Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction

Phase 3

Completed

• Conditions: Erectile Dysfunction
• Interventions: Drug: Placebo; Drug: Vardenafil ODT (STAXYN, BAY38-9456)

• Registration Number: NCT00631969
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-02-29
• Study First Submitted QC: 2008-02-29
• Study First Posted: 2008-03-10
• Study Start: 2008-04
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Disposition First Submitted: 2010-02-08
• Disposition First Submitted QC: 2010-02-08
• Disposition First Posted: 2010-02-10
• Results First Submitted: 2010-10-05
• Results First Submitted QC: 2010-12-21
• Results First Posted: 2011-01-21
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 362

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Vardenafil ODT (STAXYN, BAY38-9456)	Vardenafil ODT (STAXYN, BAY38-9456)	Vardenafil 10 mg orodispersible tablet (ODT) taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.

Primary Outcome Measures

Name	Time	Method
Change in Percentage From Baseline in Success of Penetration at 12 Weeks	from baseline up to 12 weeks of treatment	Sexual encounter profile (SEP) items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to penetrate the partner.
Change From Baseline in Success of Erection Maintenance at 12 Weeks	from baseline up to 12 weeks of treatment	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to maintain an erection after penetration.
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF	from baseline up to 12 weeks	The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: \<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \>25 'no ED').

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Achieving "Back to Normal" Erectile Function	up to 12 weeks of treatment	Responders: percentage of subjects achieving an IIEF-EF score \> 25. The primary variable was the treatment group difference from baseline to Week 12 or Last observation carried forward (LOCF) of the least square mean difference in the IIEF-EF domain score (1-30 ordinal points, specifying the severity of erectile dysfunction: \<=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; \>25 'no ED').
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks	from baseline up to 12 weeks of treatment	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to get satisfactory hardness of erections.
Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks	from baseline up to 12 weeks of treatment	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to overall satisfactory attempts.
Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks	from baseline up to 12 weeks of treatment	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to have successful ejaculations.
Number of Sexual Attempts Till First Successful Attempt	up to 12 weeks of treatment
Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma	Visit 5 after 12 weeks of treatment	Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma	Visit 5 after 12 weeks of treatment	Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks	from baseline up to 12 weeks of treatment	SEP items success rates are the percentage of all valid and successful intercourse attempts (items answered 'yes') in relation to all valid attempts. Here the SEP item refers to the ability to obtain successful erections.
Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF	from baseline up to 12 weeks	Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain " Pleasure of sexual activity" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma	Visit 5 after 12 weeks of treatment	Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Change From Baseline in Ease With Erection at 12 Weeks or LOCF	from baseline up to 12 weeks	Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Ease with Erection" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF	from baseline up to 12 weeks	Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain " Erectile function satisfaction" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF	from baseline up to 12 weeks	Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Satisfaction with orgasm" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Satisfaction With Medication at Week 12 or LOCF	up to 12 weeks	Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Satisfaction with medication" at LOCF expressed as the least square mean difference.
Change From Baseline in Confidence for Completion at 12 Weeks or LOCF	from baseline up to 12 weeks	Treatment group difference in points on the Treatment Satisfaction Scale (TSS, 0-100 normalized ordinal scores, higher scores indicate greater levels of 'ease with erection', 'erectile functioning satisfaction', 'pleasure of sexual activity', 'satisfaction with orgasm', 'confidence for completion', and 'satisfaction with medication') domain "Confidence for completion" from baseline to Week 12 or LOCF expressed as the least square mean difference.
Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale	up to 12 weeks of treatment	Categorical Rating Scale is a binary rating scale with 2 response options which is 'yes/no'; percentage of participants with positive answers to the Global Assessment Question. Global Assessment Question (GAQ): 'Has the treatment you have been taking over the past for weeks improved your erection?' (yes/no)
Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma	Visit 5 after 12 weeks of treatment	Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.