A phase I study of Femcap used with and without spermicide. Postcoital testing.

The objectives of the study were to assess the ability of the Femcap, 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 spermicide. Eight women underwent two baseline cycles of postcoital testing in which no device was used, followed by three test cycles in which Femcap with spermicide, Femcap with nonspermicidal lubricant (K'Y gel) or the Ortho All-Flex diaphragm with spermicide was used. The sequence of testing cycles was randomized. In each cycle, condoms were used prior to midcycle, then a midcycle cervical mucus specimen was examined to ensure midcycle characteristics and the absence of sperm. Each woman then had intercourse using either no device (baseline cycles) or the prescribed device (test cycles) and returned 2-3 h afterwards. Cervical mucus was again assessed for adequacy and the presence of spermatozoa. The average number of progressively motile sperm seen per high power field was as follows: first baseline cycle, 18.0; second baseline cycle, 17.8; test cycle with Femcap used with nonspermicidal lubricant, 0.1; test cycle with Femcap used with spermicide, 0.2; and test cycle with the diaphragm used with spermicide, 0.0. There was no significant difference between baseline cycles or among test cycles in the average number of progressively motile sperm seen (p > 0.05). The average number of progressively motile sperm seen in each test cycle did, however, differ significantly from the average number seen in either baseline cycle (p < 0.05). Femcap, used with either a spermicidal lubricant or a nonspermicidal lubricant, appears to be comparable with the diaphragm used with spermicide in preventing sperm from entering midcycle cervical mucus.