跳至主要内容
临床试验/NCT06530186
NCT06530186尚未招募不适用

Evaluation of a Postcoital Sponge on Self-Reported Vaginal Health Parameters

Atlantic Health System2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,000
试验地点
2
主要终点
User Experience Questionnaire

研究概览

简要总结

LiviWell has developed a product designed for postcoital semen absorption. Previous studies have demonstrated the product rapidly absorbs semen, and leads to less symptoms of postcoital vaginal microbiome disruption such as vaginal odor and discharge. This study will investigate the study device, Livi, in a broader clinical setting.

详细描述

LiviWell's consumer hygiene device is a post-coital vaginal insert called "Livi". Livi is comprised of an applicator, with a medical-grade polyurethane foam and retrieval string. It is designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal. The result is a decrease in discharge/dripping and vaginal odor. The investigators also believe the device will lower vaginal pH, as the typical premenopausal vaginal pH is acidic (pH ~4), and semen has an alkaline pH (~8). The resulting pH imbalance in sexually-active women not using male condoms had been shown to lead to vaginal odor, dripping, discomfort. Furthermore, the risk of bacterial vaginosis (BV) is higher in women who are sexually active and not using male condoms. The investigators have additional studies planned to evaluate if the product lowers the risk of BV.

The current study will be used to validate user needs requirements for the study device, understand pH changes after insertion, and evaluate change in symptoms of vaginal odor, discharge/dripping, and discomfort, common symptoms of vaginal microbiome disruption and bacterial vaginosis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Over 18 (for pH subset, 18-45)
  • Sexually-active with biological men
  • Willing and able to use product
  • Resides in continental USA
  • Understands, reads, writes, and speaks English

排除标准

  • Currently Pregnant or are trying to conceive
  • Unable to use device due to poor motor function
  • Unable to sign informed consent

结局指标

主要结局

User Experience Questionnaire

时间窗: 24 hours

Validation of User Needs Requirements as well as patient experience

次要结局

  • change in vaginal pH(2-6 hours, and 10-14 hours after use)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Ingber

Attending Physician

Atlantic Health System

研究点 (2)

Loading locations...

相似试验

Evaluation of a Postcoital Sponge on Self-Reported... | 临床试验