COLPOSCOPIC EVALUATION OF A VAGINAL GEL FORMULATION OF IOTA-CARRAGEENAN

There is an urgent need to develop safe, effective, and acceptable vag inal products for the prevention of sexually transmitted infections. P reliminary in vitro results suggest that vaginal formulations of sulfa ted polysaccharides, including iota-carrageenan, have the potential to block mucosal transmission of human immunodeficiency virus (HIV). Twe nty-five women in Jive sites participated in Phase I trials to evaluat e the safety of a formulation containing iota-carrageenan (PC 213). Th e results of this study indicate that a 5 mL 2% gel formulation of iot a-carrageenan is not associated with significant irritation of the fem ale reproductive tract when administered once daily in the absence of sexual intercourse. Given the small number of participants in this ini tial study, careful observation for potential irritation must also be included in larger studies of this and other vaginal formulations. (C) 1997 Elsevier Science Inc. All rights reserved.