A Single-center, Medically Supervised, Safety Evaluation Study of an All-in-One Body and Lubricant Product
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of Subjects With Irritation Score of "0" at Baseline and One Week
研究概览
简要总结
This is a one-week study designed to test the safety of an all-in-one body and personal lubricant product during in-home use.
详细描述
This is a single-center, medically supervised, single-arm study to evaluate the safety of an all over body and personal lubricant product in home-use conditions via clinical assessment. The study will consist of 2 visits. Subjects who meet the entrance criteria will receive investigational product (IP) and 2 subjective questionnaires for at-home completion. The subjects will be required to use the IP at least 2 times, as instructed over the 1-week home-use period. At the end of the study (visit 2) subjects will return to the study site, at which time the unused IP and questionnaires will be returned and a final clinical assessment will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal, healthy adults in a stable, monogamous, ongoing heterosexual relationship with current partner within protocol-specified parameters
- •Subjects comfortable discussing sensitive topics such as personal hygiene, menstruation and sexuality
- •Able to read and understand English
- •Voluntarily signs an Informed Consent document after the trial has been explained
- •Willing to follow all study procedures, including birth control requirements
排除标准
- •Any medical or mental health history or condition, or use of any product, drug or medication that per protocol (or in the opinion of the Investigator) might compromise the participant's safety or the analysis of results
- •Participation as a research subject in a different trial within timelines dictated by protocol
- •Participants with relationships or employment outside protocol-defined parameters
结局指标
主要结局
Number of Subjects With Irritation Score of "0" at Baseline and One Week
时间窗: Baseline and One Week
Severity of irritation on a scale from 0 (No Irritation) to 6 (Presence of Lesions). Since a score of 0 is required at baseline for inclusion in the trial, this score represents a change from baseline and the trial is considered baseline-controlled.
次要结局
未报告次要终点