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Testosterone MD-Lotion Residual Washing Study (MTE11)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00996151
First Posted: October 16, 2009
Last Update Posted: March 2, 2010
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
October 12, 2009
October 16, 2009
March 2, 2010
December 2009
February 2010   (Final data collection date for primary outcome measure)
The amount of Testerone MD-Lotion 2% remaining on the axilla after a single dose application in healthy males who undergo a post dose washing procedure. [ Time Frame: March 2010 ]
Same as current
Complete list of historical versions of study NCT00996151 on ClinicalTrials.gov Archive Site
The safety and tolerability of Testosterone MD-Lotion 2% following a single dose application. This will be performed by review of adverse events, EKG and assessment of laboratory parameters (haematology, biochemistry, urinalysis and hormone levels). [ Time Frame: March 2010 ]
Same as current
Not Provided
Not Provided
 
Testosterone MD-Lotion Residual Washing Study
A Healthy Volunteer, Single Dose Phase I Trial to Determine the Amount of Testerone MD-Lotion 2% Remaining on the Axilla After Washing.
The study will evaluate the amount of Testosteron MD-Lotion 2% remaining on the axilla after a single dose application in healthy males who undergo a post dose washing procedure.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Hypergonadism
Drug: Testosterone MD-Lotion
Single dose Testosterone MD-Lotion 2%
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
10
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects ≥18 and ≤ 70 years

Exclusion Criteria:

  • Disqualifying concurrent condition or allergy/sensitivity to Testosterone MD-Lotion
Sexes Eligible for Study: Male
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00996151
MTE11
No
Not Provided
Not Provided
Tina Soulis, Director, Clinical Development, Acrux Pharma Pty Ltd
Acrux DDS Pty Ltd
Not Provided
Study Director: Tina Soulis, PhD Acrux Pharma Pty Ltd
Acrux DDS Pty Ltd
February 2010

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