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

Primary Purpose

Erectile Dysfunction

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Levitra (Vardenafil, BAY38-9456)

Placebo

About this trial

This is an interventional treatment trial for Erectile Dysfunction focused on measuring Erectile Dysfunction, PDE5 inhibitors

Eligibility Criteria

18 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm 2

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

International Index of Erectile Function

Treatment Satisfaction Scale

Other patient diary based variables

Safety and tolerability

Full Information

NCT ID

NCT00668096

First Posted

April 24, 2008

Last Updated

December 23, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT00668096

Brief Title

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

Acronym

FINDER

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 Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

May 2004 (undefined)

Primary Completion Date

January 2005 (Actual)

Study Completion Date

January 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Erectile Dysfunction

Keywords

Erectile Dysfunction, PDE5 inhibitors

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 2

Arm Type

Placebo Comparator

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Levitra (Vardenafil, BAY38-9456)

Intervention Description

Vardenafil 5 mg or 10 mg or 20 mg, orally1 hour prior to sexual activity

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching Placebo

Primary Outcome Measure Information:

Title

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

International Index of Erectile Function

Time Frame

16 weeks

Title

Treatment Satisfaction Scale

Time Frame

16 weeks

Title

Other patient diary based variables

Time Frame

16 weeks

Title

Safety and tolerability

Time Frame

16 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Bruxelles - Brussel

ZIP/Postal Code

1000

Country

Belgium

City

Drieslinter

ZIP/Postal Code

3350

Country

Belgium

City

Genk

ZIP/Postal Code

3600

Country

Belgium

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

City

Gentofte

ZIP/Postal Code

DK-2820

Country

Denmark

City

Naestved

ZIP/Postal Code

4700

Country

Denmark

City

Svendborg

ZIP/Postal Code

DK-5700

Country

Denmark

City

Viborg

ZIP/Postal Code

8800

Country

Denmark

City

Kerava

ZIP/Postal Code

04250

Country

Finland

City

Oulu

ZIP/Postal Code

90100

Country

Finland

City

Tampere

ZIP/Postal Code

33100

Country

Finland

City

Grenoble

ZIP/Postal Code

38000

Country

France

City

Lille

ZIP/Postal Code

59000

Country

France

City

Lyon

ZIP/Postal Code

69000

Country

France

City

Marseille

ZIP/Postal Code

13009

Country

France

City

Marseille

ZIP/Postal Code

13013

Country

France

City

Marseille

ZIP/Postal Code

13015

Country

France

City

Montpellier

ZIP/Postal Code

34000

Country

France

City

Dresden

State/Province

Sachsen

ZIP/Postal Code

01129

Country

Germany

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04105

Country

Germany

City

Leipzig

State/Province

Sachsen

ZIP/Postal Code

04249

Country

Germany

City

Leisnig

State/Province

Sachsen

ZIP/Postal Code

04703

Country

Germany

City

Meißen

State/Province

Sachsen

ZIP/Postal Code

01662

Country

Germany

City

Harrislee

State/Province

Schleswig-Holstein

ZIP/Postal Code

24955

Country

Germany

City

Norderstedt

State/Province

Schleswig-Holstein

ZIP/Postal Code

22846

Country

Germany

City

Wahlstedt

State/Province

Schleswig-Holstein

ZIP/Postal Code

23812

Country

Germany

City

Altenburg

State/Province

Thüringen

ZIP/Postal Code

04600

Country

Germany

City

Hamburg

ZIP/Postal Code

22177

Country

Germany

City

Hamburg

ZIP/Postal Code

22299

Country

Germany

City

Hamburg

ZIP/Postal Code

22303

Country

Germany

City

Gavà

State/Province

Barcelona

ZIP/Postal Code

08850

Country

Spain

City

L'Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08905

Country

Spain

City

Badalona (Barcelona)

State/Province

Cataluña

ZIP/Postal Code

08043

Country

Spain

City

Barcelona

ZIP/Postal Code

08032

Country

Spain

City

Crowborough

State/Province

East Sussex

ZIP/Postal Code

TN6 1DL

Country

United Kingdom

City

Chipping Norton

State/Province

Oxfordshire

ZIP/Postal Code

OX7 5AL

Country

United Kingdom

City

Lichfield

State/Province

Staffordshire

ZIP/Postal Code

WS14 9JL

Country

United Kingdom

City

Hamilton

State/Province

Strathclyde

ZIP/Postal Code

ML3 ODR

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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