Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction

Phase 3CompletedNCT00631969

Bayer362 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

362

Conditions

Erectile Dysfunction

Interventions

Vardenafil ODT (STAXYN, BAY38-9456)DRUG

Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT)

PlaceboDRUG

Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (47)

Outcomes

Primary Outcomes

Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF

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').

Time frame: from baseline up to 12 weeks

Change in Percentage From Baseline in Success of Penetration at 12 Weeks

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.

Time frame: from baseline up to 12 weeks of treatment

Change From Baseline in Success of Erection Maintenance at 12 Weeks

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.

Time frame: from baseline up to 12 weeks of treatment

Secondary Outcomes

Percentage of Subjects Achieving "Back to Normal" Erectile Function

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').

Time frame: up to 12 weeks of treatment

Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks

Data from ClinicalTrials.gov

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Unnamed facility

Antwerp, Belgium

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Bruxelles - Brussel, Belgium

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Bruxelles - Brussel, Belgium

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Bruxelles - Brussel, Belgium

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Genk, Belgium

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Ghent, Belgium

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Liège, Belgium

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Lille, France

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Lyon, France

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Lyon, France

...and 37 more locations

Time frame: from baseline up to 12 weeks of treatment

Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks

Time frame: from baseline up to 12 weeks of treatment

Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks

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.

Time frame: from baseline up to 12 weeks of treatment

Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks

Time frame: from baseline up to 12 weeks of treatment

Number of Sexual Attempts Till First Successful Attempt

Time frame: up to 12 weeks of treatment

Change From Baseline in Ease With Erection at 12 Weeks or LOCF

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.

Time frame: from baseline up to 12 weeks

Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF

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.

Time frame: from baseline up to 12 weeks

Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF

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.

Time frame: from baseline up to 12 weeks

Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF

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.

Time frame: from baseline up to 12 weeks

Change From Baseline in Confidence for Completion at 12 Weeks or LOCF

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.

Time frame: from baseline up to 12 weeks

Satisfaction With Medication at Week 12 or LOCF

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.

Time frame: up to 12 weeks

Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale

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)

Time frame: up to 12 weeks of treatment

Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma

Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.

Time frame: Visit 5 after 12 weeks of treatment

Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma

Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.

Time frame: Visit 5 after 12 weeks of treatment

Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma

Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.

Time frame: Visit 5 after 12 weeks of treatment

Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma

Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.

Time frame: Visit 5 after 12 weeks of treatment