Trial Review

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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
15/07/2002
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] 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.