Epidemiological Study About the Clinical and Microbiological Evolution of Patients Treated for an Acute Episode of Vulvovaginal Candidiasis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Vaginal swab test
研究概览
简要总结
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sexually active women between 18 and 50 years
- •Patients attending to the gynecologist with acute vulvovaginal candidiasis.
- •Patients requiring standard treatment with clotrimazole 500 single dose and that the decision to prescribe this treatment is prior to inclusion in the study.
- •Women who agree to participate in the study and has signed the informed consent sheet.
排除标准
- •Use of any medication that may interfere significantly with study assessments.
- •Pregnant or breastfeeding
- •Women with signs of other genital infection
- •Within 3 months after childbirth or abortion
- •Patients that is expected not to attend follow-up visits
研究组 & 干预措施
Clotrimazole
Clotrimazole 500 mg
干预措施: Clotrimazole (Other)
结局指标
主要结局
Vaginal swab test
时间窗: month 6
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis, only those with a history of more than four episodes in a year
Vaginal swab test
时间窗: Baseline
To verify diagnosis of vaginal candidiasis
Vaginal swab test
时间窗: month 2
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis
Vaginal swab test
时间窗: month 3
To determine proportion of women achieving clinical and mycological cure or have recurrences / reinfection after being treated for an acute episode of vulvovaginal candidiasis
次要结局
未报告次要终点