Controlled, Multicenter, Randomized Parallel Group Pilot Study With 2 Treatment Arms in Non-pregnant Women With Acute Symptomatic Bacterial Vaginosis (BV)

Background

Bacterial vaginosis (BV) is the most common cause of vaginitis in women of childbearing age, with an estimated prevalence of 29% in the general population of women aged 14 to 49 years.

Women with symptomatic BV may present with malodorous discharge that is off-white, thin, and homogenous and has a fishy smell especially after intercourse. However, only the minority of women with BV is symptomatic.

Regardless of the symptoms, it may be of importance to treat women with BV, as this condition is associated with serious risks, such as an increased risk of preterm birth in pregnant women, particular vulnerability to the acquisition of sexually transmitted disease (STD), including gonorrhea, chlamydia trachomatis, genital herpes and HIV and a possibly higher risk of pelvic inflammatory disease (PID). Moreover, endometrial bacterial colonization, plasma-cell endometritis, postpartum fever, post-hysterectomy vaginal cluff cellulitis and post-abortal infection seem to be associated with BV.

The pathophysiology of BV consists of changes in the microbiologic composition of the vaginal flora. In the healthy vaginal flora, lactobacilli are the predominant bacteria, producing lactic acid and H2O2, maintaining a pH<4.5 and inhibiting the growth of other organisms. In BV, the concentration of H2O2-producing lactobacilli is reduced and other species become more prevalent, notably Gardnerella vaginalis, Prevotella species, Porphyromonas species, Bacteroides species, Peptostreptococcus species, Mycoplasma hominis, Ureaplasma urealyticum, and Mobiluncus species. These vaginal anaerobes produce carboxylase enzymes, breaking down peptides to amines, which get volatile and malodorous with the increased pH. More over the amines increase vaginal transudation and squamous epithelial cell exfoliation, leading to the typical discharge in BV. With the increased pH, Gardnerella vaginalis can adhere to squamous epithelial cells and create a biofilm. The mechanism by which this floral imbalance occurs is not clear, but sexual activity seems to be a major risk factor, as BV does not occur in sexual inactive women. Additionally, multiple or new sexual partners, frequency of vaginal intercourse, vaginal douching, and cigarette smoking have also been identified as risk factors, whereas the use of condoms had a protective effect.