Pharmacokinetic Evaluation of Testosterone Gel (1%)

This study has been completed.

First Received: September 11, 2005 Last Updated: December 23, 2006 History of Changes

Sponsors and Collaborators:	Solvay Pharmaceuticals Unimed Pharmaceuticals
Information provided by:	Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00193700

Purpose

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 I

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Pharmacokinetic Evaluation of Testosterone Gel (1%) in Prepubertal Boys of Adolescent Age

Further study details as provided by Solvay Pharmaceuticals:

Study Start Date:

August 2002

Eligibility

Ages Eligible for Study:	13 Years to 17 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193700

Locations

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

Investigators

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

More Information

No publications provided

Study ID Numbers:	UMD-01-080
Study First Received:	September 11, 2005
Last Updated:	December 23, 2006
ClinicalTrials.gov Identifier:	NCT00193700 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:

Hypogonadism

Study placed in the following topic categories:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Neoplasm Metastasis
Endocrinopathy
Androgens

Additional relevant MeSH terms:

Antineoplastic Agents, Hormonal
Gonadal Disorders
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Methyltestosterone
Hormones

Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Therapeutic Uses
Androgens

ClinicalTrials.gov processed this record on May 07, 2009