Treatment of Erectile Dysfunction - Long Term Safety and Efficacy
NCT ID: NCT01065012
Last Updated: 2015-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1027 participants
INTERVENTIONAL
2010-01-31
2011-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Erectile Dysfunction II
NCT01037218
Treatment of Erectile Dysfunction I
NCT01037244
A Study in Erectile Dysfunction
NCT01130532
Research Evaluating an Investigational Medication for Erectile Dysfunction - General ED
NCT00790751
A Study to Evaluate the Efficacy and Safety of 2.5mg and 5mg Tadalafil Given Once a Day to Men With Erectile Dysfunction
NCT00381732
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Udenafil 50 mg
50 mg Udenafil
Udenafil 50 mg
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo Matching 100 mg Udenafil
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo Matching 150 mg Udenafil
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Udenafil 100 mg
100 mg Udenafil
Udenafil 100 mg
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo Matching 50 mg Udenafil
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo Matching 150 mg Udenafil
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Udenafil 150 mg
150 mg Udenafil
Udenafil 150 mg
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo Matching 50 mg Udenafil
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo Matching 100 mg Udenafil
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo
Placebo Tablets matching Udenafil tablets
Placebo Matching 50 mg Udenafil
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo Matching 100 mg Udenafil
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo Matching 150 mg Udenafil
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Udenafil 50 mg
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Udenafil 100 mg
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Udenafil 150 mg
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo Matching 50 mg Udenafil
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo Matching 100 mg Udenafil
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Placebo Matching 150 mg Udenafil
Tablets via oral administration before an attempt at sexual intercourse. All subjects started at 100 mg and titrated up to 150 mg or down to 50 mg per Investigator and subject.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
19 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Warner Chilcott
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Herman Ellman, MD
Role: STUDY_DIRECTOR
Warner Chilcott
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Warner Chilcott Investigational Site
Birmingham, Alabama, United States
Warner Chilcott Investigational Site
Homewood, Alabama, United States
Warner Chilcott Investigational Site
Huntsville, Alabama, United States
Warner Chilcott Investigational Site
Mesa, Arizona, United States
Warner Chilcott Investigational Site
Phoenix, Arizona, United States
Warner Chilcott Investigational Site
Tempe, Arizona, United States
Warner Chilcott Investigational Site
Tucson, Arizona, United States
Warner Chilcott Investigational Site
Chino, California, United States
Warner Chilcott Investigational Site
Laguna Hills, California, United States
Warner Chilcott Investigational Site
Newport Beach, California, United States
Warner Chilcott Investigational Site
San Diego, California, United States
Warner Chilcott Investigational Site
Tarzana, California, United States
Warner Chilcott Investigative Site
Torrance, California, United States
Warner Chilcott Investigational Site
Denver, Colorado, United States
Warner Chilcott Investigational Site
Englewood, Colorado, United States
Warner Chilcott Investigational Site
Middlebury, Connecticut, United States
Warner Chilcott Investigational Site
Milford, Connecticut, United States
Warner Chilcott Investigative Site
New Britain, Connecticut, United States
Warner Chilcott Investigational Site
Waterbury, Connecticut, United States
Warner Chilcott Investigational Site
Aventura, Florida, United States
Warner Chilcott Investigational Site
Clearwater, Florida, United States
Warner Chilcott Investigational Site
Daytona Beach, Florida, United States
Warner Chilcott Investigational Site
DeLand, Florida, United States
Warner Chilcott Investigational Site
Miami, Florida, United States
Warner Chilcott Investigational Site
Ocala, Florida, United States
Warner Chilcott Investigational Site
Ocala, Florida, United States
Warner Chilcott Investigational Site
Tampa, Florida, United States
Warner Chilcott Investigational Site
Columbus, Georgia, United States
Warner Chilcott Investigational Site
Dawsonville, Georgia, United States
Warner Chilcott Investigational Site
Sandy Springs, Georgia, United States
Warner Chilcott Investigational Site
Melrose Park, Illinois, United States
Warner Chilcott Investigational Site
Fort Wayne, Indiana, United States
Warner Chilcott Investigational Site
Greenwood, Indiana, United States
Warner Chilcott Investigational Site
Jeffersonville, Indiana, United States
Warner Chilcott Investigational Site
West Des Moines, Iowa, United States
Warner Chilcott Investigational Site
Elkridge, Maryland, United States
Warner Chilcott Investigational Site
Omaha, Nebraska, United States
Warner Chilcott Investigational Site
Las Vegas, Nevada, United States
Warner Chilcott Investigational Site
Lawrenceville, New Jersey, United States
Warner Chilcott Investigational Site
Bay Shore, New York, United States
Warner Chilcott Investigational Site
Garden City, New York, United States
Warner Chilcott Investigational Site
Kingston, New York, United States
Warner Chilcott Investigational Site
New York, New York, United States
Warner Chilcott Investigational Site
Poughkeepsie, New York, United States
Warner Chilcott Investigational Site
Rochester, New York, United States
Warner Chilcott Investigational Site
Williamsville, New York, United States
Warner Chilcott Investigational Site
Cary, North Carolina, United States
Warner Chilcott Investigational Site
Concord, North Carolina, United States
Warner Chilcott Investigational Site
Harrisburg, North Carolina, United States
Warner Chilcott Investigational Site
Raleigh, North Carolina, United States
Warner Chilcott Investigational Site
Raleigh, North Carolina, United States
Warner Chilcott Investigational Site
Salisbury, North Carolina, United States
Warner Chilcott Investigational Site
Wilmington, North Carolina, United States
Warner Chilcott Investigative Site
Wilmington, North Carolina, United States
Warner Chilcott Investigational Site
Winston-Salem, North Carolina, United States
Warner Chilcott Investigational Site
Cincinnati, Ohio, United States
Warner Chilcott Investigational Site
Cleveland, Ohio, United States
Warner Chilcott Investigational Site
Bala-Cynwyd, Pennsylvania, United States
Warner Chilcott Investigational Site
Jenkintown, Pennsylvania, United States
Warner Chilcott Investigational Site
Lancaster, Pennsylvania, United States
Warner Chilcott Investigational Site
Greer, South Carolina, United States
Warner Chilcott Investigational Site
Mt. Pleasant, South Carolina, United States
Warner Chilcott Investigational Site
Myrtle Beach, South Carolina, United States
Warner Chilcott Investigational Site
Arlington, Texas, United States
Warner Chilcott Investigational Site
San Antonio, Texas, United States
Warner Chilcott Investigational Site
Sugar Land, Texas, United States
Warner Chilcott Investigational Site
Salt Lake City, Utah, United States
Warner Chilcott Investigational Site
Norfolk, Virginia, United States
Warner Chilcott Investigational Site
Richmond, Virginia, United States
Warner Chilcott Investigational Site
Mountlake Terrace, Washington, United States
Warner Chilcott Investigational Site
Spokane, Washington, United States
Warner Chilcott Investigational Site
Spokane, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PR-01409
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.