NCT01420510Unknown2 期
Saginil in Vaginal Cannulas vs. Placebo for the Prevention of Vaginitis in Gynecologic Oncologic Patients Receiving Chemotherapy: a Randomized Controlled Trial.
Università degli Studi dell'Insubria1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of patients with vaginitis in the group taking Adelmidrol (vaginal cannulas) vs. number of patients with vaginitis in the Placebo group
研究概览
简要总结
We hypothesise that the use of Adelmidrol (Saginil in vaginal cannulas) can reduce the incidence and magnitude of vaginitis in patients affected by gynecologic malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gynecologic malignancy
- •Current administration of chemotherapy
排除标准
- •Colpectomy
- •Vaginal cancer
- •Vulvar cancer
- •Bacterial vaginitis
研究组 & 干预措施
Adelmidrol
Experimental
Efficacy of Adelmidrol vaginal gel in preventing vaginitis in oncologic patients
干预措施: Adelmidrol vaginal gel (Drug)
Placebo
Placebo Comparator
Efficacy of Placebo in preventing vaginitis in oncologic patients
干预措施: Placebo vaginal gel (Drug)
结局指标
主要结局
Number of patients with vaginitis in the group taking Adelmidrol (vaginal cannulas) vs. number of patients with vaginitis in the Placebo group
时间窗: 2 months
次要结局
未报告次要终点
研究者
Fabio Ghezzi
Professor
Università degli Studi dell'Insubria
研究点 (1)
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