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Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism

NCT ID: NCT00220298

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

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2007-10-31

Brief Summary

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This study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations.

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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Hypogonadism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Testosterone undecanoate (TU) - NebidoTM

Intervention Type DRUG

Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals

Interventions

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Testosterone undecanoate (TU) - NebidoTM

Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hypogonadal men, aged 18-75 years with low serum total testosterone (TT) levels and symptoms of androgen deficiency

Exclusion Criteria

* Tumors of the prostate or the male mammary gland including suspicion thereof. Past or present liver tumors or chronic hepatic disease with impairment of liver function, Severe acne.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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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Nuremberg, Bavaria, Germany

Site Status

Marburg, Hesse, Germany

Site Status

Wolfsburg, Lower Saxony, Germany

Site Status

Münster, North Rhine-Westphalia, Germany

Site Status

Leipzig, Saxony, Germany

Site Status

Halle, Saxony-Anhalt, Germany

Site Status

Naumburg, Saxony-Anhalt, Germany

Site Status

Berlin, State of Berlin, Germany

Site Status

Berlin, State of Berlin, Germany

Site Status

Eisenberg, Thuringia, Germany

Site Status

Gera, Thuringia, Germany

Site Status

Jena, Thuringia, Germany

Site Status

Jena, Thuringia, Germany

Site Status

Leipzig, , Germany

Site Status

Countries

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Germany

References

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Behre HM and Elliesen J. Safety and efficacy of intramuscular injections of 1000 mg testosterone undecanoate: A prospective multicenter study in hypogonadal men under conditions resembling real-life situations. Proceedings of the 22nd Annual European Association of Urology (EAU); 2007 Mar 22; Berlin, Germany. Eur Urol Suppl 2007;6(2):108.

Reference Type RESULT

Other Identifiers

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306605

Identifier Type: OTHER

Identifier Source: secondary_id

91186

Identifier Type: -

Identifier Source: org_study_id