Phase 3
N=601
Treatment of Erectile Dysfunction II
Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01037218 ↗Enrolled (actual)
601
Serious AEs
1.0%
Results posted
Dec 2011
Primary outcome: Primary: Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward) — 3.79; 6.14; 7.94; 0.41 Units on a Scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Udenafil (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- Male
- Sponsor
- Warner Chilcott
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Erectile Function Domain Assessed by International Index of Erectile Function (IIEF), Baseline to Final Visit/Week 12, mITT (Modified Intent-to-Treat), LOCF (Last Observation Carried Forward) |
3.79; 6.14; 7.94; 0.41 | <0.0001 sig |
| PRIMARY Changes in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT |
14.47; 19.34; 27.12; -5.72 | <0.0001 sig |
| PRIMARY Changes in Sexual Encounter Profile (SEP), Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT |
33.24; 38.34; 46.93; 11.53 | <0.0001 sig |
| SECONDARY Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF |
1.49; 2.25; 2.86; -0.04 | <0.0001 sig |
| SECONDARY Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF |
0.84; 1.77; 1.78; 0.25 | 0.0673 |
| SECONDARY Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF |
0.30; 0.65; 0.65; -0.06 | 0.0566 |
| SECONDARY Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF |
1.46; 2.15; 2.69; 0.60 | 0.0019 sig |
| SECONDARY Global Assessment Questionnaire (GAQ), Week 12/Final Visit, mITT Population |
68; 85; 105; 33 | <0.0001 sig |
| SECONDARY Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/Final Visit, LOCF, mITT |
57.20; 64.16; 71.56; 44.55 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population |
0.39; 0.49; 0.78; -0.05 | <0.0001 sig |
| SECONDARY Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT |
3.39; 3.16; 9.28; -11.78 | <0.0001 sig |
| SECONDARY Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT |
27.12; 37.92; 43.42; 9.61 | <0.0001 sig |
| SECONDARY Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT |
26.27; 36.93; 41.88; 7.53 | <0.0001 sig |
Summary
Randomized, placebo-controlled, double-blind, parallel design, Phase 3 study to evaluate the safety and efficacy of udenafil, an orally administered, potent and selective inhibitor of PDE-5 versus placebo for the treatment of subjects with erectile dysfunction (ED).
Eligibility Criteria
Inclusion Criteria
- Male, at least 19 years of age
- Stable monogamous relationship for at least 6 months with a consenting female partner who is at least 19 years of age, vaginal intercourse is a required study activity
- History of ED (clinically defined as the inability to attain and maintain an erection of the penis sufficient to permit satisfactory sexual intercourse) of at least 3 months duration
- Partner is not pregnant or lactating
Exclusion Criteria
- History of new-onset symptomatic coronary artery disease within the last 3 months or a history of myocardial infarction or cardiac surgical procedure within six months
- 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 such as Viagra®, Cialis® or Levitra®
- Previously failed to respond to PDE-5 inhibitors such as Viagra®, Cialis® or Levitra®
Data sourced from ClinicalTrials.gov (NCT01037218). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.