MIFEPRISTONE for Contraception|Oral contraception

Inclusion criteria

• {"criterion_text":"- Age 18-35 at the moment of signing the informed consent"}
• {"criterion_text":"- Provide informed consent about participating in study and provide permission to request medical data in the event of complications or pregnancy"}
• {"criterion_text":"- In case of not using hormonal contraceptives, menstrual cycle of 21‐35 days"}
• {"criterion_text":"- In case of Depo-Provera (3 month injectable) at least 3 cycles of 21‐35 days after stop"}
• {"criterion_text":"- In case of necessary progesterone treatment, be willing to use condoms temporarily"}
• {"criterion_text":"- In case of 30 years or older, prior HPV or pap‐test"}
• {"criterion_text":"- Understand and speak Dutch or English"}
• {"criterion_text":"- Willing to use mifepristone as the only method of contraception for 12 months"}
• {"criterion_text":"- Able to take oral medication and willing to adhere to the study protocol"}
• {"criterion_text":"- Have unprotected vaginal heterosexual intercourse with a non‐sterilized partner at least once a month"}
• {"criterion_text":"- BMI < 35 kg/m2"}
• {"criterion_text":"- Willing to fill in a daily diary on the smartphone or computer and five times an on-line questionnaire"}
• {"criterion_text":"- Able to participate in the scheduled visits and comply with the study protocol"}

Exclusion criteria

• {"criterion_text":"- Currently pregnant or breast-feeding"}
• {"criterion_text":"- Desire to become pregnant within the following 12 months"}
• {"criterion_text":"- Signs of current endometritis, incomplete abortion after miscarriage or induced abortion, or retained placental rests after delivery"}
• {"criterion_text":"- Undiagnosed post‐coital bleeding or unscheduled bleeding (spotting with COC, patch, vaginal ring, hormonal IUD, implant allowed)"}
• {"criterion_text":"- Known subfertility or history of ectopic pregnancy, unless intra‐uterine pregnancy afterwards or grade 3-4 endometriosis proven by laparoscopy"}
• {"criterion_text":"- History of gastric reduction or gastric bypass or use of weight-loss medicines"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Current or previous cancer or DCIS"}
• {"criterion_text":"- Family history of endometrial cancer, except BRCA genome mutation"}
• {"criterion_text":"- Known allergy to mifepristone"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Treatment with another investigational drug or participating in another intervention study, unless the principal investigators agree"}
• {"criterion_text":"- Undiagnosed reason for severe anemia or increased creatinine"}
• {"criterion_text":"- Abnormal previous PAP smear > pap II without colposcopic evaluation or untreated HSIL"}
• {"criterion_text":"- Systolic blood pressure ≥ 180 mmHg and/or diastolic ≥ 110 mmHg (hypertension with medical treatment allowed)"}
• {"criterion_text":"- Intracavitary abnormalities on vaginal ultrasound, including intracavitary polyps or myomas, endometrium > 15 mm, or an obvious sign of hydrosalpinx"}

Primary endpoints

• {"endpoint_text":"- Occurrence of pregnancy during treatment caused by user and method failure (Overall Pearl Index)","definition_or_measurement_approach":"Measured as occurrence of pregnancy during treatment attributed to user and method failure; overall Pearl Index as specified."}

Secondary endpoints

• {"endpoint_text":"- Proportion of participants with endometrial thickness >15 mm, endometrium with irregular cystic appearance on US; with ALT, AST elevation three times above normal levels or bilirubin two times above normal levels; with adverse events / serious adverse events","definition_or_measurement_approach":"Measured by transvaginal ultrasound for endometrial thickness/appearance, laboratory tests for ALT/AST/bilirubin elevations, and recording of adverse events/serious adverse events."}
• {"endpoint_text":"- Acceptability assessment: User failure, Depression, Sexual functioning, Use of antidepressants, Weight changes, Bleeding profile, Side effects, Acceptability","definition_or_measurement_approach":"Acceptability assessed by user-reported measures (questionnaires) and recording of listed clinical/psychological measures; specific instruments not detailed in the CTIS record."}
• {"endpoint_text":"- Proportion of participants either opting for an abortion or opting for continuing the pregnancy. In case of continuation: outcomes of pregnancies such as miscarriages, ectopic pregnancies, preterm labor, growth restriction and congenital abnormalities will be registered","definition_or_measurement_approach":"Proportion calculated from participant outcomes; pregnancy outcomes (miscarriage, ectopic, preterm, growth restriction, congenital abnormalities) captured by clinical follow-up and registration."}
• {"endpoint_text":"- Figures about liver functions below 3 x Upper Limit Normal (ULN) (ALT/AST) or below 2 x ULN (bilirubin) are unknown, as time to normalization","definition_or_measurement_approach":"Endpoint relates to liver function test results compared to ULN thresholds; time to normalization not specified/unknown."}

Methods

• Recruitment arrangements documented (K1_ Recruitment arrangements) — channel: recruitment arrangements document (details not extractable from CTIS JSON); country context: Netherlands
• Recruitment material flyer (K2_ Recruitment material flyer) — channel: printed/digital flyer; target audience: potential participants; country context: Netherlands
• Subject information material on website (L2_ Other subject information material website womenandmore ENG/NL) — channel: trial website; target audience: potential participants; country context: Netherlands/English-speaking participants

Netherlands

Earliest CTIS Part Ii Submission Date

24-02-2025

Latest Decision Or Authorization Date

07-11-2025

Processing Time Days

256

Number Of Sites

14

Number Of Participants

1186

Primary sponsor

Full Name

Leiden University Medical Center

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Women on Waves","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Karolinska Institutet","duties_or_roles":"Source of monetary support","organisation_type":""}
• {"country":"","full_name":"Children's Investment Fund Foundation","duties_or_roles":"Source of monetary support","organisation_type":""}