Study to Evaluate Efficacy and Safety of Gyntima® Balance in Preventing Recurrences of Bacterial Vaginosis
In plain words A Phase 2 and 3 study of lactobacillus gasseri in female participants 18 to 45, run by Kaneka Americas Holding Inc.. It plans to enroll about 160 people and lists no sites yet.
Who it lists and where
Who the trial lists, as registered
Lists female participants 18 to 45. Conditions: Vaginosis, Bacterial; Bacterial Vaginosis; Bacterial Vaginosis (BV).
- Females of ages 18-45 years (both values included) who are premenopausal.
- History of recurrent BV (at least 3 episodes in the last 12 months with at least one of them documented in the last 6 months).
- Positive Amsel's criteria (confirming active BV) determined by at least 3 out of the following 4 symptoms or signs:
- Homogeneous, thin, yellowish-white/greyish white discharge that smoothly coats the vaginal walls.
9 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Lactobacillus gasseri KABP®064 10e9 CFU/capsule; Placebo (maltodextrin)
Registered summary
The vagina is a dynamic muscular organ whose health relies on a Lactobacillus-dominant microbiota that maintains low pH and protects against infections. Bacterial vaginosis (BV) is the most common vaginal imbalance in women of reproductive age, caused by depletion of protective Lactobacillus species and overgrowth of anaerobic bacteria such as Gardnerella vaginalis. The full summary is on the listing.
Where, as registered
No sites listed yet.