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Pharmacokinetic Evaluation of Testosterone Gel (1%)

NCT ID: NCT00193700

Last Updated: 2006-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Primary or Secondary Hypogonadism Constitutional Delay in Growth and Puberty (CDGP)

Keywords

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Hypogonadism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Testosterone Gel (1%)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Clinically significant uncontrolled medical condition or psychiatric disorder
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Unimed Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Solvay Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

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Global Clinical Director Solvay

Role: STUDY_DIRECTOR

Solvay Pharmaceuticals

Locations

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Site 208

Birmingham, Alabama, United States

Site Status

Site 203

Torrance, California, United States

Site Status

Site 204

Jacksonville, Florida, United States

Site Status

Site 201

Kansas City, Missouri, United States

Site Status

Site 206

Morristown, New Jersey, United States

Site Status

Site 207

Brooklyn, New York, United States

Site Status

Site 209

Cincinnati, Ohio, United States

Site Status

Site 202

Philadelphia, Pennsylvania, United States

Site Status

Site 205

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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UMD-01-080

Identifier Type: -

Identifier Source: org_study_id