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FINDER: A Randomised Study of Levitra to Treat Men With Erections Problems and Previously Untreated With Similar Therapy.

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT00668096
Collaborator
(none)
260
Enrollment
38
Locations
2
Arms
8
Duration (Months)
6.8
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study was to evaluate the efficacy and tolerability of the phosphodiesterase type 5 inhibitor (PDE5 inhibitor), vardenafil, in a broad population of subjects with erectile dysfunction of different aetiologies and severity, who have not been previously treated with a PDE5 inhibitor; Efficacy and safety was compared with placebo.

Condition or Disease Intervention/Treatment Phase
  • Drug: Levitra (Vardenafil, BAY38-9456)
  • Drug: Placebo
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
260 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double Blind, Placebo Controlled, Flexible Dose, Multicentre Study of Levitra in a Broad Population of Men With Erectile Dysfunction and Previously Untreated With PDE5 Inhibitors.
Study Start Date :
May 1, 2004
Actual Primary Completion Date :
Jan 1, 2005
Actual Study Completion Date :
Jan 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Arm 2

Drug: Placebo
Matching Placebo
Experimental: Arm 1

Drug: Levitra (Vardenafil, BAY38-9456)
Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity

Outcome Measures

Primary Outcome Measures

  1. Hierarchical significance testing was applied to the 3 primary efficacy parameters at the 5% significance level. Parameters were to be tested: GAQ first, Sexual Encounter Profile 3 second and SEP 2 third. SEP 3 will only be tested if GAQ is sign. [16 weeks]

Secondary Outcome Measures

  1. International Index of Erectile Function [16 weeks]

  2. Treatment Satisfaction Scale [16 weeks]

  3. Other patient diary based variables [16 weeks]

  4. Safety and tolerability [16 weeks]

Eligibility Criteria

Criteria

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

  • Males with erectile dysfunction according to the National Institute of Health (NIH) Consensus statement (inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance

  • Heterosexual relationship for more than 6 months

  • Partner willing to complete the TSS

Exclusion Criteria:

  • Primary hypoactive sexual desire

  • History of myocardial infarction, stroke or life-threatening arrhythmia within the prior 6 months

  • Nitrate use

  • Other exclusion criteria apply according to the Summary of Product Characteristics

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bruxelles - Brussel Belgium 1000
2 Drieslinter Belgium 3350
3 Genk Belgium 3600
4 Leuven Belgium 3000
5 Gentofte Denmark DK-2820
6 Naestved Denmark 4700
7 Svendborg Denmark DK-5700
8 Viborg Denmark 8800
9 Kerava Finland 04250
10 Oulu Finland 90100
11 Tampere Finland 33100
12 Grenoble France 38000
13 Lille France 59000
14 Lyon France 69000
15 Marseille France 13009
16 Marseille France 13013
17 Marseille France 13015
18 Montpellier France 34000
19 Dresden Sachsen Germany 01129
20 Leipzig Sachsen Germany 04105
21 Leipzig Sachsen Germany 04249
22 Leisnig Sachsen Germany 04703
23 Meißen Sachsen Germany 01662
24 Harrislee Schleswig-Holstein Germany 24955
25 Norderstedt Schleswig-Holstein Germany 22846
26 Wahlstedt Schleswig-Holstein Germany 23812
27 Altenburg Thüringen Germany 04600
28 Hamburg Germany 22177
29 Hamburg Germany 22299
30 Hamburg Germany 22303
31 Gavà Barcelona Spain 08850
32 L'Hospitalet de Llobregat Barcelona Spain 08905
33 Badalona (Barcelona) Cataluña Spain 08043
34 Barcelona Spain 08032
35 Crowborough East Sussex United Kingdom TN6 1DL
36 Chipping Norton Oxfordshire United Kingdom OX7 5AL
37 Lichfield Staffordshire United Kingdom WS14 9JL
38 Hamilton Strathclyde United Kingdom ML3 ODR

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT00668096
Other Study ID Numbers:
  • 11334
First Posted:
Apr 28, 2008
Last Update Posted:
Dec 25, 2014
Last Verified:
Dec 1, 2014
Keywords provided by Bayer
Erectile Dysfunction
PDE5 inhibitors
Additional relevant MeSH terms:
Erectile Dysfunction
Vardenafil Dihydrochloride

Study Results

No Results Posted as of Dec 25, 2014