Pharmacokinetic Evaluation of Testosterone Gel (1%)

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).

Completed

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Key information

Conditions

Primary or Secondary Hypogonadism Constitutional Delay in Growth and Puberty (CDGP) Endocrine System Diseases Gonadal Disorders Hypogonadism

Age range

13 year–17 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Site 208, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Testosterone Gel (1%)

Drug

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Collaborators

Unimed Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start: 2002
First posted: Sep 19, 2005
Registry last updated: Dec 25, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed