EUCTR2016-002199-28-DE进行中（未招募）1 期
Prospective, open-label, multicenter, multinational, randomized trial to investigate the non-inferiority of treatment with Vagisan® Moisturising Cream in comparison to an Estriol containing cream in a panel of post-menopausal women suffering from the symptoms of vulvovaginal dryness in a parallel group design
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 172
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Post-menopausal women with the subjective symptomatology 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 1.
- •Last menstruation more than 12 months before Visit 1 OR bilateral oophorectomy with or without hysterectomy more than 3 months before Visit 1.
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 86
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 86
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 Ovestin®).
- •Known thrombophilic disorders (e.g. protein C, protein S or antithrombin deficiency).
- •Any indication of other significant acute or chronic impairments which may have an impact either on the safety of the patient or on the resorption, distribution, metabolism or the excretion of estriol.
- •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®)
- •Untreated endometrial hyperplasia
- •Undiagnosed vaginal bleeding.
- •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.
- •Local hormonal therapy (vagina/vulva) within 3 months before Visit 1 (also when used for the brightening/pretreatment of cytological smears).
- •Non-healed vaginal surgery.
- •Vaginal inflammation which is not caused by vulvovaginal dryness.
- •Use of moisturizers (vagina/vulva) within 14 day before Visit 1 and during the conduct of this trial.
- •Any use of products (including lubricants), other than the test products, applied intravaginally or on the vulva during the conduct of this trial (except for the use of Vagisan® Intimwaschlotion, Note: should not be used, if allergic to chamomile).
- •Systemic corticosteroids within 14 days before Visit 1 and during the conduct of this trial (corticoid asthma sprays are allowed).
- •Chronic disease of the genital area, e.g. lichen sclerosus.
- •Patients with known infectious diseases (e.g. hepatitis or HIV infection).
- •Clinically diagnosed vaginal infection (acute or during the conduct of the trial).
- •Use of antibiotics or antimycotics within 14 days before Visit 1 and / or during this trial.
- •Body Mass Index < 19 kg/m2 or > 35 kg/m2.
- •Acute drug- or alcohol abuse.
- •Patients with poor compliance and / or poor willingness to cooperate.
- •Psychiatric conditions that might limit the participation in the trial and/or that lead to the assumption that the ability to completely understand the consequences of consent is missing.
- •Patients, who are inmates of psychiatric
研究者
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