Prospective Observational Single Arm Open-Label Multicenter Study to Assess the Safety, Tolerability and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Adult Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 579
- 试验地点
- 6
- 主要终点
- Frequency of adverse events after ellaOne® intake in routine conditions of use for emergency contraception
研究概览
简要总结
The purpose of this observational study is to assess the safety and tolerability of ellaOne® in routine conditions of use for emergency contraception in postmenarcheal adolescents and adult women who want to prevent pregnancy up to 5 days after unprotected sexual intercourse.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Having received ellaOne® as emergency contraception at the clinical site
- •Postmenarcheal adolescents or adult women
- •Willing to provide information on bleeding, sexual intercourses, method of contraception, concomitant medications and adverse events for the next two menstrual periods and to complete the diary accordingly
- •Willing to provide information on pregnancy outcome / delivery and newborn's health at delivery
- •Able to provide written informed consent
- •Willing to not participate in a clinical trial before the end of study participation
排除标准
- •Currently participating in any interventional clinical trial (testing an Investigational Medicinal Product)
研究组 & 干预措施
Adolescents
250 postmenarcheal adolescent girls
干预措施: ellaOne® (ulipristal acetate) (Drug)
Adults
250 adult women
干预措施: ellaOne® (ulipristal acetate) (Drug)
结局指标
主要结局
Frequency of adverse events after ellaOne® intake in routine conditions of use for emergency contraception
时间窗: Two months (i.e. all along 2 menstrual cycles following ellaOne® intake)
Collection of adverse events, concomitant treatments, length of menstrual cycle, and vaginal bleeding/spotting through follow-up contacts and a diary completed by the patient
次要结局
- Pregnancy rate observed after taking ellaOne® in routine conditions of use for emergency contraception(Two months (i.e. during two menstrual cycles following ellaOne® intake))