Clinical acceptability of an ethylene-vinyl-acetate nonmedicated vaginal ring.

ABSTRACT

PIP: The acceptability of a newly designed vaginal ring was evaluated in an open, randomized study conducted at Atrium Medical Center in Kerkrade, the Netherlands. 65 healthy women 18-45 years of age were assigned to use 1 of 3 types of nonmedicated vaginal rings made with ethylene-vinyl-acetate with the same diameter (54 mm) but varying cross-sectional thicknesses (3, 3.5, or 4 mm). Women were instructed to insert the ring on day 5 of the menstrual cycle and use the device for 21 days. Temporary removal of the ring was permitted during intercourse or for rinsing with water after vaginal bleeding. 59 women (91%) completed the study. 41 women (66.1%) reported at least 1 adverse effect, most frequently foreign body feeling (8 women) and vaginal discharge (15 women), but all side effects were mild. No major differences were recorded between the 3 types of rings other than a sensation of expulsion, which was more common in women assigned the ring with the smallest cross-sectional thickness. 1 woman in the 3.5 mm group experienced complete expulsion during intercourse. The ring was judged to be easy to insert and remove. The device was felt during intercourse by 5 women in the 3.5 mm group but by only 1 woman each in the 2 other groups. Although 35-50% of male partners could feel the ring during intercourse, only 11-15% cited this as a reason for disliking the device. Further development of an active combined contraceptive ethylene-vinyl-acetate ring with a cross-sectional diameter of 4 mm is recommended.