Testosterone MD-Lotion Residual Washing Study (MTE11)
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ClinicalTrials.gov Identifier: NCT00996151 |
Recruitment Status
:
Completed
First Posted
: October 16, 2009
Last Update Posted
: March 2, 2010
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Sponsor:
Acrux DDS Pty Ltd
Information provided by:
Acrux DDS Pty Ltd
Tracking Information | ||||
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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 |
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 |
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) |
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Condition ICMJE | Hypergonadism | |||
Intervention ICMJE | Drug: Testosterone MD-Lotion
Single dose Testosterone MD-Lotion 2% |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Senior) | |||
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 |
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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 |