Phase 3
N=712
Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction
Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00853606 ↗Enrolled (actual)
712
Serious AEs
1.5%
Results posted
Jun 2012
Primary outcome: Primary: Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse. — 54.75 percentage of sexual attempts
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- avanafil (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- VIVUS LLC
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse. |
54.75 | — |
| PRIMARY Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina |
36.91 | — |
| PRIMARY Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score |
10.3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00853606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.