Pharmacokinetic Evaluation of Testosterone Gel (1%)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193700
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : December 25, 2006
Unimed Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals

Brief 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).

Condition or disease Intervention/treatment Phase
Primary or Secondary Hypogonadism Constitutional Delay in Growth and Puberty (CDGP) Drug: Testosterone Gel (1%) Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Evaluation of Testosterone Gel (1%) in Prepubertal Boys of Adolescent Age
Study Start Date : August 2002

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Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193700

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
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals Identifier: NCT00193700     History of Changes
Other Study ID Numbers: UMD-01-080
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: December 25, 2006
Last Verified: November 2006

Keywords provided by Solvay Pharmaceuticals:

Additional relevant MeSH terms:
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents