Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000698673
Ethics application status
Approved
Date submitted
20/10/2005
Date registered
1/11/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mifepristone ovarian function study
Scientific title
Study to determine the effect of one day administration of mifepristone and the same regimen followed by four days of daily administration of ethinyl oestradiol on ovulatory function and cervical mucus in women using Implanon
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
The effect of administering a progestogen receptor modulator with or without oestrogen on the ovarian function and quality of cervical mucus in women using the progestogen-only sub-dermal contraceptive, Implanon. 847 0
Condition category
Condition code
Other 914 914 0 0
Cervical (Cervix)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible women will be randomised to either twice daily mifepristone 25mg on day 1 followed by 4 days of ethinyl oestradiol 20mcgs daily or placebo daily for 4 days Vaginal ultrasound, cervical mucus assessment and serum oestradiol and progestogen will be carried out at intervals for 4 weeks. Each woman will be in the study for four weeks.
Intervention code [1] 730 0
Treatment: Drugs
Comparator / control treatment
Control group
Placebo

Outcomes
Primary outcome [1] 1189 0
Progestogen level >9nmol/L in any of the serum samples taken
Timepoint [1] 1189 0
Serum samples taken 2 days prior to treatment, 2 and 6 days after treatment has been started and then twice weekly for 3 weeks
Secondary outcome [1] 2175 0
Mean maximum size of ovarian follicles
Timepoint [1] 2175 0
Cervical mucus score assessed for the individual woman at each visit and the mean score at the end of the 4 week study.

Eligibility
Key inclusion criteria
Implanon users, who have been using Implanon for three months.Women who are willing to participate in a research investigation of new approaches to the therapy of breakthrough bleeding.Women who are prepared to have regular venepuncture, vaginal ultrasound and cervical mucus collection over a period of four weeks.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy. Women who have currently or previously had Heart attack or strokeBlood clot in a veinHigh blood pressureSevere liver or kidney diseaseBlood pressure >160mm systolic or >95mm diastolicFocal migraineBreast cancer or any genital cancerWomen with known sensitivity to ethinyl oestradiol, or lactoseWomen taking phenytoin, carbamazepine or phenobarbitol or Women who are lactating.

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)
Treatments will be packaged in identical bottles and placed according to randomisation code in sequentially numbered opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer derived randomisation scheme in blocks with equal numbers in both groups
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Ultrasounds, cervical mucus assessment and serum oestradiol and progestogen levels will be carried out blind by a single operator. The randomisation code will not be broken until after the results are analysed
Phase
Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/08/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1009 0
Charities/Societies/Foundations
Name [1] 1009 0
FPA Health Foundation
Country [1] 1009 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
FPA Health
Address
Country
Australia
Secondary sponsor category [1] 870 0
None
Name [1] 870 0
None
Address [1] 870 0
Country [1] 870 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2320 0
Sydney Centre for Reproductive Health Research
Ethics committee address [1] 2320 0
Ethics committee country [1] 2320 0
Australia
Date submitted for ethics approval [1] 2320 0
Approval date [1] 2320 0
Ethics approval number [1] 2320 0
Ethics committee name [2] 2321 0
Research Division of FPA Health
Ethics committee address [2] 2321 0
Ethics committee country [2] 2321 0
Australia
Date submitted for ethics approval [2] 2321 0
Approval date [2] 2321 0
Ethics approval number [2] 2321 0

Summary
Brief summary
The aim is to determine whether the administration of mifepristone alone or in combination with ethinyl oestradiol will effect the contraceptive efficacy of Implanon whose main mode of action is ovulation suppression and a secondary effect on cervical mucus making it impenatrable to sper. Both the treaments we will use have been shown to have a beneficial effect on bleeding patterns in women using progestogen-only contraceptive methods. Bleeding problems are the major reason for women discontinuing these highly effective contraceptives.Eligible women will be randomised to either mifepristone followed by 4 days of placebo or mifepristone followed by four days of ethinyl oestradiol. Women will undergo vaginal ultrasound to assess follicular size, assessment of cervical mucus quality and have blood taken for serum levels of oestradiol and progesterone 2 days before commencing treatment, on the third treatment day, 6 days after starting treament and then twice weekly for 3 weeks. Women will be required to use condoms for the duration of the study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35340 0
Address 35340 0
Country 35340 0
Phone 35340 0
Fax 35340 0
Email 35340 0
Contact person for public queries
Name 9919 0
Dr Edith Weisberg
Address 9919 0
Sydney Centre for Reproductive Health Research
Research Division
FPA Health
328-336 Liverpool Road
Ashfield NSW 2131
Country 9919 0
Australia
Phone 9919 0
+61 2 87524342
Fax 9919 0
+61 2 97165073
Email 9919 0
[email protected]
Contact person for scientific queries
Name 847 0
Professor Ian Fraser
Address 847 0
Queen Elizabeth Research Institute
University of Sydney
Camperdown NSW 2006
Country 847 0
Australia
Phone 847 0
+61 2 93512478
Fax 847 0
+61 2 93514560
Email 847 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.