Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil vs Vardenafil PRN vs Placebo in Men Immediately After Nerve-Sparing Prostatectomy for Improving ED - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00492635

Purpose

A study to assess the efficacy of vardenafil, taken as a tablet both nightly or 'as needed' (immediately before intended sexual activity) compared to placebo, to evaluate its tolerability and if it can help in recovery of erections after a nerve sparing radical prostatectomy.

Condition	Intervention	Phase
Erectile Dysfunction Sexual Dysfunction, Physiological	Drug: Levitra (Vardenafil, BAY38-9456) Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Double-Blind, Double-Dummy, Multicenter Parallel Group Study to Compare the Tolerability and Efficacy of Once Daily Vardenafil Versus Vardenafil PRN Versus Placebo in Men Immediately After Nerve-Sparing Prostatectomy for Improving Erectile Function

Resource links provided by NLM:

MedlinePlus related topics: Erectile Dysfunction

Drug Information available for: Vardenafil

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Determine whether early, NIGHTLY dosing with vardenafil Significantly improves recovery of erectile function after surgery as compared to placebo, and whether early PRN dosing with vardenafil also improves recovery of function as compared to placebo [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess whether early dosing of either NIGHTLY or PRN vardenafil over 9 months, followed by 2 months of withdrawal, increases efficacy of subsequent PRN use significantly better than placebo [ Time Frame: 13 months ] [ Designated as safety issue: No ]

Enrollment:	630
Study Start Date:	December 2004
Study Completion Date:	September 2007

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) 9 months DAILY dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
Arm 2: Experimental	Drug: Levitra (Vardenafil, BAY38-9456) 9 months PRN dosage (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication
Arm 3: Placebo Comparator	Drug: Placebo 9 months placebo (double blind) 2 months single-blind placebo wash-out period (subject only is blinded) 2 months open-label PRN treatment with active medication

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At Screening

Males 18-64 years of age
Scheduled to undergo bilateral nerve-sparing radical retropubic BNSRRP, as selected according to the investigator's usual clinical practice
Surgery scheduled within about 1 month of screening (Visit 1)
Expressed an interest in resuming sexual activity as soon as possible after prostatectomy
Heterosexual relationship
No pre-operative erectile dysfunction:
International Index of Erectile Function (IIEF) Erectile Function Domain Score score EF domain =26 at screening without any therapy/devices for improvement of erections
No perforation of the prostate capsule by tumor

At Randomization:

Before being randomized subjects must still be meeting all Screening Inclusion Criteria, as well as the following criteria:

bilateral nerve-sparing during the retropubic prostatectomy documented on the operating report
BNSRRP occurred within approximately 1 month post screening (Visit 1)
No perforation of the prostate capsule by tumor:

No positive tumor margins confirmed after surgery: =T2 stage on pathology report from the surgery

Exclusion Criteria:

Subjects who are taking nitrates or nitric oxide donors
Subjects who are taking the following inhibitors of cytochrome P 450 CYP 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical forms are allowed) or erythromycin
Known hypersensitivity to Vardenafil
Presence of significant penile anatomical abnormalities (e.g. penile fibrosis or Peyronie's disease)
History of retinitis pigmentosa
Unstable angina pectoris
History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months
Severe chronic or acute liver disease
Symptomatic postural hypotension in the past 6 months
NYHA Class III or IV heart failure
Life expectancy <3 years
Clinical diagnosis of significant untreated sleep apnea or working night shifts (e.g. 23:00h to 7:00 h)
Anti-androgens use
Residual prostate cancer, or requirement for radiotherapy or ADT after surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492635

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Locations

United States, California

Laguna Hills, California, United States, 92653
United States, Indiana

Jeffersonville, Indiana, United States, 47130
United States, Iowa

Des Moines, Iowa, United States, 50309
United States, Mississippi

Jackson, Mississippi, United States, 39202
United States, New York

Poughkeepsie, New York, United States, 12601
United States, Ohio

Cincinnati, Ohio, United States, 45212-2787

Columbus, Ohio, United States, 43214-1419
United States, Oklahoma

Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania

Lancaster, Pennsylvania, United States, 17604
United States, Rhode Island

Providence, Rhode Island, United States, 02904
United States, Washington

Spokane, Washington, United States, 99202
Austria

Salzburg, Austria, 5020
Austria, Steiermark

Graz, Steiermark, Austria, 8036
Belgium

LEUVEN, Belgium, 3000

LIEGE, Belgium, 4000

HASSELT, Belgium, 3500

BRUXELLES, Belgium, 1200

EDEGEM, Belgium, 2650

BRUXELLES, Belgium, 1000
Canada

Victoria, Canada, V8R 6T9

St. John, Canada, E2L 3J8
Canada, Alberta

Edmonton, Alberta, Canada, T6G 2C8

Calgary, Alberta, Canada, T2V 4R6
Canada, Ontario

London, Ontario, Canada, N6A 4V2

Oakville, Ontario, Canada, L6H 3P1

Barrie, Ontario, Canada, L4M 4S5

Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec

Fleurimont, Quebec, Canada, J1H 5N4

Chicoutimi, Quebec, Canada, G7H 4A3
Finland

Tampere, Finland, 33100

Oulu, Finland, 90100

Oulu, Finland, 90020
France

LYON CEDEX, France, 69437

LILLE, France, 59037

SAINT GENIS LAVAL CEDEX, France, 69230

NIMES, France, 30000

CARPENTRAS, France, 84200
Germany, Baden-Württemberg / 275

Mannheim, Baden-Württemberg / 275, Germany, 68167
Germany, Baden-Württemberg / 277

Tübingen, Baden-Württemberg / 277, Germany, 72076
Germany, Bayern / 280

Weiden, Bayern / 280, Germany, 92637

München, Bayern / 280, Germany, 81675

München, Bayern / 280, Germany, 81377
Germany, Hamburg / 287

Hamburg, Hamburg / 287, Germany, 20251
Germany, Hessen / 307

Offenbach, Hessen / 307, Germany, 63069
Germany, Niedersachsen / 290

Braunschweig, Niedersachsen / 290, Germany, 38118
Germany, Niedersachsen / 293

Osnabrück, Niedersachsen / 293, Germany, 49076
Germany, Nordrhein-Westfalen / 331

Leverkusen, Nordrhein-Westfalen / 331, Germany, 51375
Germany, Nordrhein-Westfalen / 356

Dortmund, Nordrhein-Westfalen / 356, Germany, 44137
Germany, Nordrhein-Westfalen / 359

Herne, Nordrhein-Westfalen / 359, Germany, 44627
Italy

Milano, Italy, 20132

Trieste, Italy, 34149

Firenze, Italy, 50139

Genova, Italy, 16132

Napoli, Italy, 80131

Bari, Italy, 70124
Netherlands

LEIDEN, Netherlands, 2333 ZA

ROTTERDAM, Netherlands, 3015 GD

NIJMEGEN, Netherlands, 6525 GA
Norway

Moelv, Norway, 2390

Tønsberg, Norway, 3116
South Africa, Gauteng

Johannesburg, Gauteng, South Africa, 2132

Pretoria, Gauteng, South Africa, 0083
South Africa, Kwa Zulu Natal

Pietermaritzburg, Kwa Zulu Natal, South Africa, 3200
South Africa, Western Cape

Cape Town, Western Cape, South Africa, 7505

Cape Town, Western Cape, South Africa, 8001
Spain

Barcelona, Spain, 08036

Madrid, Spain, 28046

Málaga, Spain, 29010

Valencia, Spain, 46009
Spain, Cataluña

Barcelona, Cataluña, Spain, 08025
Spain, Pontevedra

Vigo, Pontevedra, Spain, 36211
Sweden

Göteborg, Sweden, 413 45

Halmstad, Sweden, 301 85

Skövde, Sweden, 541 30

Västerås, Sweden, 721 89

Lund, Sweden, 221 85

Göteborg, Sweden, 417 17
Switzerland

Bern, Switzerland, 3010
United Kingdom, Avon

Bristol, Avon, United Kingdom, BS10 5NB

Bath, Avon, United Kingdom, BA1 3NG
United Kingdom, Berkshire

Slough, Berkshire, United Kingdom, SL2 4HL
United Kingdom, Greater London

London, Greater London, United Kingdom, W6 8RF
United Kingdom, Greater Manchester

Manchester, Greater Manchester, United Kingdom, M20 4BX
United Kingdom, Somerset

Taunton, Somerset, United Kingdom, TA1 5DA

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Bayer Healthcare Pharmaceuticals Inc. ( Therapeutic Area Head )
Study ID Numbers:	11336, EudraCT 2004-002172-42
Study First Received:	June 26, 2007
Last Updated:	June 26, 2009
ClinicalTrials.gov Identifier:	NCT00492635 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Genital Diseases, Female
Phosphodiesterase Inhibitors
Vardenafil
Sexual Dysfunction, Physiological
Molecular Mechanisms of Pharmacological Action

Mental Disorders
Enzyme Inhibitors
Genital Diseases, Male
Sexual and Gender Disorders
Erectile Dysfunction
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009