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Assessment of Efficacy of Vardenafil, Influence on Self-esteem and Self-confidence in Subjects With Erectile Dysfunction

NCT ID: NCT00661596

Last Updated: 2014-12-30

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

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2004-01-31

Brief Summary

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Erectile problems may lead to anxiety, loss of self-esteem and depression and/or stress. The purpose of this national study was to determine if vardenafil is effective in treating impotent men (erectile dysfunction) and evaluate its influence in self-esteem and self-confidence. During the visits the patients was asked some questions about erections, and he fill different questionnaires about sexuality, mood, feelings, self-esteem and sexual activity.

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

5 mg, 10 mg and 20 mg one hour prior to sexual intercourse

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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Levitra (Vardenafil, BAY38-9456)

5 mg, 10 mg and 20 mg one hour prior to sexual intercourse

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age: 18 years and older
* Males with erectile dysfunction
* Stable heterosexual relationship

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

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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Alicante, Alicante, Spain

Site Status

Sabadell, Barcelona, Spain

Site Status

Barcelona, Catalonia, Spain

Site Status

Granada, Granada, Spain

Site Status

Hondarribia, Guipuzcoa, Spain

Site Status

Leganés, Madrid, Spain

Site Status

Móstoles, Madrid, Spain

Site Status

Málaga, Málaga, Spain

Site Status

Vigo, Pontevedra, Spain

Site Status

Oviedo, Principality of Asturias, Spain

Site Status

Seville, Sevilla, Spain

Site Status

Valencia, Valencia, Spain

Site Status

Valladolid, Valladolid, Spain

Site Status

Countries

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Spain

Other Identifiers

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11139

Identifier Type: -

Identifier Source: org_study_id