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Trial registered on ANZCTR


Registration number
ACTRN12605000520639
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 and Formulations, on the Relative Bioavailability and Pharmacokinetics of Estradiol in postmenopausal women from a Metered Dose Transdermal System (MDTS) as hormone replacement therapy.
Scientific title
A Pharmacokinetic Phase I Study to Assess the Effect of Different Application Sites and Formulations, on the Relative Bioavailability and Pharmacokinetics of Estradiol in postmenopausal women from a Metered Dose Transdermal System (MDTS) as hormone replacement therapy.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone replacement therapy in post-meonpausal women 645 0
Condition category
Condition code
Reproductive Health and Childbirth 718 718 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Estradiol MDTS, 7-days, 3-period crossover
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 880 0
Pharmacokinetic parameters
Timepoint [1] 880 0
On days 6, 7 and 8 of each period
Secondary outcome [1] 1744 0
None
Timepoint [1] 1744 0

Eligibility
Key inclusion criteria
None
Minimum age
-2147483648
Maximum age
-2147483648
Sex
Can healthy volunteers participate?
Yes
Key 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)
randomised 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] 795 0
Commercial sector/Industry
Name [1] 795 0
FemPharm Pty Ltd
Country [1] 795 0
Australia
Funding source category [2] 796 0
Commercial sector/Industry
Name [2] 796 0
Acrux DDS Pty Ltd
Country [2] 796 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] 658 0
None
Name [1] 658 0
None
Address [1] 658 0
Country [1] 658 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35656 0
Address 35656 0
Country 35656 0
Phone 35656 0
Fax 35656 0
Email 35656 0
Contact person for public queries
Name 9692 0
Karen Gard'ner
Address 9692 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 9692 0
Australia
Phone 9692 0
+61 3 83790100
Fax 9692 0
Email 9692 0
karen.gardner@acrux.com.au
Contact person for scientific queries
Name 620 0
Andrew Humberstone
Address 620 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 620 0
Australia
Phone 620 0
+61 3 83790100
Fax 620 0
Email 620 0
andrew.humberstone@acrux.com.au

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.