NCT07561905招募中不适用
An Open-Label Applicator Tampon Safety-in-Use Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Product Tolerability
研究概览
简要总结
The goal of this clinical trial is to confirm the safety of a tampon in healthy female volunteers. Participants will use the study tampons as they normally would for one menstrual cycle. Gynecological exams will be conducted before and after the menstrual cycle.
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
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing and able to read and provide written informed consent.
- •Female in good general health, age 18-49 (inclusive).
- •History of regular menstrual cycles during the previous 3months lasting approximately 21-35 days, including at least 4 days of menstruation, and expecting to menstruate during the study period.
- •History of use of applicator tampons within the past 12 months without discomfort.
- •Tracks menstruation and be able to confidently predict onset of menstruation
- •Normally use at least 6 tampons for protection during menstruation.
- •Normally uses regular, super, and/or super plus absorbency tampons for menstrual protection.
- •Agrees to the conduct of all study procedures, including gynecological exams and agrees to follow all study instructions and return for scheduled appointments.
- •Has used an acceptable form of birth control for at least one month prior to enrollment and for the duration of the study.
排除标准
- •Pregnant, lactating or is trying to become pregnant.
- •Less than six (6) weeks post-partum.
- •Has a menstrual abnormality (such as oligomenorrhea or amenorrhea).
- •Has a known allergy or sensitivity to components of the investigational products
- •Any other medical condition or history, as determined by the Investigator that could compromise the study results or subject safety.
研究组 & 干预措施
Test Tampon
Experimental
干预措施: Tampon A (Device)
结局指标
主要结局
Product Tolerability
时间窗: From enrollment to 7 days post last visit
Frequency and severity of tampon related adverse events
Incidence of Tampon Related Adverse Events
时间窗: From enrollment to 7 days post last visit
Frequency and severity of tampon related adverse events
次要结局
未报告次要终点
研究者
研究点 (1)
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