EUCTR2020-002355-38-Outside-EU/EEA进行中（未招募）1 期
Prospective multi-center single arm open label study of efficacy, safety and acceptability of long-term weekly oral Mifepristone 50 mg as contraceptive - once a week mifepristone 50 mg as contraceptive
women on web international foundation0 个研究点开始时间: 2021年11月29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
- •female, 18-35 years; no desire to become pregnant within the next 13 months; 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; at least one normal menstrual cycle after miscarriage or abortion and no abnormal blood loss; be willing to engage in at least three acts of penis-in-vagina sexual intercourse per month; be willing to use the study drug as the only method of contraception
- •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 0
排除标准
- •known infertility or subfertility; current pregnancy, within 3 months of delivery; lactation; abnormal cervical smear or within year before; history of ectopic pregnancy; any previous or current malignancy including breast cancer; abnormal liver enzymes; irregularities in endometrium; retained products of conception after miscarriage or abortion; signs of endometritis; known allergic reactions to mifepristone; 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); treatment with another investigational drug (until next normal period after stopping other trial); unable to comply with the trial protocol
研究者
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