Clinical trial NCT00655629: Vardenafil Orodispersible Tablet (ODT) Versus Placebo in Males With Erectile Dysfunction, 50% of Whom Are to be 65 Years or Older.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile Dysfunction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
name: Schering-Plough
First posted: 2008-04-10
Enrollment: 339
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in International Index of Erectile Function (IIEF-EF Sub-Score) at 12 Weeks or Last Observation Carried Forward (LOCF)
timeFrame: from baseline up to 12 weeks
measure: Change in Percentage From Baseline in Success of Penetration (SEP2) at 12 Weeks
timeFrame: from baseline up to 12 weeks of treatment
measure: Change From Baseline in Success of Erection Maintenance at 12 Weeks
timeFrame: from baseline up to 12 weeks of treatment
Secondary outcomes:
measure: Percentage of Subjects Achieving "Back to Normal" Erectile Function
timeFrame: up to 12 weeks of treatment
measure: Change in Percentage From Baseline in Ability to Obtain an Erection at 12 Weeks
timeFrame: from baseline up to 12 weeks of treatment
measure: Change in Percentage From Baseline in Satisfaction With the Hardness of Erection at 12 Weeks
timeFrame: from baseline up to 12 weeks of treatment
measure: Change in Percentage From Baseline in Overall Satisfaction at 12 Weeks
timeFrame: from baseline up to 12 weeks of treatment
measure: Change in Percentage From Baseline in Ability to Ejaculate at 12 Weeks
timeFrame: from baseline up to 12 weeks of treatment
measure: Number of Sexual Attempts Till First Successful Attempt
timeFrame: up to 12 weeks of treatment
measure: Change From Baseline in Ease With Erection at 12 Weeks or LOCF
timeFrame: from baseline up to 12 weeks
measure: Change From Baseline in Erectile Function Satisfaction at 12 Weeks or LOCF
timeFrame: from baseline up to 12 weeks
measure: Change From Baseline in Pleasure of Sexual Activity at 12 Weeks or LOCF
timeFrame: from baseline up to 12 weeks
measure: Change From Baseline in Satisfaction With Orgasm at 12 Weeks or LOCF
timeFrame: from baseline up to 12 weeks
measure: Change From Baseline in Confidence for Completion at 12 Weeks or LOCF
timeFrame: from baseline up to 12 weeks
measure: Satisfaction With Medication at Week 12 or LOCF
timeFrame: up to 12 weeks
measure: Patient Self Reported Improvement of Erectile Function Under Treatment Using a Categorical Rating Scale
timeFrame: up to 12 weeks of treatment
Other outcomes:
Locations:
city: Chandler
country: United States
facility: East Valley Family Physicians, PLC
state: Arizona
city: Mesa
country: United States
facility: Mesa Family Medical Center
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center, Inc.
state: Arizona
city: Phoenix
country: United States
facility: Tatum Highlands Medical Associates, PLLC
state: Arizona
city: Tempe
country: United States
facility: Fiel Family & Sports Medicine, PC
state: Arizona
city: Irvine
country: United States
facility: Irvine Center for Clinical Research
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: San Diego
country: United States
facility: San Diego Uro-Research
state: California
city: San Diego
country: United States
facility: San Diego Clinical Trials
state: California
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Impotence Treatment Center
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Great Neck
country: United States
facility: Office of Dr. Bruce Gilbert, MD
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Cincinnati
country: United States
facility: The Urology Group
state: Ohio
city: Columbus
country: United States
facility: Columbus Urology Research, LLC
state: Ohio
city: Levittown
country: United States
facility: Family Medical Associates
state: Pennsylvania
city: Norristown
country: United States
facility: Pearl Clinical Research
state: Pennsylvania
city: Spokane
country: United States
facility: Office of Dr. Roger Fincher, MD
state: Washington
city: Bondi Junction
country: Australia
facility: Sydney Men's Health
state: New South Wales
city: St Leonards
country: Australia
facility: Berry Road Medical Centre
state: New South Wales
city: Adelaide
country: Australia
facility: South Terrace Urology
state: South Australia
city: Melbourne
country: Australia
facility: Cabrini Medical Centre
state: Victoria
city: Nedlands
country: Australia
facility: Queen Elizabeth II Medical Centre
state: Western Australia
city: Perth
country: Australia
facility: Perth Human Sexuality Centre
state: Western Australia
city: London
country: Canada
facility: St.Joseph's Health Care-London
state: Ontario
city: Oakville
country: Canada
facility: The Male Health Centres
state: Ontario
city: Toronto
country: Canada
facility: Office of Dr. Rajiv Singal, MD
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Chicoutimi
country: Canada
facility: Clinique d'Urologie du Saguenay
state: Quebec
city: Greenfield Park
country: Canada
facility: Urology South Shore Research
state: Quebec
city: Montreal
country: Canada
facility: Centre de Recherche en Sante Sexuelle du Quebec
state: Quebec
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis Jewish General Hospital
state: Quebec
city: México, D. F.
country: Mexico
facility: Hospital Dalinde
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Consultorio Dr. Rodríguez Rivera
state: Jalisco
city: Mérida
country: Mexico
facility: Centro Médico de las Américas
state: Yucatán
city: México D. F.
country: Mexico
facility: Asociación Mexicana para la Salud Sexual A. C.
city: México, D. F.
country: Mexico
facility: Hospital Santa Fé
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.