EUCTR2006-003387-55-IE进行中（未招募）不适用
A Prospective, Randomized, Single Blind, Multicenter Study to Compare the Efficacy, Safety and Tolerability of CDB-2914 with Levonorgestrel as Emergency Contraception Within 120 Hours Unprotected Intercourse ” (Phase III). - CDB-2914 vs LNG for EC
aboratoire HRA Pharma0 个研究点目标入组 2,044 人开始时间: 2007年9月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,044
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
- •- Aged 18 years or more;
- •- Menstruating women with regular menstrual cycle between 24 and 35 days and intra-individual variations less than 5 days;
- •- Request emergency contraception within 120 hours after unprotected intercourse as defined by lack of contraceptive use, or condom breakage (including condoms lubricated with spermicide) or other barrier contraceptive method failure;
- •- No current use of hormonal contraception and having had at least one complete menstrual cycle (2 menses) since having stopped hormonal contraception;
- •- For women with a recent history of Depo Provera use, the most recent injection must have been at least 9 months before study entry and followed by at least one complete menstrual cycle (2 menses);
- •- Willing to not use hormonal methods of contraception until study completion;
- •- At least one complete menstrual cycle (2 menses) post miscarriage, delivery or abortion;
- •- For women who present more than 72 hours after intercourse, decline the insertion of an IUD for emergency contraception and/or have contraindications to IUD insertion;
- •- Able to provide Informed Consent in English;
- •- Give voluntary, written informed consent, and agree to observe all study requirements (the subject needs to be available for follow-up over the next 6 weeks).
- •-Willing to abstain from further acts of unprotected intercourse during participation in the study and until pregnancy status has been ascertained.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- One or more acts of unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle;
- •- Currently pregnant as confirmed by positive HSUP test performed at screening (Treatment Visit);
- •- Currently breast-feeding;
- •- Current use of hormonal contraception;
- •- Use of hormonal emergency contraception since last menstrual period;
- •- Current use of IUD;
- •- Tubal ligation;
- •- Partner with a vasectomy;
- •- Unsure about the date of the last menstrual period;
- •- Severe asthma insufficiently controlled by oral glucocorticoid;
- •- Currently enrolled in any other trial of investigational medicine
- •- hypersensitivity to the active substance levonorgestrel or any of the excipients of the drug products used in the study.
研究者
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