Contraceptive Used With and Without Spermicide

I i. I : The purpose of this study was to evaluate the safety, effi- cacy and acceptability of Lea's Shield@, a new vaginal con- :-. traceptive bam'er device, when used with either spermi- s. cidal or non-spermicidal lubricant. One-hundred-eighty-five (1 85) women enrolled at six centers. Half were randomized to use the device with sper- . micide and half with a non-spermicidal lubricant. To be _. eligble, volunteers had to be 18-40 years old (inclusive), in y : good health with regular menses, sexually active in an on- going relationship and at risk for pregnancy, and willing to 3 use Lea's Shield@ as their sole means of contraception for $; sixmonths. Participants were seen at admission, one week, 3, one month, three inonths and six months. Gross cumula- . tive life table rates were calculated for pregnancy and oth- ers reasons for discontinuation. Adverse experiences and 2, responses to an acceptability questionnaire were evalu- " - ated. : ' One-hundred-eighty-two (182) volunteers contributed :- data to the analysis of safety and 146 to that of contracep- ..~ ,