Randomized Trial of Lactin-V to Prevent Recurrence of Bacterial Vaginosis.
2020 05 14
Journal Article
Authors:
Cohen, C.R.;
Wierzbicki, M.R.;
French, A.L.;
Morris, S.;
Newmann, S.;
Reno, H.;
Green, L.;
Miller, S.;
Powell, J.;
Parks, T.;
Hemmerling, A.
Secondary:
N Engl J Med
Volume:
382
Pagination:
1906-1915
Issue:
20
PMID:
32402161
Keywords:
Administration, Intravaginal; Adolescent; Adult; Anti-Bacterial Agents; Antibiosis; Double-Blind Method; Female; Gels; Humans; Incidence; Lactobacillus crispatus; Metronidazole; Middle Aged; Secondary Prevention; Vagina; Vaginosis, Bacterial; Young Adult
Abstract:
BACKGROUND: Bacterial vaginosis affects 15 to 50% of women of reproductive age, and recurrence is common after treatment with an antibiotic agent. The high incidence of recurrence suggests the need for new treatments to prevent recurrent bacterial vaginosis.METHODS: We conducted a randomized, double-blind, placebo-controlled, phase 2b trial to evaluate the ability of CTV-05 (Lactin-V) to prevent the recurrence of bacterial vaginosis. Women 18 to 45 years of age who had received a diagnosis of bacterial vaginosis and who had completed a course of vaginal metronidazole gel as part of the eligibility requirements were randomly assigned, in a 2:1 ratio, to receive vaginally administered Lactin-V or placebo for 11 weeks; follow-up occurred through week 24. The primary outcome was the percentage of women who had a recurrence of bacterial vaginosis by week 12.RESULTS: A total of 228 women underwent randomization: 152 to the Lactin-V group and 76 to the placebo group; of these participants, 88% in the Lactin-V group and 84% in the placebo group could be evaluated for the primary outcome. In the intention-to-treat population, recurrence of bacterial vaginosis by week 12 occurred in 46 participants (30%) in the Lactin-V group and in 34 participants (45%) in the placebo group (risk ratio after multiple imputation for missing responses, 0.66; 95% confidence interval [CI], 0.44 to 0.87; P = 0.01). The risk ratio for recurrence by week 24 (also calculated with multiple imputation for missing responses) was 0.73 (95% CI, 0.54 to 0.92). At the 12-week visit, CTV-05 was detected in 79% of participants in the Lactin-V group. The percentage of participants who had at least one adverse event related to Lactin-V or placebo by week 24 did not differ significantly between the groups. The percentage of participants with local or systemic adverse events was similar in the two groups.CONCLUSIONS: The use of Lactin-V after treatment with vaginal metronidazole resulted in a significantly lower incidence of recurrence of bacterial vaginosis than placebo at 12 weeks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT02766023.).
