NCT00900653Unknown4 期
Low Dose Estriol With Lactobacilli (Gynoflor) Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized, Open, Parallel-Group Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Incidence of urinary tract infection
研究概览
简要总结
Recurrent urinary tract infections (UTI) are a problem for postmenopausal women. The aim of this trial is to evaluate the effectiveness of lactobacilli in combination with low dose estriol for preventing recurrent urinary tract infections in postmenopausal women.
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
- 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 woman
- •History of urinary tract infection
- •Agree to abstain from self-medication with antibiotics for UTI symptoms
- •Agree to abstain from the use of any other intra-vaginal product
- •Capable of providing informed consent
排除标准
- •Ovarian cancer, cervical cancer, breast cancer
- •Estrogen treatment within last 2 years
- •Vaginal bleeding
- •Antibiotic therapy fewer than three days prior to randomization visit
- •Known congenital urologic or gynecologic abnormalities
- •Indwelling urinary catheter
- •Thromboembolic disease
- •Uncompensated liver disease
- •Immunosuppressive drug within 60 days
研究组 & 干预措施
Gynoflor
Experimental
干预措施: Gynoflor E (low dose estriol with lactobacillus) (Drug)
结局指标
主要结局
Incidence of urinary tract infection
时间窗: 6 months
次要结局
- vaginal pH(6 months)
- lactobacillus colonization(6 months)
研究者
研究点 (1)
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