Clindamycin delivers in bacterial vaginosis
Use of a single dose of a new bioadhesive 2% clindamycin vaginal gel in the treatment of bacterial vaginosis appears to result in a rapid resolution of symptoms, with high acceptability among women, as reported in a study.
This double-blind, placebo-controlled, randomized study included 307 women with bacterial vaginosis. They were randomly assigned to receive treatment with clindamycin gel (n=204) or with placebo gel (n=103). The primary outcome was efficacy. Secondary outcomes included safety and acceptability.
The participants were assessed at screening, days 7 to 14, and days 21 to 30 (test-of-cure [TOC]). They also completed an acceptability questionnaire administered at the day 7–14 visit, and a subset of questions (#7–#9) was asked again at the TOC visit. A daily electronic diary (e-Diary) was provided at screening to record information regarding study drug administration, vaginal discharge, odour, itching, and any other treatments used.
Most (88.3 percent) of the participants reported at least one previously diagnosed bacterial vaginosis episode, and more than half (55.4 percent) received other vaginal treatments for bacterial vaginosis.
At the TOC visit, 91.1 percent of the women who received clindamycin described their overall experience with their treatment as “satisfied” or “very satisfied.” Moreover, 95.8 percent said that they would be “likely” or “very likely” to use the gel again if it became available after the study and in case of another bacterial vaginosis episode. A total of 93.7 percent would be “likely” or “very likely” to recommend clindamycin gel to a friend who had bacterial vaginosis.
About 90 percent of clindamycin-treated women indicated that application was “clean” or “fairly clean,” as opposed to “neither clean nor messy,” “fairly messy,” or “messy.” Leakage in the days after application occurred in 55.4 percent of women, but only 26.9 percent of them said that the leakage was bothersome.
Treatment with clindamycin also led to improvements in both odour and discharge, happening shortly after dosing and continuing through the assessment period, regardless of whether the women met the critical cure criteria.