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
1 other identifier
interventional
339
4 countries
40
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2008
Shorter than P25 for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 4, 2008
CompletedFirst Posted
Study publicly available on registry
April 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
January 21, 2011
CompletedAugust 1, 2014
July 1, 2014
10 months
April 4, 2008
October 7, 2010
July 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (13)
Percentage of Subjects Achieving "Back to Normal" Erectile Function
up to 12 weeks of treatment
Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
from baseline up to 12 weeks of treatment
Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
from baseline up to 12 weeks of treatment
Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
from baseline up to 12 weeks of treatment
Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
from baseline up to 12 weeks of treatment
- +8 more secondary outcomes
Study Arms (2)
Vardenafil ODT (STAXYN, BAY38-9456)
EXPERIMENTALVardenafil 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
PLACEBO COMPARATORMatching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.
Interventions
Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT)
Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- GlaxoSmithKlinecollaborator
- Schering-Ploughcollaborator
Study Sites (40)
East Valley Family Physicians, PLC
Chandler, Arizona, 85224, United States
Mesa Family Medical Center
Mesa, Arizona, 85203, United States
Desert Clinical Research
Mesa, Arizona, 85213, United States
Arizona Research Center, Inc.
Phoenix, Arizona, 85023, United States
Tatum Highlands Medical Associates, PLLC
Phoenix, Arizona, 85050, United States
Fiel Family & Sports Medicine, PC
Tempe, Arizona, 85283, United States
Irvine Center for Clinical Research
Irvine, California, 92618-3603, United States
Synergy Clinical Research Center
National City, California, 91950, United States
San Diego Uro-Research
San Diego, California, 92103, United States
San Diego Clinical Trials
San Diego, California, 92120, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Jacksonville Impotence Treatment Center
Jacksonville, Florida, 32223, United States
University Clinical Research, Inc.
Pembroke Pines, Florida, 33024, United States
Tulane Medical Center
New Orleans, Louisiana, 70112, United States
Office of Dr. Bruce Gilbert, MD
Great Neck, New York, 11021, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
The Urology Group
Cincinnati, Ohio, 45212-2787, United States
Columbus Urology Research, LLC
Columbus, Ohio, 43220, United States
Family Medical Associates
Levittown, Pennsylvania, 19056, United States
Pearl Clinical Research
Norristown, Pennsylvania, 19401, United States
Office of Dr. Roger Fincher, MD
Spokane, Washington, 99206, United States
Sydney Men's Health
Bondi Junction, New South Wales, 2022, Australia
Berry Road Medical Centre
St Leonards, New South Wales, 2065, Australia
South Terrace Urology
Adelaide, South Australia, 5000, Australia
Cabrini Medical Centre
Melbourne, Victoria, 3144, Australia
Queen Elizabeth II Medical Centre
Nedlands, Western Australia, 6009, Australia
Perth Human Sexuality Centre
Perth, Western Australia, 6009, Australia
St.Joseph's Health Care-London
London, Ontario, N6A 4V2, Canada
The Male Health Centres
Oakville, Ontario, L6H 3P1, Canada
Office of Dr. Rajiv Singal, MD
Toronto, Ontario, M4C 5T2, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Clinique d'Urologie du Saguenay
Chicoutimi, Quebec, G7H 4A3, Canada
Urology South Shore Research
Greenfield Park, Quebec, J4V 2H3, Canada
Centre de Recherche en Sante Sexuelle du Quebec
Montreal, Quebec, H2X 1N8, Canada
Sir Mortimer B. Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Consultorio Dr. Rodríguez Rivera
Guadalajara, Jalisco, 45040, Mexico
Hospital Dalinde
México, D. F., Mexico City, 06700, Mexico
Centro Médico de las Américas
Mérida, Yucatán, 97001, Mexico
Asociación Mexicana para la Salud Sexual A. C.
México D. F., 14000, Mexico
Hospital Santa Fé
México, D. F., 06700, Mexico
Related Publications (2)
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.
PMID: 21883954RESULTGittelman 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.
PMID: 20456213RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head
- Organization
- BAYER
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2008
First Posted
April 10, 2008
Study Start
April 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
August 1, 2014
Results First Posted
January 21, 2011
Record last verified: 2014-07