NCT00193661

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2002

Typical duration for phase_2

Geographic Reach
1 country

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 16, 2015

Status Verified

September 1, 2006

Enrollment Period

4.6 years

First QC Date

September 11, 2005

Last Update Submit

January 15, 2015

Conditions

Primary or Secondary HypogonadismConstitutional Delay in Growth and Puberty (CDGP)

Keywords

Hypogonadism

Interventions

Testosterone Gel (1%)DRUG

Eligibility Criteria

Age13 Years - 17 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Site 130

Birmingham, Alabama, United States

Location

Site 107

Los Angeles, California, United States

Location

Site 113

Sacramento, California, United States

Location

Site 114

Torrance, California, United States

Location

Site 121

Gainesville, Florida, United States

Location

Site 127

Jacksonville, Florida, United States

Location

Site 128

Jacksonville, Florida, United States

Location

Site 117

Indianapolis, Indiana, United States

Location

Site 111

Kansas City, Missouri, United States

Location

Site 129

Brooklyn, New York, United States

Location

Site 123

New York, New York, United States

Location

Site 131

Cincinnati, Ohio, United States

Location

Site 124

Columbus, Ohio, United States

Location

Site 103

Portland, Oregon, United States

Location

Site 109

Hershey, Pennsylvania, United States

Location

Site 125

Philadelphia, Pennsylvania, United States

Location

Site 126

Philadelphia, Pennsylvania, United States

Location

Site 104

Memphis, Tennessee, United States

Location

Site 205

Seattle, Washington, United States

Location

MeSH Terms

Conditions

Hypogonadism

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

August 1, 2002

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

January 16, 2015

Record last verified: 2006-09

Locations

US(19)