Prospective, Open-label, Multicenter, Multinational, Randomized Trial to Investigate the Non-inferiority of Treatment With WO2085 Moisturising Cream in Comparison to a Cream With 0.1% Estriol in a Panel of Post-menopausal Women Suffering From the Symptoms of Vulvovaginal Dryness in a Parallel Group Design
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 4
- 主要终点
- Change from Baseline Total Severity Score of the Treatment of "vulvovaginal dryness" at 6 weeks.
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 in comparison to a cream with 0.1% estriol.
详细描述
"Vaginal dryness" is defined as dryness, itching, burning and pain unrelated to sexual intercourse.
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
- 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 the subjective symptoms of "vulvovaginal dryness" with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 AND a VAS value "Overall impairment of daily life due to the condition "vulvovaginal dryness" > 0 on Visit
- •Last menstruation more than 12 months before Visit 1 OR bilateral oophorectomy with or without hysterectomy more than 3 months before Visit
- •Physical and mental healthy women as assessed by the medical history.
- •PAP test performed within the last 12 months before Visit 1 and result less than PAP III.
- •Signed written informed consent before participation in the Trial.
- •Willingness to actively participate in the trial and to come to the scheduled visits.
排除标准
- •Known hypersensitivity against any of the ingredients of the test products.
- •Any indication in the medical history regarding an impairment of the hepatic, renal, gastrointestinal, cardiovascular, pulmonary, endocrinological or hematological system (especially venous and arterial thromboembolism, ischemic stroke, myocardial infarction, porphyria) if clinically relevant for this clinical trial (cf. contraindications and warnings for Estriol cream 0.1%).
- •Known thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency).
- •Breast cancer (acute and / or in the medical history or suspected).
- •Estrogen-dependent tumor (acute and / or in the medical history or suspected, especially ovarian and / or endometrial carcinoma).
- •Systemic hormonal replacement therapy (tablets, patches, injections, dermal products), or phytohormonal therapy or use of SERMs (inter alia anti-estrogens) within 3 months before Visit 1 and / or during the conduct of this trial.
- •Intrauterine device (IUD) with progestogen (Mirena®, Jaydess®)
- •Pathological findings in cancer screening (Papanicolaou III, III D - V in the cervical test)
- •Pathological changes in the vaginal or cervix area, which are caused by estrogen deficiency (except symptoms and condition of "vulvovaginal dryness"), e.g. diminution of labia caused by estrogen deficiency, constricted introitus.
- •Patients with known infectious diseases (e.g. hepatitis or HIV infection).
研究组 & 干预措施
Medical Device: WO2085 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)
Drug: Estriol Cream 0.1%
Estriol Cream 0.1% is a standard therapy for the treatment of vulvovaginal atrophy in postmenopausal women.
干预措施: Estriol Cream 0.1% (Drug)
结局指标
主要结局
Change from Baseline Total Severity Score of the Treatment of "vulvovaginal dryness" at 6 weeks.
时间窗: Baseline, after 3 and 6 weeks
"Vulvovaginal dryness" will be measured by the Total Severity Score. It is defined as the sum score of the single subjective symptom parameters dryness, itching, burning and pain unrelated to sexual intercourse, each scored from 0=none to 4=very severe. In total a range of 0=no complaints to 16=very severe complaints is possible. Differences to Baseline (Visit 1) of the Total Severity Score assessed after six weeks of treatment (Visit 3) serve as the primary endpoint for the test of non-inferiority.
次要结局
- Global judgement of efficacy(6 weeks)
- Overall impairment of daily life(6 weeks)
- Global judgement of tolerability(6 weeks)
- Adverse Events(after 3 and 6 weeks)