Efficacy, Safety, and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive
NCT ID: NCT06394999
Last Updated: 2025-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1186 participants
INTERVENTIONAL
2025-05-02
2030-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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mifepristone 50 mg
mifepristone 50 mg once weekly
Mifepristone 50 mg
Once-weekly oral mifepristone 50 mg
Interventions
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Mifepristone 50 mg
Once-weekly oral mifepristone 50 mg
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
35 Years
FEMALE
Yes
Sponsors
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Karolinska Institutet
OTHER
Women on Waves
UNKNOWN
Children's Investment Fund Foundation
OTHER
Leiden University Medical Center
OTHER
Responsible Party
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Rebecca Gomperts, MD, PhD
Researcher
Principal Investigators
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Rebecca Gomperts, PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Locations
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Noordwest Ziekenhuisgroep
Alkmaar, , Netherlands
Ziekenhuisgroep Twente
Almelo, , Netherlands
Flevoziekenhuis
Almere Stad, , Netherlands
Amsterdam Universitair Medische Centra
Amsterdam, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Admiraal De Ruyter Ziekenhuis
Goes, , Netherlands
Martini Ziekenhuis
Groningen, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Maastricht Universitair Medisch Centrum
Maastricht, , Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Franciscus Gasthuis
Rotterdam, , Netherlands
Diakonessenhuis
Utrecht, , Netherlands
Maxima Medisch Centrum
Veldhoven, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Annemarie van der Steen
Role: primary
Judith Huirne, Prof.Dr.
Role: primary
Marloes Maassen
Role: primary
Jana Munster
Role: primary
Dries Twijnstra
Role: primary
Koen Deurloo
Role: primary
Other Identifiers
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2022-502694-41-00
Identifier Type: -
Identifier Source: org_study_id
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