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

Solvay

Status and phase: Completed; Phase 2

Conditions: Constitutional Delay in Growth and Puberty (CDGP); Primary or Secondary Hypogonadism

Treatments: Drug: Testosterone Gel (1%)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00193661

UMD-01-090

Details and patient eligibility

About

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).

Sex: Male

Ages: 13 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)