Safety and tolerability of BufferGel, a novel vaginal microbicide, in women in the United States

BufferGel (ReProtect, LLC) is a vaginal gel with an acidic buffering action that was designed to prevent vaginal neutralization by semen. The purpose of this study was to evaluate the safety and tolerability of BufferGel (ReP rotect, Limited Liability Company) applied vaginally either once or twice d aily by 27 women who were at low risk for acquisition of human immunodefici ency virus (HIV). Participants initially used the product once daily for 14 days and then twice daily for 14 days; they underwent colposcopy before an d after product exposure. BufferGel was well tolerated, although two-thirds of the participants reported at least 1 mild or moderate adverse experienc e. The most common adverse events were irritative genitourinary symptoms. P roduct use was discontinued after 3 adverse events. BufferGel was well tole rated in women at low risk for acquisition of HIV; toxicity was limited and occurred at frequencies similar to those in women who did not use any vagi nal product and at levels lower than in women who used detergent-based micr obicides.