Status:

COMPLETED

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

Lead Sponsor:

Bayer

Conditions:

Hypogonadism

Eligibility:

MALE

18-75 years

Phase:

PHASE3

Brief Summary

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

Detailed Description

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.

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

February 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2007

Estimated Enrollment :

96 Patients enrolled

Trial Details

Trial ID

NCT00220298

Start Date

February 1 2003

End Date

October 1 2007

Last Update

December 30 2014

Active Locations (14)

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Page 1 of 4 (14 locations)

1

Nuremberg, Bavaria, Germany, 90441

2

Marburg, Hesse, Germany, 35037

3

Wolfsburg, Lower Saxony, Germany, 38440

4

Münster, North Rhine-Westphalia, Germany, 48129