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Treatment of Erectile Dysfunction - Long Term Safety and Efficacy

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ClinicalTrials.gov Identifier: NCT01065012
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : April 20, 2015
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

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
Erectile Dysfunction 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 Type : Interventional  (Clinical Trial)
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 : January 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine


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 Name: 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 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 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 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 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 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 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

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 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




Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065012


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

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01065012     History of Changes
Other Study ID Numbers: PR-01409
First Posted: February 9, 2010    Key Record Dates
Last Update Posted: April 20, 2015
Last Verified: March 2015

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