NCT05273333Unknown不适用
Effect of Ultra-gyn® on Vulvovaginal Candidiasis
适应症
试验速览
- 阶段
- 不适用
- 发起方
- Biocodex
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To assess the effect of Ultra-gyn® in relieving the symptoms of Vulvovaginal Candidiasis
研究概览
简要总结
The aim of this post-market clinical follow up study is to confirm the performance and the safety of Ultra-gyn® (when used in accordance with its approved labelling)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •To be eligible, each patient must satisfy the following criteria:
- •Is a non-menopausal woman aged 18 to 45 years,
- •Suffering from a vulvovaginal candidiasis (according to clinical examination),
- •Who was being prescribed standard antifungal therapy for Vulvovaginal Candidiasis,
- •Has regular menstrual cycles (21-35 days) or no menstruation due to continuous use of contraception,
- •Is able to understand the study related information and to give a written informed consent,
- •Has signed the informed consent form before beginning any study procedure,
- •Agrees not to use other vaginal products than those planned in the study protocol, during participation in the study,
- •Agrees not to use a diaphragm, spermicide or latex condoms, contraceptive creams and spermicide ovules during participation in the study,
- •Uses an effective method of contraception (contraceptive steroid [oral, patch, injection, implant], intrauterine device, vasectomized partner, history of permanent sterilization such as tubal ligation, hysterectomy, etc.) or abstinence,
- •Has no condition that may interfere with the study assessments
- •Is affiliated to a health social security system,
- •Is able to comply with protocol requirements and respect the conditions of the study,
排除标准
- •Patients meeting at least one of the following criteria cannot be included in the study:
- •Criteria related to a medical condition that would compromise patient safety or data fidelity:
- •Has had a sexually transmitted disease in the 21 days preceding screening or detected on this occasion,
- •Has a history of recurrent fungaemia,
- •Has a history of recurrent vulvovaginal candidiasis (defined as more than four episodes of vulvovaginal candidiasis in the previous year or two episodes in the last six months),
- •Has had pelvic surgery in the 3 months prior to screening,
- •Has had uterine or vaginal bleeding of unknown etiology,
- •Immunocompromised,
- •Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments,
- •Is pregnant (positive pregnancy test at screening), has given birth less than 2 months ago or is breastfeeding,
- •Has changed her method of contraception in the 2 months prior to screening,
- •Criteria related to contraindications to the product used within the study:
- •With a known allergy or presenting an hypersensitivity to one of the component of the study product,
- •Presenting a contraindication or special warning to the study product, according to the package leaflet, including concomitant use of antifungal therapy during Ultra-gyn application,
- •Criteria related to medications or situations that would interfere with or compromise data fidelity
- •Has taken systemic or intravaginal antibiotic or antifungal agents (other than those prescribed during the inclusion visit) in the 14 days preceding the screening visit,
- •Is not willing to stop taking probiotics dietary supplements and food products enriched with probiotics,
- •Is planning to change her usual habits (hygiene, dietary habits, tobacco and alcohol consumption, physical activity and sexual life) during the study,
- •Has participated in an interventional clinical study in the month prior to inclusion.
结局指标
主要结局
To assess the effect of Ultra-gyn® in relieving the symptoms of Vulvovaginal Candidiasis
时间窗: Day 0 to Day 30 (+/-5)
Change in vulvovaginal symptoms (5-point rating scale (ranging from 0 to 4, where 0=None and 4=Very severe) for vaginal itching, vaginal burning or soreness and vaginal discharge)
次要结局
- To assess the effect of Ultra-gyn® on vaginal microbiota(Day 0 and Day 30 (+/-5))
- To assess the incidence of device deficiencies(Day 1 to Day 30 (+/-5))
- To assess the effect of Ultra-gyn® on Candida spp(Day 0 and Day 30 (+/-5))
- To assess the incidence of adverse effects(Day 1 to Day 30 (+/-5))
研究者
研究点 (2)
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