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Trial registered on ANZCTR


Registration number
ACTRN12605000522617
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 phase I pharmacokinetic study to compare the steady-state pharmacokinetics of testosterone following application of a Testosterone Metered-Dose Transdermal Spray (MDTS) to the forearm or abdomen in healthy postmenopausal women with low libido and low serum testosterone
Scientific title
A phase I pharmacokinetic study to compare the steady-state pharmacokinetics of testosterone following application of a Testosterone Metered-Dose Transdermal Spray (MDTS) to the forearm or abdomen in healthy postmenopausal women with low libido and low serum testosterone
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low libido in post-menopausal women with low serum testosterone 647 0
Condition category
Condition code
Reproductive Health and Childbirth 720 720 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Testosterone Metered-Dose Transdermal Spray (MDTS), 5-days.
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 882 0
Pharmacokinetic parameters
Timepoint [1] 882 0
On days 4 - 6
Secondary outcome [1] 1746 0
None
Timepoint [1] 1746 0

Eligibility
Key inclusion criteria
Healthy post-menopausal women
Minimum age
18 Years
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] 799 0
Commercial sector/Industry
Name [1] 799 0
FemPharm Pty Ltd
Address [1] 799 0
Country [1] 799 0
Australia
Funding source category [2] 800 0
Commercial sector/Industry
Name [2] 800 0
Acrux DDS Pty Ltd
Address [2] 800 0
Country [2] 800 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
FemPharm Pty Ltd and/or Acrux DDS Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 660 0
None
Name [1] 660 0
None
Address [1] 660 0
Country [1] 660 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35462 0
Address 35462 0
Country 35462 0
Phone 35462 0
Fax 35462 0
Email 35462 0
Contact person for public queries
Name 9698 0
Karen Gard'ner
Address 9698 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 9698 0
Australia
Phone 9698 0
+61 3 83790100
Fax 9698 0
Email 9698 0
karen.gardner@acrux.com.au
Contact person for scientific queries
Name 626 0
Andrew Humberstone
Address 626 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 626 0
Australia
Phone 626 0
+61 3 83790100
Fax 626 0
Email 626 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