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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
History of Changes
  Purpose

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 Intervention Phase
Erectile Dysfunction
 Drug: Udenafil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1027
Study Start Date: January 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065012

  Show 72 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Herman Ellman, MD Warner Chilcott
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01065012     History of Changes
Other Study ID Numbers: PR-01409
Study First Received: February 5, 2010
Last Updated: April 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
 Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013