Female condom (Femidom). A clinical study of its use-effectiveness and patient acceptability.

Abstract

106 self-selected women took part in an open prospective study which was designed to assess the use-effectiveness and patient acceptability of a female condom (Femidom). They used the device as their role method of contraception over 441 months of observation. 7 accidental pregnancies were documented of which 4 were reported as being associated with inconsistent use in the conception cycle. The use- effectiveness failure rate (life table) at 12 months was therefore 15% (95% confidence interval 3.5-26). In excess of 1000 initial enquiries from potential volunteers demonstrated the attractiveness of the female condom concept; however the 56% dropout rate observed in this study for a variety of method acceptability reasons implies that there is room for further research that tests modified designs. In a proportion of 29% of the women initially recruited who can be considered a select subpopulation as compared to the earlier dropouts who found the method unacceptable there were 11 women who used it for 12 months (subgroup A) and an additional 20 who were forced to discontinue between 3-11 months since supplies of the product were terminated by the manufacturer (subgroup B). Taking into account partner reaction 27 of the women would have preferred to continue with this method either as their main form of contraceptive or as in 2 cases as an alternative with the male condom. Although the majority of study participants did not find the product acceptable the authors confirm that there was the existence of a subpopulation of sexually active couples who linked this method and would continue using it if it were available. (authors modified)