An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Bacterial Vaginosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Clinical Cure Rate
研究概览
简要总结
This is an open-label, single-armed, multi-center study to evaluate clinical performance, tolerability, and safety of Gedea Pessary in 24 adult women with confirmed bacterial vaginosis (BV) according to fulfillment of at least 3 of the 4 Amsel criteria. On Day 0, patients will have gynecological examination, vaginal samples taken, and will receive the investigational product to be self-administered. Patients will be examined after 7 days with respect to 3 Amsel criteria (the criterion: "pH of vaginal fluid above 4.5" is only included at study inclusion for diagnosis), and if not cured, will receive prolonged treatment for one additional week. Patients will be followed-up by telephone up to 29 days after last treatment. Vaginal samples will be used for confirming diagnosis and microbiome analyzes. Patient questionnaires will be used for assessing BV symptoms, usability, and adverse events (AEs).
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
- •Adult, post-menarchal, pre-menopausal women aged 18 years or older
- •Diagnosis of BV according to Amsel's criteria, defined as having at least 3 of the 4 following criteria:
- •Thin, white, yellow, homogenous discharge
- •Clue cells on microscopy (more than 20 percent of epithelial cells)
- •pH of vaginal fluid above 4.5
- •Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide [KOH] solution) is added
- •Having decisional capacity and providing written informed consent
- •Negative urine pregnancy test at screening
- •Refrain from using any intravaginal products (i.e., contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) during the study period
- •Refrain from sexual intercourse or use a condom until Day 7
- •Signed informed consent and willing and able to comply with all study requirements
排除标准
- •Patients with known or apparent signs of other infectious causes of BV (vulvovaginal candidiasis, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening
- •Anticipated menstruation during the treatment period (Day 0 till Day 7)
- •Patients who are pregnant or breastfeeding
- •Patients who were treated for BV within the past 14 days
- •Patients who are currently receiving antibiotic therapy unrelated to BV or have received antibiotic therapy within the past 14 days
- •Patients who have used pH-modifying vaginal products within the last 14 days
- •Patients who have received an investigational drug in a clinical investigation within 30 days prior to screening
- •Known/previous allergy or hypersensitivity to any product constituent
- •Any medical condition that in the Investigator's judgments would make the patient unsuitable for inclusion
结局指标
主要结局
Clinical Cure Rate
时间窗: Day 7
Defined as absence of all of the following 3 Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
Clinical Cure Rate
时间窗: Day 7
Defined as absence of all of the following 3 Amsel criteria: 1. Thin, white, yellow, homogenous discharge 2. Clue cells on microscopy (more than 20% of epithelial cells) 3. Release of fishy odor "i.e. a positive whiff test" when alkali (10% potassium hydroxide \[KOH\] solution) is added
次要结局
- Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 2(Day 7 compared to Day 0)
- Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 3(Day 7 compared to Day 0)
- Usability, Measured by Patient Questionnaire(Day 7)
- Proportion of Patients Having a Recurrence of the BV(Up to Day 35)
- Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 1(Day 7 compared to Day 0)
- Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 1(Day 7 compared to Day 0)
- Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 2(Day 7 compared to Day 0)
- Proportion of Patients Being Negative for Each of the 3 Amsel Criteria - Criterion 3(Day 7 compared to Day 0)
- Usability, Measured by Patient Questionnaire(Day 7)
- Proportion of Patients Having a Recurrence of the BV(Up to Day 35)