Actively Recruiting
Efficacy, Safety, and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive
Led by Leiden University Medical Center · Updated on 2025-09-16
1186
Participants Needed
14
Research Sites
256 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
K
Karolinska Institutet
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy, Safety, and Acceptability of Mifepristone 50 mg Once-weekly as a Contraceptive
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18-35 at the moment of signing informed consent
- For women 30 years or older, prior HPV or pap-test required
- Understand and speak Dutch or English
- Willing to use mifepristone as the only contraception method for 12 months
- Able to take oral medication and follow the study protocol
- Have unprotected vaginal heterosexual intercourse with a non-sterilized partner at least once a month
- Body mass index (BMI) less than 35 kg/m2
- Willing to fill in a daily diary on smartphone or computer and complete five online questionnaires
- Able to attend scheduled visits and comply with the study protocol
- Provide informed consent and permission to request medical data if complications or pregnancy occur
- If not using hormonal contraceptives, have a menstrual cycle of 21-35 days
- If previously using Depo-Provera, allow at least three cycles of 21-35 days after stopping
- If using progesterone treatment, willing to use condoms temporarily
You will not qualify if you...
- Currently pregnant or breastfeeding
- Desire to become pregnant within the next 12 months
- Signs of current endometritis, incomplete abortion after miscarriage or induced abortion, or retained placental tissue after delivery
- Undiagnosed post-coital or unscheduled bleeding (spotting allowed with hormonal contraceptives except for some methods)
- Known subfertility or history of ectopic pregnancy unless followed by intra-uterine pregnancy, or severe endometriosis proven by laparoscopy
- History of gastric reduction, gastric bypass, or use of weight-loss medicines
- Previous or current liver disease or infection affecting the liver, or moderately abnormal liver enzymes at screening
- Current or past cancer or ductal carcinoma in situ (DCIS)
- Family history of endometrial cancer except for BRCA gene mutation
- Known allergy to mifepristone
- Use of non-dermal corticosteroids or drugs that interact with mifepristone
- Participation in another investigational drug study unless principal investigators agree
- Undiagnosed severe anemia or increased creatinine
- Abnormal previous PAP smear without colposcopic evaluation or untreated high-grade lesions
- High blood pressure with systolic ≥ 180 mmHg or diastolic ≥ 110 mmHg
- Abnormal vaginal ultrasound findings such as polyps, myomas, thickened endometrium, or hydrosalpinx
- Previous participation in the WOMEN&More trial
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands, 1815 JD
Actively Recruiting
2
Ziekenhuisgroep Twente
Almelo, Netherlands, 7609 PP
Not Yet Recruiting
3
Flevoziekenhuis
Almere Stad, Netherlands, 1315 RA
Not Yet Recruiting
4
Amsterdam Universitair Medische Centra
Amsterdam, Netherlands, 1105 AZ
Not Yet Recruiting
5
Medisch Spectrum Twente
Enschede, Netherlands, 7512 KZ
Actively Recruiting
6
Admiraal De Ruyter Ziekenhuis
Goes, Netherlands, 4462 RA
Actively Recruiting
7
Martini Ziekenhuis
Groningen, Netherlands, 9728 NZ
Actively Recruiting
8
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands, 8934 AD
Actively Recruiting
9
Leiden University Medical Center
Leiden, Netherlands, 2333 ZA
Actively Recruiting
10
Maastricht Universitair Medisch Centrum
Maastricht, Netherlands, 6229 HX
Not Yet Recruiting
11
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands, 6532 SZ
Not Yet Recruiting
12
Franciscus Gasthuis
Rotterdam, Netherlands, 3045 PM
Actively Recruiting
13
Diakonessenhuis
Utrecht, Netherlands, 3582 KE
Not Yet Recruiting
14
Maxima Medisch Centrum
Veldhoven, Netherlands, 5504 DB
Actively Recruiting
Research Team
R
Rebecca Gomperts, PhD
CONTACT
E
Elma Meershoek, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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