Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

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

PHASE2/PHASE3

Total Enrollment

463 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2003-05-31

Brief Summary

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This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

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Detailed Description

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Conditions

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Erectile Dysfunction

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 ACTIVE_COMPARATOR

Levitra (Vardenafil, BAY38-9456)

Intervention Type DRUG

Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse

Interventions

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Levitra (Vardenafil, BAY38-9456)

Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men \>/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
* History of unresponsiveness to sildenafil
* Stable sexual relationship for \> 6 month