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Trial registered on ANZCTR


Registration number
ACTRN12605000438651
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
25/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase l Study to Determine the Pharmacokinetics of Testosterone from a Metered Dose Transdermal System (MDTS) in low libido in post-menopausal women suffering from low serum testosterome
Scientific title
A Phase l Study to Determine the Pharmacokinetics of Testosterone from a Metered Dose Transdermal System (MDTS) in low libido in post-menopausal women suffering from low serum testosterome
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low libido in post-menopausal women suffering from low serum testosterone 550 0
Condition category
Condition code
Reproductive Health and Childbirth 628 628 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Testosterone metered-dose transdermal system (MDTS), single then repeat dose for 6 days.
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 736 0
Pharmacokinetic parameters
Timepoint [1] 736 0
On days 1 and 6 - 8.
Secondary outcome [1] 1514 0
None
Timepoint [1] 1514 0

Eligibility
Key inclusion criteria
Healthy post-menopausal women
Minimum age
18 Years
Maximum age
Not stated
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
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] 685 0
Commercial sector/Industry
Name [1] 685 0
FemPharm Pty Ltd
Address [1] 685 0
Country [1] 685 0
Funding source category [2] 686 0
Commercial sector/Industry
Name [2] 686 0
Acrux DDS Pty Ltd
Address [2] 686 0
Country [2] 686 0
Primary sponsor type
Commercial sector/Industry
Name
FemPharm Pty Ltd and/or Acrux DDS Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 574 0
None
Name [1] 574 0
None
Address [1] 574 0
Country [1] 574 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36315 0
Address 36315 0
Country 36315 0
Phone 36315 0
Fax 36315 0
Email 36315 0
Contact person for public queries
Name 9683 0
Karen Gard'ner
Address 9683 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3181
Country 9683 0
Australia
Phone 9683 0
+61 3 83790100
Fax 9683 0
Email 9683 0
karen.gardner@acrux.com.au
Contact person for scientific queries
Name 611 0
Andrew Humberstone
Address 611 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3181
Country 611 0
Australia
Phone 611 0
+61 3 83790100
Fax 611 0
Email 611 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