Perception & Acceptability of a Cervical Cancer Prevention Prebiotic Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Sensory perceptual characteristics of gels based on forearm testing
研究概览
简要总结
PreBioGyn will be compared to market leading vaginal pH buffering gels using established forearm test methods associated with vaginal lubricity sensation in 42 women. Women will also rate each gel for smell and appearance using established methods. The PreBioGyn gel enclosure and intravaginal applicator design will be evaluated for: look and feel, ability to prepare for dosing, ability to expulse dose, and likelihood of future use by subjects. Open-ended feedback on the gel and applicator will occur to gather contributions for each product.
详细描述
This study is being conducted as a component of a NIH/NCI sponsored Small Business Technology Transfer (STTR) project entitled "Cervical Cancer Prevention Prebiotic Device."
The prebiotic vaginal gel, PreBioGyn, has been developed to optimize vaginal health and reduce the risk of cervical cancer in women. Use of the gel targets a combination of biological risk factors for cervical cancer including restoring and maintaining healthy vaginal microbiota, pH, and mucosal function, thereby preventing disturbed immunity and inflammation caused by dysbiosis and mucosal microtrauma. The purpose of this study is to provide a quantitative perception evaluation of the acceptability of PreBioGyn and its applicator system.
The objectives of this study are to:
- Perform a quantitative sensory evaluation to determine the topical acceptability of PreBioGyn, as well as receive qualitative feedback on the gel, as compared to competitive products.
- Obtain quantitative and qualitative feedback regarding acceptability of the PreBioGyn applicator compared to those for existing competitive products.
These Study Objectives do not involve actual intravaginal use of the product. Rather, this activity will involve presentation of the products in a forearm and finger-touch sensory evaluation, and the answering of questions related to this perceptual evaluation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •hrHPV positive
- •30 years of age or older
- •Have not received the HPV vaccine
- •Not pregnant or nursing
- •Medicaid eligible
排除标准
- •history of skin irritation and/or allergic skin reactions
结局指标
主要结局
Sensory perceptual characteristics of gels based on forearm testing
时间窗: 1 hour
User acceptability of gel delivery system
时间窗: 1 hour
次要结局
未报告次要终点