Testosterone MD-Lotion Residual Washing Study (MTE11)

This study has been completed.
Sponsor:
Information provided by:
Acrux DDS Pty Ltd
ClinicalTrials.gov Identifier:
NCT00996151
First received: October 12, 2009
Last updated: February 28, 2010
Last verified: February 2010

October 12, 2009
February 28, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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: 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
Male
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00996151
MTE11
No
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