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

Vivus

Status and phase

Completed

Phase 3

Conditions

Erectile Dysfunction

Treatments

Drug: avanafil

Study type

Interventional

Funder types

Industry

Identifiers

NCT00853606

TA-314

Details and patient eligibility

About

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.

Enrollment

712 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.