NCT00193700

Brief Summary

Measure and evaluate the level of testosterone in blood, and determine the safety and tolerability following daily applications of testosterone gel. Subjects who complete this trial may participate in the extension part (UMD-01-080E).

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

9 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
Last Updated

December 25, 2006

Status Verified

November 1, 2006

First QC Date

September 11, 2005

Last Update Submit

December 23, 2006

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:

  • Diagnosis of primary or secondary hypogonadism or constitutional delay in growth and puberty (CDGP)

You may not qualify if:

  • Clinically significant uncontrolled medical condition or psychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Site 208

Birmingham, Alabama, United States

Location

Site 203

Torrance, California, United States

Location

Site 204

Jacksonville, Florida, United States

Location

Site 201

Kansas City, Missouri, United States

Location

Site 206

Morristown, New Jersey, United States

Location

Site 207

Brooklyn, New York, United States

Location

Site 209

Cincinnati, Ohio, United States

Location

Site 202

Philadelphia, Pennsylvania, 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 1
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

Last Updated

December 25, 2006

Record last verified: 2006-11

Locations

US(9)