NCT04222647已完成2 期
Prospective, Open-label, Monocenter, Trial to Investigate the Efficacy and Tolerability of WO533, a Lactic Acid Containing Vaginal Suppository, in a Panel of Post-menopausal Women Suffering From Vulvovaginal Atrophy (VVA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- VMI
研究概览
简要总结
The aim of the study is to investigate the efficacy and tolerability of a lactic acid containing vaginal suppository with respect to the application in post-menopausal women with VVA.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menopausal women with subjective symptomatology of vulvovaginal atrophy
- •Signed written informed consent before participation in the trial
排除标准
- •Known hypersensitivity against any of the ingredients of the investigational product
- •Systemic hormonal replacement therapy, or phytohormonal therapy or use of SERMs within 3 months before and / or during the conduct of the trial
- •Local hormonal therapy (vagina/vulva) within 3 months before the trial
- •If in the opinion of the investigator the patient should not participate in the study for any reason
研究组 & 干预措施
WO533
Experimental
Formulation containing WO533 for intravaginal application
干预措施: WO533 (Drug)
结局指标
主要结局
VMI
时间窗: Day 1 to 43
Change of the Vaginal Maturation Index (VMI)
次要结局
- Vaginal pH(Day 1 to 8, day 8 to 43, and day 1 to 43)
- Subjective vulvovaginal atrophy symptoms(Day 1 to 8, day 8 to 43, and day 1 to 43)
- Global judgment of the tolerability by the Investigator(Day 1 to 43)
- Global judgment of the tolerability by the patient(Day 1 to 43)
- Adverse events(Day 1 to 43)
研究者
研究点 (1)
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