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| Sponsors and Collaborators: |
Solvay Pharmaceuticals Unimed Pharmaceuticals |
|---|---|
| Information provided by: | Solvay Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00193661 |
Purpose
This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty adolescents. Subjects who complete this trial may enter a 3 month extension study (UMD-01-090E).
| Condition | Intervention | Phase |
|---|---|---|
|
Primary or Secondary Hypogonadism Constitutional Delay in Growth and Puberty (CDGP) |
Drug: Testosterone Gel (1%) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Multi-Center, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Hypogonadism |
Eligibility| Ages Eligible for Study: | 13 Years to 17 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Alabama | |
| Site 130 | |
| Birmingham, Alabama, United States | |
| United States, California | |
| Site 107 | |
| Los Angeles, California, United States | |
| Site 113 | |
| Sacramento, California, United States | |
| Site 114 | |
| Torrance, California, United States | |
| United States, Florida | |
| Site 121 | |
| Gainesville, Florida, United States | |
| Site 127 | |
| Jacksonville, Florida, United States | |
| Site 128 | |
| Jacksonville, Florida, United States | |
| United States, Indiana | |
| Site 117 | |
| Indianapolis, Indiana, United States | |
| United States, Missouri | |
| Site 111 | |
| Kansas City, Missouri, United States | |
| United States, New York | |
| Site 123 | |
| New York, New York, United States | |
| Site 129 | |
| Brooklyn, New York, United States | |
| United States, Ohio | |
| Site 124 | |
| Columbus, Ohio, United States | |
| Site 131 | |
| Cincinnati, Ohio, United States | |
| United States, Oregon | |
| Site 103 | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Site 109 | |
| Hershey, Pennsylvania, United States | |
| Site 125 | |
| Philadelphia, Pennsylvania, United States | |
| Site 126 | |
| Philadelphia, Pennsylvania, United States | |
| United States, Tennessee | |
| Site 104 | |
| Memphis, Tennessee, United States | |
| United States, Washington | |
| Site 205 | |
| Seattle, Washington, United States | |
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
| Study ID Numbers: | UMD-01-090 |
| Study First Received: | September 11, 2005 |
| Last Updated: | December 23, 2006 |
| ClinicalTrials.gov Identifier: | NCT00193661 |
| Health Authority: | United States: Food and Drug Administration |
|
Hypogonadism |
|
Testosterone Hypogonadism Gonadal Disorders Neoplasm Metastasis |
Endocrine System Diseases Methyltestosterone Endocrinopathy Testosterone 17 beta-cypionate |
|
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |
