Study of the vaginal tolerance to acidform, an acid-buffering, bioadhesivegel

Vaginal tolerance tests were performed with a new potential microbicidal an d spermicidal product, an acid-buffering vaginal gel (Acidform) without or with nonoxynol-9 (N-9). The potential advantages over other vaginal product s include keeping a low pH, decrease of the irritating effect of N-9 on the cervix or vaginal mucosa associated with greater retention of the product after application, and decreasing "messiness" as compared to other vaginal products. Three groups of six women were admitted and randomly assigned to use Acidform with 0%, 2.5%, and 5% N-9. Colposcopic evaluation for vulvar, vaginal, and cervical signs of irritation was performed and photographs wer e taken, following a specific World Health Organization protocol, at time 0 , and after 24 h and 6 days of application of the gel. No irritation or sym ptom was reported by users of Acidform without N-9. A generalized and inten se erythema in cervix was observed in 10 of 12 Acidform/N-9 users and abras ion occurred in nine of them. Vulvar irritation was seen in seven of these 10 volunteers. N-9 concentration in the gel (2.5% or 5.0%) was not related to the findings. No ulcer, exulceration, or de-epithelialization was observ ed. Acidform without N-9 was well tolerated by volunteers, but it was unabl e to protect the cervix, vagina, and vulva from the N-9 effects. CONTRACEPT ION 2000;60: 361-366 (C) 2000 Elsevier Science Inc. All rights reserved.