LEAS SHIELD(R) - A PHASE-I POSTCOITAL STUDY OF A NEW CONTRACEPTIVE BARRIER DEVICE

Lea's Shield(R) is a new vaginal barrier contraceptive that may offer advantages over existing methods. It is made of silicone which is resi stant to petroleum-based lubricants, does not absorb odors, and does n ot 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 f ornix, which helps keep it in place and prevent sperm from entering th e cervical os. This study evaluated with a standard postcoital test (P CT) the ability of the Lea's Shield(R) used with spermicide or non-spe rmicidal lubricant to prevent sperm from entering midcycle cervical mu cus. Ten sterilized women underwent four PCT cycles: one cycle in whic h no contraceptive barrier was used (a baseline cycle) and 3 cycles in which one of the following was used: Lea's Shield(R) with spermicide, or with non-spermicidal lubricant, or the contraceptive diaphragm use d with spermicide. All volunteers demonstrated more than 5 progressive ly motile sperm per high power field in the cervical mucus after inter course in the baseline cycle. No motile sperm were found in the cervic al mucus in any cycle in which Lea's Shield(R) or the diaphragm was us ed with spermicide. No motile sperm were found in cervical mucus in 9 of 10 cycles in which Lea's Shield(R) was used without spermicide. Onl y two progressively motile sperm were present in the cervical mucus of one volunteer who used the shield with non-spermicidal lubricant. Thi s volunteer used a smaller Lea's Shield(R) which is no longer manufact ured. There were no serious adverse experiences in any volunteer. This study suggests that the Lea's Shield(R) can prevent the passage of mo tile sperm into midcycle cervical mucus with or without the use of spe rmicide and is as effective as the standard diaphragm used with spermi cide.