Testosterone MD-Lotion Residual Washing Study (MTE11)

Tracking Information
First Submitted Date ICMJE	October 12, 2009
First Posted Date ICMJE	October 16, 2009
Last Update Posted Date	March 2, 2010
Study Start Date ICMJE	December 2009
Actual Primary Completion Date	February 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 15, 2009)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00996151 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 15, 2009)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Testosterone MD-Lotion Residual Washing Study
Official Title ICMJE	A Healthy Volunteer, Single Dose Phase I Trial to Determine the Amount of Testerone MD-Lotion 2% Remaining on the Axilla After Washing.
Brief Summary	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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label)
Condition ICMJE	Hypergonadism
Intervention ICMJE	Drug: Testosterone MD-Lotion; Single dose Testosterone MD-Lotion 2%
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 15, 2009)	10
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	February 2010
Actual Primary Completion Date	February 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Healthy male subjects ≥18 and ≤ 70 years Exclusion Criteria: Disqualifying concurrent condition or allergy/sensitivity to Testosterone MD-Lotion
Sex/Gender	Sexes Eligible for Study: Male
Ages	18 Years to 70 Years (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Australia
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00996151
Other Study ID Numbers ICMJE	MTE11
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Tina Soulis, Director, Clinical Development, Acrux Pharma Pty Ltd
Study Sponsor ICMJE	Acrux DDS Pty Ltd
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Tina Soulis, PhD Acrux Pharma Pty Ltd
PRS Account	Acrux DDS Pty Ltd
Verification Date	February 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP