Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction - Full Text View

Purpose

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.

Condition	Intervention	Phase
Erectile Dysfunction	Drug: Vardenafil ODT (STAXYN, BAY38-9456) Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Pivotal Phase III Trial to Investigate the Efficacy and Safety of an Orodispersible Tablet Vardenafil Versus Placebo in the Treatment of Men With Erectile Dysfunction (ED) - a Fixed-dose, Double-blind, Randomized Multi-center Trial - POTENT I

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil Vardenafil hydrochloride Vardenafil dihydrochloride Vardenafil hydrochloride trihydrate

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or LOCF [ Time Frame: from baseline up to 12 weeks ] [ Designated as safety issue: No ]
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 Success of Penetration at 12 Weeks [ Time Frame: from baseline up to 12 weeks of treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: from baseline up to 12 weeks of treatment ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Percentage of Subjects Achieving "Back to Normal" Erectile Function [ Time Frame: up to 12 weeks of treatment ] [ Designated as safety issue: No ]
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 Ability to Obtain an Erection at 12 Weeks [ Time Frame: from baseline up to 12 weeks of treatment ] [ Designated as safety issue: No ]
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 in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks [ Time Frame: from baseline up to 12 weeks of treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: from baseline up to 12 weeks of treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: from baseline up to 12 weeks of treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: up to 12 weeks of treatment ] [ Designated as safety issue: No ]
Change From Baseline in Ease With Erection at 12 Weeks or LOCF [ Time Frame: from baseline up to 12 weeks ] [ Designated as safety issue: No ]
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 [ Time Frame: from baseline up to 12 weeks ] [ Designated as safety issue: No ]
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 Pleasure of Sexual Activity at 12 Weeks or LOCF [ Time Frame: from baseline up to 12 weeks ] [ Designated as safety issue: No ]
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.
Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF [ Time Frame: from baseline up to 12 weeks ] [ Designated as safety issue: No ]
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.
Change From Baseline in Confidence for Completion at 12 Weeks or LOCF [ Time Frame: from baseline up to 12 weeks ] [ Designated as safety issue: No ]
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.
Satisfaction With Medication at Week 12 or LOCF [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
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.
Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale [ Time Frame: up to 12 weeks of treatment ] [ Designated as safety issue: No ]
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 Area Under Curve (AUC) of Vardenafil in Plasma [ Time Frame: Visit 5 after 12 weeks of treatment ] [ Designated as safety issue: No ]
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 Vardenafil in Plasma [ Time Frame: Visit 5 after 12 weeks of treatment ] [ Designated as safety issue: No ]
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.
Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma [ Time Frame: Visit 5 after 12 weeks of treatment ] [ Designated as safety issue: No ]
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 [ Time Frame: Visit 5 after 12 weeks of treatment ] [ Designated as safety issue: No ]
Plasma concentrations after single dose administration of 10 mg Vardenafil ODT followed for up to 24 hours post-dose.

Enrollment:	362
Study Start Date:	April 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: Vardenafil ODT (STAXYN, BAY38-9456) Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT)
Placebo Comparator: Placebo Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.	Drug: Placebo Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00631969

Show 47 Study Locations

Sponsors and Collaborators

Bayer

GlaxoSmithKline

Schering-Plough

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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Publications:

Debruyne FM, Gittelman M, Sperling H, Börner M, Beneke M. Time to onset of action of vardenafil: a retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. J Sex Med. 2011 Oct;8(10):2912-23. doi: 10.1111/j.1743-6109.2011.02462.x. Epub 2011 Aug 30.

Responsible Party:	Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier:	NCT00631969 History of Changes
Other Study ID Numbers:	12093, 2008-000536-40
Study First Received:	February 29, 2008
Results First Received:	October 5, 2010
Last Updated:	August 1, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices United States: Food and Drug Administration

Keywords provided by Bayer:

Erectile Dysfunction

Additional relevant MeSH terms:

Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Vardenafil
Vasodilator Agents

Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013