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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

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
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

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

Active Comparator: Group 1 -

Active Comparator: Group 2 -

Active Comparator: Group 3 -

Active Comparator: Group 4 -

Active Comparator: Group 5 -

Active Comparator: Group 6 -

Treatment: Drugs: Testosterone MD-Lotion

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

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

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
Can healthy volunteers participate?
Key exclusion criteria
- Disqualifying concurrent condition or allergy/sensitivity to testosterone replacement

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
Other design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis

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

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

Ethics approval
Ethics application status

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
Trial website
Trial related presentations / publications
Public notes

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