Testosterone MD-Lotion Residual Washing Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00996151
• Date of registration: 12/10/2009
• Primary sponsor: Acrux DDS Pty Ltd
• Public title: Testosterone MD-Lotion Residual Washing Study MTE11
• Scientific title: A Healthy Volunteer, Single Dose Phase I Trial to Determine the Amount of Testerone MD-Lotion 2% Remaining on the Axilla After Washing.
• Date of first enrolment: December 2009
• Target sample size: 10
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00996151
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label

Countries of recruitment

Australia

Contacts

• Name: Tina Soulis, PhD
• Affiliation: Acrux Pharma Pty Ltd

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy male subjects =18 and = 70 years

Exclusion Criteria:

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



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Hypergonadism

Intervention(s)

Drug: Testosterone MD-Lotion

Primary Outcome(s)

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]

Secondary Outcome(s)

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]

Secondary ID(s)

MTE11

Source(s) of Monetary Support

Please refer to primary and secondary sponsors