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NCT00372008 Clinical Trial

Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males

Hypogonadism Clinical Trial

Official title:
A Phase II Randomised, Two-Way Crossover Study to Compare the Steady State Pharmacokinetics of Testosterone Following Application of Different Testosterone Metered-Dose (MD) Lotion Doses in Hypogonadal Male Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00372008
Other study ID # MTE05
Secondary ID
Status Completed
Phase Phase 2
First received September 5, 2006
Last updated June 18, 2008
Start date October 2006
Est. completion date April 2007

Study information
Verified date June 2008
Source Acrux DDS Pty Ltd
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 2007
Est. primary completion date April 2007
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• Testosterone

Locations
Country Name City State
United States Birmingham Birmingham Alabama

Sponsors (1)
Lead Sponsor Collaborator
Acrux DDS Pty Ltd

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic
Secondary Safety and tolerability
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