NCT05432154已完成不适用
Efficacy and Safety of a Novel Silicone Wound Dressing for the Management of Atrophic Vaginitis
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Patient-reported Vulvar Quality of Life
研究概览
简要总结
The objective of the study is to determine the efficacy of 7-0940 in the management of atrophic vaginitis in female patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to provide informed consent
- •Diagnosed acute or chronic Atrophic Vaginitis
- •Controlled disease, or uncontrolled disease that did not respond to standard therapy with HRT
排除标准
- •Unable to provide informed consent
- •Patient unable to apply topical device
- •Allergy or intolerance to ingredients or excipients of the formulation of studied products
- •Currently on HRT (orally or topically)
- •Currently on corticosteroid treatment
研究组 & 干预措施
Treatment arm
Experimental
Patients apply 7-0940 at least 2 times daily for 3 months.
干预措施: Film forming silicone gel (7-0940) (Device)
结局指标
主要结局
Patient-reported Vulvar Quality of Life
时间窗: 3 months
Vulvar Quality of Life Index
次要结局
- Severity of overall condition(3 months)
- Patient-reported symptoms(3 months)
- Product rating(3 months)
研究者
研究点 (1)
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