Pharmacokinetic Evaluation of Testosterone Gel (1%)

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193700

Enrollment

Unknown

Registered

2005-09-19

Start date

2002-08-31

Completion date

Unknown

Last updated

2006-12-25

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

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).

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

* Diagnosis of primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)

Exclusion criteria

* Clinically significant uncontrolled medical condition or psychiatric disorder

Countries

United States

Outcome results

None listed

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