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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00996151




Registration number
NCT00996151
Ethics application status
Date submitted
12/10/2009
Date registered
16/10/2009
Date last updated
2/03/2010

Titles & IDs
Public title
Testosterone MD-Lotion Residual Washing Study
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.
Secondary ID [1] 0 0
MTE11
Universal Trial Number (UTN)
Trial acronym
MTE11
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypergonadism 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Testosterone MD-Lotion

Treatment: Drugs: Testosterone MD-Lotion
Single dose Testosterone MD-Lotion 2%

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
March 2010
Secondary outcome [1] 0 0
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).
Timepoint [1] 0 0
March 2010

Eligibility
Key inclusion criteria
- Healthy male subjects =18 and = 70 years
Minimum age
18 Years
Maximum age
70 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Disqualifying concurrent condition or allergy/sensitivity to Testosterone MD-Lotion

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
QPharm Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Acrux DDS Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00996151
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tina Soulis, PhD
Address 0 0
Acrux Pharma Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications