EUCTR2008-003120-37-DE进行中（未招募）1 期
EV(E)A StudieEstriol versus Estradiol - Eine prospektive, randomisierte Multizenterstudie zur Evaluation der Wirkung einer lokalen Therapie auf urogenitale Beschwerden, Zytologie und Mammographiedichte
Medizinische Fakultät der Otto von Guericke Universität Magdeburg0 个研究点目标入组 0 人开始时间: 2008年10月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- 性别
- Female
入选标准
- •postmenopausal women
- •vaginal atrophy
- •mammogram without pathological findings
- •vaginal cytology without pathological findings
- •informed consent
- •age not older than 75 years
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •gynecological malignant tumor
- •systemic therapy with hormons (estrogens, androgens) (within the last 6 months)
- •lokale therapy with estrogens (within the last 6 weeks)
- •therapy with phytoestrogens (within the last 3 months; the use longer then 3 months is permitted but must be continued during the trail)
- •Lichen sclerosus et atrophicans
- •Dermatological disease (z.B. severe acne) or drug eruption
- •cerebrovasculare disease, thromboembolic disease, heart attac, angina pectoris or thrombophlebitis (within the last 5 years)
- •akute liver oder kidney disease or other severe disease (within the last 6 months)
- •postmenopausal bleeding
- •vaginale infection
- •breast surgery within the last 6 months
- •endometrial hyperplasia
- •known allergy to the IMPs
研究者
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