Prospective multi-center single arm open label study of efficacy, safety and acceptability of longterm weekly oral Mifepristone 50 mg as contraceptive

Women on Waves0 个研究点目标入组 949 人开始时间: 2021年2月24日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•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

•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

发起方

Women on Waves