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WOMEN&More: Efficacy, safety, and acceptability of mifepristone 50 mg once-weekly as a contraceptive
EU CTIS ID: 2022-502694-41-00
What this study is testing
Efficacy, safety, and acceptability of mifepristone 50 mg once-weekly as a contraceptive
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18-35 at the moment of signing the informed consent
- Provide informed consent about participating in study and provide permission to request medical data in the event of complications or pregnancy
- In case of not using hormonal contraceptives, menstrual cycle of 21‐35 days
- In case of Depo-Provera (3 month injectable) at least 3 cycles of 21‐35 days after stop
- In case of necessary progesterone treatment, be willing to use condoms temporarily
- In case of 30 years or older, prior HPV or pap‐test
You likely can't join if
- Currently pregnant or breast-feeding
- Known allergy to mifepristone
- Using non‐dermal or non-inhaled corticosteroids or any drugs that may interact with mifepristone. These include hydantoins (e.g. phenytoin), barbiturates (e.g. phenobarbital), primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, rifabutin, felbamate, ritonavir, nelfinavir, griseofulvin and products containing St. John's wort (Hypericum perforatum)
- Treatment with another investigational drug or participating in another intervention study, unless the principal investigators agree
- Undiagnosed reason for severe anemia or increased creatinine
- Abnormal previous PAP smear > pap II without colposcopic evaluation or untreated HSIL
See the full eligibility criteria
Who can join
- Age 18-35 at the moment of signing the informed consent
- Provide informed consent about participating in study and provide permission to request medical data in the event of complications or pregnancy
- In case of not using hormonal contraceptives, menstrual cycle of 21‐35 days
- In case of Depo-Provera (3 month injectable) at least 3 cycles of 21‐35 days after stop
- In case of necessary progesterone treatment, be willing to use condoms temporarily
- 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
- Able to participate in the scheduled visits and comply with the study protocol
What rules you out
- Currently pregnant or breast-feeding
- Known allergy to mifepristone
- Using non‐dermal or non-inhaled corticosteroids or any drugs that may interact with mifepristone. These include hydantoins (e.g. phenytoin), barbiturates (e.g. phenobarbital), primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, rifabutin, felbamate, ritonavir, nelfinavir, griseofulvin and products containing St. John's wort (Hypericum perforatum)
- Treatment with another investigational drug or participating in another intervention study, unless the principal investigators agree
- Undiagnosed reason for severe anemia or increased creatinine
- Abnormal previous PAP smear > pap II without colposcopic evaluation or untreated HSIL
- Systolic blood pressure ≥ 180 mmHg and/or diastolic ≥ 110 mmHg (hypertension with medical treatment allowed)
- Intracavitary abnormalities on vaginal ultrasound, including intracavitary polyps or myomas, endometrium > 15 mm, or an obvious sign of hydrosalpinx
- Previous participation in the WOMEN&More trial
- Desire to become pregnant within the following 12 months
- Signs of current endometritis, incomplete abortion after miscarriage or induced abortion, or retained placental rests after delivery
- Undiagnosed post‐coital bleeding or unscheduled bleeding (spotting with COC, patch, vaginal ring, hormonal 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 C) or moderately abnormal liver enzymes at screening (ALAT, ASAT or bilirubin > 2 ULN)
- Current or previous cancer or DCIS
- Family history of endometrial cancer, except BRCA genome mutation
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.