Mifepristone 50 mg as a weekly contraceptive

Phase 2

• Conditions: Prevention of unwanted pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN29802260
• Lead Sponsor: Women on Waves

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-24
• Last Update Posted: 8 July 2024
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 949

Inclusion Criteria

1. No desire to become pregnant within the next 13 months
2. Provision of signed and dated informed consent form for participation in the study
3. Willing to comply with all study procedures and available for the duration of the study
4. Aged between 18 and 35 years
5. Have a normal menstrual cycle length between 25 and 35 days
6. At least one normal menstrual cycle after miscarriage or abortion and no abnormal blood loss
7. Willing to engage in at least three acts of penis-in-vagina sexual intercourse per month
8. Willing to use the study drug as the only method of contraception over the course of the study. If the potential participant is taking another contraceptive, they would have to stop and have one menstruation to be included in the trial.
9. Able to take oral medication and be willing to adhere to the contraceptive regimen

Exclusion Criteria

1. Current pregnancy
2. Within 3 months of delivery
3. Abnormal cervical smear or within the year before
4. Known infertility or subfertility
5. History of ectopic pregnancy
6. Any previous or current malignancy including breast cancer
7. Abnormal liver enzymes
8. Irregularities in the endometrium
9. Retained products of conception after miscarriage or abortion
10. Signs of endometritis
11. Known allergic reactions to mifepristone
12. Lactation
13. Using high doses of corticosteroids or any drugs that may interact with mifepristone including 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)
14. Treatment with another investigational drug
15. Unable to comply with the trial protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified