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Evaluating the Efficacy Vardenafil 10 mg vs Tadalafil 10 mg in in Subjects With Erectile Dysfunction (ED)

NCT ID: NCT00663130

Last Updated: 2013-10-11

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

759 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2004-07-31

Brief Summary

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Evaluating the efficacy of 10mg vardenafil versus 10mg tadalafil in the first 45 minutes post-dosing, in an as-required regimen for 4 weeks in subjects with mild/moderate to severe ED

Detailed Description

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Conditions

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Erectile Dysfunction

Keywords

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Erectile Dysfunction Vardenafil

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 1

Group Type EXPERIMENTAL

Levitra (Vardenafil, BAY38-9456)

Intervention Type DRUG

Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse

Arm 2

Group Type ACTIVE_COMPARATOR

Tadalafil

Intervention Type DRUG

Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse

Interventions

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Levitra (Vardenafil, BAY38-9456)

Vardenafil 10mg, taken orally within 1 hour prior to sexual intercourse

Intervention Type DRUG

Tadalafil

Tadalafil 10mg, taken orally within 1 hour prior to sexual intercourse

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 64 years
* Heterosexual males
* Erectile dysfunction for more than 6 months

Exclusion Criteria

* Penile anatomical abnormalities
* Spinal cord injury
* History of surgical prostatectomy
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

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

Other Identifiers

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11333

Identifier Type: -

Identifier Source: org_study_id