A randomized comparison of the effects on vaginal and cervical epithelium of a placebo vaginal ring with non-use of a ring

Little is known about the effects of contraceptive vaginal rings on the vag inal surface epithelium, although most studies have not demonstrated any si gnificant deleterious effect. However, one study found that some medium-to- long-term levonorgestrel-releasing ring users developed chronic erythematou s and ulcerative lesions in the posterior vaginal fornix. Subsequently, thi s ring was completely redesigned (IVR-2) with different dimensions acid muc h greater flexibility. The first version of IVR-2 was designed as a placebo ring to explore effects on the vagina and cervix without addition of a pro gestogen. One-hundred-sixty-six healthy sexually active women volunteers we re recruited in four centers acid randomly assigned for 6 months to either placebo ring use or control (non-use) using a predetermined randomization c ode generated by WHO in a 2:1 ratio. Careful inspections of the vaginal and cervical epithelium were performed with a colposcope at admission and at 2 -month intervals. No clinically significant lesions were detected in any ce nter either among ring users or controls. However, a number of minor change s in appearance of the vaginal and cervical epithelium (erythema, petechiae , ecchymosis, acid minor aceto-white changes) were described from the Sydne y Center. some of which were present on admission and some of which were fo und on subsequent examination. Ten of eleven "red" changes on the cervix an d vagina were noted in IVR-2 users, and only one in the controls, suggestin g a contribution by the IVR-2 to minor epithelial surface changes. Five of ten resolved completely with continued ring use. There was no correlation i n this study between epithelial changes and cigarette smoking or frequency of intercourse in the 14 days prior to colposcopic examination but a signif icant relationship between tampon use in the last 7 days and all epithelial changes (p = 0.05) and especially red changes (p = 0.027) was noted. Red c hanges were significantly less likely to be found among condom users (p = 0 .007). The IVR-2 placebo ring did not produce clinically significant change s in the vaginal epithelium and cervical mucosa and a carefully controlled and randomized study should be considered to compare the epithelial appeara nces in women using a placebo IVR-2 and one releasing 20 mug levonorgestrel . (C) 2000 Elsevier Science Inc. All rights reserved.