COMPARISON OF SPERMICIDES ON VULVAR, VAGINAL, AND CERVICAL MUCOSA

The objective of this study was to compare the tolerability of Advanta ge 24(R) to two other spermicides containing nonoxynol-9 (N-9). These spermicides were Today(R) Sponge (Sponge) and Conceptrol(R). in order to examine the incidence of complaints and the clinical observation of vaginal ulceration and irritation of the three spermicides, a randomi zed, open label, three period cross-over trial was conducted. Thirty-t hree women, ages 18-45, with a normal vaginal environment based on phy sical exam, Pap smear, vaginal wet prep, colposcopy, and serum N-9 wer e randomized into four treatment groups. Each treatment was for seven consecutive days with a 21-day washout. Data obtained were studied by one-way analysis of variance, chi-square, and Kruskal-Wallis test. No vulvar or vaginal abnormality was observed from either spermicide. Sub jects had fewer and less severe cervical lesions by colposcopy during treatment with Advantage 24 than with Conceptrol or the Sponge (p<0.01 ). Comparison of the incidence of abnormal gynecological findings, ser um N-9 levels, and the incidence of adverse events before and after tr eatment with the three study drugs indicate that most subjects had nor mal examinations pre- and post-treatment. Pap smear and colposcopy cha nges from normal to abnormal accounted for about 50% of all gynecologi cal findings during the Conceptrol and Sponge treatments, but less tha n 20% during treatment with Advantage 24. All serum N-9 levels were be low the level of detection (<1.9 mu g/ml). Advantage 24 is better tole rated than Conceptrol or the Sponge. Furthermore, the cervical mucosa appears to be less resilient to spermicides than vulvo-vaginal mucosa.