Phase 3
N=618
Treatment of Erectile Dysfunction I
Erectile Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01037244 ↗Enrolled (actual)
618
Serious AEs
1.5%
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) — 4.85; 6.98; 7.76; -0.19 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
- Mar 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) |
4.85; 6.98; 7.76; -0.19 | <0.0001 sig |
| PRIMARY Change in Sexual Encounter Profile (SEP), Question 2, Change From Baseline to Overall Study/Weeks 1-12, mITT |
16.74; 27.16; 29.65; -1.86 | <0.0001 sig |
| PRIMARY Change in SEP Question 3, Change From Baseline to Overall Study/Weeks 1-12, mITT |
31.17; 38.78; 49.00; 11.20 | <0.0001 sig |
| SECONDARY Global Assessment Questionnaire (GAQ), While Using the Study Medication, Did You Feel That Your Erections Improved? (Yes Responders), Week 12/Final Visit, mITT Population |
82; 92; 111; 26 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 12/Final Visit in Mean Patient Self-Assessment of Erection (PSAE), mITT Population |
0.38; 0.62; 0.75; -0.06 | <0.0001 sig |
| SECONDARY Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Derived Score, Subject Version, Week 12/ Final Visit, LOCF, mITT Population |
59.59; 65.49; 71.31; 42.92 | <0.0001 sig |
| SECONDARY Change in Satisfaction of Intercourse Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF |
1.81; 2.18; 2.93; -0.09 | <0.0001 sig |
| SECONDARY Change in Orgasmic Function Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF |
1.37; 1.60; 1.93; -0.05 | <0.0001 sig |
| SECONDARY Change in Sexual Desire Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF |
0.45; 0.61; 0.73; -0.12 | 0.0019 sig |
| SECONDARY Change in Overall Satisfaction Domain Score Assessed by IIEF, Baseline to Week 12/Final Visit, mITT, LOCF |
1.98; 2.08; 2.88; 0.32 | <0.0001 sig |
| SECONDARY Change in SEP Question 1, Change From Baseline to Overall/Weeks 1-12, mITT |
0.60; 7.55; 7.42; -11.74 | <0.0001 sig |
| SECONDARY Change in SEP Question 4, Change From Baseline to Overall Study/Weeks 1-12, mITT |
27.36; 32.83; 45.55; 9.30 | <0.0001 sig |
| SECONDARY Change in SEP Question 5, Change From Baseline to Overall/Weeks 1-12, mITT |
26.72; 33.78; 45.52; 8.53 | <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 (NCT01037244). 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.