- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00193700
Pharmacokinetic Evaluation of Testosterone Gel (1%)
December 23, 2006 updated by: Solvay Pharmaceuticals
Pharmacokinetic Evaluation of Testosterone Gel (1%) in Prepubertal Boys of Adolescent Age
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).
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States
- Site 208
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California
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Torrance, California, United States
- Site 203
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Florida
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Jacksonville, Florida, United States
- Site 204
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Missouri
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Kansas City, Missouri, United States
- Site 201
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New Jersey
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Morristown, New Jersey, United States
- Site 206
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New York
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Brooklyn, New York, United States
- Site 207
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Ohio
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Cincinnati, Ohio, United States
- Site 209
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Pennsylvania
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Philadelphia, Pennsylvania, United States
- Site 202
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Washington
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Seattle, Washington, United States
- Site 205
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2002
Study Registration Dates
First Submitted
September 11, 2005
First Submitted That Met QC Criteria
September 11, 2005
First Posted (Estimate)
September 19, 2005
Study Record Updates
Last Update Posted (Estimate)
December 25, 2006
Last Update Submitted That Met QC Criteria
December 23, 2006
Last Verified
November 1, 2006
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMD-01-080
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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