Efficacy, Safety, and Dose-response of a Live Biotherapeutic Product in Women With Acute Vaginal Infection
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorNEXBIOME THERAPEUTICS
About this trial
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
Eligibility criteria
Qualifiers
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,
Disqualifiers
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);
Trial design
Treatments tested in this trial
- BGY-1601-VT
- PLACEBO
Treatment groups
165 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov