Lea's Shield is a new vaginal barrier contraceptive that may offer advantages over existing methods. It is made of silicone which is resistant to petroleum-based lubricants, does not absorb odors, and does not cause allergic reactions in users with latex sensitivity. It has an anterior loop for ease of insertion and removal and a one-way flutter valve. Its novel design has sufficient volume to fill the posterior fornix, which helps keep it in place and prevent sperm from entering the cervical os. This study evaluated with a standard postcoital test (PCT) the ability of the Lea's Shield used with spermicide or non-spermicidal lubricant to prevent sperm from entering midcycle cervical mucus. Ten sterilized women underwent four PCT cycles: one cycle in which no contraceptive barrier was used (a baseline cycle) and 3 cycles in which one of the following was used: Lea's Shield with spermicide, or with non-spermicidal lubricant, or the contraceptive diaphragm used with spermicide. All volunteers demonstrated more than 5 progressively motile sperm per high power field in the cervical mucus after intercourse in the baseline cycle. No motile sperm were found in the cervical mucus in any cycle in which Lea's Shield or the diaphragm was used with spermicide. No motile sperm were found in cervical mucus in 9 of 10 cycles in which Lea's Shield was used without spermicide. Only two progressively motile sperm were present in the cervical mucus of one volunteer who used the shield with non-spermicidal lubricant.(ABSTRACT TRUNCATED AT 250 WORDS)
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.