Clinical acceptability of an ethylene-vinyl-acetate nonmedicated vaginal ring.
In an open study the acceptability of a newly designed vaginal ring was evaluated. The ring being developed for contraceptive purposes was made of ethylene-vinyl-acetate copolymer (EVA). In this study the ring did not contain active medication. Three groups of 20 healthy female volunteers were asked to use rings--with a diameter of 54 mm--for 21 consecutive days; each group was assigned rings with a different cross-sectional thickness of 3, 3.5, or 4 mm. Subjects were given diary cards to report on insertion and removal of the ring and on complaints. Of the 65 women who participated, 59 completed the study and used the ring for at least 21 days, giving an acceptability of 91% (59/65). No major differences were found between the three types of rings except for a sensation of expulsion, which was reported more often in the group assigned the smallest cross-sectional-thickness ring. Expulsion was reported once during intercourse in the 3.5-mm group. Insertion and removal of the rings were judged to be easy by the overall majority of the women. The ring was felt by the partner during intercourse in 35%-50% of couples. Further development of an active combined contraceptive EVA ring with a cross-sectional thickness of 4 mm seems a reasonable option. In future studies with the active ring, allowance for temporary removal of the ring during intercourse, if preferred, may be suggested.
Roumen
F J
FJ
Department of Obstetrics & Gynecology, Atrium, Medical Centre Heerlen, The Netherlands.
Dieben
T O
TO
D000293:Adolescent; D000328:Adult; D003075:Coitus / Q000523:psychology; D003274:Contraceptive Devices, Female / Q000592:standards*; D004867:Equipment Design / Q000523:psychology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011145:Polyvinyls; D014621:Vagina / Q000502:physiology
D011145:Polyvinyls; C016438:ethylenevinylacetate copolymer