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

January 15, 2015 updated by: Solvay Pharmaceuticals

A Multi-Center, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Hypogonadism

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Site 130
    • California
      • Los Angeles, California, United States
        • Site 107
      • Sacramento, California, United States
        • Site 113
      • Torrance, California, United States
        • Site 114
    • Florida
      • Gainesville, Florida, United States
        • Site 121
      • Jacksonville, Florida, United States
        • Site 127
      • Jacksonville, Florida, United States
        • Site 128
    • Indiana
      • Indianapolis, Indiana, United States
        • Site 117
    • Missouri
      • Kansas City, Missouri, United States
        • Site 111
    • New York
      • Brooklyn, New York, United States
        • Site 129
      • New York, New York, United States
        • Site 123
    • Ohio
      • Cincinnati, Ohio, United States
        • Site 131
      • Columbus, Ohio, United States
        • Site 124
    • Oregon
      • Portland, Oregon, United States
        • Site 103
    • Pennsylvania
      • Hershey, Pennsylvania, United States
        • Site 109
      • Philadelphia, Pennsylvania, United States
        • Site 125
      • Philadelphia, Pennsylvania, United States
        • Site 126
    • Tennessee
      • Memphis, Tennessee, United States
        • Site 104
    • Washington
      • Seattle, Washington, United States
        • Site 205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Collaborators

Unimed Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2002

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 11, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

January 16, 2015

Last Update Submitted That Met QC Criteria

January 15, 2015

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMD-01-090

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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