An Open Labelled Study to Evaluate Clinical Performance of the 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
- 26
- 试验地点
- 8
- 主要终点
- Clinical Cure Rate at Day 7-14
研究概览
简要总结
This is a multi-centre, multi-national study to evaluate the clinical performance and safety of treatment with Gedea Pessary in adult women with confirmed vulvovaginal candidiasis (VVC).
The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms. A total of 26 patients are planned to be included in the study. On Day 0 (Screening, Visit 1), eligible patients will undergo a gynaecological examination, including collection of composite vulvovaginal signs-and-symptoms (CVVS) score data, and vaginal samples. Patients will be provided with 6 doses of Gedea Pessary that will be self-administered as a daily treatment (Days 0 to 5).
Patients will visit the clinic on Day 7 (+2 days, Visit 2) for gynaecological examinations, including collection of CVVS data for the assessment of clinical cure and reporting of AEs and concomitant medications. On Day 14 (±2 days, Visit 3), patients that did not have a clinical and mycological cure Day 7 will re-visit the clinic for additional gynaecological examinations, including collection of CVVS data for the assessment of clinical cure. Rescue treatment will be offered during visits 2 and 3, if necessary. Patients will have a final telephone follow-up on Day 25 (±3 days, Visit 4), for for reporting of AEs, concomitant medications and potential menstruation onset. Vaginal sampling for culture and sequencing, as well as vaginal pH measurements will be performed at the clinic on Day 0, Day 7, and Day 14. On Day 25, patients will self-perform vaginal swabs at home for sequencing and vaginal culture. Patient questionnaires for assessing VVC symptoms, will be used during the treatment period (Days 0 to 5), 1 day after the treatment (Day 6) and on Days 11 and 25. Usability will be assessed on Day 7, also via the patient questionnaire. The patient questionnaire will be based on an electronic patient reported outcomes (ePRO) system, i.e. a mobile application (ViedocMe™).
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
- •Having decisional capacity and providing written informed consent.
- •Adult, post-menarchal, pre-menopausal women, aged 18 years or older
- •Diagnosis of VVC, defined as:
- •Having a white or creamy vaginal discharge
- •At least 2 of the following signs and symptoms of VVC that are characterised as at least moderate: itching, burning, irritation, oedema, erythema, or excoriation.
- •KOH or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.
- •Negative urine pregnancy test at Screening.
- •Refrain from using any intravaginal products (i.e. contraceptive creams, gels, foams, sponges, lubricants, or tampons, etc.) until Day
- •Refrain from sexual intercourse or use a condom until Day
- •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 vaginal infection (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 14 days prior to Screening.
- •Patients who are currently receiving anti-fungal therapy unrelated to VVC or has taken anti-fungal therapy within 14 days prior to Screening.
- •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 judgements would make the patient unsuitable for inclusion.
- •More than 3 previous VVC infections during the last 12 months.
结局指标
主要结局
Clinical Cure Rate at Day 7-14
时间窗: Day 7-14
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, with no intercurrent events (concomitant anti-fungal therapy or other treatments related to VVC due to lack of clinical performance prior to CVVS evaluation for the primary endpoint definition, treatment discontinuation due to lack of clinical performance, or rescue medication prior to CVVS evaluation for the primary endpoint definition). Each of the following vulvovaginal signs and symptoms was individually scored using the scoring scale below. The CVVS score is the sum of the 6 individual scores. * Vulvovaginal signs: erythema, edema, or excoriation * Vulvovaginal symptoms: itching, burning, or irritation Scoring scale: each score was objectively defined as: 0 = none (absent), 1 = mild (slight), 2 = moderate (definitely present), 3= severe (marked, intense)
次要结局
- Continued Clinical Response to Treatment at Day 25(Day 25)
- Combined Clinical and Mycological Cure at Day 7-14(Day 7-14)
- Mycological Cure at Day 7-14(Day 7-14)
- Mycological Cure at Day 25(Day 25)
- Absence of Candida Hyphae in the Wet Smear(Day 7-14)
- Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14(From Screening to Day 7-14)
- Change in the Composite Vulvovaginal Signs and Symptoms (CVVS) Score From Screening to Day 7-14 - Proportions(From Screening to Day 7-14)
- Proportion of Patients Having a Reduction in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening(Day 1-7, Day 11, Day 14, Day 25)
- Change in the Sum of the 3 Vulvovaginal Symptoms Scores (Itching, Burning, and Irritation) Over Time Compared to Screening(Day 1-7, Day 11, Day 14, Day 25)
- Usability, Measured by Patient Questionnaire on Day 6.(Day 6)