Pharmacokinetic Evaluation of Testosterone Gel (1%)
Information source: Solvay Pharmaceuticals
Information obtained from ClinicalTrials.gov on May 08, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary or Secondary Hypogonadism; Constitutional Delay in Growth and Puberty (CDGP)
Intervention: Testosterone Gel (1%) (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Solvay Pharmaceuticals Official(s) and/or principal investigator(s):
Global Clinical Director Solvay, Study Director, Affiliation: Solvay Pharmaceuticals
Summary
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).
Clinical Details
Official title:
Pharmacokinetic Evaluation of Testosterone Gel (1%) in Prepubertal Boys of Adolescent Age
Study design: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Eligibility
Minimum age: 13 Years.
Maximum age: 17 Years.
Gender(s): Male.
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
Locations and Contacts
Site 208, Birmingham, Alabama, United States
Site 203, Torrance, California, United States
Site 204, Jacksonville, Florida, United States
Site 201, Kansas City, Missouri, United States
Site 206, Morristown, New Jersey, United States
Site 207, Brooklyn, New York, United States
Site 209, Cincinnati, Ohio, United States
Site 202, Philadelphia, Pennsylvania, United States
Site 205, Seattle, Washington, United States
Additional Information
Starting date:
August 2002
Last updated: December 23, 2006
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