Pharmacokinetic Evaluation of Testosterone Gel (1%)
This study has been completed.
Sponsor:
Solvay Pharmaceuticals
Collaborator:
Unimed Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00193700
First received: September 11, 2005
Last updated: December 23, 2006
Last verified: November 2006
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Purpose
Measure and evaluate the level of testosterone in blood, and determine the safety and tolerability following daily applications of testosterone gel. Subjects who complete this trial may participate in the extension part (UMD-01-080E).
| Condition | Intervention | Phase |
|---|---|---|
|
Primary or Secondary Hypogonadism Constitutional Delay in Growth and Puberty (CDGP) |
Drug: Testosterone Gel (1%) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pharmacokinetic Evaluation of Testosterone Gel (1%) in Prepubertal Boys of Adolescent Age |
Resource links provided by NLM:
MedlinePlus related topics:
Puberty
Drug Information available for:
Testosterone propionate
Methyltestosterone
Testosterone cypionate
Testosterone
Testosterone enanthate
U.S. FDA Resources
Further study details as provided by Solvay Pharmaceuticals:
Eligibility| Ages Eligible for Study: | 13 Years to 17 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)
Exclusion Criteria:
- Clinically significant uncontrolled medical condition or psychiatric disorder
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193700
Locations
| United States, Alabama | |
| Site 208 | |
| Birmingham, Alabama, United States | |
| United States, California | |
| Site 203 | |
| Torrance, California, United States | |
| United States, Florida | |
| Site 204 | |
| Jacksonville, Florida, United States | |
| United States, Missouri | |
| Site 201 | |
| Kansas City, Missouri, United States | |
| United States, New Jersey | |
| Site 206 | |
| Morristown, New Jersey, United States | |
| United States, New York | |
| Site 207 | |
| Brooklyn, New York, United States | |
| United States, Ohio | |
| Site 209 | |
| Cincinnati, Ohio, United States | |
| United States, Pennsylvania | |
| Site 202 | |
| Philadelphia, Pennsylvania, United States | |
| United States, Washington | |
| Site 205 | |
| Seattle, Washington, United States | |
Sponsors and Collaborators
Solvay Pharmaceuticals
Unimed Pharmaceuticals
Investigators
| Study Director: | Global Clinical Director Solvay | Solvay Pharmaceuticals |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00193700 History of Changes |
| Other Study ID Numbers: | UMD-01-080 |
| Study First Received: | September 11, 2005 |
| Last Updated: | December 23, 2006 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Solvay Pharmaceuticals:
|
Hypogonadism |
Additional relevant MeSH terms:
|
Hypogonadism Gonadal Disorders Endocrine System Diseases Testosterone Testosterone enanthate Testosterone undecanoate Testosterone 17 beta-cypionate Methyltestosterone Androgens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anabolic Agents |
ClinicalTrials.gov processed this record on May 16, 2013