search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Testosterone Gel (1%)
Sponsored by
Solvay Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary or Secondary Hypogonadism focused on measuring Hypogonadism

Eligibility Criteria

13 Years - 17 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Site 130
  • Site 107
  • Site 113
  • Site 114
  • Site 121
  • Site 127
  • Site 128
  • Site 117
  • Site 111
  • Site 129
  • Site 123
  • Site 131
  • Site 124
  • Site 103
  • Site 109
  • Site 125
  • Site 126
  • Site 104
  • Site 205

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 11, 2005
Last Updated
January 15, 2015
Sponsor
Solvay Pharmaceuticals
Collaborators
Unimed Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT00193661
Brief Title
Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism
Official Title
A Multi-Center, Open-Label, Observational Study of Testosterone Gel (1%) in the Treatment of Adolescent Boys With Hypogonadism
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals
Collaborators
Unimed Pharmaceuticals

4. Oversight

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary or Secondary Hypogonadism, Constitutional Delay in Growth and Puberty (CDGP)
Keywords
Hypogonadism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Testosterone Gel (1%)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Director Solvay
Organizational Affiliation
Solvay Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Site 130
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Site 107
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Site 113
City
Sacramento
State/Province
California
Country
United States
Facility Name
Site 114
City
Torrance
State/Province
California
Country
United States
Facility Name
Site 121
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
Site 127
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Site 128
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Site 117
City
Indianapolis
State/Province
Indiana
Country
United States
Facility Name
Site 111
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Site 129
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Site 123
City
New York
State/Province
New York
Country
United States
Facility Name
Site 131
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Site 124
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Site 103
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Site 109
City
Hershey
State/Province
Pennsylvania
Country
United States
Facility Name
Site 125
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 126
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 104
City
Memphis
State/Province
Tennessee
Country
United States
Facility Name
Site 205
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs