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Clinical Trials/NCT00193700
NCT00193700CompletedPhase 1

Pharmacokinetic Evaluation of Testosterone Gel (1%) in Prepubertal Boys of Adolescent Age

Solvay Pharmaceuticals9 sites in 1 countryStarted: August 2002Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Locations
9
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
13 Years to 17 Years (Child)
Sex
Male
Accepts Healthy Volunteers
No

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

Investigators

Sponsor Class
Industry

Study Sites (9)

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