Efficacy, Safety, and Acceptability of Mifepristone 50 Mg Once-weekly As a Contraceptive

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Apr 29, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the use of mifepristone, a medication taken once a week, as a method of contraception for women. The goal is to see if taking 50 mg of mifepristone weekly for a year can effectively prevent pregnancy while ensuring it is safe and has fewer side effects compared to other hormonal contraceptives. Researchers are particularly interested in understanding how well women tolerate this method and their experiences while using it.

To be eligible for the study, participants need to be between 18 and 35 years old, able to take oral medication, and willing to use mifepristone as their only form of birth control for the entire year. They should also be in a relationship that includes unprotected intercourse at least once a month. Participants will need to fill out a daily online diary and complete questionnaires, along with attending scheduled visits. Importantly, women who are currently pregnant, breastfeeding, or planning to become pregnant soon are not eligible for the trial. This study is not yet recruiting, but it represents a promising step in exploring new contraceptive options.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18-35.
• • 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 on-line diary 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 placental rests after delivery.
• • 4. Undiagnosed post-coital bleeding or unscheduled bleeding (spotting with COC, patch, vaginal ring, hormonal IUD, implant allowed).
• • 5. Known subfertility or history of ectopic pregnancy, unless intra-uterine pregnancy afterwards.
• • 6. History of gastric bypass.
• • 7. Previous or current liver illness, previous or current infection affecting the liver (such as Hepatitis) or moderately abnormal liver enzymes at screening (ALAT, ASAT or bilirubin \> 2 ULN).
• • 8. Current or previous cancer.
• • 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 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).
• • 12. Treatment with another investigational drug or participating in another intervention study.
• • 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, irregular cystic endometrium, endometrium \> 15 mm, or an obvious sign of hydrosalpinx.