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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: April 11, 2012
Last verified: April 2012

February 5, 2010
April 11, 2012
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
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.
Experimental: Open-Label
Subjects initially assigned to 100 mg dose but may titrate down to 50 mg or up to 150 mg as determined by subject and Investigator.
Intervention: Drug: 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
April 2012

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