Effects of a Moisturizing Cream on Vaginal and Vulvar Mucous Membranes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 2
- 主要终点
- Change in vaginal and vulvar pH
研究概览
简要总结
Vulvovaginal atrophy is a common problem associated with decreased levels of estrogen. Typical symptoms include feelings of dryness and uncomfort of the mucous membranes of intimate area. The objective of this study is to investigate the effects of a non-hormonal moisturizing cream on symptoms and signs of vulvovaginal atrophy and dryness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Symptoms of vaginal dryness, burning or itching
- •Symptom severity at least moderate
排除标准
- •Systemic hormonal replacement therapy during the last 12 months
- •Local hormonal replacement therapy during the last 4 weeks
- •Known allergy to ingredients of the study creams
- •Pregnancy
- •Breast-feeding
结局指标
主要结局
Change in vaginal and vulvar pH
时间窗: Baseline, 5 weeks
Change in signs of vaginal and vulvar inflammation and irritation: VAS evaluation by the study gynecologist
时间窗: Baseline, 5 weeks
Change in symptoms of vaginal and vulvar atrophy and dryness: symptom questionnaires; scoring from 0 to 3 dryness, burning, itching; VAS evaluation of mucosal dryness, irritation, soreness, pain during exercise, pain during intercourse
时间窗: Baseline, 5 weeks
Change in signs of vaginal and vulvar mucosal integrity: VAS evaluation by the study gynecologist
时间窗: Baseline, 5 weeks
Change in signs of vaginal and vulvar dryness: VAS evaluation by the study gynecologist
时间窗: Baseline, 5 weeks
Change in symptoms of vaginal health index: scores of vaginal mucosa elasticity, fluid, pH, epithelial integrity, moisture
时间窗: Baseline, 5 weeks
次要结局
- Change in symptoms of vaginal and vulvar atrophy and dryness: symptom logbooks; daily scoring from 0 to 3 dryness, burning, itching, pain, soreness, symptoms during intercourse(From baseline to 5 weeks)
研究者
Petra Larmo
R&D Manager
Aromtech Ltd.