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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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Erectile Dysfunction; Sexual Dysfunction, Physiological

Intervention: Levitra (Vardenafil, BAY38-9456) (Drug); Levitra (Vardenafil, BAY38-9456) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: 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

Secondary outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Male.

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

Locations and Contacts

Salzburg 5020, Austria

Bruxelles - Brussel 1000, Belgium

Bruxelles - Brussel 1200, Belgium

Edegem 2650, Belgium

Hasselt 3500, Belgium

Leuven 3000, Belgium

Liege 4000, Belgium

St. John E2L 3J8, Canada

Victoria V8R 6T9, Canada

Oulu FI-90100, Finland

Oulu 90220, Finland

Tampere 33100, Finland

Carpentras 84200, France

Lille 59037, France

Lyon Cedex 69437, France

Nimes 30000, France

Saint Genis Laval Cedex 69230, France

Hamburg 20246, Germany

Bari 70124, Italy

Firenze 50139, Italy

Genova 16132, Italy

Milano 20127, Italy

Milano 20132, Italy

Napoli 80131, Italy

Trieste 34149, Italy

Leiden 2333 ZA, Netherlands

Nijmegen 6525 GA, Netherlands

Rotterdam 3015 GD, Netherlands

Moelv 2390, Norway

Tønsberg 3103, Norway

Barcelona 08025, Spain

Barcelona 08036, Spain

Madrid 28046, Spain

Málaga 29010, Spain

Valencia 46009, Spain

Valencia 46026, Spain

Göteborg 417 17, Sweden

Göteborg 413 45, Sweden

Halmstad 301 85, Sweden

Lund 221 85, Sweden

Skövde 541 30, Sweden

Västerås 721 89, Sweden

Bern 3010, Switzerland

London W6 8RF, United Kingdom

Manchester M20 4BX, United Kingdom

Calgary, Alberta T2V 4R6, Canada

Edmonton, Alberta T6G 2C8, Canada

Bath, Avon BA1 3NG, United Kingdom

Bristol, Avon BS10 5NB, United Kingdom

Mannheim, Baden-Württemberg 68167, Germany

Tübingen, Baden-Württemberg 72076, Germany

München, Bayern 81377, Germany

München, Bayern 81675, Germany

Weiden, Bayern 92637, Germany

Slough, Berkshire SL2 4HL, United Kingdom

Laguna Hills, California 92653, United States

Johannesburg, Gauteng 2193, South Africa

Pretoria, Gauteng 0083, South Africa

Offenbach, Hessen 63069, Germany

Jeffersonville, Indiana 47130, United States

Des Moines, Iowa 50309, United States

Pietermaritzburg, Kwazulu-Natal 3200, South Africa

Jackson, Mississippi 39202, United States

Poughkeepsie, New York 12601, United States

Braunschweig, Niedersachsen 38118, Germany

Osnabrück, Niedersachsen 49076, Germany

Dortmund, Nordrhein-Westfalen 44137, Germany

Herne, Nordrhein-Westfalen 44627, Germany

Leverkusen, Nordrhein-Westfalen 51375, Germany

Cincinnati, Ohio 45212-2787, United States

Columbus, Ohio 43214-1419, United States

Oklahoma City, Oklahoma 73104, United States

Barrie, Ontario L4M 7G1, Canada

London, Ontario N6A 4V2, Canada

Oakville, Ontario L6H 3P1, Canada

Toronto, Ontario M4N 3M5, Canada

Lancaster, Pennsylvania 17604, United States

Vigo, Pontevedra 36211, Spain

Chicoutimi, Quebec G7H 4A3, Canada

Fleurimont, Quebec J1H 5N4, Canada

Providence, Rhode Island 02904, United States

Taunton, Somerset TA1 5DA, United Kingdom

Graz, Steiermark 8036, Austria

Spokane, Washington 99202, United States

Cape Town, Western Cape 7505, South Africa

Cape Town, Western Cape 8001, South Africa

Additional Information

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Starting date: December 2004
Last updated: October 27, 2014

Page last updated: August 23, 2015

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