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

NCT00492635 | Completed Phase 3

• 2 other identifiers: 113362004-002172-42
• Study Type: interventional
• Target: 628
• Locations: 15 countries
• Sites: 86

Brief 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.

Conditions

Erectile Dysfunction; Sexual Dysfunction, Physiological

Outcome Measures

Primary Outcomes (1)

• 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

  9 months

Secondary Outcomes (1)

• 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

  13 months

Study Arms (3)

Arm 1

EXPERIMENTAL

Drug: Levitra (Vardenafil, BAY38-9456)

Arm 2

EXPERIMENTAL

Drug: Levitra (Vardenafil, BAY38-9456)

Arm 3

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Levitra (Vardenafil, BAY38-9456) DRUG

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 1

Placebo DRUG

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

Arm 3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (86)

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Laguna Hills, California, 92653, United States

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Jeffersonville, Indiana, 47130, United States

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Des Moines, Iowa, 50309, United States

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Jackson, Mississippi, 39202, United States

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Poughkeepsie, New York, 12601, United States

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Cincinnati, Ohio, 45212-2787, United States

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Columbus, Ohio, 43214-1419, United States

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Oklahoma City, Oklahoma, 73104, United States

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Lancaster, Pennsylvania, 17604, United States

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Providence, Rhode Island, 02904, United States

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Spokane, Washington, 99202, United States

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Salzburg, Salzburg, 5020, Austria

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Graz, Styria, 8036, Austria

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Bruxelles - Brussel, 1000, Belgium

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Bruxelles - Brussel, 1200, Belgium

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Edegem, 2650, Belgium

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Hasselt, 3500, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Calgary, Alberta, T2V 4R6, Canada

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Edmonton, Alberta, T6G 2C8, Canada

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Barrie, Ontario, L4M 7G1, Canada

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London, Ontario, N6A 4V2, Canada

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Oakville, Ontario, L6H 3P1, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Chicoutimi, Quebec, G7H 4A3, Canada

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Fleurimont, Quebec, J1H 5N4, Canada

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St. John's, E2L 3J8, Canada

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Victoria, V8R 6T9, Canada

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Oulu, 90220, Finland

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Oulu, FI-90100, Finland

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Tampere, 33100, Finland

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Carpentras, 84200, France

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Lille, 59037, France

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Lyon, 69437, France

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Nîmes, 30000, France

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Saint-Genis-Laval, 69230, France

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Mannheim, Baden-Wurttemberg, 68167, Germany

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Tübingen, Baden-Wurttemberg, 72076, Germany

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München, Bavaria, 81377, Germany

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München, Bavaria, 81675, Germany

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Weiden, Bavaria, 92637, Germany

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Hamburg, Hamburg, 20246, Germany

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Offenbach, Hesse, 63069, Germany

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Braunschweig, Lower Saxony, 38118, Germany

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Osnabrück, Lower Saxony, 49076, Germany

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Dortmund, North Rhine-Westphalia, 44137, Germany

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Herne, North Rhine-Westphalia, 44627, Germany

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Leverkusen, North Rhine-Westphalia, 51375, Germany

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Bari, 70124, Italy

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Florence, 50139, Italy

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Genova, 16132, Italy

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Milan, 20127, Italy

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Milan, 20132, Italy

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Napoli, 80131, Italy

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Trieste, 34149, Italy

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Leiden, 2333 ZA, Netherlands

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Nijmegen, 6525 GA, Netherlands

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Rotterdam, 3015 GD, Netherlands

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Moelv, 2390, Norway

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Tønsberg, 3103, Norway

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Johannesburg, Gauteng, 2193, South Africa

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Pretoria, Gauteng, 0083, South Africa

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Pietermaritzburg, KwaZulu-Natal, 3200, South Africa

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Cape Town, Western Cape, 7505, South Africa

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Cape Town, Western Cape, 8001, South Africa

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Barcelona, Barcelona, 08025, Spain

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Barcelona, Barcelona, 08036, Spain

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Madrid, Madrid, 28046, Spain

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Málaga, Málaga, 29010, Spain

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Vigo, Pontevedra, 36211, Spain

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Valencia, Valencia, 46009, Spain

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Valencia, Valencia, 46026, Spain

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Gothenburg, 413 45, Sweden

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Gothenburg, 417 17, Sweden

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Halmstad, 301 85, Sweden

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Lund, 221 85, Sweden

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Skövde, 541 30, Sweden

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Västerås, 721 89, Sweden

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Bern, Canton of Bern, 3010, Switzerland

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Bath, Avon, BA1 3NG, United Kingdom

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Bristol, Avon, BS10 5NB, United Kingdom

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Slough, Berkshire, SL2 4HL, United Kingdom

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London, London, W6 8RF, United Kingdom

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Manchester, Manchester, M20 4BX, United Kingdom

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Taunton, Somerset, TA1 5DA, United Kingdom

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Related Links

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MeSH Terms

Conditions

Erectile Dysfunction; Sexual Dysfunction, Physiological

Interventions

Vardenafil Dihydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2007
• First Posted: June 27, 2007
• Study Start: December 1, 2004
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

DE (12); ES (7); CH (1); FR (5); US (11); GB (6); SE (6); IT (7); FI (3); AU (2); BE (6); CA (10); NL (3); NO (2); ZA (5)