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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853606
• Other study ID #: TA-314
• Status: Completed
• Phase: Phase 3
• First received: February 27, 2009
• Last updated: August 10, 2012
• Start date: March 2009
• Est. completion date: April 2010

Study information

• Verified date: August 2012
• Source: VIVUS, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 712
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

Intervention

Drug:
• avanafil
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.

Locations

Country	Name	City	State
United States	Research Site	Albany	New York
United States	Research Site	Bala Cynwyd	Pennsylvania
United States	Research Site	Birmingham	Alabama
United States	Research Site	Cary	North Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Clearwater	Florida
United States	Research Site	Clearwater	Florida
United States	Research Site	Cleveland	Ohio
United States	Research Site	Coral Gables	Florida
United States	Research Site	El Paso	Texas
United States	Research Site	Harrisburg	North Carolina
United States	Research Site	Hialeah	Florida
United States	Research Site	Hickory	North Carolina
United States	Research Site	Homewood	Alabama
United States	Research Site	Houston	Texas
United States	Research Site	Jacksonville	Florida
United States	Research Site	Jupiter	Florida
United States	Research Site	Kansas City	Missouri
United States	Research Site	Lancaster	Pennsylvania
United States	Research Site	Lawrenceville	New Jersey
United States	Research Site	Madisonville	Kentucky
United States	Research Site	New York	New York
United States	Research Site	Ocala	Florida
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Ponte Vedra	Florida
United States	Research Site	Raleigh	North Carolina
United States	Research Site	Sacramento	California
United States	Research Site	Salisbury	North Carolina
United States	Research Site	San Diego	California
United States	Research Site	San Diego	California
United States	Research Site	Sandy Springs	Georgia
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Spring	Texas
United States	Research Site	Tampa	Florida
United States	Research Site	Tucson	Arizona
United States	Research Site	Waterbury	Connecticut
United States	Research Site	Wichita	Kansas
United States	Research Site	Wilmington	North Carolina
United States	Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VIVUS, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.	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.	Baseline, 52 weeks	No
Primary	Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina	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.	Baseline, 52 weeks	No
Primary	Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score	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.	Baseline, End of Treatment	No