Clinical trial NCT00492635: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Sexual Dysfunction, Physiological
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-06-27
Enrollment: 628
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: 9 months
Secondary outcomes:
measure: 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
timeFrame: 13 months
Other outcomes:
Locations:
city: Laguna Hills
country: United States
state: California
city: Jeffersonville
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Jackson
country: United States
state: Mississippi
city: Poughkeepsie
country: United States
state: New York
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Lancaster
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Spokane
country: United States
state: Washington
city: Graz
country: Austria
state: Steiermark
city: Salzburg
country: Austria
city: Bruxelles - Brussel
country: Belgium
city: Bruxelles - Brussel
country: Belgium
city: Edegem
country: Belgium
city: Hasselt
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Barrie
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Oakville
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Chicoutimi
country: Canada
state: Quebec
city: Fleurimont
country: Canada
state: Quebec
city: St. John
country: Canada
city: Victoria
country: Canada
city: Oulu
country: Finland
city: Oulu
country: Finland
city: Tampere
country: Finland
city: Carpentras
country: France
city: Lille
country: France
city: Lyon Cedex
country: France
city: Nimes
country: France
city: Saint Genis Laval Cedex
country: France
city: Mannheim
country: Germany
state: Baden-Württemberg
city: Tübingen
country: Germany
state: Baden-Württemberg
city: München
country: Germany
state: Bayern
city: München
country: Germany
state: Bayern
city: Weiden
country: Germany
state: Bayern
city: Offenbach
country: Germany
state: Hessen
city: Braunschweig
country: Germany
state: Niedersachsen
city: Osnabrück
country: Germany
state: Niedersachsen
city: Dortmund
country: Germany
state: Nordrhein-Westfalen
city: Herne
country: Germany
state: Nordrhein-Westfalen
city: Leverkusen
country: Germany
state: Nordrhein-Westfalen
city: Hamburg
country: Germany
city: Bari
country: Italy
city: Firenze
country: Italy
city: Genova
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Napoli
country: Italy
city: Trieste
country: Italy
city: Leiden
country: Netherlands
city: Nijmegen
country: Netherlands
city: Rotterdam
country: Netherlands
city: Moelv
country: Norway
city: Tønsberg
country: Norway
city: Johannesburg
country: South Africa
state: Gauteng
city: Pretoria
country: South Africa
state: Gauteng
city: Pietermaritzburg
country: South Africa
state: Kwazulu-Natal
city: Cape Town
country: South Africa
state: Western Cape
city: Cape Town
country: South Africa
state: Western Cape
city: Vigo
country: Spain
state: Pontevedra
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Málaga
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Göteborg
country: Sweden
city: Göteborg
country: Sweden
city: Halmstad
country: Sweden
city: Lund
country: Sweden
city: Skövde
country: Sweden
city: Västerås
country: Sweden
city: Bern
country: Switzerland
city: Bath
country: United Kingdom
state: Avon
city: Bristol
country: United Kingdom
state: Avon
city: Slough
country: United Kingdom
state: Berkshire
city: Taunton
country: United Kingdom
state: Somerset
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: