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WOMEN&More Research into Mifepriston as a contraceptive halted

The LUMC has discontinued the WOMEN&More study into the drug mifepriston. An interim evaluation showed that mifepriston 50 mg is not suitable as a contraceptive.

The evaluation revealed a higher number of positive pregnancy tests and pregnancies than expected. The percentage of ectopic pregnancies, in particular, gave cause for concern.

This is very disappointing, as this drug appeared suitable for women with contraindications to existing hormonal contraception or who experienced side effects from contraception containing estrogens and/or progestogens.

14 Dutch hospitals and more than 560 women participated in the study. All participants have since been informed via their own research teams and thanked for their contribution to scientific research.

The results of the study will be published in scientific journals in due course.

Mifepriston 200 mg in combination with misoprostol is prescribed for medical abortion and in the treatment of miscarriages. The current research results concern a different mechanism of action. The use of mifepriston 200 mg for medical abortion or medical treatment of a miscarriage is extremely safe and effective.

This research is about a contraceptive that is:

  • Weekly: one tablet once a week
  • Oral: swallowing the tablet
  • Mifepristone as its name
  • Easy: once a week and reminder via the app
  • No 'normal hormones' from the pill or other contraceptives

And More? 

  • Almost anyone who menstruates (18 up to and including 35 years) can participate in the study
  • Mifepristone 50 mg once a week is expected to be a safe and effective contraceptive, with few side effects
  • It is expected that monthly blood loss will decrease significantly when using this contraceptive and may possibly stop completely

Are you interested in participating in this study?  First fill out the questionnaire here to check if you are suitable to participate. At the end of the questions you will get a list of the participating hospitals and contact information.  

At this moment Alkmaar/Den Helder (NoordWestZiekenhuis), Almelo (ZGT), Almere (Flevoziekenhuis), Amsterdam (Amsterdam UMC), Enschede (Medisch Spectrum Twente), Goes (Admiraal de Ruyter Ziekenhuis), Groningen (Martini Ziekenhuis), Leeuwarden (Frisius MC), Leiden (LUMC), Maastricht (MUMC+), Nijmegen (CWZ), Rotterdam (Franciscus Gasthuis), Utrecht (Diakonessenhuis) en Veldhoven (MMC) are open for enrollment.

If you have questions you can also email: clinicalresearchcenter@lumc.nl