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

Phase 2CompletedNCT00193661

Solvay Pharmaceuticals

Overview

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).

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: * 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

Locations (19)

Site 130

Birmingham, Alabama, United States

Site 107

Los Angeles, California, United States

Site 113

Data from ClinicalTrials.gov

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