A Multi-Center, Open-Label Trial Investigating Behavior Related to Ella® Use in a Simulated OTC Environment (LIBRella)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,270
- 试验地点
- 1
- 主要终点
- Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.
研究概览
简要总结
This study is designed to assess whether consumers select and use ella® (ulipristal acetate 30mg), an emergency contraceptive, in a manner consistent with the OTC package directions in an OTC-like setting.
详细描述
All potential subject coming to a site looking to purchase EC will be offered to participate in the study. Subjects who meet the initial screening inclusion criteria for the study will review package information and make a self-selection and purchase decision. Subjects who meet all remaining inclusion criteria will purchase ella®, and use based on their understanding of the package information.
Follow-up data regarding product use and adverse events will be obtained during telephone interviews at approximately Week-2 and Week-6 after the date the subject was dispensed study product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are self-pay or who are willing to be self-pay for the purposes of the study and who present for emergency contraception only for their own use
排除标准
- •Cannot read, speak and understand English
- •Cannot see well enough to read information on the label
研究组 & 干预措施
Use Phase (Ulipristal Acetate, 30 mg)
One tablet of 30 mg of ulipristal acetate for emergency contraception
干预措施: Use Phase (Ulipristal Acetate, 30 mg) (Drug)
结局指标
主要结局
Proportion of Female Selectors Who Are Not Pregnant at the Time of Selection Decision.
时间窗: Day 1
The third primary endpoint is the proportion in which the denominator includes all females who selected to use the product (regardless of whether they purchased/used) and the numerator includes all female selectors who were not pregnant at the time of the selection decision.
Proportion of Dosing Instances Among User Population Taken Within 120 Hours (5 Days) of Most Recent Episode of Unprotected Sex.
时间窗: Up to 6 Weeks
The first primary endpoint is the proportion in which the denominator includes all dosing instances of the IP and the numerator includes all dosing instances of the IP which were taken within 120 hours (5 days) of the subject's most recent episode of unprotected sex.
Proportion of Dosing Instances Among User Population in Which no More Than One Tablet Was Taken.
时间窗: Up to 6 Weeks
The second primary endpoint is the proportion in which the denominator is all discrete dosing instances of the IP and the numerator includes all dosing instances where no more than one tablet was taken.
次要结局
未报告次要终点