A PHASE-I STUDY OF FEMCAP(R) USED WITH AND WITHOUT SPERMICIDE - POSTCOITAL TESTING

The objectives of the study were to assess the ability of the Femcap(R ), a new vaginal contraceptive device made of silicone and designed to fit snugly around the cervix to prevent the penetration of sperm into midcycle cervical mucus when used with and without spermicide; and to compare it with the standard contraceptive diaphragm used with spermi cide. Eight women underwent two baseline cycles of postcoital tasting in which no device was used, followed by three test cycles in which Fe mcap with spermicide, Femcap with nonspermicidal lubricant (KY(R) gel) or the Ortho All-Flex(R) diaphragm with spermicide was used. The sequ ence of testing cycles was randomized.In each cycle, condoms were used prior to midcycle, then a midcycle cervical mucus specimen was examin ed to ensure midcycle characteristics and the absence of sperm. Each w oman then had intercourse using either no device (baseline cycles) or the prescribed device (test cycles) and returned 2-3 h afterwards. Cer vical mucus was again assessed for adequacy and the presence of sperma tozoa. The average number of progressively motile sperm seen per high power field was as follows: first baseline cycle, 18.0; second baselin e cycle, 17.8; test cycle with Femcap used with nonspermicidal lubrica nt, 0.1, test cycle with Femcap used with spermicide, 0.2; and test cy cle with the diaphragm used with spermicide, 0.0. There was no signifi cant difference between baseline cycles or among test cycles in the av erage number of progressively motile sperm seen (p > 0.05). The averag e number of progressively motile sperm seen in each test cycle did, ho wever, differ significantly from the average number seen in either bas eline cycle (p < 0.05). Femcap, used with either a spermicidal lubrica nt or a nonspermicidal lubricant, appears to be comparable with the di aphragm used with spermicide in preventing sperm from entering midcycl e cervical mucus. (C) 1997 Elsevier Science Inc. All rights reserved.