Testosterone MD-Lotion Residual Washing Study (MTE11)

February 28, 2010 updated by: Acrux DDS Pty Ltd

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Brisbane, Queensland, Australia, 4006
        • QPharm Pty Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male subjects ≥18 and ≤ 70 years

Exclusion Criteria:

  • Disqualifying concurrent condition or allergy/sensitivity to Testosterone MD-Lotion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
March 2010

Secondary Outcome Measures

Outcome Measure
Time Frame
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
March 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acrux DDS Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

October 12, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (Estimate)

October 16, 2009

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 28, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTE11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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