RecruitingPhase 3ACTRN12605000698673

Mifepristone ovarian function study

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


Sponsor

FPA Health

Enrollment

40 participants

Start Date

Aug 9, 2005

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study is for women who are using Implanon (a small rod implanted under the skin of the arm that prevents pregnancy). A common problem with Implanon is irregular bleeding. This study is testing whether a medicine called mifepristone, with or without oestrogen, can help reduce unexpected bleeding while keeping Implanon working as a contraceptive. Participants will have ultrasound scans, cervical mucus checks, and blood tests over 4 weeks. You may be eligible if: - You are a woman between 18 and 45 years old - You have been using Implanon for at least 3 months - You are willing to have regular blood tests, vaginal ultrasounds, and cervical mucus collections over a 4-week period - You are willing to use condoms for the entire study period You may NOT be eligible if: - You are pregnant - You have had a heart attack, stroke, or blood clot in a vein - You have high blood pressure (above 160/95) - You have severe liver or kidney disease - You have a history of focal migraines - You have or have had breast cancer or genital cancer - You have a known sensitivity to ethinyl oestradiol or lactose - You are taking phenytoin, carbamazepine, or phenobarbitol - You are breastfeeding Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.


Locations(1)

Australia

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ACTRN12605000698673