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

Constitutional Delay in Growth and Puberty (CDGP) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193661
• Other study ID #: UMD-01-090
• Status: Completed
• Phase: Phase 2
• First received: September 11, 2005
• Last updated: January 15, 2015
• Start date: August 2002
• Est. completion date: March 2007

Study information

• Verified date: September 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 13 Years to 17 Years

Eligibility

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 Design

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

Sponsors (2)

Lead Sponsor	Collaborator
Solvay Pharmaceuticals	Unimed Pharmaceuticals

Country where clinical trial is conducted

United States,