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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Avanafil

Drug

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.

Other names: TA-1790, Stendra

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.

Sponsors and collaborators

Lead sponsor

VIVUS LLC

Industry

Registry information

Official study title

An Open-Label, Long-Term Evaluation of the Safety and Efficacy of Avanafil in Men With Erectile Dysfunction

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Mar 2, 2009
Registry last updated: Aug 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed