An Open-label Study to Evaluate Clinical Performance of Gedea Pessary in Adult Women With Vulvovaginal Candidiasis
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 vulvovaginal candidias (VVC). 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 VVC signs and symptoms 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 VVC 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 VVC, defined as having a white or creamy vaginal discharge plus the following findings:
- •At least 2 of the following signs and symptoms of VVC that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation.
- •Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.
- •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 VVC (BV, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, Herpes simplex, or human papillomavirus) at screening
- •Patients who are pregnant or breastfeeding
- •Patients who were treated for VVC within the past 14 days
- •Patients who are currently receiving antifungal therapy unrelated to VVC or has taken antifungal 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 or fluconazole
- •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
Clinical cure was defined as the absence of signs and symptoms of vulvovaginal candidiasis (VVC) in terms of having a composite vulvovaginal signs-and-symptoms (CVVS) score equal to or below 3. * Each of the following 6 vulvovaginal signs and symptoms were individually scored using the scoring scale below and then added together to determine the CVVS score. * Vulvovaginal signs: erythema, edema, or excoriation * Vulvovaginal symptoms: itching, burning, or irritation * Scoring Scale: each score should be objectively defined. 0 = none (absent) 1. = mild (slight) 2. = moderate (definitely present) 3. = severe (marked, intense)
Clinical Cure Rate
时间窗: Day 7
Clinical cure was defined as the absence of signs and symptoms of vulvovaginal candidiasis (VVC) in terms of having a composite vulvovaginal signs-and-symptoms (CVVS) score equal to or below 3. * Each of the following 6 vulvovaginal signs and symptoms were individually scored using the scoring scale below and then added together to determine the CVVS score. * Vulvovaginal signs: erythema, edema, or excoriation * Vulvovaginal symptoms: itching, burning, or irritation * Scoring Scale: each score should be objectively defined. 0 = none (absent) 1. = mild (slight) 2. = moderate (definitely present) 3. = severe (marked, intense)
次要结局
- Proportion of Patients Having a Reduction in CVVS Score(Day 7 compared to Day 0)
- Usability, Measured by Patient Questionnaire(Day 7)
- Proportion of Patients Having a Recurrence(Up to day 35)
- Proportion of Patients Having a Reduction in CVVS Score(Day 7 compared to Day 0)
- Usability, Measured by Patient Questionnaire(Day 7)
- Proportion of Patients Having a Recurrence(Up to day 35)