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Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00372008
First Posted: September 6, 2006
Last Update Posted: June 20, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Acrux DDS Pty Ltd
September 5, 2006
September 6, 2006
June 20, 2008
October 2006
April 2007   (Final data collection date for primary outcome measure)
Pharmacokinetic
Same as current
Complete list of historical versions of study NCT00372008 on ClinicalTrials.gov Archive Site
Safety and tolerability
Same as current
Not Provided
Not Provided
 
Pharmacokinetics of Testosterone Lotion in the Treatment of Hypogonadal Males
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Hypogonadism
Drug: Testosterone
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2007
April 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00372008
MTE05
Not Provided
Not Provided
Not Provided
Not Provided
Acrux DDS Pty Ltd
Not Provided
Study Director: Tina Soulis, PhD Acrux Ltd
Acrux DDS Pty Ltd
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP