2023-508958-26-00招募中2 期
Efficacy, safety, and dose-response of a Live Biotherapeutic Product (BGY-1601-VT, vaginal tablet) as a first-line monotherapy in women with acute vaginal infection: a randomized, double-blind, placebo-controlled study
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 13
- 主要终点
- Percentage of responders, i.e. participants with clinical cure at V2 AND no rescue therapy started before V2.
研究概览
简要总结
The main objective is to compare the efficacy of BGY-1601-VT, according to the dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection :
- 7 days (-1/+3) after treatment start (V2)
- In women with confirmed diagnosis of Bacterial Vaginosis (BV), Vulvovaginal Candidiadis (VVC), or mixed infection (BV+VCC).
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menarche / premenopausal women aged 18 to 50 years old (inclusive)
- •With suspected BV and/or VVC, presenting at least two of the following symptoms of acute vaginal infection: Fluid abundant discharge, thick abundant discharge, fishy odor, external (vulvar) or internal (vaginal) itching, external (vulvar) or internal (vaginal) burning.
- •Women not at risk of pregnancy.
- •Negative pregnancy urinary test performed during the screening visit.
- •Good general and mental health in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination.
- •Able and willing to participate to the trial by complying with the protocol procedures as evidenced by her dated and signed informed consent form.
- •Affiliated with a health insurance through a public or private health insurance provider.
排除标准
- •Other already diagnosed or suspected infectious causes of bacterial vaginal infection (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae) within 1 month.
- •Impossible to contact in case of emergency.
- •Current herpes simplex flare-up in the genital area.
- •Vulvar condyloma due to the human papilloma virus.
- •Vulvar dermatoses (e.g.: psoriasis or lichenification).
- •Clinical diagnosis of BV or VVC within 4 months.
- •Treatment received (local or systemic) with any antibiotic, antifungal, antiseptic or probiotic therapy (etc.) within 7 days prior to screening or within 5 known half-lives of the drug (whichever is longer), regardless of the indication
- •Participant using any intravaginal product (local contraceptive [spermicide, hormonal ring], moisturizer, tampon, intimate hygiene product, etc.).
- •Participant who is likely to be menstruating between D0 and D
- •Participant who had a sexual intercourse from 48h prior to D0, or who is planning to have a sexual intercourse from V1 to V2, or within 48h prior to V
- •Participant with a chronic disease or condition or treatment known to impact the immune system, including auto-immune disease, diabetes, cancer, renal failure, etc.
- •Pregnant or breastfeeding patient or intending to become pregnant within 1 month ahead, or having given birth within 3 months.
- •Participant in perimenopause, i.e. aged 45 years or more, with irregular menstrual cycles that could lead to a suspicion of menopause.
- •With a known or suspected food allergy or intolerance or hypersensitivity to any of the trial intervention ingredient.
- •Taking part in another clinical trial or being in the exclusion period of a previous clinical trial.
- •Under legal protection (guardianship, wardship) or deprived from her rights following administrative or judicial decision.
- •Presenting a psychological or linguistic incapability to sign the informed consent.
结局指标
主要结局
Percentage of responders, i.e. participants with clinical cure at V2 AND no rescue therapy started before V2.
Percentage of responders, i.e. participants with clinical cure at V2 AND no rescue therapy started before V2.
次要结局
- Percentage of participants with clinical cure at the time point AND no rescue therapy started.
- Percentage of participants with improved symptoms at the time point, related to D0 (self-assessment): PGI-C scale ≤ 2 AND no rescue therapy started.
- Percentage of participants with improved symptoms at the time point, related to D0 (as per the investigator’s assessment): CGI-C scale ≤ 2 AND no rescue therapy started.
- Percentage of participants who started a rescue therapy before the time point.
- Evolution of each symptom from D0 to the time point, as per the participant’s assessment (resolution / improvement / no change / worsening): Itching / pruritus, burning / irritation, pain, leucorrhea / vaginal discharge.
- Evolution of each symptom from D0 to the time point, as per the investigator’s assessment (resolution / improvement / no change / worsening): Leucorrhoea / vaginal discharge, edema, erythema, ulceration, pH.
- Time to resolution of all symptoms present at D0, as reported in the participant’s diary.
- Time to symptom recurrence after resolution, if applicable, as reported in the participant’s diary.
- Time to rescue therapy.
- Number of events / participants with adverse events (Aes), depending on their classification (systemic / local; severe; treatment-emergent).
- Quantification of Lcr35 in the vaginal microbiota, from quantitative polymerase chain reaction (qPCR) on vaginal secretions at the time point.
研究者
Véronique Trochon-Joseph
Scientific
Nexbiome Therapeutics
研究点 (13)
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