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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

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00492635
Collaborator
(none)
628
Enrollment
86
Locations
3
Arms
33
Duration (Months)
7.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Levitra (Vardenafil, BAY38-9456)
  • Drug: Levitra (Vardenafil, BAY38-9456)
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
628 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2004
Actual Primary Completion Date :
Sep 1, 2007
Actual Study Completion Date :
Sep 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

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
Experimental: Arm 2

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
Placebo Comparator: Arm 3

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

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  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]

Eligibility Criteria

Criteria

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

Locations

Site City State Country Postal Code
1 Laguna Hills California United States 92653
2 Jeffersonville Indiana United States 47130
3 Des Moines Iowa United States 50309
4 Jackson Mississippi United States 39202
5 Poughkeepsie New York United States 12601
6 Cincinnati Ohio United States 45212-2787
7 Columbus Ohio United States 43214-1419
8 Oklahoma City Oklahoma United States 73104
9 Lancaster Pennsylvania United States 17604
10 Providence Rhode Island United States 02904
11 Spokane Washington United States 99202
12 Graz Steiermark Austria 8036
13 Salzburg Austria 5020
14 Bruxelles - Brussel Belgium 1000
15 Bruxelles - Brussel Belgium 1200
16 Edegem Belgium 2650
17 Hasselt Belgium 3500
18 Leuven Belgium 3000
19 Liege Belgium 4000
20 Calgary Alberta Canada T2V 4R6
21 Edmonton Alberta Canada T6G 2C8
22 Barrie Ontario Canada L4M 7G1
23 London Ontario Canada N6A 4V2
24 Oakville Ontario Canada L6H 3P1
25 Toronto Ontario Canada M4N 3M5
26 Chicoutimi Quebec Canada G7H 4A3
27 Fleurimont Quebec Canada J1H 5N4
28 St. John Canada E2L 3J8
29 Victoria Canada V8R 6T9
30 Oulu Finland 90220
31 Oulu Finland FI-90100
32 Tampere Finland 33100
33 Carpentras France 84200
34 Lille France 59037
35 Lyon Cedex France 69437
36 Nimes France 30000
37 Saint Genis Laval Cedex France 69230
38 Mannheim Baden-Württemberg Germany 68167
39 Tübingen Baden-Württemberg Germany 72076
40 München Bayern Germany 81377
41 München Bayern Germany 81675
42 Weiden Bayern Germany 92637
43 Offenbach Hessen Germany 63069
44 Braunschweig Niedersachsen Germany 38118
45 Osnabrück Niedersachsen Germany 49076
46 Dortmund Nordrhein-Westfalen Germany 44137
47 Herne Nordrhein-Westfalen Germany 44627
48 Leverkusen Nordrhein-Westfalen Germany 51375
49 Hamburg Germany 20246
50 Bari Italy 70124
51 Firenze Italy 50139
52 Genova Italy 16132
53 Milano Italy 20127
54 Milano Italy 20132
55 Napoli Italy 80131
56 Trieste Italy 34149
57 Leiden Netherlands 2333 ZA
58 Nijmegen Netherlands 6525 GA
59 Rotterdam Netherlands 3015 GD
60 Moelv Norway 2390
61 Tønsberg Norway 3103
62 Johannesburg Gauteng South Africa 2193
63 Pretoria Gauteng South Africa 0083
64 Pietermaritzburg Kwazulu-Natal South Africa 3200
65 Cape Town Western Cape South Africa 7505
66 Cape Town Western Cape South Africa 8001
67 Vigo Pontevedra Spain 36211
68 Barcelona Spain 08025
69 Barcelona Spain 08036
70 Madrid Spain 28046
71 Málaga Spain 29010
72 Valencia Spain 46009
73 Valencia Spain 46026
74 Göteborg Sweden 413 45
75 Göteborg Sweden 417 17
76 Halmstad Sweden 301 85
77 Lund Sweden 221 85
78 Skövde Sweden 541 30
79 Västerås Sweden 721 89
80 Bern Switzerland 3010
81 Bath Avon United Kingdom BA1 3NG
82 Bristol Avon United Kingdom BS10 5NB
83 Slough Berkshire United Kingdom SL2 4HL
84 Taunton Somerset United Kingdom TA1 5DA
85 London United Kingdom W6 8RF
86 Manchester United Kingdom M20 4BX

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00492635
Other Study ID Numbers:
  • 11336
  • 2004-002172-42
First Posted:
Jun 27, 2007
Last Update Posted:
Oct 28, 2014
Last Verified:
Oct 1, 2014
Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Vardenafil Dihydrochloride

Study Results

No Results Posted as of Oct 28, 2014