Phase 3
Completed N=362
Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction
Source: ClinicalTrials.gov NCT00631969 ↗Enrolled (actual)
362
Serious AEs
1.4%
Results posted
Jan 2011
Primary outcomePrimary: Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF — 9.6; 2.1; 7.7; 0.9 scores on a scale — p=< 0.0001
Summary
This study investigates the safety and efficacy of a new dosage form of Vardenafil, an orodispersible tablet (ODT), and compares it to the safety and efficacy of a placebo (inactive) tablet in the treatment of erectile dysfunction. After a 4-week unmedicated phase, patients will receive Vardenafil ODT or matching placebo for 12 weeks. Safety will be determined by laboratory and other evaluations. Efficacy will be determined by the results of different questionnaires and the patient diary that will be used.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF |
9.6; 2.1; 7.7; 0.9; 8.6; 1.4 | < 0.0001 sig |
| PRIMARY Change in Percentage From Baseline in Success of Penetration at 12 Weeks |
35.8; 5.5; 35.2; 8.7; 35.5; 7.2 | < 0.0001 sig |
| PRIMARY Change From Baseline in Success of Erection Maintenance at 12 Weeks |
54.5; 15.2; 49.2; 7.7; 51.7; 11.3 | < 0.0001 sig |
| SECONDARY Percentage of Subjects Achieving "Back to Normal" Erectile Function |
46; 13; 34; 11; 40; 12 | <0.0001 sig |
| SECONDARY Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks |
18.8; -1.8; 14.6; 1.2; 16.6; -0.2 | < 0.0001 sig |
| SECONDARY Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks |
51.7; 11.2; 45.3; 7.5; 48.4; 9.2 | < 0.0001 sig |
| SECONDARY Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks |
55.7; 14.4; 45.8; 5.6; 50.5; 9.8 | < 0.0001 sig |
| SECONDARY Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks |
34.5; 5.4; 32.7; 10.1; 33.5; 7.9 | < 0.0001 sig |
| SECONDARY Number of Sexual Attempts Till First Successful Attempt |
1.0; 2.7; 1.4; 4.4; 1.2; 3.6 | — |
| SECONDARY Change From Baseline in Ease With Erection at 12 Weeks or LOCF |
28.6; 4.2; 25.0; 0.8; 26.7; 2.4 | < 0.0001 sig |
| SECONDARY Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF |
1.3; 0.1; 1.2; -0.1; 1.3; 0.0 | < 0.0001 sig |
| SECONDARY Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF |
28.6; 3.2; 25.3; -3.6; 26.8; -0.4 | < 0.0001 sig |
| SECONDARY Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF |
31.0; 7.1; 26.8; 5.5; 28.8; 6.3 | < 0.0001 sig |
| SECONDARY Change From Baseline in Confidence for Completion at 12 Weeks or LOCF |
28.7; 5.0; 25.8; 3.6; 27.7; 4.2 | < 0.0001 sig |
| SECONDARY Satisfaction With Medication at Week 12 or LOCF |
57.2; 22.1; 52.3; 20.4; 54.6; 21.2 | < 0.0001 sig |
| SECONDARY Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale |
76; 30; 69; 22; 72; 26 | <0.0001 sig |
| SECONDARY Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma |
47.16; 55.37 | 0.7064 |
| SECONDARY Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma |
10.09; 13.43 | 0.8749 |
| SECONDARY Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma |
33.36; 41.80 | 0.7375 |
| SECONDARY Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma |
9.260; 11.47 | 0.3940 |
Eligibility Criteria
Inclusion Criteria
- Males 18 years-of-age or older
- Stable, heterosexual relationship for at least 6 months
- A history of erectile dysfunction (ED) for at least 6 months
Exclusion Criteria
- Any underlying cardiovascular condition, including unstable angina pectoris
- History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to visit 1
- Uncontrolled atrial fibrillation / flutter at screening
- History of surgical prostatectomy for prostate cancer
- Hereditary degenerative retinal disorders
- History of loss of vision because of Non-arteritic anterior ischemic optic neuropathy (NAION), temporary or permanent loss of vision
- Presence of penile anatomical abnormalities
- Subjects who have been confirmed with phenylketonuria (PKU)
- Spinal cord injury
- Resting or postural hypotension or hypertension
- Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha- blockers, medication known to prolong QT interval, Human immunodeficiency virus (HIV) protease inhibitors, itraconazole or ketoconazole, an clarithromycin and erythromycin
- Use of any treatment for ED within 7 days of Visit 1
- History of congenital QT prolongation
- History of syncope within the last 6 months prior to entry into the study
Data sourced from ClinicalTrials.gov (NCT00631969). 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. Informational only — not medical advice.