Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT01065012
First received: February 5, 2010
Last updated: March 30, 2015
Last verified: March 2015

February 5, 2010
March 30, 2015
January 2010
February 2011   (final data collection date for primary outcome measure)
International Index of Erectile Function (IIEF) score [ Time Frame: Assessment will be made after each use of the study drug over a 36 week use period. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01065012 on ClinicalTrials.gov Archive Site
Changes in the satisfaction of intercourse, orgasmic function, sexual desire and overall satisfaction [ Time Frame: Assessment will be made after each use of the study drug over a 36 week use period. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Erectile Dysfunction - Long Term Safety and Efficacy
Open-Label Phase 3 Study to Evaluate the Long-Term Safety and Efficacy of Udenafil Tablets in Male Subjects With Erectile Dysfunction

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).

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

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Erectile Dysfunction
  • 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 Name: WC3043
  • 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 Name: WC3043
  • 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 Name: 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 Name: 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 Name: 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 Name: Placebo 150 mg
  • Experimental: Udenafil 50 mg
    50 mg Udenafil
    Interventions:
    • Drug: Udenafil 50 mg
    • Drug: Placebo Matching 100 mg Udenafil
    • Drug: Placebo Matching 150 mg Udenafil
  • Experimental: Udenafil 100 mg
    100 mg Udenafil
    Interventions:
    • Drug: Udenafil 100 mg
    • Drug: Placebo Matching 50 mg Udenafil
    • Drug: Placebo Matching 150 mg Udenafil
  • Experimental: Udenafil 150 mg
    150 mg Udenafil
    Interventions:
    • Drug: Udenafil 150 mg
    • Drug: Placebo Matching 50 mg Udenafil
    • Drug: Placebo Matching 100 mg Udenafil
  • Placebo Comparator: Placebo
    Placebo Tablets matching Udenafil tablets
    Interventions:
    • Drug: Placebo Matching 50 mg Udenafil
    • Drug: Placebo Matching 100 mg Udenafil
    • Drug: Placebo Matching 150 mg Udenafil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1027
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Male
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01065012
PR-01409
No
Warner Chilcott
Warner Chilcott
Not Provided
Study Director: Herman Ellman, MD Warner Chilcott
Warner Chilcott
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP