Clinical trial NCT00853606: Long-Term Safety and Efficacy Study of Avanafil in Men With Erectile Dysfunction
Official title: An Open-Label, Long-Term Evaluation of the Safety and Efficacy of Avanafil in Men With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: ED
Erectile Dysfunction
Dysfunction
Erectile
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2009-03-02
Enrollment: 712
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Percentage of Sexual Attempts in Which Subjects Were Able to Maintain an Erection of Sufficient Duration to Have Successful Intercourse.
timeFrame: Baseline, 52 weeks
measure: Change in Percentage of Sexual Attempts in Which Subjects Were Able to Insert the Penis Into the Partner's Vagina
timeFrame: Baseline, 52 weeks
measure: Change in International Index of Erectile Function - Erectile Function Domain (IIEF-EF) Score
timeFrame: Baseline, End of Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Homewood
country: United States
facility: Research Site
state: Alabama
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Waterbury
country: United States
facility: Research Site
state: Connecticut
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Clearwater
country: United States
facility: Research Site
state: Florida
city: Coral Gables
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Jupiter
country: United States
facility: Research Site
state: Florida
city: Ocala
country: United States
facility: Research Site
state: Florida
city: Pembroke Pines
country: United States
facility: Research Site
state: Florida
city: Ponte Vedra
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Sandy Springs
country: United States
facility: Research Site
state: Georgia
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Madisonville
country: United States
facility: Research Site
state: Kentucky
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Lawrenceville
country: United States
facility: Research Site
state: New Jersey
city: Albany
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Cary
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Harrisburg
country: United States
facility: Research Site
state: North Carolina
city: Hickory
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Salisbury
country: United States
facility: Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Cleveland
country: United States
facility: Research Site
state: Ohio
city: Bala Cynwyd
country: United States
facility: Research Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Research Site
state: Pennsylvania
city: El Paso
country: United States
facility: Research Site
state: Texas
city: Houston
country: United States
facility: Research Site
state: Texas
city: Spring
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: NYU Urology Associates
name: Andrew McCullough, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belkoff LH, McCullough A, Goldstein I, Jones L, Bowden CH, DiDonato K, Trask B, Day WW. An open-label, long-term evaluation of the safety, efficacy and tolerability of avanafil in male patients with mild to severe erectile dysfunction. Int J Clin Pract. 2013 Apr;67(4):333-41. doi: 10.1111/ijcp.12065.