Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction

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”

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.

Intervention(s) in this Clinical Trial

• Drug: Vardenafil ODT (STAXYN, BAY38-9456)
  • Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10mg orodispersible tablet (ODT)
• Drug: Placebo
  • Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet

Arms, Groups and Cohorts in this Clinical Trial

• 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.
• 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.

Primary 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
    Safety Issue?: No
• Change in Percentage From Baseline in Success of Penetration at 12 Weeks
  • Time Frame: from baseline up to 12 weeks of treatment
    Safety Issue?: No
• Change From Baseline in Success of Erection Maintenance at 12 Weeks
  • Time Frame: from baseline up to 12 weeks of treatment
    Safety Issue?: No

Secondary Measures

• Percentage of Subjects Achieving "Back to Normal" Erectile Function
  • Time Frame: up to 12 weeks of treatment
    Safety Issue?: No
• Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
  • Time Frame: from baseline up to 12 weeks of treatment
    Safety Issue?: No
• 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
    Safety Issue?: No
• Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
  • Time Frame: from baseline up to 12 weeks of treatment
    Safety Issue?: No
• Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
  • Time Frame: from baseline up to 12 weeks of treatment
    Safety Issue?: No
• Number of Sexual Attempts Till First Successful Attempt
  • Time Frame: up to 12 weeks of treatment
    Safety Issue?: No
• Change From Baseline in Ease With Erection at 12 Weeks or LOCF
  • Time Frame: from baseline up to 12 weeks
    Safety Issue?: No
• Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
  • Time Frame: from baseline up to 12 weeks
    Safety Issue?: No
• Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
  • Time Frame: from baseline up to 12 weeks
    Safety Issue?: No
• Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
  • Time Frame: from baseline up to 12 weeks
    Safety Issue?: No
• Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
  • Time Frame: from baseline up to 12 weeks
    Safety Issue?: No
• Satisfaction With Medication at Week 12 or LOCF
  • Time Frame: up to 12 weeks
    Safety Issue?: No
• Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
  • Time Frame: up to 12 weeks of treatment
    Safety Issue?: No
• Pharmacokinetics Measured as Area Under Curve (AUC) of Vardenafil in Plasma
  • Time Frame: Visit 5 after 12 weeks of treatment
    Safety Issue?: No
• Pharmacokinetics Measured as Maximum Concentration (Cmax) of Vardenafil in Plasma
  • Time Frame: Visit 5 after 12 weeks of treatment
    Safety Issue?: No
• Pharmacokinetics Measured as Area Under Curve (AUC) of Metabolite M-1 (BAY44-5576) in Plasma
  • Time Frame: Visit 5 after 12 weeks of treatment
    Safety Issue?: No
• Pharmacokinetics Measured as Maximum Concentration (Cmax) of Metabolite M-1 (BAY44-5576) in Plasma
  • Time Frame: Visit 5 after 12 weeks of treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00631969

Study ID Number: 12093

ClinicalTrials.gov Identifier: NCT00631969

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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