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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
N/A
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
1/12/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2010
Sample size
Target
Accrual to date
Final
10
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00996151