NCT04612881Unknown不适用
Clinical Verification of the Activity and Tolerability of Fitostimoline Vaginal Pessaries in Women With Hysterectomy. Randomized, Perspective, Monoscentric Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- TSS
研究概览
简要总结
Clinical evaluation of Fitostimoline vaginal pessaries in the treatment of hysterectomy. An observational, randomized, perspective study performed on 60 women where 30 women are treated with fitostimoline pessaries and 30 women are treated with the standard of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patient aged between 35 and 80 years
- •patient undergoing hysterectomy
- •Willingness to understand the procedures and aims of the study
排除标准
- •Anamnestic or clinical data of metabolic or endocrine diseases (such as uncontrolled diabetes mellitus) or any other local and / or systemic pathology potentially able to interfere with the study parameters;
- •Concomitant treatment with antibiotics / antiseptics, NSAIDs, analgesics (excl. Paracetamol)
- •Non-therapeutic use of psychoactive substances;
- •Abuse of drugs and / or alcohol / smoking;
- •Neurological disorders or psychiatric conditions potentially capable of affecting the validity of the consent and / or compromising the patient's adherence to the study procedures;
- •Known allergy, hypersensitivity or intolerance to the constituents of the preparations under study;
- •Any condition, medical or otherwise, that could significantly reduce the possibility of obtaining reliable data, achieving the objectives of the study, perfecting its completion;
- •Presumption of poor reliability or collaboration;
- •Treatment with any preparation in the last 30 days prior to the start of the study;
- •Patients already enrolled in this study;
- •Center staff directly involved in the study and close relatives
研究组 & 干预措施
fitostimoline vaginal pessaries
干预措施: fitostimoline vaginal pessaries (Drug)
fitostimoline vaginal pessaries
干预措施: standard of care (Other)
结局指标
主要结局
TSS
时间窗: 60 days
total symptom score (TSS) on a scale from 0 to 10 from worst to best
次要结局
未报告次要终点
研究者
Michele Vignali
PROFESSOR
University of Milan
研究点 (1)
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