For a study, researchers sought to evaluate the effectiveness and safety of a single-dose vaginal clindamycin gel for treating bacterial vaginosis. They conducted a randomized, double-blind, placebo-controlled research comparing clindamycin gel to placebo (2:1 ratio). Entry needed a clinical diagnosis of bacterial vaginosis, which met all four Amsel criteria and was free of other genital diseases. According to revised 2019 U.S. Food and Drug Administration recommendations, Nugent scores of 7–10 were necessary for effectiveness evaluation. Patients were assessed at the screening on days 7–14 and 21–30 (test of cure). Clinical cure was defined as meeting three of the four Amsel criteria. The bacteriologic cure was defined as having a Nugent score of less than 4. Therapeutic cures included both clinical and bacteriologic treatment. At the test-of-cure visit, the primary outcome was the clinical cure. Secondary goals were clinical cure at days 7–14, bacteriologic and therapeutic cures at days 7–14, and a cure test. A sample size of 188 patients in the clindamycin group vs. 94 individuals in the placebo group provided 90% power to detect a statistically significant difference (P=.05, two-tailed).
Participants were observed between July 9, 2020, and November 12, 2020. About 56.0% of the 307 randomized women were Black, and 88.3% had previously had bacterial vaginosis. In the modified intention-to-treat population, 70.5% of clindamycin patients and 35.6% of placebo patients achieved clinical cure at the test of cure (primary outcome) (difference of 34.9, 95% CI 19.0–50.8), as did 77.5% of clindamycin patients and 42.6% of placebo patients in the per-protocol population (difference of 34.9, 95% CI 17.0–52.7). All secondary endpoints showed statistically significant differences between groups. The clinical cure rate in clindamycin group patients with more than three bacterial vaginosis episodes in the previous year was 70.0%. Approximately 15% (15.3%) of participants in the clindamycin group and 9.7% of patients in the placebo group suffered one or more treatment-emergent adverse events linked to study therapy. Vulvovaginal candidiasis was the most common treatment-related, treatment-emergent adverse event. A novel, single-dose clindamycin vaginal gel was extremely efficacious and safe in women with bacterial vaginosis who had Nugent scores of 7–10 at the start of the research.
