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Trial registered on ANZCTR


Registration number
ACTRN12605000468628
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
23/09/2005
Date last updated
25/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pharmacokinetic study to assess the comparative bioavailability of 17-B-estradiol from Metered-Dose Transdermal Sprays (MDTS) and Estraderm 50 patches as hormone replacement therapy in postmenopausal women.
Scientific title
A pharmacokinetic study to assess the comparative bioavailability of 17-B-estradiol from Metered-Dose Transdermal Sprays (MDTS) and Estraderm 50 patches as hormone replacement therapy in postmenopausal women.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone replacement therapy in postmenopausal women 587 0
Condition category
Condition code
Reproductive Health and Childbirth 659 659 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Estradiol Metered-Dose Transdermal Sprays (MDTS) vs Estraderm 50 patches for 6-days.
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 784 0
Pharmacokinetic parameters - serum concentration of estradiol
Timepoint [1] 784 0
On day 1 and 6 - 8.
Secondary outcome [1] 1594 0
Safety and Tolerability
Timepoint [1] 1594 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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Open label - no concealment
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] 728 0
Commercial sector/Industry
Name [1] 728 0
FemPharm Pty Ltd
Address [1] 728 0
Country [1] 728 0
Australia
Funding source category [2] 729 0
Commercial sector/Industry
Name [2] 729 0
Acrux DDS Pty Ltd
Address [2] 729 0
Country [2] 729 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] 604 0
None
Name [1] 604 0
None
Address [1] 604 0
Country [1] 604 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35957 0
Address 35957 0
Country 35957 0
Phone 35957 0
Fax 35957 0
Email 35957 0
Contact person for public queries
Name 9680 0
Karen Gard'ner
Address 9680 0
Acrux
103-113 Stanley Street
West Melbourne VIC 3003
Country 9680 0
Australia
Phone 9680 0
+61 3 83790100
Fax 9680 0
Email 9680 0
karen.gardner@acrux.com.au
Contact person for scientific queries
Name 608 0
Andrew Humberstone
Address 608 0
Acrux
103-113 Stanley Street
West Melbourne VIC 3003
Country 608 0
Australia
Phone 608 0
+61 3 83790100
Fax 608 0
Email 608 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