The cervical cap as a barrier contraceptive
Cagen, R.
Contraception 33(5): 487-496
1986
ISSN/ISBN: 0010-7824 PMID: 3757513 DOI: 10.1016/s0010-7824(86)80007-5Document Number: 354746
In 1980 the United States Food and Drug Administration classified the cervical cap used as a barrier contraceptive as a "significant risk device". Shortly thereafter I began an FDA-approved study and this report covers the first four years of an ongoing investigation. Overall pregnancy rate per 100 women in the first year of use was 8.1, 13.6 in two years, 15.5 in three years and 17.3 in four years in a group of 620 participants, amounting to 1,124.5 women-years of study. Forty-two (or 6.1%) of 691 women were unable to be fit. The most frequently determined reason for failure was user failure. Side effects, including odor and partner discomfort, are minimal. Participants used a "back-up" method of contraception during the first two to four weeks of use. The cervical cap appears to be a safe and convenient family planning tool for the motivated contraceptor.