Weekly pill could revolutionize birth control without hormones

NCT ID NCT06394999

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

615 people

The number who actually took part.

Started

May 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 35 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Admiraal De Ruyter Ziekenhuis

    Goes, 4462 RA, Netherlands

  • Amsterdam Universitair Medische Centra

    Amsterdam, 1105 AZ, Netherlands

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen, 6532 SZ, Netherlands

  • Diakonessenhuis

    Utrecht, 3582 KE, Netherlands

  • Flevoziekenhuis

    Almere Stad, 1315 RA, Netherlands

  • Franciscus Gasthuis

    Rotterdam, 3045 PM, Netherlands

  • Leiden University Medical Center

    Leiden, 2333 ZA, Netherlands

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX, Netherlands

  • Martini Ziekenhuis

    Groningen, 9728 NZ, Netherlands

  • Maxima Medisch Centrum

    Veldhoven, 5504 DB, Netherlands

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934 AD, Netherlands

  • Medisch Spectrum Twente

    Enschede, 7512 KZ, Netherlands

  • Noordwest Ziekenhuisgroep

    Alkmaar, 1815 JD, Netherlands

  • Ziekenhuisgroep Twente

    Almelo, 7609 PP, Netherlands

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