Plan B® 1.5 Emergency Contraception Actual Use Study in Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 343
- 试验地点
- 2
- 主要终点
- Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions
研究概览
简要总结
This is a non-comparative case series study to assess the ability of females 11-16 years of age, inclusive, who are requesting emergency contraception (EC) to use the study product, DR-104 (Plan B® 1.5), appropriately and safely without provider counseling.
详细描述
To simulate an over-the-counter (OTC) setting, each potential subject was expected to read the label text on the outside of the study package and determine whether and how to use the study product without provider direction or assistance. The study product, Plan B® 1.5, was to be dispensed only to those subjects who appropriately self-selected and indicated that they wanted to participate in the study and receive study product. Subjects could also appropriately self-select not to use the study product.
Follow-up contact was to be conducted at approximately one, four, and eight weeks following the date the subject was dispensed study product. At these contacts, subjects answered questions regarding product use, health problems since last contact, and pregnancy status. Subjects were not to be permitted to enroll more than once in this Actual Use Study, however to assess repeat use of emergency contraceptives (EC) (use in addition to the study product) subjects were also queried at the one-, four-, and eight-week follow-up contacts regarding use of additional EC.
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
- 11 Years 至 16 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female and 11-16 years of age, inclusive
- •Subject must be requesting emergency contraception for her own use (not for use by another person) and for current (not future) use
- •Subject can read and understand English, according to her own judgment
- •Others as dictated by FDA-approved protocol
排除标准
- 未提供
研究组 & 干预措施
DR-104
One tablet for emergency contraception
干预措施: DR-104 (Drug)
结局指标
主要结局
Percentage of Participants Who Appropriately Self-selected DR-104 (Plan B® 1.5) When Dispensed Under Simulated Over-the-counter (OTC) Conditions
时间窗: Day 1
The percentage of participants who appropriately self-selected Plan B® 1.5 at the Screening/Enrollment Visit after reading the product label. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-diagnose the condition and that treatment with the product is appropriate for them.
Percentage of Participants Who Correctly Used DR-104 When Dispensed Under Simulated OTC Conditions
时间窗: Week 1
The percentage of participants who having appropriately self-selected and been dispensed Plan B® 1.5, correctly used it according to product labeling. Correct use was considered to have occurred if participants reported at the Week 1 follow-up contact that she took Plan B® 1.5 within 72 hours following unprotected sexual intercourse. Following the standard norms for a therapy to over-the-counter (Rx-to-OTC) switch process, this outcome is an evaluation of potential consumers' ability to self-treat with the product according to the product instructions.
次要结局
- Participants With Treatment-Emergent Adverse Events (TEAE)(Day 1 to week 8)
- Participants Summarized by Repeat Use of Emergency Contraception (EC)(up to week 8)