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Pharmacokinetic Evaluation of Testosterone Gel (1%)

Primary Purpose

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

Status
Completed
Phase
Phase 1
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: Diagnosis of primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP) Exclusion Criteria: Clinically significant uncontrolled medical condition or psychiatric disorder

Sites / Locations

  • Site 208
  • Site 203
  • Site 204
  • Site 201
  • Site 206
  • Site 207
  • Site 209
  • Site 202
  • Site 205

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 11, 2005
Last Updated
December 23, 2006
Sponsor
Solvay Pharmaceuticals
Collaborators
Unimed Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00193700
Brief Title
Pharmacokinetic Evaluation of Testosterone Gel (1%)
Official Title
Pharmacokinetic Evaluation of Testosterone Gel (1%) in Prepubertal Boys of Adolescent Age
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Solvay Pharmaceuticals
Collaborators
Unimed Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
Measure and evaluate the level of testosterone in blood, and determine the safety and tolerability following daily applications of testosterone gel. Subjects who complete this trial may participate in the extension part (UMD-01-080E).

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 1
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: Diagnosis of primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP) Exclusion Criteria: Clinically significant uncontrolled medical condition or psychiatric disorder
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 208
City
Birmingham
State/Province
Alabama
Country
United States
Facility Name
Site 203
City
Torrance
State/Province
California
Country
United States
Facility Name
Site 204
City
Jacksonville
State/Province
Florida
Country
United States
Facility Name
Site 201
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
Site 206
City
Morristown
State/Province
New Jersey
Country
United States
Facility Name
Site 207
City
Brooklyn
State/Province
New York
Country
United States
Facility Name
Site 209
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Site 202
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Site 205
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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Pharmacokinetic Evaluation of Testosterone Gel (1%)

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