Lea's Shield: a phase I postcoital study of a new contraceptive barrier device.

ABSTRACT

PIP: The results of a Phase I postcoital study of Lea's Shield, a new vaginal barrier contraceptive, suggest that this device is as effective as the vaginal diaphragm, even when used without spermicide. Evaluated was the ability of the Lea's Shield to prevent sperm from entering midcycle cervical mucus. Ten sterilized women underwent a baseline cycle followed by three additional cycles under one of the following conditions: Lea's Shield with spermicide, Lea's Shield with a nonspermicidal lubricant, or standard vaginal diaphragm with spermicide. In the baseline cycle, all subjects demonstrated more than five progressively motile sperm per high power field in the cervical mucus after intercourse. No sperm were detected in the post-intercourse cervical mucus in either the women who used the standard diaphragm with spermicide or those using the Lea's Shield with spermicide. One volunteer who used the Lea's Shield without spermicide had two progressively motile sperm in the cervical mucus; however, this involved a small size device that is no longer manufactured and was considered unlikely to result in pregnancy. There were no side effects reported by Lea's Shield users. Advantages of this new device include its silicone composition (more resistant to heat and deterioration, less absorbent of odors, and less likely to cause allergic reactions than latex), anterior loop for ease of insertion and removal, one-way flutter valve, and lack of pressure on the urethra.