QUANTITATION OF VAGINALLY ADMINISTERED NONOXYNOL-9 IN PREMENOPAUSAL WOMEN

A feasibility study was performed in 11 healthy nonpregnant premenopau sal women to determine a method for collection and recovery of vaginal ly administered nonoxynol-9. We also determined ii nonoxynol-9 could b e quantitated in vaginal lavage fluid obtained 2 h after instillation of a standard precoital dose of a foam formulation of nonoxynol-9. Sam ples were analyzed in batch using a validated normal phase high-perfor mance liquid chromatography (HPLC) method. Two hours after instillatio n of one dose oi Delfen(R) Contraceptive Foam (100 mg), the quantity o i nonoxynol-9 collected ranged from 10.8 to 67.8 mg (mean: 35.4 mg). T his corresponds to a recovery of 11-70% of the administered dose. Quan titation of vaginally administered nonoxynol-9 is both practical and f easible. These data represent a critical first step in the evaluation of the safety and effectiveness of nonoxynol-9-containing products in the prevention of sexually transmitted diseases. (C) 1997 Elsevier Sci ence Inc.