Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000141347
Ethics application status
Approved
Date submitted
4/03/2008
Date registered
19/03/2008
Date last updated
18/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing the provision of twelve months versus four months supply of the combined oral contraceptive pill on continuation rates at twelve months after initiation
Scientific title
A randomised controlled trial comparing the provision of twelve months versus four months supply of the combined oral contraceptive pill on continuation rates at twelve months after initiation.
Secondary ID [1] 290964 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contraceptive pill continuation 2888 0
Condition category
Condition code
Reproductive Health and Childbirth 3026 3026 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prescription of a 12-month combined oral contraceptive pill supply at initiation of this contraceptive method - the prescription may be for any of the Therapeutic Goods Administration (TGA) approved combined contraceptive pills available on the australian market. All pills are given in a once daily dosage. Type of pill prescribed will be recorded.
Intervention code [1] 2619 0
Other interventions
Comparator / control treatment
Prescription of a 4-month combined oral contraceptive pill supply at initiation of this contraceptive method - the prescription may be for any of the Therapeutic Goods Administration (TGA) approved combined contraceptive pills available on the australian market. All pills are given in a once daily dosage. Type of pill prescribed will be recorded.
Control group
Active

Outcomes
Primary outcome [1] 3903 0
Pill continuation rate - all participants will be phoned or e-mailed according to their preference at 12-months after initiation by a research nurse.
Timepoint [1] 3903 0
12-months
Secondary outcome [1] 6582 0
Preference and attitude for initiation regimen -this willl be measured using a short questionnaire administered by phone or e-mail according to stated preference
Timepoint [1] 6582 0
12-months

Eligibility
Key inclusion criteria
Women aged 18-40 years who choose this method of contraception and are eligible according to standard World Health Organisation (WHO) criteria to use the combined oral contraceptive pill; have not used it in the past 2 years; are not intending to become pregnant in the next 12-months.
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Ineligible for the combined contraceptive pill; outside age criteria; do not consent to randomisation; require an interpreter.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Women presenting to routine family planning clinics who are eligible to use the combined contraceptive pill and who choose this method over other methods are given information about the study and asked to sign the consent form. An opaque envelope is taken in order (using a computer generated randomisation scheme) by the prescribing clinician which tells the participant about their allocation. The women are then prescribed their preferred contraceptive pill according to the allocated regimen and the clinical record form is completed. The clinician and participant are blinded as to the allocation prior to pill prescription.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence is generated by a computer randomization scheme at www. randomization.com
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/03/2008
Actual
28/02/2008
Date of last participant enrolment
Anticipated
Actual
23/06/2009
Date of last data collection
Anticipated
Actual
23/06/2010
Sample size
Target
454
Accrual to date
Final
144
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 791 0
2131

Funding & Sponsors
Funding source category [1] 3155 0
Charities/Societies/Foundations
Name [1] 3155 0
Family Planning NSW
Country [1] 3155 0
Australia
Funding source category [2] 3156 0
Charities/Societies/Foundations
Name [2] 3156 0
Family Planning NSW
Country [2] 3156 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Family Planning NSW
Address
328-336 Liverpool Rd
Ashfield NSW 2131
Country
Australia
Secondary sponsor category [1] 2858 0
None
Name [1] 2858 0
Address [1] 2858 0
Country [1] 2858 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5135 0
Family Planning NSW Ethics Committee
Ethics committee address [1] 5135 0
328 - 336 Liverpool Rd
Ashfield NSW 2131
Ethics committee country [1] 5135 0
Australia
Date submitted for ethics approval [1] 5135 0
26/11/2007
Approval date [1] 5135 0
11/12/2007
Ethics approval number [1] 5135 0
EC00120

Summary
Brief summary
The primary purpose of the study is to determine whether women prescibed a twelve month supply rather than the usual four month supply of the combined oral contraceptive pill at initiation of this contraceptive method are more likley to continue this method when followed-up by phone or e-mail twelve months later. The study will also look at womens' preferences for each initiation regimen through administration of a questionnaire. The hypothesis is that women are more likley to continue the contraceptive pill if they are prescribed the longer initiation regimen and will have a preference for this regimen over the shorter four month regimen.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28412 0
Dr Dr Deborah Bateson
Address 28412 0
Family Planning NSW
328-336 Liverpool Rd
Ashfield NSW 2131
Country 28412 0
Australia
Phone 28412 0
+61 02 87524341
Fax 28412 0
Email 28412 0
[email protected]
Contact person for public queries
Name 11569 0
Dr Dr Deborah Bateson
Address 11569 0
Family Planning NSW
328-336 Liverpool Rd
Ashfield New South Wales 2131
Country 11569 0
Australia
Phone 11569 0
+61 2 87524344
Fax 11569 0
Email 11569 0
[email protected]
Contact person for scientific queries
Name 2497 0
Dr Dr Deborah Bateson
Address 2497 0
Family Planning NSW
328-336 Liverpool Rd
Ashfield New South Wales 2131
Country 2497 0
Australia
Phone 2497 0
+61 2 87524344
Fax 2497 0
Email 2497 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.