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Trial registered on ANZCTR


Registration number
ACTRN12605000518662
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 phase I study to assess the effect of different application sites on the pharmacokinetics of testosterone from a Testosterone Metered Dose (MD) Lotion in hypogonadism.
Scientific title
A pharmacokinetic phase I study to assess the effect of different application sites on the pharmacokinetics of testosterone from a Testosterone Metered Dose (MD) Lotion in hypogonadism.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypogonadism 643 0
Condition category
Condition code
Metabolic and Endocrine 716 716 0 0
Diabetes

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

Outcomes
Primary outcome [1] 878 0
Pharmacokinetic parameters
Timepoint [1] 878 0
On days 1 - 4 each period
Secondary outcome [1] 1742 0
None
Timepoint [1] 1742 0

Eligibility
Key inclusion criteria
Healthy female volunteers
Minimum age
Not stated
Maximum age
Not stated
Gender
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
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)

Funding & Sponsors
Funding source category [1] 792 0
Commercial sector/Industry
Name [1] 792 0
Acrux DDS Pty Ltd
Address [1] 792 0
Country [1] 792 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Acrux DDS Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 656 0
None
Name [1] 656 0
None
Address [1] 656 0
Country [1] 656 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35883 0
Address 35883 0
Country 35883 0
Phone 35883 0
Fax 35883 0
Email 35883 0
Contact person for public queries
Name 9714 0
Karen Gard'ner
Address 9714 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 9714 0
Australia
Phone 9714 0
+61 3 83790100
Fax 9714 0
Email 9714 0
karen.gardner@acrux.com.au
Contact person for scientific queries
Name 642 0
Andrew Humberstone
Address 642 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 642 0
Australia
Phone 642 0
+61 3 83790100
Fax 642 0
Email 642 0
andrew.humberstone@acrux.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary