Clincosm LogoSign in Get a demo

Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

Sponsor
Warner Chilcott (Industry)
Overall Status
Completed
CT.gov ID
NCT01065012
Collaborator
(none)
1,027
Enrollment
72
Locations
4
Arms
13
Duration (Months)
14.3
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Udenafil 50 mg
  • Drug: Udenafil 100 mg
  • Drug: Udenafil 150 mg
  • Drug: Placebo Matching 50 mg Udenafil
  • Drug: Placebo Matching 100 mg Udenafil
  • Drug: Placebo Matching 150 mg Udenafil
 Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1027 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Feb 1, 2011
Actual Study Completion Date :
Feb 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Udenafil 50 mg

50 mg Udenafil

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.
Other Names:
  • WC3043

    • Drug: 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.
    Other Names:
  • Placebo 100 mg

    • Drug: 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 Names:
  • Placebo 150 mg

    		•
    Experimental: Udenafil 100 mg

    100 mg Udenafil

    Drug: 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.
    Other Names:
  • WC3043

    • Drug: 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.
    Other Names:
  • Placebo 50 mg

    • Drug: 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 Names:
  • Placebo 150 mg

    		•
    Experimental: Udenafil 150 mg

    150 mg Udenafil

    Drug: 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.
    Other Names:
  • WC3043

    • Drug: 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.
    Other Names:
  • Placebo 50 mg

    • Drug: 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.
    Other Names:
  • Placebo 100 mg

    		•
    Placebo Comparator: Placebo

    Placebo Tablets matching Udenafil tablets

    Drug: 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.
    Other Names:
  • Placebo 50 mg

    • Drug: 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.
    Other Names:
  • Placebo 100 mg

    • Drug: 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 Names:
  • Placebo 150 mg

    		•

    Outcome Measures

    Primary Outcome Measures

    1. International Index of Erectile Function (IIEF) score [Assessment will be made after each use of the study drug over a 36 week use period.]

    Secondary Outcome Measures

    1. 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.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Warner Chilcott Investigational Site Birmingham Alabama United States 35209
    2 Warner Chilcott Investigational Site Homewood Alabama United States 35209
    3 Warner Chilcott Investigational Site Huntsville Alabama United States 35801
    4 Warner Chilcott Investigational Site Mesa Arizona United States 85213
    5 Warner Chilcott Investigational Site Phoenix Arizona United States 85023
    6 Warner Chilcott Investigational Site Tempe Arizona United States 85282
    7 Warner Chilcott Investigational Site Tucson Arizona United States 85741
    8 Warner Chilcott Investigational Site Chino California United States 91710
    9 Warner Chilcott Investigational Site Laguna Hills California United States 92653
    10 Warner Chilcott Investigational Site Newport Beach California United States 92660
    11 Warner Chilcott Investigational Site San Diego California United States 92103
    12 Warner Chilcott Investigational Site Tarzana California United States 91356
    13 Warner Chilcott Investigative Site Torrance California United States 90505
    14 Warner Chilcott Investigational Site Denver Colorado United States 80211
    15 Warner Chilcott Investigational Site Englewood Colorado United States 80113
    16 Warner Chilcott Investigational Site Middlebury Connecticut United States 06762
    17 Warner Chilcott Investigational Site Milford Connecticut United States 06460
    18 Warner Chilcott Investigative Site New Britain Connecticut United States 06052
    19 Warner Chilcott Investigational Site Waterbury Connecticut United States 06708
    20 Warner Chilcott Investigational Site Aventura Florida United States 33180
    21 Warner Chilcott Investigational Site Clearwater Florida United States 33761
    22 Warner Chilcott Investigational Site Daytona Beach Florida United States 32114
    23 Warner Chilcott Investigational Site DeLand Florida United States 32720
    24 Warner Chilcott Investigational Site Miami Florida United States 33143
    25 Warner Chilcott Investigational Site Ocala Florida United States 34471
    26 Warner Chilcott Investigational Site Ocala Florida United States 34474
    27 Warner Chilcott Investigational Site Tampa Florida United States 33607
    28 Warner Chilcott Investigational Site Columbus Georgia United States 31904
    29 Warner Chilcott Investigational Site Dawsonville Georgia United States 30534
    30 Warner Chilcott Investigational Site Sandy Springs Georgia United States 30328
    31 Warner Chilcott Investigational Site Melrose Park Illinois United States 60160
    32 Warner Chilcott Investigational Site Fort Wayne Indiana United States 46825
    33 Warner Chilcott Investigational Site Greenwood Indiana United States 46143
    34 Warner Chilcott Investigational Site Jeffersonville Indiana United States 47130
    35 Warner Chilcott Investigational Site West Des Moines Iowa United States 50266
    36 Warner Chilcott Investigational Site Elkridge Maryland United States 21075
    37 Warner Chilcott Investigational Site Omaha Nebraska United States 68114
    38 Warner Chilcott Investigational Site Las Vegas Nevada United States 89106
    39 Warner Chilcott Investigational Site Lawrenceville New Jersey United States 08648
    40 Warner Chilcott Investigational Site Bay Shore New York United States 11706
    41 Warner Chilcott Investigational Site Garden City New York United States 11530
    42 Warner Chilcott Investigational Site Kingston New York United States 12401
    43 Warner Chilcott Investigational Site New York New York United States 10016
    44 Warner Chilcott Investigational Site Poughkeepsie New York United States 12601
    45 Warner Chilcott Investigational Site Rochester New York United States 14609
    46 Warner Chilcott Investigational Site Williamsville New York United States 14221
    47 Warner Chilcott Investigational Site Cary North Carolina United States 27518
    48 Warner Chilcott Investigational Site Concord North Carolina United States 28025
    49 Warner Chilcott Investigational Site Harrisburg North Carolina United States 28075
    50 Warner Chilcott Investigational Site Raleigh North Carolina United States 27609
    51 Warner Chilcott Investigational Site Raleigh North Carolina United States 27612
    52 Warner Chilcott Investigational Site Salisbury North Carolina United States 28144
    53 Warner Chilcott Investigational Site Wilmington North Carolina United States 28401
    54 Warner Chilcott Investigative Site Wilmington North Carolina United States 28401
    55 Warner Chilcott Investigational Site Winston-Salem North Carolina United States 27103
    56 Warner Chilcott Investigational Site Cincinnati Ohio United States 45212
    57 Warner Chilcott Investigational Site Cleveland Ohio United States 44122
    58 Warner Chilcott Investigational Site Bala Cynwyd Pennsylvania United States 19004
    59 Warner Chilcott Investigational Site Jenkintown Pennsylvania United States 19046
    60 Warner Chilcott Investigational Site Lancaster Pennsylvania United States 17604
    61 Warner Chilcott Investigational Site Greer South Carolina United States 29650
    62 Warner Chilcott Investigational Site Mt. Pleasant South Carolina United States 29464
    63 Warner Chilcott Investigational Site Myrtle Beach South Carolina United States 29572
    64 Warner Chilcott Investigational Site Arlington Texas United States 76017
    65 Warner Chilcott Investigational Site San Antonio Texas United States 78229
    66 Warner Chilcott Investigational Site Sugar Land Texas United States 77479
    67 Warner Chilcott Investigational Site Salt Lake City Utah United States 84107
    68 Warner Chilcott Investigational Site Norfolk Virginia United States 23502
    69 Warner Chilcott Investigational Site Richmond Virginia United States 23294
    70 Warner Chilcott Investigational Site Mountlake Terrace Washington United States 98043
    71 Warner Chilcott Investigational Site Spokane Washington United States 99204
    72 Warner Chilcott Investigational Site Spokane Washington United States 99208

    Sponsors and Collaborators

    • Warner Chilcott

    Investigators

    • Study Director: Herman Ellman, MD, Warner Chilcott

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Warner Chilcott
    ClinicalTrials.gov Identifier:
    NCT01065012
    Other Study ID Numbers:
    • PR-01409
    First Posted:
    Feb 9, 2010
    Last Update Posted:
    Apr 20, 2015
    Last Verified:
    Mar 1, 2015
    Additional relevant MeSH terms:
    Erectile Dysfunction
    Udenafil

    Study Results

    No Results Posted as of Apr 20, 2015