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| Sponsor: | Ardana Bioscience Ltd |
|---|---|
| Information provided by: | Ardana Bioscience Ltd |
| ClinicalTrials.gov Identifier: | NCT00562731 |
Purpose
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 |
|---|---|---|
|
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
More Information
| 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 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 |
