NCT05553600已完成不适用
An Open-Label Clinical Validation Study of an Applicator Tampon
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 732
- 试验地点
- 16
- 主要终点
- The Percentage of Used Tampons That Have Elongated
研究概览
简要总结
This prospective multi-center, open-label, randomized, cross-over study is designed to validate the user needs of a tampon design. The hypothesis is that user needs are met.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 without discomfort.
- •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 (if applicable), 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, including rayon.
- •Any other medical condition or history, as determined by the Investigator that could compromise the study results or subject safety.
结局指标
主要结局
The Percentage of Used Tampons That Have Elongated
时间窗: At the end of 1 menstrual period (up to 10 days) for each intervention
The percentage of used tampons within each test code that have elongated \>10mm. The denominator for the percentage calculation is based upon the number of used tampons returned within each test code.
次要结局
- Validation of Performance User Needs Based on Participant Diary Responses(At the end of 1 menstrual period (up to 10 days) for each intervention)
- Number of Subjects That Had Any Lesions Noted During Gynecological Exam(Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention)
- Validation of Performance User Needs Based on Participant Diary Responses.(At the end of 1 menstrual period (up to 10 days) for each intervention)
- Additional Gynecological Exam Results: Post-use Vaginal pH(Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention)
- Additional Gynecological Exam Results: Number of Participants With Suspected Infections, Other Abnormal Findings, and Clinically Significant Results(Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention)
- Additional Gynecological Exam Results: Pre-use Vaginal pH(Within 72 hours prior expected menstruation (pre-use) and within 72 hours after last tampon use (post-use) for each intervention)
- Validation of Packaging/Labeling User Needs Based on Interview Responses(At baseline, prior to any interventions)
研究者
研究点 (16)
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