Pharmacokinetic Evaluation of Testosterone Gel (1%)

This study has been completed.
Unimed Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals Identifier:
First received: September 11, 2005
Last updated: December 23, 2006
Last verified: November 2006
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:

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: August 2002

Ages Eligible for Study:   13 Years to 17 Years
Genders 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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information 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:

Additional relevant MeSH terms:
Endocrine System Diseases
Gonadal Disorders
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Anabolic Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on May 04, 2016