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Trial registered on ANZCTR


Registration number
ACTRN12609000391279
Ethics application status
Approved
Date submitted
4/03/2009
Date registered
1/06/2009
Date last updated
1/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative 12 month study of menstrually-signalled use of a combined contraceptive pill versus a combined contraceptive vaginal ring
Scientific title
Comparative 12 month study of menstrually-signalled use of an ethinyl oestradiol and levonorgestrel low-dose pill and a low-dose contraceptive vaginal ring containing ethinyl oestradiol and etonogestrel to assess the number of bleeding spotting days
Universal Trial Number (UTN)
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Contraception 4754 0
Condition category
Condition code
Reproductive Health and Childbirth 237092 237092 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of a low dose oral contraceptive pill containing ethinyl oestradiol 20mcg and levonorgestrel 100mcg once daily for a total of 12 months
Intervention code [1] 4530 0
Prevention
Comparator / control treatment
12 month use of a contraceptive vaginal ring releasing 15 mcg ethinyl oestradiol and 150mcgs etonorgestrel over 24 hours replaced every 4 weeks
Control group
Active

Outcomes
Primary outcome [1] 5924 0
Total number of bleeding/spotting days over a 12 month treatment period from information recorded on a daily bleeding diary and verified by telephone and face to face interviews
Timepoint [1] 5924 0
The total number of bleeding/spotting days will be calculated for the 12 month study period but divided into 4 X 90 day reference periods as recommended by the World Health Organisation.
Secondary outcome [1] 242012 0
Comparison of haematological and biochemical parameters prior to starting the contraceptive method and at termination of the method.
Timepoint [1] 242012 0
Prior to inclusion in the study and at the termination visit.
Secondary outcome [2] 242013 0
To determine whether 4 days cessation of treatment is sufficient to stop an episode of breakthrough bleeding (BTB) determined from a daily bleeding diary and verified by telephone and face to face interviews.
Timepoint [2] 242013 0
Over the 12 months study period this will be assessed for each 90 day reference period from the bleeding diaries and verified by telephone and face to face interviews

Eligibility
Key inclusion criteria
Can be new users, restarters or switchers
No contraindications to combined hormonal contraceptive use
Willing to give informed consent to randomisation
Willing to be contacted monthly by research assistant and to maintain a menstrual chart
Willing to have a blood samples taken at inclusion and completion of study for biochemical and haematological testing.
Willing to keep account of sanitary protection used and cost over duration of study.
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Currently pregnant or trying to get pregnant.
Sterilisation.
Contraindications to combined hormonal contraceptive use
Smokers aged = 35 years and over are excluded
Depot medroxyprogestogen acetateuse within last six months
Undiagnosed intermenstrual bleeding
Problems with cycle control whilst taking combined oral contraceptives leading to discontinuation
Unwilling to stop taking non-steroidal anti-inflammatory drugs
Taking any concomitant medications which cause enzyme induction and could effect steroidal blood levels

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)
Volunteers will be assigned to treatment according to a computerised randomisation code. The treatment allocation for each subject is inside an opaque envelope which will be opened in the presence of the subject once she has been consented and assessed as eligible to enter the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated by a computer program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
women will maintain a menstrual diary. if they have breakthrough bleeding and/or spotting during therapy which lasts more than 4 days they will be instructed to stop treatment for 4 days and recommence on the fifth day
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5066 0
Self funded/Unfunded
Name [1] 5066 0
Family Planning NSW
Address [1] 5066 0
328-336 Liverpool Road
Ashfield NSW 2131
Country [1] 5066 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Family Planning NSW
Address
328-336 Liverpool Road
Ashfield NSW 2131
Country
Australia
Secondary sponsor category [1] 4458 0
Commercial sector/Industry
Name [1] 4458 0
Bayer Australia Ltd.
Address [1] 4458 0
875 Pacific Highway
Pymble
NSW 2073
Country [1] 4458 0
Australia
Secondary sponsor category [2] 4574 0
Charities/Societies/Foundations
Name [2] 4574 0
Schering Plough
Address [2] 4574 0
Level 4
66 Waterloo Road
North Ryde
NSW 2113
Country [2] 4574 0
Australia
Other collaborator category [1] 696 0
Individual
Name [1] 696 0
Professor Ian Fraser
Address [1] 696 0
Queen Elizabeth II Research Institute for Mothers and Infants.University of Sydney, Camperdown NSW 2006
Country [1] 696 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239167 0
Family Planning NSW
Ethics committee address [1] 239167 0
328-336 Liverpool Road
Ashfield NSW 2131
Ethics committee country [1] 239167 0
Australia
Date submitted for ethics approval [1] 239167 0
22/01/2008
Approval date [1] 239167 0
22/10/2008
Ethics approval number [1] 239167 0
EC00120

Summary
Brief summary
Women requiring hormonal contraception who have consented to enter the study will complete a menstrual attitude questionnaire and undergo physical and gynaecological examination and routine haematological and biochemical tests before being randomly assigned to continuous ring or pill use. Women will maintain menstrual diaries for the 12 month study duration. If a bleeding/spotting episode excedes 4 days they will stop their method for 4 days and restart on the fifth day. Women will be contacted monthly to ensure compliance and will be seen at 2 months, 6 months and 12 months from randomisation for follow up At each visit the women will complete an acceptability questionnaire and a menstrual attitudes questionnaire at the final visit.
Trial website
www.fpnsw.org.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29347 0
Address 29347 0
Country 29347 0
Phone 29347 0
Fax 29347 0
Email 29347 0
Contact person for public queries
Name 12594 0
Jane Hangan
Address 12594 0
Family Planning NSW (FPNSW)
328-336 Liverpool Road Ashfield 2131 NSW
Country 12594 0
Australia
Phone 12594 0
+61 2 8752 4345
Fax 12594 0
+61 2 8752 4394
Email 12594 0
janeh@fpnsw.org.au
Contact person for scientific queries
Name 3522 0
Dr Edith Weisberg
Address 3522 0
Sydney Centre for Reproductive Health Research
FPNSW
328-336 Liverpool Road Ashfield 2131 NSW
Country 3522 0
Australia
Phone 3522 0
+61 2 8752 4342
Fax 3522 0
+61 2 8752 4394
Email 3522 0
edithw@fpnsw.org.au

No information has been provided regarding IPD availability
Summary results
No Results