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”

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

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Levitra (Vardenafil, BAY38-9456)
  • Subjects will receive 12 weeks of PRN treatment with vardenafil 10 mg ODT or matching placebo ODT
• Drug: Placebo
  • Subjects will receive 12 weeks of PRN treatment with vardenafil 10 mg ODT or matching placebo ODT
• Drug: Levitra (Vardenafil, BAY38-9456)
  • After completion of Arm 1 and 2, a subset of subjects (24) will receive one dose of vardenafil 10 mg ODT, after which samples for pharmacokinetics will be taken between 0 and 24 hours

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
  • n/a
• Placebo Comparator: Arm 2
  • n/a
• Experimental: Arm 3
  • n/a

Primary Measures

• IIEF-EF Domain score at visit 4 (week 12) or LOCF see point 7.9 for co-primary variable
  • Time Frame: Between visit 2 and visit 4 (12 weeks)
    Safety Issue?: No
• SEP 2 (success rates of penetration) at Visit 4 (Week 12) overall
  • Time Frame: Between visit 2 and visit 4 (12 weeks)
    Safety Issue?: No
• SEP 3 (maintenance of erection) at Visit 4 (Week 12) overall
  • Time Frame: Between visit 2 and visit 4 (12 weeks)
    Safety Issue?: No

Secondary Measures

• Percentage of subjects achieving "back to normal" erectile function (IIEF-EF > / = 26) at visit 4 (week 12) or LOCF;
  • Time Frame: At week 12
    Safety Issue?: No
• All diary questions other than SEP 2 and 3 concerning erectile function administered over the entire treatment period;
  • Time Frame: At week 0, 4 and 12
    Safety Issue?: No
• Number of sexual attempts under medication till first successful attempt (SEP 3)
  • Time Frame: Week -4 to Week 12
    Safety Issue?: No
• Treatment Satisfaction Scale (TSS) to be administered at the randomization visit and the final visit (or at Premature Discontinuation).
  • Time Frame: At week 0 and 12
    Safety Issue?: No
• A Global Assessment Question (GAQ) concerning the overall effect on erectile function to be administered at the final visit only.
  • Time Frame: At week 12
    Safety Issue?: No
• Safety laboratory examinations, vital signs, physical examination, ECG, and adverse event monitoring
  • Time Frame: At week - 4, 0, 4 and 12, in addition AE monitoring from time of Informed Consent to 48 hours after last tablet (16 or 17 weeks approx.)
    Safety Issue?: Yes
• Pharmacokinetics in a subset of 24 subjects
  • Time Frame: 48 to 168 hours after week 12
    Safety Issue?: Yes

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 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, HIV protease inhibitors, itraconazole or ketoconazole, and 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 Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Overall Contact: Bayer Clinical Trials Contact  clinical-trials-contact@bayerhealthcare.com

Information obtained from ClinicalTrials.gov on August 29, 2008

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

Study ID Number: 12093

ClinicalTrials.gov Identifier: NCT00631969

Health Authority: United States: Food and Drug Administration

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