Vaginal epithelial surface appearances in women using vaginal rings for contraception
Fraser,Ian S.; Lacarra,Maria; Mishell,Daniel R.,Jr.; Alvarez-Sanchez,Francisco; Brache,Vivian; Lahteenmaki,Pekka; Elomaa,Kaisa; Weisberg,Edith; Nash,Harold A.
Contraception 61(2): 131-138
Publication date: 2000
Vaginal inspections using colposcopy before insertion of contraceptive vaginal rings and at 2-month intervals during ring use were conducted on 169 users of four different formulations. The rings studied released Nestorone® alone (50, 75, 100 µg daily over 6 months); ethinyl estradiol: Nestorone (30:100 and 15:150 µg daily over 6 months); ethinylestradiol:norethindrone acetate (20:1000 and 15:1000 µg daily over 4 months); and ethinyl estradiol:norethindrone acetate (20:1000 µg daily over 12 months). A total of 88 altered or atypical conditions of the vaginal surface appearance were recorded in 507 inspections (17.4% of inspections). Many of these atypical appearances were quite subtle. The incidence was significantly higher (p <0.01) than in the single pretreatment examinations (11 in 158 inspections; 7.0%), but closely matched that of a "control group" of sexually active women who were the subject of an earlier study by the same investigators. In that study, the incidence was 18% (57 atypical conditions in 317 inspections). In all, 83% of atypical conditions identified in the vagina during ring use had disappeared by the next scheduled colposcopy despite continued ring use. Findings of potential significance were conservatively defined as all ulcerations, those abrasions and ecchymoses that were >0.5 cm in any direction, and fields of five or more petechiae. Findings fitting those criteria comprised 30% of atypical conditions in ring users, 33% in the control group, and 27% pretreatment. The corresponding incidence as a percentage of inspections were 5.3%, 6.0%, and 2.5% in the ring users, control groups, and pretreatment groups, respectively. These differences were not statistically significant. The findings suggest that the vaginal rings included in the studies contributed little, if at all, to clinically significant lesions or to total lesion incidence. Further definition would require a larger and longer-term study with matched controls.