Testosterone MD-Lotion Residual Washing Study

Hypergonadism Clinical Trial

— MTE11  

Official title:

A Healthy Volunteer, Single Dose Phase I Trial to Determine the Amount of Testerone MD-Lotion 2% Remaining on the Axilla After Washing.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996151
• Other study ID #: MTE11
• Status: Completed
• Phase: Phase 1
• First received: October 12, 2009
• Last updated: February 28, 2010
• Start date: December 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: Acrux DDS Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Healthy male subjects =18 and = 70 years

Exclusion Criteria:

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypergonadism

Intervention

Drug:
• Testosterone MD-Lotion
Single dose Testosterone MD-Lotion 2%

Locations

Country	Name	City	State
Australia	QPharm Pty Ltd	Brisbane	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Acrux DDS Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		March 2010	No
Secondary	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).		March 2010	No