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Use of Nebido® to Assess Tolerability and Treatment Outcomes in Daily Clinical Practice

NCT ID: NCT00410306

Last Updated: 2010-09-24

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

Total Enrollment

1493 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2010-07-31

Brief Summary

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This is an observational study with a drug called Nebido, a new testosterone replacement therapy, which is available for the treatment of male hypogonadism. The benefit and safety of Nebido have already been thoroughly evaluated through well controlled clinical trials. The main purpose of this observational study is to confirm the established safety profile of Nebido in daily clinical practice.

Detailed Description

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The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Conditions

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Male Hypogonadism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Testosterone Undecanoate (Nebido, BAY86-5037)

Intervention Type DRUG

Patients from routine practice

Interventions

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Testosterone Undecanoate (Nebido, BAY86-5037)

Patients from routine practice

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male hypogonadal patients eligible for long-term testosterone therapy who have newly been prescribed Nebido® in accordance with the terms of the marketing authorization

Exclusion Criteria

* Patients presenting with contraindications as stated in the product information
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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Bayer Schering Pharma AG

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Australia

Site Status

Many Locations, , Austria

Site Status

Many Locations, , Bulgaria

Site Status

Many Locations, , Colombia

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Many Locations, , Czechia

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Many Locations, , Estonia

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Many Locations, , Germany

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Many Locations, , Hong Kong

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Many Locations, , Indonesia

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Many Locations, , Italy

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Many Locations, , Jordan

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Many Locations, , Kazakhstan

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Many Locations, , Latvia

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Many Locations, , Lebanon

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Many Locations, , Lithuania

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Many Locations, , Malaysia

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Many Locations, , Malta

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Many Locations, , Mexico

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Many Locations, , Moldova

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Many Locations, , North Macedonia

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Many Locations, , Philippines

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Many Locations, , Romania

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Many Locations, , Russia

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Many Locations, , Saudi Arabia

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Many Locations, , Singapore

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Many Locations, , Slovenia

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Many Locations, , South Korea

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Many Locations, , Spain

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Many Locations, , Taiwan

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Many Locations, , Thailand

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Many Locations, , Turkey (Türkiye)

Site Status

Many Locations, , Ukraine

Site Status

Many Locations, , United Kingdom

Site Status

Countries

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Australia Austria Bulgaria Colombia Czechia Estonia Germany Hong Kong Indonesia Italy Jordan Kazakhstan Latvia Lebanon Lithuania Malaysia Malta Mexico Moldova North Macedonia Philippines Romania Russia Saudi Arabia Singapore Slovenia South Korea Spain Taiwan Thailand Turkey (Türkiye) Ukraine United Kingdom

Other Identifiers

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2005/00888

Identifier Type: -

Identifier Source: secondary_id

MP-04199

Identifier Type: -

Identifier Source: secondary_id

NE0601

Identifier Type: -

Identifier Source: secondary_id

39732

Identifier Type: -

Identifier Source: secondary_id

14203

Identifier Type: -

Identifier Source: org_study_id