Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000519651
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 Study to Determine the Linearity of the Pharmacokinetics and the Effect of Washing the Application Site on the Bioavailability of Estradiol from an Estradiol MDTS as hormone replacement therapy in post-menopausal women
Scientific title
A Study to Determine the Linearity of the Pharmacokinetics and the Effect of Washing the Application Site on the Bioavailability of Estradiol from an Estradiol MDTS as hormone replacement therapy in post-menopausal women
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone replacement therapy in post-menopausal women 644 0
Condition category
Condition code
Reproductive Health and Childbirth 717 717 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Estradiol MDTS for 8 days
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 879 0
Pharmacokinetic parameters
Timepoint [1] 879 0
On days 1 - 8
Secondary outcome [1] 1743 0
Safety and Tolerability
Timepoint [1] 1743 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)
None - 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
16/07/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 793 0
Commercial sector/Industry
Name [1] 793 0
FemPharm Pty Ltd
Country [1] 793 0
Australia
Funding source category [2] 794 0
Commercial sector/Industry
Name [2] 794 0
Acrux DDS Pty Ltd
Country [2] 794 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] 657 0
None
Name [1] 657 0
None
Address [1] 657 0
Country [1] 657 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35544 0
Address 35544 0
Country 35544 0
Phone 35544 0
Fax 35544 0
Email 35544 0
Contact person for public queries
Name 9688 0
Karen Gard'ner
Address 9688 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 9688 0
Australia
Phone 9688 0
+61 3 83790100
Fax 9688 0
Email 9688 0
karen.gardner@acrux.com.au
Contact person for scientific queries
Name 616 0
Andrew Humberstone
Address 616 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 616 0
Australia
Phone 616 0
+61 3 83790100
Fax 616 0
Email 616 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.