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Mifepriston, an agent that is already used as an abortion pill, may also be prescribed as a contraceptive in the future. The big advantage: this pill contains no hormones, in contrast to the contraceptive pills that are already on the market. The drug is therefore also suitable for women who are not allowed to get progestin or estrogen for medical reasons, the hormones from the combination pill. Mifepriston is also expected to have the nasty side effects that hormonal contraceptive pills sometimes have, such as mood swings, an increased risk of thrombosis and a low libido.
The pill only needs to be swallowed once a week as a contraceptive, but can also be used as a MorningaFterpil for women who occasionally have sex. A flexible front and except-for-assistance.
It started eight years ago. Then the Women On Waves organization joined forces with the Leiden University Medical Center to investigate the safety and efficacy of Mifepriston as a contraceptive. Women On Waves was founded in 1999 by the Dutch doctor Rebecca Gomperts to give women better access to contraception worldwide and to prevent unsafe abortions.
Through crowdfunding and donations from a number of female philanthropes, the foundation raised enough money to finance the research. This month the first part of the investigation started in Leiden, thirteen Dutch hospitals are getting ready to participate. If the investigation goes well, the researchers hope to be able to register the drug at the European Medicines Office (EMA). The drug must then be available within three to five years.
Antihormoon
Mifepriston is a ‘anti -hormone’ crafted in the laboratory, a so -called selective progesterone receptor modulator. The drug, already discovered in the 80s, blocks the effect of progesterone, a hormone that is needed to support a pregnancy. Progesterone ensures, among other things, the structure of thick mucosa in the womb, so that the fertilized egg can implant there. The hormone also relaxes the muscles in the wall of the womb, which prevents it from controlling and repel the fertilized egg.
Mifepriston blocks the receptors for progesterone, so that it can no longer do its work in the body. The uterus is made unsuitable for pregnancy and ovulation is inhibited or postponed.
In European countries, Mifepriston is registered in a high dose (200 milligrams) and is mainly used to break down unwanted pregnancies and treat miscarriages. In the Netherlands, since this year, this is not only possible via the abortion clinic, but also through the doctor. Women who are undesirable can take the medicine early in their pregnancy (up to nine weeks after the last menstruation). Two days later they also enter the drug misoprostol vaginal, which causes severe contractions of the womb.
In some countries outside of Europe, the lower dose of 50 milligrams of mifepriston is also registered, including for treating fibroids (benign bumps in the wall of the uterus), endometriosis (uterine tissue that is outside the uterus) and adenomyosis (uterine glue glue. The same low dosage is now being investigated as a contraceptive in the study of Women on Waves.
No patent
It is striking that already in the 90s the first studies to Mifepriston appeared as a contraceptive. Then a few small studies followed. The research by Women on Waves, with around a thousand participants, is by far the largest so far. The setup is mainly based on a Chinese study from twenty years ago with 76 participants, in which both a weekly dosage of 25 and 50 milligrams of Mifepriston were tested. The outcome: no pregnancies, hardly any blood loss and no significant side effects.
Why has so little happened in the last twenty years? “Very simple, there is little to be earned for pharmaceuticals,” says gynecologist Gunilla Kleiverda, coordinator of the study. “The patent on the drug has long been because it has been on the market for decades.” The foundation therefore had to gather the money for the investigation. The pill was also developed at its own expense by Women on Waves and the LUMC.
Pregnancy test
The women who participate in the study must take the pill weekly for a year and keep up with a diary about their blood loss and side effects, and the moments when they (preferably unprotected) have ‘penis-in-vaginasex’. They must also regularly have a vaginal ultrasound made to check for abnormalities of the womb lining. Blood tests must also rule out that liver disorders occur.
Because women who take this pill usually hardly get their period anymore, the participants have to do a pregnancy test every month. “This pill will never protect one hundred percent, that, just like with other contraceptive pills, depends on how accurately you use it,” says Kleiverda. “The Chinese study shows that the chance of pregnancy is very small, but we cannot yet give guarantees. This examination is intended.”
A possible additional advantage of this pill, says Kleiverda, is that it could reduce the chance of breast cancer. “There are indications that progesterone increases the risk of breast cancer, an anti-progesterone preparation could possibly prevent that.” Women with a BRCA-1 gene mutation, with a 60 to 80 percent chance of developing breast cancer in their lives, may participate in this study.
