Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism

This study is to observe efficacy and safety after T-Gel 1% treatment in delayed puberty adolescents. Subjects who complete this trial may enter a 3 month extension study (UMD-01-090E).

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 2

Primary location

Site 130, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)

Exclusion criteria

Skin intolerance to alcohol or allergy to soy
Generalized skin disease
Contraindication to testosterone or androgen products

Treatment and study plan

Testosterone Gel (1%)

Drug

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Collaborators

Unimed Pharmaceuticals

Registry information

Official study title

A Multi-Center, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Hypogonadism

Important dates

Study start: 2002
Primary completion: 2007
Study completion: 2007
First posted: Sep 19, 2005
Registry last updated: Jan 16, 2015

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