Pharmacokinetic Evaluation of Testosterone Gel (1%)

Solvay

Status and phase: Completed; Phase 1

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

Treatments: Drug: Testosterone Gel (1%)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00193700

UMD-01-080

Details and patient eligibility

About

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).

Sex: Male

Ages: 13 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)