Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000528651
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
26/09/2005
Date last updated
25/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pharmacokinetic study to assess the effect of two different formulations of Testosterone Metered Dose (MD) Lotion on the pharmacokinetics of testosterone in hypogonadism
Scientific title
A pharmacokinetic study to assess the effect of two different formulations of Testosterone Metered Dose (MD) Lotion on the pharmacokinetics of testosterone in hypogonadism
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypogonadism 653 0
Condition category
Condition code
Metabolic and Endocrine 726 726 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Testosterone Metered Dose (MD) Lotion, single dose.
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 888 0
Pharmacokinetic parameters
Timepoint [1] 888 0
On days 1 - 4
Secondary outcome [1] 1752 0
None
Timepoint [1] 1752 0

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

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



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 807 0
Commercial sector/Industry
Name [1] 807 0
Acrux DDS Pty Ltd
Country [1] 807 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Acrux DDS Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 666 0
None
Name [1] 666 0
None
Address [1] 666 0
Country [1] 666 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35459 0
Address 35459 0
Country 35459 0
Phone 35459 0
Fax 35459 0
Email 35459 0
Contact person for public queries
Name 9712 0
Karen Gard'ner
Address 9712 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd 103-113 Stanley Street West Melbourne VIC 3003
Country 9712 0
Australia
Phone 9712 0
+61 3 83790100
Fax 9712 0
Email 9712 0
[email protected]
Contact person for scientific queries
Name 640 0
Andrew Humberstone
Address 640 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd 103-113 Stanley Street West Melbourne VIC 3003
Country 640 0
Australia
Phone 640 0
+61 3 83790100
Fax 640 0
Email 640 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.