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Sponsored by: |
Ardana Bioscience Ltd |
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Information provided by: | Ardana Bioscience Ltd |
ClinicalTrials.gov Identifier: | NCT00562731 |
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.
Condition | Intervention | Phase |
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Hypogonadism |
Drug: ARD-0403 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase III, Open-Label Follow-on Study for Long-Term Safety and Efficacy of Testosterone Cream, in Testosterone Deficinet Men Completing Study ARD-0403-004 |
Estimated Enrollment: | 150 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Medical Affiliated Research Center, Inc | |
Huntsville, Alabama, United States, 35801 | |
United States, California | |
Harbor-UCLA Medical Center | |
Torrance, California, United States, 90502 | |
Stanford University | |
Stanford, California, United States, 94305-5826 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States, 60611-3008 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27706 | |
United States, Oregon | |
Oregon Health and Science University | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Hospital of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, 77030 | |
dgd Research | |
San Antonio, Texas, United States, 78229-4801 | |
United States, Washington | |
VA Puget Sound Health Care System | |
Seattle, Washington, United States, 98493 |
Principal Investigator: | R Swerdloff | University of California, Los Angeles |
Study ID Numbers: | ARD-0403-010 |
Study First Received: | November 21, 2007 |
Last Updated: | March 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00562731 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Antineoplastic Agents, Hormonal Gonadal Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Methyltestosterone Hormones |
Testosterone 17 beta-cypionate Testosterone Anabolic Agents Hypogonadism Endocrinopathy Androgens |
Antineoplastic Agents, Hormonal Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Endocrine System Diseases Methyltestosterone Hormones |
Pharmacologic Actions Testosterone 17 beta-cypionate Anabolic Agents Testosterone Hypogonadism Therapeutic Uses Androgens |