An Open-Label, Long-Term Evaluation of the Safety and Efficacy of Avanafil in Men With Erectile Dysfunction
Overview
- Phase
- Phase 3
- Intervention
- avanafil
- Conditions
- Erectile Dysfunction
- Sponsor
- VIVUS LLC
- Enrollment
- 712
- Locations
- 1
- Primary Endpoint
- Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
avanafil
Intervention: avanafil
Outcomes
Primary Outcomes
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.
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.
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.