Vardenafil ODT Versus Placebo in Males With Erectile Dysfunction

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 362
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium, 2020
  • Bruxelles - Brussel, Belgium, 1070
  • Bruxelles - Brussel, Belgium, 1200
  • Bruxelles - Brussel, Belgium, 1000
  • Genk, Belgium, 3600
  • Gent, Belgium, 9000
  • Liege, Belgium, 4000
• France
  • Lille, France, 59000
  • Lyon, France, 69000
  • Lyon Cedex, France, 69437
  • Marseille, France, 13009
  • Marseille, France, 13006
  • Mont-de-marsan, France, 40000
  • Paris, France, 75008
• Germany
  • Hamburg, Germany, 20246
  • Hamburg, Germany, 20354
  • Bayern
    • München, Bayern, Germany, 81925
    • Weiden, Bayern, Germany, 92637
  • Niedersachsen
    • Osnabrück, Niedersachsen, Germany, 49076
  • Nordrhein-Westfalen
    • Mönchengladbach, Nordrhein-Westfalen, Germany, 41063
    • Mülheim, Nordrhein-Westfalen, Germany, 45468
  • Sachsen
    • Bautzen, Sachsen, Germany, 02625
    • Leipzig, Sachsen, Germany, 04109
    • Meißen, Sachsen, Germany, 01662
• Netherlands
  • Arnhem, Netherlands, 6836 BH
  • Deurne, Netherlands, 5751 XJ
  • Leiden, Netherlands, 2316 ZL
  • Losser, Netherlands, 7581 BV
  • Maastricht, Netherlands, 6212 XN
  • Nijverdal, Netherlands, 7442 LS
• South Africa
  • Gauteng
    • Centurion, Gauteng, South Africa, 0140
    • Johannesburg, Gauteng, South Africa, 1818
    • Johannesburg, Gauteng, South Africa, 2198
    • Krugersdorp, Gauteng, South Africa, 1739
    • Pretoria, Gauteng, South Africa, 0083
    • Pretoria, Gauteng, South Africa, 0001
  • KwaZulu Natal
    • Durban, KwaZulu Natal, South Africa, 4091
    • Durban, KwaZulu Natal, South Africa, 4037
  • Kwazulu-Natal
    • Durban, Kwazulu-Natal, South Africa, 4001
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7530
    • Cape Town, Western Cape, South Africa, 7463
• Spain
  • Alicante, Spain, 03010
  • Barcelona, Spain, 08003
  • Barcelona, Spain, 08034
  • La Laguna, Spain, 38320
  • Valencia, Spain, 46010
  • Vigo, Spain, 36211

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 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

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 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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').	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.	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
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
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.	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.	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.	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.	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.	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.	up to 12 weeks
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.	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.	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.	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.	Visit 5 after 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.
• Sperling H, Debruyne F, Boermans A, Beneke M, Ulbrich E, Ewald S. The POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction. J Sex Med. 2010 Apr;7(4 Pt 1):1497-507. doi: 10.1111/j.1743-6109.2010.01806.x. Epub 2010 Mar 3.
• Heinig R, Weimann B, Dietrich H, Bottcher MF. Pharmacokinetics of a new orodispersible tablet formulation of vardenafil: results of three clinical trials. Clin Drug Investig. 2011;31(1):27-41. doi: 10.2165/11584950-000000000-00000.
• Sperling H, Gittelman M, Norenberg C, Ulbrich E, Ewald S. Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials. J Sex Med. 2011 Jan;8(1):261-71. doi: 10.1111/j.1743-6109.2010.02005.x. Epub 2010 Aug 30.

Helpful Links

• Click here and search for information of Bayer products for Europe

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: February 29, 2008
• First Submitted That Met QC Criteria: February 29, 2008
• First Posted (Estimate): March 10, 2008

Study Record Updates

• Last Update Posted (Estimate): December 30, 2014
• Last Update Submitted That Met QC Criteria: December 8, 2014
• Last Verified: December 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: 12093; 2008-000536-40 (EudraCT Number)