Status:
COMPLETED
Observation Study of T-Gel (1%) in Treatment of Adolescent Boys With Hypogonadism
Lead Sponsor:
Solvay Pharmaceuticals
Collaborating Sponsors:
Unimed Pharmaceuticals
Conditions:
Primary or Secondary Hypogonadism
Constitutional Delay in Growth and Puberty (CDGP)
Eligibility:
MALE
13-17 years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- Primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)
Exclusion
- Skin intolerance to alcohol or allergy to soy
- Generalized skin disease
- Contraindication to testosterone or androgen products
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00193661
Start Date
August 1 2002
End Date
March 1 2007
Last Update
January 16 2015
Active Locations (19)
Enter a location and click search to find clinical trials sorted by distance.
1
Site 130
Birmingham, Alabama, United States
2
Site 107
Los Angeles, California, United States
3
Site 113
Sacramento, California, United States
4
Site 114
Torrance, California, United States