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Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism

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: NCT00193661
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : January 16, 2015
Unimed Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment Phase
Primary or Secondary Hypogonadism Constitutional Delay in Growth and Puberty (CDGP) Drug: Testosterone Gel (1%) Phase 2

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Hypogonadism
Study Start Date : August 2002
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

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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:

  • Primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)

Exclusion Criteria:

  • Skin intolerance to alcohol or allergy to soy
  • Generalized skin disease
  • Contraindication to testosterone or androgen products

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): NCT00193661

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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 129
Brooklyn, New York, United States
Site 123
New York, New York, United States
United States, Ohio
Site 131
Cincinnati, Ohio, United States
Site 124
Columbus, 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
Sponsors and Collaborators
Solvay Pharmaceuticals
Unimed Pharmaceuticals
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Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals

Layout table for additonal information Identifier: NCT00193661     History of Changes
Other Study ID Numbers: UMD-01-090
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: September 2006
Keywords provided by Solvay Pharmaceuticals:
Additional relevant MeSH terms:
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Gonadal Disorders
Endocrine System Diseases
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents