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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 12, 2009

Last Updated Date

February 28, 2010

Start Date ^ICMJE

December 2009

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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: Open Label

Condition ^ICMJE

Hypergonadism

Intervention ^ICMJE

Drug: Testosterone MD-Lotion

Single dose Testosterone MD-Lotion 2%

Study Arm (s)

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

Enrollment ^ICMJE

Completion Date

February 2010

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

Gender

Male

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

Plan to Share Data

Not Provided

IPD Description

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

Information Provided By

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

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