Vaginal inspections using colposcopy before insertion of contraceptive vagi
nal rings and at e-month intervals during ring use were conducted on 169 us
ers of four different formulations. The rings studied released Nestorone(R)
alone (50, 75, 100 mu g daily over 6 months); ethinyl estradiol: Nestorone
(30:200 and 25:150 mu g daily over 6 months); ethinylestradiol:norethindro
ne acetate (20:1000 and 25: 1000 mu g daily over 4 months); and ethinyl est
radiol:norethindrone acetate (20:1000 mu g daily over 22 months). A total O
f 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 wom
en who were the subject of an earlier study by the same investigators. In t
hat study, the incidence was 18% (57 atypical conditions in 327 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 direc
tion, and fields of five or more petechiae. Findings fitting those criteria
comprised 30% of atypical conditions in ring users, 33% in the control gro
up, and 27% pretreatment. The corresponding incidence as a percentage of in
spections 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 s
tudies contributed little, if at all, so clinically significant lesions or
to total lesion incidence. Further definition would require a larger and lo
nger-term study with matched controls. (C) 2000 Elsevier Science Inc. All r
ights reserved.