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Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males

NCT ID: NCT00372008

Last Updated: 2008-06-20

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

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-04-30

Brief Summary

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Testosterone replacement treatment is the most effective way of treating hypogonadism in men. Acrux has a proprietry testosterone replacement product - Testosterone-MD Lotion, and this study will evaluate the efficacy and safety of this product.

Detailed Description

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Conditions

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Hypogonadism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Interventions

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Testosterone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hypogonadal males between 18-70 years old with qualifying general medical health

Exclusion Criteria

* Disqualifying concurrent conditions or allergy/sensitivity to testosterone replacement therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Acrux DDS Pty Ltd

INDUSTRY

Sponsor Role lead

Principal Investigators

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Tina Soulis, PhD

Role: STUDY_DIRECTOR

Acrux Ltd

Locations

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Birmingham

Birmingham, Alabama, United States

Site Status

La Mesa, California, United States

Site Status

Torrance, California, United States

Site Status

New Britain, Connecticut, United States

Site Status

Ocala, Florida, United States

Site Status

Shreveport, Louisiana, United States

Site Status

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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MTE05

Identifier Type: -

Identifier Source: org_study_id