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

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solvay Pharmaceuticals
• Collaborator: Unimed Pharmaceuticals
• Treatments: Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

Criteria

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