Clinical Trials Logo
  1. Home
  2. Erectile Dysfunction
  3. NCT01065012
  4. Details
NCT01065012 Clinical Trial

Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

Erectile Dysfunction Clinical Trial

Official title:
Open-Label Phase 3 Study to Evaluate the Long-Term Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01065012
Other study ID # PR-01409
Secondary ID
Status Completed
Phase Phase 3
First received February 5, 2010
Last updated March 30, 2015
Start date January 2010
Est. completion date February 2011

Study information
Verified date March 2015
Source Warner Chilcott
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility
Status Completed
Enrollment 1027
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers No
Gender Male
Age group 19 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• 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.

Locations
Country Name City State
United States Warner Chilcott Investigational Site Arlington Texas
United States Warner Chilcott Investigational Site Aventura Florida
United States Warner Chilcott Investigational Site Bala Cynwyd Pennsylvania
United States Warner Chilcott Investigational Site Bay Shore New York
United States Warner Chilcott Investigational Site Birmingham Alabama
United States Warner Chilcott Investigational Site Cary North Carolina
United States Warner Chilcott Investigational Site Chino California
United States Warner Chilcott Investigational Site Cincinnati Ohio
United States Warner Chilcott Investigational Site Clearwater Florida
United States Warner Chilcott Investigational Site Cleveland Ohio
United States Warner Chilcott Investigational Site Columbus Georgia
United States Warner Chilcott Investigational Site Concord North Carolina
United States Warner Chilcott Investigational Site Dawsonville Georgia
United States Warner Chilcott Investigational Site Daytona Beach Florida
United States Warner Chilcott Investigational Site DeLand Florida
United States Warner Chilcott Investigational Site Denver Colorado
United States Warner Chilcott Investigational Site Elkridge Maryland
United States Warner Chilcott Investigational Site Englewood Colorado
United States Warner Chilcott Investigational Site Fort Wayne Indiana
United States Warner Chilcott Investigational Site Garden City New York
United States Warner Chilcott Investigational Site Greenwood Indiana
United States Warner Chilcott Investigational Site Greer South Carolina
United States Warner Chilcott Investigational Site Harrisburg North Carolina
United States Warner Chilcott Investigational Site Homewood Alabama
United States Warner Chilcott Investigational Site Huntsville Alabama
United States Warner Chilcott Investigational Site Jeffersonville Indiana
United States Warner Chilcott Investigational Site Jenkintown Pennsylvania
United States Warner Chilcott Investigational Site Kingston New York
United States Warner Chilcott Investigational Site Laguna Hills California
United States Warner Chilcott Investigational Site Lancaster Pennsylvania
United States Warner Chilcott Investigational Site Las Vegas Nevada
United States Warner Chilcott Investigational Site Lawrenceville New Jersey
United States Warner Chilcott Investigational Site Melrose Park Illinois
United States Warner Chilcott Investigational Site Mesa Arizona
United States Warner Chilcott Investigational Site Miami Florida
United States Warner Chilcott Investigational Site Middlebury Connecticut
United States Warner Chilcott Investigational Site Milford Connecticut
United States Warner Chilcott Investigational Site Mountlake Terrace Washington
United States Warner Chilcott Investigational Site Mt. Pleasant South Carolina
United States Warner Chilcott Investigational Site Myrtle Beach South Carolina
United States Warner Chilcott Investigative Site New Britain Connecticut
United States Warner Chilcott Investigational Site New York New York
United States Warner Chilcott Investigational Site Newport Beach California
United States Warner Chilcott Investigational Site Norfolk Virginia
United States Warner Chilcott Investigational Site Ocala Florida
United States Warner Chilcott Investigational Site Ocala Florida
United States Warner Chilcott Investigational Site Omaha Nebraska
United States Warner Chilcott Investigational Site Phoenix Arizona
United States Warner Chilcott Investigational Site Poughkeepsie New York
United States Warner Chilcott Investigational Site Raleigh North Carolina
United States Warner Chilcott Investigational Site Raleigh North Carolina
United States Warner Chilcott Investigational Site Richmond Virginia
United States Warner Chilcott Investigational Site Rochester New York
United States Warner Chilcott Investigational Site Salisbury North Carolina
United States Warner Chilcott Investigational Site Salt Lake City Utah
United States Warner Chilcott Investigational Site San Antonio Texas
United States Warner Chilcott Investigational Site San Diego California
United States Warner Chilcott Investigational Site Sandy Springs Georgia
United States Warner Chilcott Investigational Site Spokane Washington
United States Warner Chilcott Investigational Site Spokane Washington
United States Warner Chilcott Investigational Site Sugar Land Texas
United States Warner Chilcott Investigational Site Tampa Florida
United States Warner Chilcott Investigational Site Tarzana California
United States Warner Chilcott Investigational Site Tempe Arizona
United States Warner Chilcott Investigative Site Torrance California
United States Warner Chilcott Investigational Site Tucson Arizona
United States Warner Chilcott Investigational Site Waterbury Connecticut
United States Warner Chilcott Investigational Site West Des Moines Iowa
United States Warner Chilcott Investigational Site Williamsville New York
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

Sponsors (1)
Lead Sponsor Collaborator
Warner Chilcott

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary International Index of Erectile Function (IIEF) score Assessment will be made after each use of the study drug over a 36 week use period. No
Secondary Changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction Assessment will be made after each use of the study drug over a 36 week use period. No
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05366504 - LiST Plus PRP Injection Therapy vs LiST Monotherapy for ED Treatment Phase 2/Phase 3
Recruiting NCT02745808 - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Recruiting NCT02573805 - the Diagnostic Value of Rigiscan Test (Nocturnal Penile Tumescence and Rigidity, NPTR) in Chinese Males N/A
Withdrawn NCT01967251 - Efficacy, Safety and Dose-response of Udenafil in Patients With Benign Prostatic Hyperplasia and Erectile Dysfunction Phase 2
Withdrawn NCT02579148 - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes Phase 1
Recruiting NCT02225548 - Sagene 2014 - Parkinson's Disease and Erectile Dysfunction Phase 4
Completed NCT02587988 - Trial to Evaluate the Efficacy and Safety of HCP1302 Phase 3
Completed NCT02945462 - Bone Marrow Mesenchymal Stem Cells in Erectile Dysfunction (ED) Phase 1
Completed NCT01937871 - A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED) Phase 3
Completed NCT01698684 - Research Evaluating a PDE5 Inhibitor for Erectile Dysfunction Phase 4
Not yet recruiting NCT01321489 - A Study to Evaluate a Possible Superiority Expressed by the Faster Onset of Action and the Efficacy and Safety of Sildenafil Citrate 20mg Sublingual Tablet in the Treatment of Erectile Dysfunction of Different Etiologies Phase 3
Completed NCT02226237 - Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy N/A
Completed NCT01230541 - Effect of Udenafil on Spermatogenesis Phase 1
Terminated NCT01262833 - Pudendal Assessment in Erectile Dysfunction N/A
Completed NCT01037218 - Treatment of Erectile Dysfunction II Phase 3
Completed NCT01037244 - Treatment of Erectile Dysfunction I Phase 3
Recruiting NCT00313898 - Effect of Sildenafil on Quality of Sexual Life in Mild to Normally Sexually Functioning Males Phase 4
Completed NCT00667979 - Evaluating the Efficacy of Vardenafil in Subjects With Erectile Dysfunction (ED) Administered 12, 18 or 24 Hours Prior to Intercourse Phase 4
Completed NCT00663728 - Assessment of Duration of Erection With Vardenafil 10 mg Phase 4
Completed NCT00421083 - Efficacy and Safety of Tadalafil in Subjects With Erectile Dysfunction Caused by Spinal Cord Injury Phase 3