MedTrace Logo

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

NCT00193661 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-01-16

No results posted yet for this study

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).

Conditions

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

Interventions

DRUG

Testosterone Gel (1%)

Sponsors & Collaborators

  • Unimed Pharmaceuticals

    collaborator INDUSTRY

  • Solvay Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31
Primary Completion
2007-03-31
Completion
2007-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00193661 on ClinicalTrials.gov