States, Connecticut
Research Site
Waterbury, Connecticut, United States, 06708
United States, Florida
Research Site
Clearwater, Florida, United States, 33756
Research Site
Clearwater, Florida, United States, 33761
Research Site
Coral Gables, Florida, United States, 33134
Research Site
Hialeah, Florida, United States, 33012
Research Site
Jacksonville, Florida, United States, 32205
Research Site
Jupiter, Florida, United States, 33458
Research Site
Ocala, Florida, United States, 34471
Research Site
Pembroke Pines, Florida, United States, 33024
Research Site
Ponte Vedra, Florida, United States, 32081
Research Site
Tampa, Florida, United States, 33624
United States, Georgia
Research Site
Sandy Springs, Georgia, United States, 30328
United States, Kansas
Research Site
Wichita, Kansas, United States, 67205
United States, Kentucky
Research Site
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Research Site
Shreveport, Louisiana, United States, 71106
United States, Missouri
Research Site
Kansas City, Missouri, United States, 64114
United States, New Jersey
Research Site
Lawrenceville, New Jersey, United States, 08648
United States, New York
Research Site
Albany, New York, United States, 12206
Research Site
New York, New York, United States, 10016
United States, North Carolina
Research Site
Cary, North Carolina, United States, 27518
Research Site
Charlotte, North Carolina, United States, 28207
Research Site
Charlotte, North Carolina, United States, 28209
Research Site
Harrisburg, North Carolina, United States, 28075
Research Site
Hickory, North Carolina, United States, 28601
Research Site
Raleigh, North Carolina, United States, 27609
Research Site
Salisbury, North Carolina, United States, 28144
Research Site
Wilmington, North Carolina, United States, 28401
Research Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Research Site
Cleveland, Ohio, United States, 44122
United States, Pennsylvania
Research Site
Bala Cynwyd, Pennsylvania, United States, 19004
Research Site
Lancaster, Pennsylvania, United States, 17601
United States, Texas
Research Site
El Paso, Texas, United States, 79935
Research Site
Houston, Texas, United States, 77074
Research Site
Spring, Texas, United States, 77386
Sponsors and Collaborators
VIVUS, Inc.
Investigators
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Principal Investigator: Andrew McCullough, MD NYU Urology Associates
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00853606    
Other Study ID Numbers: TA-314
First Posted: March 2, 2009    Key Record Dates
Results First Posted: June 28, 2012
Last Update Posted: August 17, 2012
Last Verified: August 2012
Keywords provided by VIVUS, Inc.:
ED
Erectile Dysfunction
Dysfunction
Erectile
Additional relevant MeSH terms:
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Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders