Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000521628
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 study to compare the steady-state pharmacokinetics of estradiol following application to the abdomen of an Estradiol Metered-Dose Transdermal Spray (MDTS) and Estraderm 50 patches in healthy postmenopausal women, as hormone replacement therapy.
Scientific title
A phase I study to compare the steady-state pharmacokinetics of estradiol following application to the abdomen of an Estradiol Metered-Dose Transdermal Spray (MDTS) and Estraderm 50 patches in healthy postmenopausal women, 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 for post-menopausal women 646 0
Condition category
Condition code
Reproductive Health and Childbirth 719 719 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Estradiol Metered-Dose Transdermal Spray (MDTS) and Estraderm 50 patches up to 7 days.
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 881 0
Pharmacokinetic parameters
Timepoint [1] 881 0
On days 5 - 8
Secondary outcome [1] 1745 0
Safety and Tolerability
Timepoint [1] 1745 0

Eligibility
Key inclusion criteria
Healthy post-menopausal women
Minimum age
18 Years
Maximum age
Not stated
Sex
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
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/03/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 797 0
Commercial sector/Industry
Name [1] 797 0
FemPharm Pty Ltd
Country [1] 797 0
Australia
Funding source category [2] 798 0
Commercial sector/Industry
Name [2] 798 0
Acrux DDS Pty Ltd
Country [2] 798 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] 659 0
None
Name [1] 659 0
None
Address [1] 659 0
Country [1] 659 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35945 0
Address 35945 0
Country 35945 0
Phone 35945 0
Fax 35945 0
Email 35945 0
Contact person for public queries
Name 9694 0
Karen Gard'ner
Address 9694 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 9694 0
Australia
Phone 9694 0
+61 3 83790100
Fax 9694 0
Email 9694 0
[email protected]
Contact person for scientific queries
Name 622 0
Andrew Humberstone
Address 622 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 622 0
Australia
Phone 622 0
+61 3 83790100
Fax 622 0
Email 622 0
[email protected]

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.