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

NCT ID: NCT00668096

Last Updated: 2014-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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Erectile Dysfunction PDE5 inhibitors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching Placebo

Arm 1

Group Type EXPERIMENTAL

Levitra (Vardenafil, BAY38-9456)

Intervention Type DRUG

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

Interventions

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Levitra (Vardenafil, BAY38-9456)

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

Intervention Type DRUG

Placebo

Matching Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Bruxelles - Brussel, , Belgium

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Drieslinter, , Belgium

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Genk, , Belgium

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Leuven, , Belgium

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Gentofte Municipality, , Denmark

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Næstved, , Denmark

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Svendborg, , Denmark

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Viborg, , Denmark

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Kerava, , Finland

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Oulu, , Finland

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Tampere, , Finland

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Grenoble, , France

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Lille, , France

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Lyon, , France

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Marseille, , France

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Marseille, , France

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Marseille, , France

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Montpellier, , France

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Hamburg, City state of Hamburg, Germany

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Hamburg, City state of Hamburg, Germany

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Hamburg, City state of Hamburg, Germany

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Leisnig, Saxony, Germany

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Meissen, Saxony, Germany

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Harrislee, Schleswig-Holstein, Germany

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Norderstedt, Schleswig-Holstein, Germany

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Wahlstedt, Schleswig-Holstein, Germany

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Altenburg, Thuringia, Germany

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Barcelona, Barcelona, Spain

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Gavà, Barcelona, Spain

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L'Hospitalet de Llobregat, Barcelona, Spain

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Badalona (Barcelona), Catalonia, Spain

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Crowborough, East Sussex, United Kingdom

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Chipping Norton, Oxfordshire, United Kingdom

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Lichfield, Staffordshire, United Kingdom

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Hamilton, Strathclyde, United Kingdom

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Countries

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Belgium Denmark Finland France Germany Spain United Kingdom

Other Identifiers

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11334

Identifier Type: -

Identifier Source: org_study_id