EUCTR2020-000866-41-Outside-EU/EEA进行中（未招募）1 期
Combined Phase II/ III Multicentre Single-arm Trial of a Mifepristone 50 mg as a weekly Contraceptive - Mife50
Women on Web International Foundation0 个研究点开始时间: 2021年2月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •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.stated willingness to comply with all study procedures and availability for the duration of the study
- •4.female, aged 18-35
- •5.have a normal menstrual cycle of 25-35 days cycles which differ by no more than 3 days with less than 7 days of bleeding
- •6.at least one normal menstrual cycle after miscarriage or abortion and no abnormal blood loss
- •7.be willing to engage in at least three acts of penis-in-vagina sexual intercourse per month
- •8.be 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.ability to take oral medication and be willing to adhere to the contraceptive regimen
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 949
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.current pregnancy
- •2.within 3 months of delivery
- •3.abnormal cervical smear or within 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 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 - 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)
- •14.treatment with another investigational drug
- •15. unable to comply with the trial protocol
研究者
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