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

Erectile Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00492635
• Other study ID #: 11336
• Secondary ID: 2004-002172-42
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2007
• Last updated: October 27, 2014
• Start date: December 2004
• Est. completion date: September 2007

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 628
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Erectile Dysfunction
• Sexual Dysfunction, Physiological

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Finland,  France,  Germany,  Italy,  Netherlands,  Norway,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

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