EUCTR2008-005007-26-IT进行中（未招募）不适用
An open-label, controlled, randomized, prospective, between groups, multicenter clinical trial on the efficacy and safety of Fitostimoline (vaginal cream, vaginal suppositories and vaginal solution) and of Tantum Rosa (vaginal cream and vaginal solution) in the treatment of the vaginosis (non specific vaginitis) - ND
FARMACEUTICI DAMOR0 个研究点开始时间: 2008年10月9日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 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
- •Female outpatients;
- •Age ≥ 18 years and ≤ 70 years;
- •Presence of at least two subjective symptoms and at least two signs at the gynaecological examination (of at least mild degree) indicative of vaginal phlogosis;
- •Availability of abstaining from vaginal sexual intercourses during the study period;
- •Start of the study within the 15th day of the menstrual cycle, in fertile women;
- •Availability in taking part in the study and in adhering to experimental procedures by signing the informed consent.
- •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
- •Pregnancy or lactation;
- •Gynaecological diseases (in addition to the vaginal phlogosis) or other diseases whose symptoms or treatment could interfere with the evaluations scheduled in the protocol;
- •Treatment with antibiotics/antisepticals, anti-inflammatory drugs (steroidal and non-steroidal), analgesic drugs, antineoplastic drugs or immunosuppressant drugs (by any route) in the last 10 days prior to the start of the study;
- •Immunodepressant drugs (e.g. HIV infection);
- •Non-therapeutic use of psychoactive drugs;
- •Drug or alcohol abuse;
- •Serious psychiatric diseases;
- •Known hypersensitivity to study compounds;
- •Presumed poor adherence or cooperation;
- •Treatment with any investigational study drug in the last 30 days prior to the study start.
研究者
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