NCT03943823终止4 期
Postmenopausal Pessary Users: Estrogen Versus Trimosan
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Vaginal pH as Measured by pH Strips
研究概览
简要总结
The purpose of the study is to compare vaginally applied estrogen with the vaginal gel trimosan for their effects on vaginal pH and vaginal symptoms in postmenopausal pessary users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal female pessary user (ring with support pessaries only). Postmenopausal will be defined as: amenorrhea for a year or 3 months after surgical bilateral salpingo-oophorectomy
- •Is a new pessary user, or has not had a pessary for a year
排除标准
- •Pregnancy
- •Persistent Bacterial Vaginosis infection in the first two clinic encounters
- •Currently on hormone replacement therapy
- •Previously on hormone replacement therapy in the past 6 months
- •Currently on antibiotics
- •Patients with existing vaginal erosions/ulcerations
研究组 & 干预措施
Estrogen vaginal cream
Active Comparator
干预措施: Estrogen vaginal cream (Drug)
Trimo-San vaginal gel
Active Comparator
干预措施: Trimo-San vaginal gel (Drug)
结局指标
主要结局
Vaginal pH as Measured by pH Strips
时间窗: 3 months
pH is measured on a scale of 0 to 14, with lower values indicating greater acidity and higher values indicating greater alkalinity.
次要结局
- Number of Participants Who Exhibited Vaginal Symptoms as Assessed by a Questionnaire(3 months)
研究者
Gazala Siddiqui
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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