Pharmacokinetic Evaluation of Testosterone Gel (1%)

Phase 1CompletedNCT00193700

Solvay Pharmaceuticals

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

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

Interventions

Testosterone Gel (1%)DRUG

Eligibility

Sex: MALEMin age: 13 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (9)

Site 208

Birmingham, Alabama, United States

Site 203

Torrance, California, United States

Site 204

Jacksonville, Florida, United States

Site 201

Kansas City, Missouri, United States

Data from ClinicalTrials.gov

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