Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000591651
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
5/10/2005
Date last updated
25/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A PHARMACOKINETIC PHASE I STUDY TO ASSESS THE COMPARATIVE BIOAVAILABILITY OF 17-B-ESTRADIOL FROM A METERED DOSE TRANSDERMAL SYSTEM (MDTS) AND ESTRADERM 50 PATCHES IN HEALTHY
POSTMENOPAUSAL WOMEN, AS HORMONE REPLACEMENT THERAPY
Scientific title
A PHARMACOKINETIC PHASE I STUDY TO ASSESS THE COMPARATIVE BIOAVAILABILITY OF 17-B-ESTRADIOL FROM A METERED DOSE TRANSDERMAL SYSTEM (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 in postmenopausal women 718 0
Condition category
Condition code
Reproductive Health and Childbirth 795 795 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ESTRADIOL METERED DOSE TRANSDERMAL SYSTEM (MDTS) AND ESTRADERM 50 PATCHES FOR 6 DAYS.
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1016 0
Pharmacokinetic parameters
Timepoint [1] 1016 0
On days 1 - 8
Secondary outcome [1] 1906 0
Safety and tolerability
Timepoint [1] 1906 0

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/02/2001
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] 883 0
Commercial sector/Industry
Name [1] 883 0
FemPharm Pty Ltd
Country [1] 883 0
Australia
Funding source category [2] 884 0
Commercial sector/Industry
Name [2] 884 0
Acrux DDS Pty Ltd
Country [2] 884 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] 746 0
None
Name [1] 746 0
None
Address [1] 746 0
Country [1] 746 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35491 0
Address 35491 0
Country 35491 0
Phone 35491 0
Fax 35491 0
Email 35491 0
Contact person for public queries
Name 9681 0
Karen Gard'ner
Address 9681 0
Acrux
103-113 Stanley Street
West Melbourne VIC 3003
Country 9681 0
Australia
Phone 9681 0
+61 3 83790100
Fax 9681 0
Email 9681 0
[email protected]
Contact person for scientific queries
Name 609 0
Andrew Humberstone
Address 609 0
Acrux
103-113 Stanley Street
West Melbourne VIC 3003
Country 609 0
Australia
Phone 609 0
+61 3 83790100
Fax 609 0
Email 609 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.