Ongoing Clinical Trials for Vaginal Infection
There is currently 1 ongoing clinical trial investigating new treatments for vaginal infections, specifically targeting bacterial vaginosis and vulvovaginal candidiasis (yeast infections). This trial is being conducted in France and Germany and is testing a live biotherapeutic vaginal tablet containing beneficial bacteria to help restore vaginal balance.
Clinical trial locations
- France
- Germany
Study on the Effectiveness and Safety of BGY-1601-VT for Women with Acute Vaginal Infections, Including Bacterial Vaginosis and Yeast Infections
This clinical trial is testing a new treatment for women experiencing acute vaginal infections, including bacterial vaginosis (an imbalance of natural vaginal bacteria), vulvovaginal candidiasis (a yeast infection), or a combination of both conditions.
Inclusion criteria: Women eligible to participate must be between 18 and 50 years old and still having menstrual periods. They need to have symptoms suggesting a vaginal infection, such as unusual or heavy discharge, thick discharge, a fishy smell, or itching and burning in the vaginal area. Participants must not be at risk of becoming pregnant and must have a negative pregnancy test. They should be in good general and mental health with no significant medical issues, able to follow study procedures, and have health insurance coverage.
Exclusion criteria: The study cannot include men or women without a confirmed diagnosis of bacterial vaginosis, vulvovaginal candidiasis, or a mixed infection of both conditions. Individuals who are part of vulnerable populations and may not be able to provide informed consent are also excluded.
Focus and goal: The trial aims to compare the effectiveness and safety of BGY-1601-VT vaginal tablets with a placebo (an inactive treatment that looks identical). The study is double-blind, meaning neither participants nor researchers know who receives the active treatment until the study ends, which helps ensure unbiased results. Participants receive treatment for 7 to 10 days, with follow-up evaluations occurring 7 days after starting treatment. Researchers will monitor how well the treatment reduces symptoms such as discharge, itching, and burning, while also tracking any side effects to assess safety.
Investigational drug: The treatment being tested is BGY-1601-VT, a vaginal tablet containing live Lactobacillus rhamnosus bacteria (strain LCR35). This beneficial bacteria is designed to help restore the natural balance of the vaginal environment. The medication is classified as a live biotherapeutic product and is being evaluated as a potential first-line treatment for these common types of vaginal infections.
Summary
Currently, there is one active clinical trial available for women with vaginal infections, being conducted in two European countries: France and Germany. This trial focuses on testing a probiotic-based treatment that uses beneficial bacteria to address bacterial vaginosis and yeast infections. The approach represents an alternative to traditional antibiotic and antifungal treatments by attempting to restore the natural vaginal environment. Women experiencing symptoms of these infections and residing in or able to travel to the trial locations may wish to learn more about participation eligibility.
