Safety and acceptability of 6% cellulose sulfate vaginal gel applied four times per day for 14 days

Background: Six percent cellulose sulfate (CS) is a vaginal gel that has been in development as a microbicide. Study Design: This was a single-center, multi-dose, Phase I, placebo-controlled, randomized, fully masked study conducted in Yaounde, Cameroon, and involving sexually active women at low risk for sexually transmitted infections (STIs). Methods: The study assessed the effect of CS and K-Y-(R) Jelly applied vaginally four times per day, for 14 consecutive days, on genital epithelial disruption, candidiasis and bacterial vaginosis (BV). Acceptability of the products was also assessed. Twenty-seven women were enrolled in each treatment group. Results: Two (7.4%) of the women in each group developed genital epithelial disruption. One (3.7%) of the women in each group developed candidiasis, and one (3.7%) of the K-Y users developed BV. One (3.7%) of the CS users said she would not buy her product for pregnancy prevention but would for STI prevention. All the remaining women indicated they would buy their product for both indications. Conclusion: The results suggest that the safety and acceptability of 6% CS gel are comparable to that of K-Y Jelly. (c) 2007 Elsevier Inc. All rights reserved.