Weekly pill could revolutionize birth control without hormones
NCT ID NCT06394999
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking mifepristone 50 mg once a week can safely prevent pregnancy. 615 women aged 18-35 will use it as their only birth control for one year. The goal is to see if it works well with fewer side effects than daily hormone pills.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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615 people
The number who actually took part.
- Started
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May 2025
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 35 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-35 at the moment of signing the informed consent. 2. In case of 30 years or older, prior HPV or pap-test. 3. Understand and speak Dutch or English. 4. Willing to use mifepristone as the only method of contraception for 12 months. 5. Able to take oral medication and willing to adhere to the study protocol. 6. Have unprotected vaginal heterosexual intercourse with a non-sterilized partner at least once a month. 7. BMI \< 35 kg/m2. 8. Willing to fill in a daily diary on the smartphone or computer and five times an on-line questionnaire. 9. Able to participate in the scheduled visits and comply with the study protocol. 10. Provide informed consent about participating in study and provide permission to request medical data in the event of complications or pregnancy. 11. In case of not using hormonal contraceptives, menstrual cycle of 21-35 days. 12. In case of Depo-Provera (3 month injectable) at least 3 cycles of 21-35 days after stop. 13. In case of necessary progesterone treatment, be willing to use condoms temporarily. Exclusion Criteria: 1. Currently pregnant or breast-feeding. 2. Desire to become pregnant within the following 12 months. 3. Signs of current endometritis, incomplete abortion after miscarriage or induced abortion, or retained pla-cental rests after delivery. 4. Undiagnosed post-coital bleeding or unscheduled bleeding (spotting with COC, patch, vaginal ring, hormo-nal IUD, implant allowed). 5. Known subfertility or history of ectopic pregnancy, unless intra-uterine pregnancy afterwards, or grade 3-4 endometriosis proven by laparoscopy. 6. History of gastric reduction or gastric bypass or use of weight-loss medicines. 7. 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). 8. Current or previous cancer or DCIS. 9. Family history of endometrial cancer, except BRCA genome mutation. 10. Known allergy to mifepristone. 11. Using non-dermal corticosteroids or any drugs that may interact with mifepristone. These include hydan-toins (e.g. phenytoin), barbiturates (e.g. phenobarbital), primidone, carbamazepine, rifampicin, oxcarbaze-pine, topiramate, rifabutin, felbamate, ritonavir, nelfinavir, griseofulvin and products containing St. John's wort (Hypericum perforatum). 12. Treatment with another investigational drug or participating in another intervention study, unless the prin-cipal investigators agree. 13. Undiagnosed reason for severe anemia or increased creatinine. 14. Abnormal previous PAP smear \> pap II without colposcopic evaluation or untreated HSIL. 15. Systolic blood pressure ≥ 180 mmHg and/or diastolic ≥ 110 mmHg (hypertension with medical treatment allowed). 16. Intracavitary abnormalities on vaginal ultrasound, including intracavitary polyps or myomas, endometrium \> 15 mm, or an obvious sign of hydrosalpinx. 17. Previous participation in the WOMEN\&More trial.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Admiraal De Ruyter Ziekenhuis
Goes, 4462 RA, Netherlands
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Amsterdam Universitair Medische Centra
Amsterdam, 1105 AZ, Netherlands
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Canisius Wilhelmina Ziekenhuis
Nijmegen, 6532 SZ, Netherlands
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Diakonessenhuis
Utrecht, 3582 KE, Netherlands
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Flevoziekenhuis
Almere Stad, 1315 RA, Netherlands
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Franciscus Gasthuis
Rotterdam, 3045 PM, Netherlands
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Leiden University Medical Center
Leiden, 2333 ZA, Netherlands
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Maastricht Universitair Medisch Centrum
Maastricht, 6229 HX, Netherlands
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Martini Ziekenhuis
Groningen, 9728 NZ, Netherlands
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Maxima Medisch Centrum
Veldhoven, 5504 DB, Netherlands
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Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD, Netherlands
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Medisch Spectrum Twente
Enschede, 7512 KZ, Netherlands
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Noordwest Ziekenhuisgroep
Alkmaar, 1815 JD, Netherlands
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Ziekenhuisgroep Twente
Almelo, 7609 PP, Netherlands
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