None listed
Conditions
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.
Interventions
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.
Sponsors
FPA Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed