NCT03770065已完成不适用
A Phase II, Open-label, Single-Centre, Randomized, Cross-over, Exploratory Study on Two Different Doses of VML-0001, the Base Formulation of Viramal's pH Regulating and Vaginal Moisturizing Cream, on the Effects on Vaginal pH in Healthy Post-Menopausal Women
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- To determine the duration of action measured on the ability of VML-0001 (base formulation) to reduce vaginal pH.
研究概览
简要总结
The study is designed to determine the effect on vaginal pH and the duration of action measured on the ability of the base formulation to reduce the vaginal pH
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •be greater than 45 years
- •no positive findings on screening gynaecological examination
- •negative smear test within the last 5 years
排除标准
- •has signs of vaginal infection
- •has evidence of alcohol abuse
- •has used hormonal replacement therapy in three months prior to study entry
结局指标
主要结局
To determine the duration of action measured on the ability of VML-0001 (base formulation) to reduce vaginal pH.
时间窗: 7-14 days
The Vaginal pH will be measured daily for 7 days after single dose of VML-0001 using pH kits.
次要结局
未报告次要终点
研究者
研究点 (1)
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