Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000523606
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 Determine the Pharmacokinetics of Nestorone Delivered with the Metered Dose Transdermal System (MDTS) in Postmenopausal Women, to be used in contraception
Scientific title
A Phase I Study to Determine the Pharmacokinetics of Nestorone Delivered with the Metered Dose Transdermal System (MDTS) in Postmenopausal Women, to be used in contraception
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contraception 648 0
Condition category
Condition code
Reproductive Health and Childbirth 721 721 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nestorone Metered Dose Transdermal System (MDTS), 6 days.
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 883 0
Pharmacokinetic parameters
Timepoint [1] 883 0
On days 1and 5
Secondary outcome [1] 1747 0
None
Timepoint [1] 1747 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 801 0
Commercial sector/Industry
Name [1] 801 0
FemPharm Pty Ltd
Country [1] 801 0
Australia
Funding source category [2] 802 0
Commercial sector/Industry
Name [2] 802 0
Acrux DDS Pty Ltd
Country [2] 802 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] 661 0
None
Name [1] 661 0
None
Address [1] 661 0
Country [1] 661 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35282 0
Address 35282 0
Country 35282 0
Phone 35282 0
Fax 35282 0
Email 35282 0
Contact person for public queries
Name 9701 0
Karen Gard'ner
Address 9701 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 9701 0
Australia
Phone 9701 0
+61 3 83790100
Fax 9701 0
Email 9701 0
[email protected]
Contact person for scientific queries
Name 629 0
Andrew Humberstone
Address 629 0
Acrux Drug Delivery Solutions (DDS) Pty Ltd
103-113 Stanley Street
West Melbourne VIC 3003
Country 629 0
Australia
Phone 629 0
+61 3 83790100
Fax 629 0
Email 629 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.