Multicentric Study on the Application of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From the Symptoms of Vulvovaginal Dryness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 17
- 主要终点
- Change from Baseline of subjective vulvovaginal atrophy symptoms (e.g. feeling of dryness, itching)
研究概览
简要总结
The aim of the study is to gain further experience with regard to the performance of the medical device WO2085 Moisturising Cream for breast cancer patients undergoing chemotherapy or treatment with anti-oestrogens / aromatase inhibitors
详细描述
The goal of this application study was to answer the question as to whether the application of WO2085 Moisturising Cream for breast cancer patients undergoing chemotherapy or treatment with anti-oestrogens / aromatase inhibitors can result in an improvement in the subjective symptoms and objective diagnoses of vulvovaginal dryness while also ensuring good tolerability.
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
- •Women with breast cancer undergoing chemotherapy OR therapy with aromatase inhibitors or anti-oestrogens (either at present or up to 3 months after ending treatment) AND with symptoms of vulvovaginal dryness since the start of tumour treatment
- •Written declaration of consent for the voluntary participation in the study is present
排除标准
- •Women who suffered symptoms of vulvovaginal dryness prior to the start of tumour treatment
- •Patients undergoing radiation therapy
- •Patients with other tumours
- •A current vaginal infection
- •Medical conditions related to the vulva or vagina
- •Current additional therapy of vulvovaginal dryness or vulvovaginal atrophy
- •Women who are not able to participate properly in this study
- •Current alcohol and/or drug abuse
- •Pregnant or lactating women
研究组 & 干预措施
WO 2085 Moisturising Cream
WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms.
干预措施: WO2085 Moisturising Cream (Device)
结局指标
主要结局
Change from Baseline of subjective vulvovaginal atrophy symptoms (e.g. feeling of dryness, itching)
时间窗: Baseline, after 4 weeks
Each symptom is rated according to severity on a scale from 0 to 4 (0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced)
次要结局
- Change from Baseline of objective vulvovaginal atrophy symptoms (e.g. thinning of the vaginal epithelium, redness)(4 weeks)
- Global judgement of efficacy(4 weeks)
- Adverse Events(after 4 weeks)
- Global judgement of tolerability(4 weeks)