Status:
COMPLETED
Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction
Lead Sponsor:
VIVUS LLC
Conditions:
Erectile Dysfunction
Eligibility:
MALE
18+ years
Phase:
PHASE3
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 en...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
712 Patients enrolled
Trial Details
Trial ID
NCT00853606
Start Date
March 1 2009
End Date
April 1 2010
Last Update
August 17 2012
Active Locations (40)
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1
Research Site
Birmingham, Alabama, United States, 35209
2
Research Site
Homewood, Alabama, United States, 35209
3
Research Site
Tucson, Arizona, United States, 85712
4
Research Site
Sacramento, California, United States, 95821