A Double-blind, Randomized, Placebo-controlled Study to Confirm the Efficacy and Safety of Multi- Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Clinical cure rate of BV at 3 weeks after start of treatment (end-of treatment visit; Visit 2).
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled clinical investigation. The objective of the study is to confirm the efficacy of Multi-Gyn ActiGel Plus to treat BV as compared to a placebo control.
Treatment arm 1: Multi-Gyn ActiGel Plus Treatment arm 2: placebo gel Both the Multi-Gyn ActiGel Plus and the placebo will be applied twice a day for 7 consecutive days. Visit 2 will be performed at 3 weeks after start of treatment A phone call will take place, at 5 weeks after start of treatment for subject with clinical cure at Visit 2. The total duration per subject is estimated 5 weeks and the total study duration is 13 months. Sample size is 100 subjects per treatment arm.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 (incl. clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis)
- •Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amstel 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
- •Use of intravaginal devices during the investigation or 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
Clinical cure rate of BV at 3 weeks after start of treatment (end-of treatment visit; Visit 2).
时间窗: 3 weeks
Clinical cure is defined based on the following Amsel criteria: 1. presence of clue cells \<20% of the total epithelial cells on microscopic examination of the saline wet mount 2. resolution of the abnormal vaginal discharge, and 3. a negative whiff test
次要结局
- Microbiological cure rate (based on Nugent score <4) at Visit 2(3 weeks)