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

This study has been completed.
Sponsor:
Collaborator:
Unimed Pharmaceuticals
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00193661
First received: September 11, 2005
Last updated: December 23, 2006
Last verified: September 2006
  Purpose

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).


Condition Intervention Phase
Primary or Secondary Hypogonadism
Constitutional Delay in Growth and Puberty (CDGP)
Drug: Testosterone Gel (1%)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Hypogonadism

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: August 2002
  Eligibility

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193661

Locations
United States, Alabama
Site 130
Birmingham, Alabama, United States
United States, California
Site 107
Los Angeles, California, United States
Site 113
Sacramento, California, United States
Site 114
Torrance, California, United States
United States, Florida
Site 121
Gainesville, Florida, United States
Site 127
Jacksonville, Florida, United States
Site 128
Jacksonville, Florida, United States
United States, Indiana
Site 117
Indianapolis, Indiana, United States
United States, Missouri
Site 111
Kansas City, Missouri, United States
United States, New York
Site 129
Brooklyn, New York, United States
Site 123
New York, New York, United States
United States, Ohio
Site 131
Cincinnati, Ohio, United States
Site 124
Columbus, Ohio, United States
United States, Oregon
Site 103
Portland, Oregon, United States
United States, Pennsylvania
Site 109
Hershey, Pennsylvania, United States
Site 125
Philadelphia, Pennsylvania, United States
Site 126
Philadelphia, Pennsylvania, United States
United States, Tennessee
Site 104
Memphis, Tennessee, United States
United States, Washington
Site 205
Seattle, Washington, United States
Sponsors and Collaborators
Solvay Pharmaceuticals
Unimed Pharmaceuticals
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00193661     History of Changes
Other Study ID Numbers: UMD-01-090
Study First Received: September 11, 2005
Last Updated: December 23, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
Hypogonadism

Additional relevant MeSH terms:
Hypogonadism
Gonadal Disorders
Endocrine System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on July 29, 2014