Efficacy, Safety, and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive (NCT06394999) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Efficacy, Safety, and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive
Netherlands615 participantsStarted 2025-05-02
Plain-language summary
Participants in the study will use mifepristone 50 mg once-a-week for one year as a contraceptive. With this, we want to confirm that the chances of getting pregnant while using this contraceptive are very small. We also want to demonstrate that the use of mifepristone is safe, and it does not lead to any severe health problems. We expect fewer side effects compared to other frequently used contraceptives with hormones. Mifepristone does not contain these hormones. It is important to know how people experience that use of one tablet a week.
Who can participate
Age range
18 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18-35 at the moment of signing the informed consent.
. In case of 30 years or older, prior HPV or pap-test.
. Understand and speak Dutch or English.
. Willing to use mifepristone as the only method of contraception for 12 months.
. Able to take oral medication and willing to adhere to the study protocol.
. Have unprotected vaginal heterosexual intercourse with a non-sterilized partner at least once a month.
. BMI \< 35 kg/m2.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Pearl Index
Timeframe: 0-12 months
2
Pearl Index by Method failure
Timeframe: 0-12 months
3
Assess the contraceptive safety of once-weekly mifepristone 50 mg
. Willing to fill in a daily diary on the smartphone or computer and five times an on-line questionnaire.
Exclusion criteria
. Currently pregnant or breast-feeding.
. Desire to become pregnant within the following 12 months.
. Signs of current endometritis, incomplete abortion after miscarriage or induced abortion, or retained pla-cental rests after delivery.
. Undiagnosed post-coital bleeding or unscheduled bleeding (spotting with COC, patch, vaginal ring, hormo-nal IUD, implant allowed).
. Known subfertility or history of ectopic pregnancy, unless intra-uterine pregnancy afterwards, or grade 3-4 endometriosis proven by laparoscopy.
. History of gastric reduction or gastric bypass or use of weight-loss medicines.
. Previous or current liver illness, previous or current infection affecting the liver (such as Hepatitis) or mod-erately abnormal liver enzymes at screening (ALAT, ASAT or bilirubin \> 2 ULN).