Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.

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

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 Overview

• Status: Completed
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Drug: Vardenafil ODT (STAXYN, BAY38-9456); Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 339
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Bondi Junction, New South Wales, Australia, 2022
      • Sydney Men's Health
    • St Leonards, New South Wales, Australia, 2065
      • Berry Road Medical Centre
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • South Terrace Urology
  • Victoria
    • Melbourne, Victoria, Australia, 3144
      • Cabrini Medical Centre
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Queen Elizabeth II Medical Centre
    • Perth, Western Australia, Australia, 6009
      • Perth Human Sexuality Centre
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • St.Joseph's Health Care-London
    • Oakville, Ontario, Canada, L6H 3P1
      • The Male Health Centres
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada, M4C 5T2
      • Office of Dr. Rajiv Singal, MD
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 4A3
      • Clinique d'Urologie du Saguenay
    • Greenfield Park, Quebec, Canada, J4V 2H3
      • Urology South Shore Research
    • Montreal, Quebec, Canada, H3T 1E2
      • Sir Mortimer B. Davis Jewish General Hospital
    • Montreal, Quebec, Canada, H2X 1N8
      • Centre de Recherche en Sante Sexuelle du Quebec
• Mexico
  • México D. F., Mexico, 14000
    • Asociación Mexicana para la Salud Sexual A. C.
  • México, D. F., Mexico, 06700
    • Hospital Santa Fé
  • Distrito Federal
    • México, D. F., Distrito Federal, Mexico, 06700
      • Hospital Dalinde
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 45040
      • Consultorio Dr. Rodríguez Rivera
  • Yucatán
    • Mérida, Yucatán, Mexico, 97001
      • Centro Medico de las Américas
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • East Valley Family Physicians, PLC
    • Mesa, Arizona, United States, 85213
      • Desert Clinical Research
    • Mesa, Arizona, United States, 85203
      • Mesa Family Medical Center
    • Phoenix, Arizona, United States, 85023
      • Arizona Research Center, Inc.
    • Phoenix, Arizona, United States, 85050
      • Tatum Highlands Medical Associates, PLLC
    • Tempe, Arizona, United States, 85283
      • Fiel Family & Sports Medicine, PC
  • California
    • Irvine, California, United States, 92618-3603
      • Irvine Center for Clinical Research
    • National City, California, United States, 91950
      • Synergy Clinical Research Center
    • San Diego, California, United States, 92120
      • San Diego Clinical Trials
    • San Diego, California, United States, 92103
      • San Diego Uro-Research
  • Florida
    • Aventura, Florida, United States, 33180
      • South Florida Medical Research
    • Jacksonville, Florida, United States, 32223
      • Jacksonville Impotence Treatment Center
    • Pembroke Pines, Florida, United States, 33024
      • University Clinical Research, Inc.
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Medical Center
  • New York
    • Great Neck, New York, United States, 11021
      • Office of Dr. Bruce Gilbert, MD
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45212-2787
      • The Urology Group
    • Columbus, Ohio, United States, 43220
      • Columbus Urology Research, LLC
  • Pennsylvania
    • Levittown, Pennsylvania, United States, 19056
      • Family Medical Associates
    • Norristown, Pennsylvania, United States, 19401
      • Pearl Clinical Research
  • Washington
    • Spokane, Washington, United States, 99206
      • Office of Dr. Roger Fincher, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 congenital QT prolongation
• History of surgical prostatectomy due to prostate cancer
• Hereditary degenerative retinal disorders
• History of loss of vision because of NAION (Non-arteritic anterior ischemic optic neuropathy), temporary or permanent loss of vision
• Presence of penile anatomical abnormalities
• Spinal cord injury
• Resting or postural hypotension or hypertension
• Subjects who are taking nitrates or nitric oxide donors, androgens, anti-androgens, alpha-blockers, HIV (Human immunodeficiency virus) protease inhibitors, itraconazole or ketoconazole, and clarithromycin and erythromycin.
• Subjects taking medication known to prolong QT interval, such as Type Ia and Type 3 anti-arrhythmics.
• Subjects who have been confirmed with phenylketonuria (PKU).
• Use of any treatment for ED within 7 days of Visit 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 10 mg 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF)	The primary variable was the treatment group difference from baseline to Week 12 or LOCF of the least square mean difference in the IIEF-EF domain score (Range: 1-30 ordinal. Directionality: severity of erectile dysfunction: <=10 'severe'; 11-16 'moderate'; 17-21 'mild to moderate'; 22-25 'mild'; >25 'no ED'.)	from baseline up to 12 weeks
Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks	SEP (Sexual Encounter Profile) 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.	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.	from baseline up to 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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').	up to 12 weeks of treatment
Change in Percentage From Baseline in Ability to Obtain an Erection 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 obtain successful erections.	from baseline up to 12 weeks of treatment
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection 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 get satisfactory hardness of erections.	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.	from baseline up to 12 weeks of treatment
Change in Percentage From Baseline in Ability to Ejaculate 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 have successful ejaculations.	from baseline up to 12 weeks of treatment
Number of Sexual Attempts Till First Successful Attempt		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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Ease with Erection" from baseline to Week 12 or LOCF expressed as the least square mean difference.	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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Erectile function satisfaction" from baseline to Week 12 or LOCF expressed as the least square mean difference	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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Pleasure of sexual activity" from baseline to Week 12 or LOCF expressed as the least square mean difference	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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Satisfaction with orgasm" from baseline to Week 12 or LOCF expressed as the least square mean difference	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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Confidence for completion" from baseline to Week 12 or LOCF expressed as the least square mean difference	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; Directionality: Higher scores indicate greater levels of (i) ease with erection, (ii) erectile functioning satisfaction, (iii) pleasure of sexual activity, (iv) satisfaction with orgasm, (v) confidence for completion, and (vi) satisfaction with medication.) domain "Satisfaction with medication" at LOCF expressed as the least square mean difference	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)	up to 12 weeks of treatment

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: GlaxoSmithKline; Schering-Plough

Publications and helpful links

General Publications

• Debruyne FM, Gittelman M, Sperling H, Borner 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.
• Gittelman M, McMahon CG, Rodriguez-Rivera JA, Beneke M, Ulbrich E, Ewald S. The POTENT II randomised trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. Int J Clin Pract. 2010 Apr;64(5):594-603. doi: 10.1111/j.1742-1241.2010.02358.x.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: April 4, 2008
• First Submitted That Met QC Criteria: April 9, 2008
• First Posted (Estimate): April 10, 2008

Study Record Updates

• Last Update Posted (Estimate): August 1, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Erectile Dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Urological Agents; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Vardenafil Dihydrochloride
• Other Study ID Numbers: 12094