BACKGROUND: Bacterial vaginosis (BV) is a common vaginal infection caused by a 
lack of endogenous lactobacilli and overgrowth of pathogens that frequently 
recurs following antibiotic treatment.
METHODS: A phase 2a study assessed colonization efficiency, safety, 
tolerability, and acceptability of Lactobacillus crispatus CTV-05 (LACTIN-V) 
administered by a vaginal applicator. Twenty-four women with BV were randomized 
in a 3:1 ratio of active product to placebo. Participants used LACTIN-V at 2 × 
10 colony-forming units (cfu)/dose or placebo for 5 initial consecutive days, 
followed by a weekly application over 2 weeks. They returned for follow-up on 
Days 10 and 28.
RESULTS: Sixty-one percent of the 18 women randomized to the LACTIN-V group were 
colonized with L. crispatus CTV-05 at Day 10 or Day 28. Among LACTIN-V users 
with complete adherence to the study regimen, 78% were colonized at Day 10 or 
Day 28. Of the 120 adverse events (AEs) that occurred, 108 (90%) and 12 (10%) 
were of mild and moderate severity, respectively. AEs were evenly distributed 
between the LACTIN-V and placebo group. Of the total AEs, 93 (78%) were 
genitourinary in origin. The most common genitourinary AEs included vaginal 
discharge (46%), abdominal pain (46%), dysuria (21%), pollakiuria (21%), vaginal 
odor (21%), and genital pruritus (17%). No grade 3 or 4 AEs or serious AEs 
occurred and no deep epithelial disruption was seen during colposcopic 
evaluation. The product was well tolerated and accepted.
CONCLUSIONS: LACTIN-V colonized well, and was safe and acceptable in women 
treated for BV.