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

Completed · Phase 2

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

In brief

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).

Key facts

Study ID: NCT00193661
Run by: Solvay Pharmaceuticals
Starts: 2002-08-01
Expected to finish: 2007-03-01
Last updated by the study team: 2015-01-16

Who can join

Age: 13 and older, up to 17. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

Primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)

You may not qualify if…

Skin intolerance to alcohol or allergy to soy
Generalized skin disease
Contraindication to testosterone or androgen products

Where it is running

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

Full record on ClinicalTrials.gov

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