Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00857168




Registration number
NCT00857168
Ethics application status
Date submitted
5/03/2009
Date registered
6/03/2009
Date last updated
14/10/2009

Titles & IDs
Public title
To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD Lotion
Scientific title
A Phase I Trial to Determine the Impact of Application of Antiperspirant and Deodorant as Well as Washing the Application Site, on the Pharmacokinetics of Testosterone Following Single Dose Applications of 2% Testosterone MD-Lotion® (Cutaneous Solution)
Secondary ID [1] 0 0
MTE10
Universal Trial Number (UTN)
Trial acronym
MTE10
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active comparator: Group 1 -

Active comparator: Group 2 -

Active comparator: Group 3 -

Active comparator: Group 4 -

Active comparator: Group 5 -

Active comparator: Group 6 -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution). Also to evaluate the impact of washing.
Timepoint [1] 0 0
April 2009
Secondary outcome [1] 0 0
To assess the safety and tolerability of Testosterone MD-Lotion® (cutaneous solution) following single dose application.
Timepoint [1] 0 0
April 2009

Eligibility
Key inclusion criteria
* Healthy premenopausal female subjects =18 and =45 years of age with qualifying general medical health.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Disqualifying concurrent condition or allergy/sensitivity to testosterone replacement therapy.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
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
Parallel
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
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
36
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
- Brisbane

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

Ethics approval
Ethics application status

Summary
Brief summary
Testosterone replacement treatment is the most effective way of treating hypogonadism in men.

Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution).

The study also aim to evaluate the impact of washing the application site on the absorption of testosterone, when washed post-application of Testosterone MD-Lotion® (cutaneous solution).
Trial website
https://clinicaltrials.gov/study/NCT00857168
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/study/NCT00857168