NCT06450990尚未招募1 期
Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product (BGY-1601-VT) as a First-line Monotherapy in Women With Acute Vaginal Infection: a Randomized, Double-blind, Placebo-controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 165
- 主要终点
- To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection
研究概览
简要总结
The purpose of this clinical trial is to investigate the clinical efficacy and safety of a Live Biotherapeutic Product (BGY-1601-VT) intended as a first line of treatment in cases of acute vaginal infection without upfront microbiological confirmed diagnosis
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post-menarche woman aged 18 to 50 years old (inclusive),
- •With suspected Bacterial Vaginosis (BV) and/or Vulvovaginal Candidiasis (VVC), presenting symptoms of acute vaginal infection
- •No clinically significant and relevant abnormalities of medical history (including mental disorders) 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,
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
- •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 with any antibiotic or antifungal therapy (local or systemic) within 2 months, regardless of the indication;
- •Treatment with any local treatment (probiotics, antiseptic, etc.) within 1 month, regardless of the indication;
- •Participant using any intravaginal product (local contraceptive [spermicide, hormonal ring], moisturizer, tampon, intimate hygiene product, etc.);
- •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;
研究组 & 干预措施
BGY-1601-VT #1
Experimental
Arm 1: BGY-1601#1: one verum tablet at Day 0 (D0) and one placebo tablet at Day 2 (D2)
干预措施: BGY-1601-VT (Drug)
BGY-1601-VT #1
Experimental
Arm 1: BGY-1601#1: one verum tablet at Day 0 (D0) and one placebo tablet at Day 2 (D2)
干预措施: PLACEBO (Other)
BGY-1601-VT #2
Experimental
BGY-1601#2: one verum tablet at D0 and one verum tablet at D2
干预措施: BGY-1601-VT (Drug)
PLACEBO
Placebo Comparator
Placebo: one placebo tablet at D0 and one placebo tablet at D2
干预措施: PLACEBO (Other)
结局指标
主要结局
To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection
时间窗: Visit 2 (V2) = 7 days
Percentage of responders with clinical cure at Visit 2 (V2) without rescue therapy
次要结局
- To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo, dosing regimen #2 versus placebo, and dosing regimen #1 versus dosing regimen #2, to treat acute vaginal infection(Visit 2 (7 days) and Visit 3 (28 days))
- To assess the safety of BGY-1601-VT in dosing regimen #1 and dosing regimethe safety of placebo #2, and(V2 (7 days) and V3 (28 days))
- To compare the evolution of Lcr35 into the vaginal microbiome between dosing regimen #1 and dosing regimen #2.(Visit 2 (7 days) and Visit 3 (28 days))
研究者
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