Pharmacokinetic Evaluation of Testosterone Gel (1%)

Constitutional Delay in Growth and Puberty (CDGP) Clinical Trial

Official title:

Pharmacokinetic Evaluation of Testosterone Gel (1%) in Prepubertal Boys of Adolescent Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193700
• Other study ID #: UMD-01-080
• Status: Completed
• Phase: Phase 1
• First received: September 11, 2005
• Last updated: December 23, 2006
• Start date: August 2002

Study information

• Verified date: November 2006
• Source: Solvay Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 13 Years to 17 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Testosterone Gel (1%)

Locations

Country	Name	City	State
United States	Site 208	Birmingham	Alabama
United States	Site 207	Brooklyn	New York
United States	Site 209	Cincinnati	Ohio
United States	Site 204	Jacksonville	Florida
United States	Site 201	Kansas City	Missouri
United States	Site 206	Morristown	New Jersey
United States	Site 202	Philadelphia	Pennsylvania
United States	Site 205	Seattle	Washington
United States	Site 203	Torrance	California

Sponsors (2)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals	Unimed Pharmaceuticals

Country where clinical trial is conducted

United States,