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Lea's Shield® is a new, bowl-shaped female contraceptive device, made of silicone, that is placed within the posterior fornix of the vagina. Designed to fit all users, it has a one-way valve and a loop to facilitate placement and removal. It is left in place for 8 hours after intercourse and can remain for 48 hours. This study tested its safety and efficacy, used with or without spermicide, in 185 healthy women reporting an average coital frequency of 12 times per month.
The six-month life-table pregnancy rate, adjusted for age, research site, and experience with barrier contraceptives, was 5.6% for spermicide users and 9.3% for non-spermicide users (p=0.086). None of the nulliparous women became pregnant. Since 84% of subjects were parous, …