Real Life Safety and Efficacy of Vardenafil

NCT ID: NCT01215409

Last Updated: 2014-05-19

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

TERMINATED

Total Enrollment

372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-11-30

Brief Summary

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In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile dysfunction. The general objectives are to evaluate the product safety (primarily by recording adverse events), efficacy and patient acceptance.

Detailed Description

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Conditions

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Erectile Dysfunction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Vardenafil (Levitra, BAY38-9456)

Intervention Type DRUG

5 mg or 10 mg or 20 mg of Vardenafil, orally when necessary for 2 months

Interventions

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Vardenafil (Levitra, BAY38-9456)

5 mg or 10 mg or 20 mg of Vardenafil, orally when necessary for 2 months

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Any adult patient (\>/=18 years) with erectile dysfunction treated with LEVITRA®.
* Patients must be able to give written informed consent for participation in the study after receiving detailed written and oral information prior to the study.
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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Many Locations, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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LV0611TW

Identifier Type: OTHER

Identifier Source: secondary_id

14328

Identifier Type: -

Identifier Source: org_study_id

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