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

Phase 2
Completed
Conditions
Primary or Secondary Hypogonadism
Constitutional Delay in Growth and Puberty (CDGP)
Registration Number
NCT00193661
Lead Sponsor
Solvay Pharmaceuticals
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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
Not specified
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

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (19)

Site 125

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Philadelphia, Pennsylvania, United States

Site 126

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Philadelphia, Pennsylvania, United States

Site 111

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Kansas City, Missouri, United States

Site 130

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Birmingham, Alabama, United States

Site 107

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Los Angeles, California, United States

Site 113

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Sacramento, California, United States

Site 114

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Torrance, California, United States

Site 121

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Gainesville, Florida, United States

Site 127

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Jacksonville, Florida, United States

Site 117

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Indianapolis, Indiana, United States

Site 123

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New York, New York, United States

Site 131

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Cincinnati, Ohio, United States

Site 109

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Hershey, Pennsylvania, United States

Site 103

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Portland, Oregon, United States

Site 124

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Columbus, Ohio, United States

Site 205

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Seattle, Washington, United States

Site 104

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Memphis, Tennessee, United States

Site 129

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Brooklyn, New York, United States

Site 128

🇺🇸

Jacksonville, Florida, United States

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