NCT07405853进行中（未招募）不适用
A Randomised, Partly Blinded Investigation to Evaluate the Clinical Performance and Safety of pHyph in Adult Women With Vulvovaginal Candidiasis Compared With an Untreated Control Group
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- The change in CVVS score on Day 7 compared to that on Day 0.
研究概览
简要总结
The goal of this clinical trial is to learn if pHyph works to reduce signs and symptoms of vulvovaginal candidiasis (thrush). It will also learn about the safety of pHyph. The main questions it aims to answer are:
- Does pHyph reduce the signs and symptoms of vulvovaginal candidiasis after an initial 6 day daily treatment?
- Does an additional 6 day treatment course after the initial one further reduce signs and symptoms of vulvovaginal candidiasis?
- What medical problems do participants have when applying pHyph? Researchers will compare pHyph to no treatment Day 0 to Day 7 to see if pHyph reduces signs and symptoms of vulvovaginal candidiasis. For patients that received initial treatment, researchers will also compare the treatment outcome Day 7 to the treatment outcome after an additional treatment course of pHyph, Day 14.
Participants will:
- Apply pHyph every day for 6 days or receive no treatment and visit the clinic 7 days after the initial screening visit. Patients that received treatment will continue with pHyph every day for 6 days and patients that did not receive any treatment will receive standard of care for vulvovaginal candidiasis and leave the study.
- Patients that receive pHyph will visit the clinic Day 0 (screening), Day 7, and Day 14, and have a telephone call Day 25. Patients that do not receive pHyph will visit the clinic Day 0 (screening) and Day 7.
- Keep a diary of their symptoms and confirm that they have applied pHyph.
详细描述
- Full title A randomized, partly blinded investigation to evaluate the clinical performance and safety of pHyph in adult women with vulvovaginal candidiasis compared with an untreated control group
- Rationale Vulvovaginal candidiasis (VVC) is a vaginal yeast infection that can cause abnormal vaginal discharge and often itching, affecting up to 75% of all women. Several approved drugs are already available for VVC, but they are not always effective, which means that the infection can recur.
Given the limitations of current treatment and prevention strategies for vulvovaginal infections, as well as the high frequency of women misdiagnosing themselves, there is a need for new over-the-counter (OTC) treatment options that can treat both VVC and bacterial vaginosis, are safe during pregnancy, and have a low risk of resistance development.
The treatment investigated in this research study is a medical device in the form of a vaginal tablet called pHyph. pHyph contains - glucono-delta-lactone, a substance that occurs naturally in the body, as it is a temporary substance in the breakdown of common sugar. It is also an approved food additive. In pHyph, glucono-delta-lactone causes the acidity (pH value) in the vagina to decrease to normal. In a slightly acidic environment, yeast fungi do not cause VVC in the same extent and lactobacilli are also favored, which can also inhibit yeast fungi.
The main aim of the study is to investigate the change in signs and symptoms of VVC after 6 days of treatment with pHyph compared to an untreated control group. 3. Objectives
Primary objective:
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
- Single (Investigator)
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
- •Willing and able to give written informed consent for participation in the clinical investigation, and to comply with all clinical investigation requirements.
- •Adult, post-menarchal, pre-menopausal women aged 18 years or older.
- •Diagnosis of VVC, defined as:
- •Having a white or creamy vaginal discharge, and
- •at least two signs (erythema, oedema and excoriation) and/or symptoms (itching, burning irritation) of VVC scored as at least 2 = moderate on a scale of 0-3, and
- •potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts upon microscopic analysis.
- •Negative urine pregnancy test at screening.
- •Willing to refrain from using any intravaginal products (e.g., contraceptive creams, gels, foams, sponges, sex toys, lubricants or tampons, etc.) until EOT for the active treatment group (Day 14) or EOI for the no treatment group (Day 7).
- •Willing to use condoms during any sexual intercourse with a male sexual partner until EOT for the active treatment group (Day 14) or EOI for the no treatment group (Day 7).
- •Willing to use a method of contraception, e.g., condoms, hormonal contraception (oral, injectable, implantable, intravaginal, or transdermal), IUD (if a copper IUD is used, it must be combined with a condom) or intrauterine hormone-releasing system (IUS), during any sexual intercourse that might result in pregnancy from Visit 1 (Day 0) until EOI (Day 25 for the active treatment group or Day 7 for the no treatment group) to prevent pregnancy.
排除标准
- •Patients with known or apparent signs of other infectious causes of vaginal infection and/or vaginitis (e.g., BV, Trichomonas vaginalis, Neisseria gonorrhoeae, Chlamydia trachomatis, herpes simplex virus or human papillomavirus) at screening.
- •History of or presence at screening (Day 0) of any other clinically significant disease or disorder, medical/surgical procedure, or trauma, which, in the opinion of the Investigator, may either put the patient at risk because of participation in the clinical investigation, or influence the results or the patient's ability to participate in the clinical investigation.
- •Anticipated menstruation during the first treatment period (Day 0 until Day 7). If a patient is menstruating on Day 0, or if menstruation is anticipated during Days 0 to 7, inclusion can be postponed to an additional visit at a later date when the menstrual bleeding is no longer heavy (light bleeding or brown discharge is acceptable).
- •Patients who are pregnant or breastfeeding.
- •Patients who are planning to conceive within the 25 days of the investigation.
- •Patients who were treated for VVC (both OTC and prescription therapies) within the 14 days preceding screening.
- •Patients who are currently receiving antifungal therapy unrelated to VVC or have received antifungal therapy within the 14 days preceding screening.
- •Patients who have used any pH-modifying vaginal products within the 14 days preceding screening.
- •Patients who have received an investigational drug in a clinical trial within 30 days prior to screening.
- •History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, to any of the product components.
- •The Investigator considers the patient unlikely to comply with clinical investigation procedures, restrictions and requirements.
研究组 & 干预措施
No treatment
No Intervention
pHyph treatment
Active Comparator
Application of vaginal tablet every day for 6 days
干预措施: pHyph (Device)
结局指标
主要结局
The change in CVVS score on Day 7 compared to that on Day 0.
时间窗: From enrollment to Day 7
The primary endpoint is defined as the numerical change in the CVVS score on Day 7 compared to that on Day 0. Each of the of the 6 VVC signs (erythema, oedema and excoriation) and symptoms (itching, burning and irritation) will be scored using the scale below: * 0 = none (absent) * 1 = mild (slight) * 2 = moderate (definitely present) * 3 = severe (marked, intense) The CVVS score is the sum of the six individual scores for vulvovaginal signs and symptoms.
次要结局
- The proportion of clinically cured patients, defined as having a CVVS score ≤3.(As applicable from enrollment to Day 14)
- The proportion of patients showing an absence of fungal hyphae in the wet smear.(As applicable from enrollment to Day 14)
- The proportion of mycologically cured patients, defined as vaginal cultures negative for growth of fungal species.(As applicable from enrollment to Day 25)
- The proportion of patients having both clinical cure according to secondary endpoint no. 7 as well as mycological cure according to secondary endpoint no. 9.(As applicable from enrollment to Day 14)
- The proportion of patients having both clinical cure according to secondary endpoint no. 7 as well as mycologically confirmed fungus at screening.(As applicable from enrollment to Day 14)
- The proportion of patients having a CVVS score = 0, i.e., the absence of all signs and symptoms.(As applicable from enrollment to Day 14)
- The change in CVVS score, i.e., the primary endpoint parameter, for patients that received treatment on Day 7-12.(From enrollment to Day 14)
- Change in vaginal pH(As applicable from enrollment to Day 14)
- The occurrence of vaginal yeasts, assessed by analysis (qPCR) of the vaginal microbiome, i.e., qPCR count of fungal species.(As applicable from enrollment to Day 25)
- Reported treatment-emergent adverse events (TEAEs) and device deficiencies in the active treatment group.(From enrollment to Day 25)
- Usability, measured by patient questionnaire administered via mobile application on Day 14.(From enrollment to Day 14)
- Other vulvovaginal symptom scores, as self-reported by patients.(As applicable from enrollment to Day 25)
- The proportion of patients having a reduction in CVVS score(As applicable from enrollment to Day 14)
- The proportion of patients having a reduction in the sum of the three vulvovaginal symptom scores (itching, burning and irritation).(As applicable from enrollment to Day 25)
- The sum of the three vulvovaginal symptom scores (itching, burning and irritation).(As applicable from enrollment until Day 25)
- Individual vulvovaginal symptom scores (itching, burning and irritation).(As applicable from enrollment to Day 25)
研究者
研究点 (3)
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