NCT05211921已完成不适用
A Single Arm Study to Confirm the Efficacy and Safety of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis.
Karo Pharma AB1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年12月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary endpoint is clinical cure rate of BV at 3 weeks after start of treatment (Visit 2).
研究概览
简要总结
Open, single arm trial that intends to confirm the safety and efficacy of Multi-Gyn ActiGel Plus for treatment of Bacterial Vaginosis. Adult women will be diagnosed by the gynaecologist based on the Amsel criteria at day 0. They will use the product for 7 days and will come to the practice at day 21. The primary endpoint is the clinical cure rate of Bacterial Vaginosis at 3 weeks after start of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with BV (3 out of 4 Amsel criteria positive, with at least presence of clue cells (>20%)
- •Women of childbearing potential
- •Aged >18 years
- •Signed written informed consent form
- •Willing to comply to the follow-up schedule
排除标准
- •Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis
- •Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amsel criteria (clue cells detection)
- •Current genital malignancies
- •Chemotherapy for any reason in last 6 months
- •Radiotherapy in the genitourinary system in the last 12 months
- •Use of antibiotics for any reason in the last 14 days
- •Pregnancy or currently attempting to conceive
- •Lactation
- •Use of other treatment for vaginal conditions during the course of the clinical investigation
- •Known allergies to ingredients of the product
- •Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation
结局指标
主要结局
The primary endpoint is clinical cure rate of BV at 3 weeks after start of treatment (Visit 2).
时间窗: 3 weeks after start of treatment
Primary endpoint is to demonstrate a responder rate significantly higher than 30% in treatment of bacterial vaginosis at 3 weeks after start of treatment using a two tailed binomial test.
次要结局
- Relief of vaginal symptoms related to BV at Visit 2(3 weeks after start of treatment)
研究者
研究点 (1)
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