Clinical trial NCT01065012: Treatment of Erectile Dysfunction - Long Term Safety and Efficacy
Official title: Open-Label Phase 3 Study to Evaluate the Long-Term Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2010-02-09
Enrollment: 1027
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open-Label Phase 3 study to evaluate the long-term safety and efficacy of udenafil, an orally administered selective inhibitor of PDE-5 for the treatment of subjects with erectile dysfunction (ED).

Detailed description: Patients completing the double-blind phase will be entered into Study 01409 at the intermediate dose. Up and down dose adjustments will be allowed.

Eligibility criteria: Inclusion Criteria:

* Subject has completed Study PR-01209 or PR-01309
* Continues in a stable monogamous relationship with a consenting female partner who is at least 19 years of age.
* Partner is not pregnant or lactating

Exclusion Criteria:

* Symptomatic coronary artery disease, myocardial infarction or cardiac surgical procedure.
* Cardiac arrhythmias requiring antiarrhythmic treatment
* Symptomatic congestive heart failure
* Taking nitrate medication in any form
* Uncontrolled diabetes (HbA1c ≥ 13%)
* Hypersensitivity to phosphodiesterase type 5 (PDE-5) inhibitors

Primary outcomes:
measure: International Index of Erectile Function (IIEF) score
timeFrame: Assessment will be made after each use of the study drug over a 36 week use period.
Secondary outcomes:
measure: Changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction
timeFrame: Assessment will be made after each use of the study drug over a 36 week use period.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Warner Chilcott Investigational Site
state: Alabama
city: Homewood
country: United States
facility: Warner Chilcott Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Warner Chilcott Investigational Site
state: Alabama
city: Mesa
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Tempe
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Warner Chilcott Investigational Site
state: Arizona
city: Chino
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Laguna Hills
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Newport Beach
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: San Diego
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Tarzana
country: United States
facility: Warner Chilcott Investigational Site
state: California
city: Torrance
country: United States
facility: Warner Chilcott Investigative Site
state: California
city: Denver
country: United States
facility: Warner Chilcott Investigational Site
state: Colorado
city: Englewood
country: United States
facility: Warner Chilcott Investigational Site
state: Colorado
city: Middlebury
country: United States
facility: Warner Chilcott Investigational Site
state: Connecticut
city: Milford
country: United States
facility: Warner Chilcott Investigational Site
state: Connecticut
city: New Britain
country: United States
facility: Warner Chilcott Investigative Site
state: Connecticut
city: Waterbury
country: United States
facility: Warner Chilcott Investigational Site
state: Connecticut
city: Aventura
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Daytona Beach
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: DeLand
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Miami
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Ocala
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Ocala
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Tampa
country: United States
facility: Warner Chilcott Investigational Site
state: Florida
city: Columbus
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Dawsonville
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Warner Chilcott Investigational Site
state: Georgia
city: Melrose Park
country: United States
facility: Warner Chilcott Investigational Site
state: Illinois
city: Fort Wayne
country: United States
facility: Warner Chilcott Investigational Site
state: Indiana
city: Greenwood
country: United States
facility: Warner Chilcott Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: Warner Chilcott Investigational Site
state: Indiana
city: West Des Moines
country: United States
facility: Warner Chilcott Investigational Site
state: Iowa
city: Elkridge
country: United States
facility: Warner Chilcott Investigational Site
state: Maryland
city: Omaha
country: United States
facility: Warner Chilcott Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Warner Chilcott Investigational Site
state: Nevada
city: Lawrenceville
country: United States
facility: Warner Chilcott Investigational Site
state: New Jersey
city: Bay Shore
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Garden City
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Kingston
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: New York
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Poughkeepsie
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Rochester
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Williamsville
country: United States
facility: Warner Chilcott Investigational Site
state: New York
city: Cary
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Concord
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Harrisburg
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Salisbury
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Warner Chilcott Investigative Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Warner Chilcott Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Warner Chilcott Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Warner Chilcott Investigational Site
state: Ohio
city: Bala Cynwyd
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Jenkintown
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Warner Chilcott Investigational Site
state: Pennsylvania
city: Greer
country: United States
facility: Warner Chilcott Investigational Site
state: South Carolina
city: Mt. Pleasant
country: United States
facility: Warner Chilcott Investigational Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Warner Chilcott Investigational Site
state: South Carolina
city: Arlington
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Warner Chilcott Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Warner Chilcott Investigational Site
state: Utah
city: Norfolk
country: United States
facility: Warner Chilcott Investigational Site
state: Virginia
city: Richmond
country: United States
facility: Warner Chilcott Investigational Site
state: Virginia
city: Mountlake Terrace
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
city: Spokane
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
city: Spokane
country: United States
facility: Warner Chilcott Investigational Site
state: Washington
Study officials:
affiliation: Warner Chilcott
name: Herman Ellman, MD
role: STUDY_DIRECTOR
References: