EUCTR2015-003356-51-SE进行中（未招募）1 期
A single-centre, open-label, single-arm, Phase I/II study to investigate the effect of a hydrogen peroxide foam on clinical signs and symptoms and the vaginal flora in patients with bacterial vaginosis
Zelmic AB0 个研究点目标入组 30 人开始时间: 2015年8月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1) Willing and able to provide informed consent
- •3) Age =18 years
- •4) BV, as defined by the following criteria (Amsel criteria):
- •a. pH of vaginal fluid greater than 4.5
- •and at least two of the following criteria:
- •b. Positive amine test
- •c. Presence of clue cells
- •d. Presence of characteristic, homogenous vaginal discharge
- •5) Regular menstruation cycle
- •6) Using adequate contraceptive measures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1) Hypersensitivity or allergy to the IMP (investigational medical product) or to chemically related products
- •2) Current use of a copper intrauterine device
- •3) Currently pregnant or intending to become pregnant within 1 month after treatment
- •4) Antibiotic treatment within 2 weeks before treatment
- •5) Signs of infection requiring specific antibiotic treatment
- •6) Immunosuppression, including HIV1 or 2 infection
- •7) Vaginal or cervical ulcer or cancer
研究者
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