Status:

COMPLETED

Open-Label Study of ARD-0403 in Testosterone Deficient Men

Lead Sponsor:

Ardana Bioscience Ltd

Conditions:

Hypogonadism

Eligibility:

MALE

18+ years

Phase:

PHASE3

Brief Summary

Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient wellbeing. The purpose of this study is to investi...

Eligibility Criteria

Inclusion

  • Testosterone deficiency

Exclusion

  • Previous treatment with testosterone replacement therapy within 4 weeks
  • Moderate-severe benign prostatic hypertrophy, or prostatic cancer
  • Haematocrit \>50%

Key Trial Info

Start Date :

May 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2008

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT00448955

Start Date

May 1 2007

End Date

February 1 2008

Last Update

April 18 2008

Active Locations (12)

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Page 1 of 3 (12 locations)

1

Medical Affiliated Research Center, Inc

Huntsville, Alabama, United States, 35801

2

Stanford University

Stanford, California, United States, 94305-5826

3

Los Angeles Biomedical Research Institute at Harbor-UCLA

Torrance, California, United States, 90502

4

Northwestern University

Chicago, Illinois, United States, 60611-3008