NCT04489290进行中（未招募）不适用
A Randomised, Double-blind, and Placebo-controlled Post Market Clinical Follow-Up Investigation to Investigate the Clinical Performance of a Medical Device on Clinical Signs and Symptoms, and the Vaginal Environment in Patients With Bacterial Vaginosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pharmiva AB
- 入组人数
- 83
- 试验地点
- 10
- 主要终点
- Clinical cure rate
研究概览
简要总结
This is a randomised, double-blind clinical investigation to evaluate the efficacy and safety of D005 vaginal mousse compared to placebo, in women with bacterial vaginosis.
The study will be conducted at one site in Scotland, United Kingdom and at six different sites in Sweden. The study population will consist of approximately 83 female subjects.
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Willingness and ability to provide informed consent
- •Female in fertile age
- •Age ≥18 years
- •Bacterial vaginosis, as defined by the following criteria (Amsel criteria):
- •A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of potassium hydroxide (KOH)
- •Presence of clue cells (≥20%)
- •Off-white (milky or gray), thin, homogeneous discharge
- •Refrain from using any intravaginal products during the investigation period
- •Refrain from sexual intercourse during treatment. Refrain from sexual intercourse or use a condom during rest of the investigation period to Visit 3.
排除标准
- •Hypersensitivity or allergy to the investigational devices or to chemically related products
- •Current use of an intrauterine device.
- •Current pregnancy or intention to become pregnant within 1 month after treatment
- •Antibiotic treatment within 2 weeks before treatment
- •Signs of other infections (such as chlamydia, gonorrhoea, trichomonas, candida, HSV or HPV) requiring specific antibiotic, antifungal or other treatment at screening.
- •Immunosuppression therapy (Allergy medications allowed) at the discretion of the PI
- •Existing or suspected vaginal or cervical cancer or ulcer
- •Unprotected vaginal sex within 24 hours prior to Visit 1
- •Be identified by the Investigator as inappropriate from a medical or compliance perspective to participate in this investigation (e.g. hysterectomised or inability to report daily using smartphone/computer [eDiary]).
结局指标
主要结局
Clinical cure rate
时间窗: 1 to 3 days after last dosing
Clinical cure at Visit 2, defined as absence of all of the following 3 Amsel criteria: 1. Off-white (milky or gray), thin, homogeneous discharge. 2. The presence of clue cells greater than 20% of the total epithelial cells on microscopic examination. 3. A fishy odour (i.e., a positive whiff test) of the vaginal discharge with the addition of a drop of potassium hydroxide (KOH).
次要结局
- Modified Hay/Ison <grade III at Visit 3(23 to 28 days after last dosing)
- Clinical cure + Modified Hay/Ison <grade III at Visit 3(23 to 28 days after last dosing)
- Clinical cure + Modified Hay/Ison <grade III at Visit 2(1 to 3 days after last dosing)
- pH of the vaginal fluid during treatment(Day 1-7)
- Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 2(1 to 3 days after last dosing)
- Subject-reported experiences and symptoms of vaginal malodour, discharge or itch during treatment, at Visit 3(23 to 28 days after last dosing)
- pH of the vaginal fluid at Visit 2(1 to 3 days after last dosing)
- Absence of clue cells greater than 20 % of the total epithelial cells on microscopic examination at Visit 2 and Visit 3.(1 to 3 days + 23 to 28 days after last dosing)
- Clinical cure rate(23 to 28 days after last dosing)
- pH of the vaginal fluid at Visit 3(23 to 28 days after last dosing)
- Modified Hay/Ison <grade III at Visit 2(1 to 3 days after last dosing)
- Total absence of clue cells (0%) of the total epithelial cells on microscopic examination at Visit 2 and Visit 3.(1 to 3 days + 23 to 28 days after last dosing)
研究者
研究点 (10)
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