NCT00411684已完成3 期
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CDB-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Sex
HRA Pharma17 个研究点 分布在 1 个国家目标入组 1,623 人开始时间: 2006年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,623
- 试验地点
- 17
- 主要终点
- Pregnancy Rate
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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 or equal to 5 days
- •Request emergency contraception between 48 hours and 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 delivery, miscarriage or abortion
- •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
排除标准
- •One or more acts of one unprotected intercourse more than 120 hours before requesting emergency contraception in the current cycle
- •All acts of unprotected intercourse (in the current cycle) within 48 hours of presentation
- •Currently pregnant as confirmed by positive HSUP test performed at screening
- •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 an investigational medicine
研究组 & 干预措施
CDB-2914
Experimental
A Prospective, Open-Label, Single Arm, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of CBD-2914 as Emergency Contraception When Taken Between 48 Hours and 120 Hours of Unprotected Intercourse
干预措施: CDB-2914 (Drug)
结局指标
主要结局
Pregnancy Rate
时间窗: Up to 60 days after enrollment
A high sensitivity pregnancy test was performed at inclusion (between 48h and 120h after unprotected intercourse) and then until menses occured or up to 60 days if they did not, at the following time points: * 5-7 days after expected date of menses * 1 week later * every two week after
次要结局
- Prevented Fraction (Number of Prevented Pregnancies Divided by the Number of Expected Pregnancies)(within the menstrual cycle of the unprotected Intercourse)
- Impact on Menstrual Bleeding Patterns(within the menstrual cycle of the unprotected Intercourse)
- Frequencies of Subjects With Treatment Emergent Adverse Events(12-14 days after expected menses)
研究者
研究点 (17)
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