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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
EU CTIS ID: 2023-508958-26-00
What this study is testing
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).
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- I1. Post-menarche / premenopausal women aged 18 to 50 years old (inclusive)
- I2. 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.
- I3. Women not at risk of pregnancy.
- I4. Negative pregnancy urinary test performed during the screening visit.
- I5. Good general and mental health in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination.
- I6. Able and willing to participate to the trial by complying with the protocol procedures as evidenced by her dated and signed informed consent form.
You likely can't join if
- E1. Other already diagnosed or suspected infectious causes of bacterial vaginal infection (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae) within 1 month.
- E17. Impossible to contact in case of emergency.
- E2. Current herpes simplex flare-up in the genital area.
- E3. Vulvar condyloma due to the human papilloma virus.
- E4. Vulvar dermatoses (e.g.: psoriasis or lichenification).
- E5. Clinical diagnosis of BV or VVC within 4 months.
See the full eligibility criteria
- I1. Post-menarche / premenopausal women aged 18 to 50 years old (inclusive)
- I2. 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.
- I3. Women not at risk of pregnancy.
- I4. Negative pregnancy urinary test performed during the screening visit.
- I5. Good general and mental health in the opinion of the investigator: no clinically significant and relevant abnormalities of medical history or physical examination.
- I6. Able and willing to participate to the trial by complying with the protocol procedures as evidenced by her dated and signed informed consent form.
- I7. Affiliated with a health insurance through a public or private health insurance provider.
- E1. Other already diagnosed or suspected infectious causes of bacterial vaginal infection (e.g., Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae) within 1 month.
- E17. Impossible to contact in case of emergency.
- E2. Current herpes simplex flare-up in the genital area.
- E3. Vulvar condyloma due to the human papilloma virus.
- E4. Vulvar dermatoses (e.g.: psoriasis or lichenification).
- E5. Clinical diagnosis of BV or VVC within 4 months.
- E6. 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
- E7. Participant using any intravaginal product (local contraceptive [spermicide, hormonal ring], moisturizer, tampon, intimate hygiene product, etc.).
- E8. Participant who is likely to be menstruating between D0 and D4.
- E9. 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 V3.
- E10. Participant with a chronic disease or condition or treatment known to impact the immune system, including auto-immune disease, diabetes, cancer, renal failure, etc.
- E11. Pregnant or breastfeeding patient or intending to become pregnant within 1 month ahead, or having given birth within 3 months.
- E12. Participant in perimenopause, i.e. aged 45 years or more, with irregular menstrual cycles that could lead to a suspicion of menopause.
- E13. With a known or suspected food allergy or intolerance or hypersensitivity to any of the trial intervention ingredient.
- E14. Taking part in another clinical trial or being in the exclusion period of a previous clinical trial.
- E15. Under legal protection (guardianship, wardship) or deprived from her rights following administrative or judicial decision.
- E16. Presenting a psychological or linguistic incapability to sign the informed consent.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.