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Pharmacokinetic Evaluation of Testosterone Gel (1%)

NCT00193700 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2006-12-25

No results posted yet for this study

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).

Conditions

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

Interventions

DRUG

Testosterone Gel (1%)

Sponsors & Collaborators

  • Unimed Pharmaceuticals

    collaborator INDUSTRY

  • Solvay Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Director Solvay · Solvay Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00193700 on ClinicalTrials.gov