Erectile Dysfunction
Conditions
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).
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.
Interventions
DRUGUdenafil 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.
DRUGUdenafil 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.
DRUGUdenafil 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.
DRUGPlacebo 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.
DRUGPlacebo 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.
DRUGPlacebo 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.
Sponsors
Warner Chilcott
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. |
Countries
United States
Outcome results
None listed