Efficacy, Safety, and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive (NCT06394999) | Clinical Trial Compass
RecruitingPhase 3
Efficacy, Safety, and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive
Netherlands1,186 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 range18 Years – 35 Years
SexFEMALE
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.
✓. 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.
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
✕. 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).