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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193661

Enrollment

Unknown

Registered

2005-09-19

Start date

2002-08-31

Completion date

2007-03-31

Last updated

2015-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Hypogonadism

Brief summary

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).

Interventions

DRUGTestosterone Gel (1%)

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

13 Years to 17 Years

Healthy volunteers

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026