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

Stopped early · Phase 3

Conditions studied: Hypogonadism

In brief

Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient well-being. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.

Key facts

Study ID

NCT00562731

Run by

Ardana Bioscience Ltd

People needed

150

Starts

2007-10-01

Expected to finish

2008-06-01

Last updated by the study team

2008-04-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Testosterone deficiency
• Completed study ARD-0403-004

You may not qualify if…

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

Where it is running

• Medical Affiliated Research Center, Inc — Huntsville, Alabama, United States
• Stanford University — Stanford, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• Northwestern University — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Baylor College of Medicine — Houston, Texas, United States
• dgd Research — San Antonio, Texas, United States
• VA Puget Sound Health Care System — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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