Pharmacokinetic Evaluation of Testosterone Gel (1%) - Tabular View

Tracking Information

First Received Date ^ICMJE

September 11, 2005

Last Updated Date

December 23, 2006

Start Date ^ICMJE

August 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00193700 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Pharmacokinetic Evaluation of Testosterone Gel (1%)

Official Title ^ICMJE

Pharmacokinetic Evaluation of Testosterone Gel (1%) in Prepubertal Boys of Adolescent Age

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).

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Non-Randomized
Control:  Uncontrolled
Endpoint Classification:  Pharmacokinetics Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Primary or Secondary Hypogonadism
Constitutional Delay in Growth and Puberty (CDGP)

Intervention ^ICMJE

Drug: Testosterone Gel (1%)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

13 Years to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00193700

Responsible Party

Study ID Numbers ^ICMJE

UMD-01-080

Study Sponsor ^ICMJE

Solvay Pharmaceuticals

Collaborators ^ICMJE

Unimed Pharmaceuticals

Investigators ^ICMJE

Study Director:

Global Clinical Director Solvay

Solvay Pharmaceuticals

Information Provided By

Solvay Pharmaceuticals

Verification Date

November 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP