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

Completed · 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 wellbeing. 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

NCT00448955

Run by

Ardana Bioscience Ltd

People needed

150

Starts

2007-05-01

Expected to finish

2008-02-01

Last updated by the study team

2008-04-18

Who can join

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

You may qualify if…

• Testosterone deficiency

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
• Los Angeles Biomedical Research Institute at Harbor-UCLA — 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
• Michael E. Debakey VAMC — 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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