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

NCT ID: NCT00655629

Last Updated: 2014-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 339 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-02-28

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.

Conditions

Erectile Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Vardenafil ODT (STAXYN, BAY38-9456)

Intervention Type: DRUG

Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT)

Placebo

Matching placebo tablet taken on demand (PRN), approximately one hour before start of sexual activity, no more than one dose per day.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet

Interventions

Vardenafil ODT (STAXYN, BAY38-9456)

Subjects will receive 12 weeks of PRN (on demand) treatment with Vardenafil 10 mg orodispersible tablet (ODT)

Intervention Type: DRUG

Placebo

Subjects will receive 12 weeks of PRN (on demand) treatment with matching placebo tablet

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Schering-Plough

INDUSTRY

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

East Valley Family Physicians, PLC

Chandler, Arizona, United States

Mesa Family Medical Center

Mesa, Arizona, United States

Desert Clinical Research

Mesa, Arizona, United States

Arizona Research Center, Inc.

Phoenix, Arizona, United States

Tatum Highlands Medical Associates, PLLC

Phoenix, Arizona, United States

Fiel Family & Sports Medicine, PC

Tempe, Arizona, United States

Irvine Center for Clinical Research

Irvine, California, United States

Synergy Clinical Research Center

National City, California, United States

San Diego Uro-Research

San Diego, California, United States

San Diego Clinical Trials

San Diego, California, United States

South Florida Medical Research

Aventura, Florida, United States

Jacksonville Impotence Treatment Center

Jacksonville, Florida, United States

University Clinical Research, Inc.

Pembroke Pines, Florida, United States

Tulane Medical Center

New Orleans, Louisiana, United States

Office of Dr. Bruce Gilbert, MD

Great Neck, New York, United States

Mount Sinai Medical Center

New York, New York, United States

The Urology Group

Cincinnati, Ohio, United States

Columbus Urology Research, LLC

Columbus, Ohio, United States

Family Medical Associates

Levittown, Pennsylvania, United States

Pearl Clinical Research

Norristown, Pennsylvania, United States

Office of Dr. Roger Fincher, MD

Spokane, Washington, United States

Sydney Men's Health

Bondi Junction, New South Wales, Australia

Berry Road Medical Centre

St Leonards, New South Wales, Australia

South Terrace Urology

Adelaide, South Australia, Australia

Cabrini Medical Centre

Melbourne, Victoria, Australia

Queen Elizabeth II Medical Centre

Nedlands, Western Australia, Australia

Perth Human Sexuality Centre

Perth, Western Australia, Australia

St.Joseph's Health Care-London

London, Ontario, Canada

The Male Health Centres

Oakville, Ontario, Canada

Office of Dr. Rajiv Singal, MD

Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Clinique d'Urologie du Saguenay

Chicoutimi, Quebec, Canada

Urology South Shore Research

Greenfield Park, Quebec, Canada

Centre de Recherche en Sante Sexuelle du Quebec

Montreal, Quebec, Canada

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Quebec, Canada

Consultorio Dr. Rodríguez Rivera

Guadalajara, Jalisco, Mexico

Hospital Dalinde

México, D. F., Mexico City, Mexico

Centro Médico de las Américas

Mérida, Yucatán, Mexico

Asociación Mexicana para la Salud Sexual A. C.

México D. F., , Mexico

Hospital Santa Fé

México, D. F., , Mexico

Countries

United States; Australia; Canada; Mexico

References

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.

Reference Type: RESULT

PMID: 21883954 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20456213 (View on PubMed)

Other Identifiers

12094

Identifier Type: -

Identifier Source: org_study_id