Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction
An Open-Label, Long-Term Evaluation of the Safety and Efficacy of Avanafil in Men With Erectile Dysfunction
1 other identifier
interventional
712
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2009
Shorter than P25 for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedFirst Posted
Study publicly available on registry
March 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
June 28, 2012
CompletedAugust 17, 2012
August 1, 2012
1.1 years
February 27, 2009
May 25, 2012
August 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.
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
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
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
Study Arms (1)
avanafil
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VIVUS LLClead
Study Sites (40)
Research Site
Birmingham, Alabama, 35209, United States
Research Site
Homewood, Alabama, 35209, United States
Research Site
Tucson, Arizona, 85712, United States
Research Site
Sacramento, California, 95821, United States
Research Site
San Diego, California, 92120, United States
Research Site
San Diego, California, 92123, United States
Research Site
Waterbury, Connecticut, 06708, United States
Research Site
Clearwater, Florida, 33756, United States
Research Site
Clearwater, Florida, 33761, United States
Research Site
Coral Gables, Florida, 33134, United States
Research Site
Hialeah, Florida, 33012, United States
Research Site
Jacksonville, Florida, 32205, United States
Research Site
Jupiter, Florida, 33458, United States
Research Site
Ocala, Florida, 34471, United States
Research Site
Pembroke Pines, Florida, 33024, United States
Research Site
Ponte Vedra, Florida, 32081, United States
Research Site
Tampa, Florida, 33624, United States
Research Site
Sandy Springs, Georgia, 30328, United States
Research Site
Wichita, Kansas, 67205, United States
Research Site
Madisonville, Kentucky, 42431, United States
Research Site
Shreveport, Louisiana, 71106, United States
Research Site
Kansas City, Missouri, 64114, United States
Research Site
Lawrenceville, New Jersey, 08648, United States
Research Site
Albany, New York, 12206, United States
Research Site
New York, New York, 10016, United States
Research Site
Cary, North Carolina, 27518, United States
Research Site
Charlotte, North Carolina, 28207, United States
Research Site
Charlotte, North Carolina, 28209, United States
Research Site
Harrisburg, North Carolina, 28075, United States
Research Site
Hickory, North Carolina, 28601, United States
Research Site
Raleigh, North Carolina, 27609, United States
Research Site
Salisbury, North Carolina, 28144, United States
Research Site
Wilmington, North Carolina, 28401, United States
Research Site
Winston-Salem, North Carolina, 27103, United States
Research Site
Cleveland, Ohio, 44122, United States
Research Site
Bala-Cynwyd, Pennsylvania, 19004, United States
Research Site
Lancaster, Pennsylvania, 17601, United States
Research Site
El Paso, Texas, 79935, United States
Research Site
Houston, Texas, 77074, United States
Research Site
Spring, Texas, 77386, United States
Related Publications (1)
Belkoff LH, McCullough A, Goldstein I, Jones L, Bowden CH, DiDonato K, Trask B, Day WW. An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction. Int J Clin Pract. 2013 Apr;67(4):333-41. doi: 10.1111/ijcp.12065.
PMID: 23521325DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wesley W Day PhD
- Organization
- Vivus, Inc
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew McCullough, MD
NYU Urology Associates
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2009
First Posted
March 2, 2009
Study Start
March 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
August 17, 2012
Results First Posted
June 28, 2012
Record last verified: 2012-08