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

August 10, 2012 updated by: VIVUS LLC

An Open-Label, Long-Term Evaluation of the Safety and Efficacy of Avanafil in Men With Erectile Dysfunction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

712

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Research Site
      • Homewood, Alabama, United States, 35209
        • Research Site
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Research Site
    • California
      • Sacramento, California, United States, 95821
        • Research Site
      • San Diego, California, United States, 92120
        • Research Site
      • San Diego, California, United States, 92123
        • Research Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Research Site
    • Florida
      • 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
        • Research Site
    • Georgia
      • Sandy Springs, Georgia, United States, 30328
        • Research Site
    • Kansas
      • Wichita, Kansas, United States, 67205
        • Research Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Research Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • Research Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Research Site
    • New York
      • Albany, New York, United States, 12206
        • Research Site
      • New York, New York, United States, 10016
        • Research Site
    • North Carolina
      • 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
        • Research Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Research Site
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Research Site
      • Lancaster, Pennsylvania, United States, 17601
        • Research Site
    • Texas
      • El Paso, Texas, United States, 79935
        • Research Site
      • Houston, Texas, United States, 77074
        • Research Site
      • Spring, Texas, United States, 77386
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 52 weeks
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.
Baseline, 52 weeks
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.
Baseline, End of Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIVUS LLC

Investigators

  • Principal Investigator: Andrew McCullough, MD, NYU Urology Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

February 27, 2009

First Submitted That Met QC Criteria

February 27, 2009

First Posted (Estimate)

March 2, 2009

Study Record Updates

Last Update Posted (Estimate)

August 17, 2012

Last Update Submitted That Met QC Criteria

August 10, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA-314

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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