SAFETY OF A NONOXYNOL-9 VAGINAL GEL IN KENYAN PROSTITUTES - A RANDOMIZED CLINICAL-TRIAL

Objectives: To evaluate the safety and toxicity of once-daily administ ration of Advantage-24 (Columbia Research Laboratories, Inc., Rockvill e Centre, NY), a vaginal gel containing 52,5 mg of nonoxynol-9 (N-9), including the effects of this gel on the vaginal and cervical epitheli um. Study Design: Randomized, placebo-controlled, double-blind crossov er trial, with a 2-week product application period and a 2-week washou t period, Methods: Female sex workers in Mombasa, Kenya were randomize d to one of two sequences, N-9 followed by placebo, or vice versa, Wom en were instructed to apply one applicator of N-9 or placebo gel vagin ally once each day, During each of the two product periods, subjects w ere evaluated by questionnaire and physical examination, including col poscopy, after 7 and 14 days of product use, The primary outcome was g enital epithelial disruption, Results: Sixty subjects were randomized, of whom 52 (87%) had complete follow-up, There were four episodes of epithelial disruption, three of which occurred during the placebo peri od and one during the N-9 period. The estimated risk of epithelial dis ruption associated with N-9 use was 0.33 (95% confidence interval, 0.0 3-3.26). There was no increased frequency of other, nondisruptive epit helial lesions during N-9 use, Conclusions: No genital epithelial toxi city of N-9 vaginal gel was observed. This safety profile suggests tha t this N-9 product is appropriate for evaluation for human immunodefic iency virus type 1 prevention in a phase III efficacy trial.