NCT04268758撤回不适用
A Single-center Study Designed to Evaluate the Safety and Efficacy of a New Hygienic Device, Tulipon, in Adult Females With Normal Monthly Menstruation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- safety and efficacy of the Tulipon.
研究概览
简要总结
Subjects who normally use tampons will use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.
详细描述
Subjects use Tulipon device during one menstrual cycle. Baseline and post usage clinical evaluation will be performed for safety testing.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-45 years
- •Regular menstrual cycles (21-35 days)
- •Uses tampons every month for the last 2 months to handle their monthly bleeding.
- •Active Bleeding lasts at least 3 days
- •Willing not to change their feminine care or hygiene practices during their participation in the study (except as directed by the protocol and instructions for participants)
- •Non-pregnant, with no intentions to get pregnant during the clinical trial
- •Willing to use pads provided thought the study only for the duration of this study
- •Subject is able to comply with all the requirements of the study and agrees to participate in all the activities of the study
- •Signed written informed consent form (ICF) to participate in the study
排除标准
- •Pregnant or lactating women
- •Gave birth less than a 12 month prior to the study.
- •Using medications to manage pain during active bleeding
- •Using intrauterine device or intrauterine device with hormones (Mirena)
- •Had experienced Toxic shock syndrome (TSS)
- •Previous diagnosis of primary or secondary dysmenorrhea
- •Previous diagnosis of endometriosis
- •Experiences urinary incontinence
- •Suffers from uterus or urine prolapse
- •Abnormal findings following the gynecological exam
- •Subjects with a known or suspected sensitivity to any of the device materials (Polyethylene, Polyurethane, Nylon, Cotton)
- •Been through a vaginal operation in the last 6 months prior to the study.
- •Participation in current or recent clinical trial within 30 days prior to baseline visit
结局指标
主要结局
safety and efficacy of the Tulipon.
时间窗: 1 month
We will take vaginal cultures to show no vaginal infection. By questionnaire we will find out about leakage of period blood from the Tulipon.
次要结局
未报告次要终点
研究者
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