Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal … (NCT06450990) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection
165 participantsStarted 2024-07-08
Plain-language summary
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
Who can participate
Age range18 Years – 50 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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,
Exclusion Criteria:
* 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 inten…
What they're measuring
1
To compare the efficacy of BGY-1601-VT, dosing regimen #1 versus placebo and dosing regimen #2 versus placebo, to treat acute vaginal infection