Pharmacokinetic Evaluation of Testosterone Gel (1%)

This study has been completed.

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

Sponsor:	Solvay Pharmaceuticals
Collaborator:	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

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:

MedlinePlus related topics: Puberty

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

U.S. FDA Resources

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

ClinicalTrials.gov 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:

Hypogonadism

Additional relevant MeSH terms:

Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens

Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on February 09, 2012